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Clinical Trial Results:
A Phase IIIb, open-label, hybrid type III trial evaluating implementation strategies for long-acting cabotegravir plus long-acting rilpivirine every two months in HIV-1 infected, virologically suppressed adults in select European healthcare settings

Summary
EudraCT number	2020-000424-19
Trial protocol	FR DE NL BE
Global end of trial date

Results information
Results version number	v1
This version publication date	28 Mar 2023
First version publication date	28 Mar 2023
Other versions	v2 , v3

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

213199

ISRCTN number

US NCT number

NCT04399551

WHO universal trial number (UTN)

Sponsor organisation name

ViiV Healthcare

Sponsor organisation address

980 Great WestRoad, Brentford, Middlesex, United Kingdom, TW8 9GS

Public contact

GSK ResponseCenter, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Interim

Date of interim/final analysis

07 Mar 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

07 Mar 2022

Global end of trial reached?

Main objective of the trial

To evaluate acceptability, appropriateness, and feasibility of long-acting cabotegravir plus long-acting rilpivirine on the basis of staff study participants ratings.

Protection of trial subjects

Not Applicable

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Sep 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 71

Country: Number of subjects enrolled

France: 177

Country: Number of subjects enrolled

Germany: 54

Country: Number of subjects enrolled

Netherlands: 39

Country: Number of subjects enrolled

Spain: 96

Worldwide total number of subjects

437

EEA total number of subjects

437

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

427

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

A total of 437 patient study participants (PSPs) [people living with HIV] were enrolled. 430 PSP received study treatment and were included in the safety population. Staff Study Participants (SSP) (HIV care providers, nurses/staff performing injections administrators/clinic managers) are not counted in the enrolment.

Screening details

SSP were randomized based on implementation strategy - Enhanced (Arm-E) and Standard (Arm -S). SSP provided input through surveys, semi-structured interviews and a selected group from the enhanced arm (Arm-E) participated in facilitation calls.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Patient Study Participants

Arm description

PSPs received one tablet of cabotegravir (CAB) 30 milligrams (mg) + rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month during the oral lead-in phase (OLI). Participants received last dose of oral regimen followed by CAB long-acting injectable (LA) 600 mg + RPV LA 900 mg injections in Month 1, one month later (Month 2), and every 2 months (Q2M) thereafter via intramuscular (IM) route.

Arm type

Experimental

Investigational medicinal product name

CAB OLI

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral cabotegravir (CAB) was administered as a 30 milligram (mg) tablet, taken once daily with food from Day 1 to Month 1.

Investigational medicinal product name

RPV OLI

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Oral rilpivirine (RPV) was administered as a 25 mg tablet, taken once daily with food from Day 1 to Month 1.

Investigational medicinal product name

RPV LA

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Long-acting rilpivirine (RPV LA) 900 mg (3 mL) was administered via intramuscular injection by a healthcare professional.

Investigational medicinal product name

CAB LA

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Long-acting cabotegravir (CAB LA) 600 mg (3 mL) was administered via intramuscular injection by a healthcare professional.

Number of subjects in period 1 ^[1]	Patient Study Participants
Started	430
Completed	306
Not completed	124
Consent withdrawn by subject	6
Physician decision	3
Adverse event, non-fatal	12
Protocol Deviation	2
Ongoing	100
Lost to follow-up	1

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 437 participants were enrolled and 430 participants received study treatment and were included in the safety population.

Baseline characteristics

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Reporting group title

Patient Study Participants

Reporting group description

Reporting group values	Patient Study Participants	Total
Number of subjects	430	430
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	420	420
From 65-84 years	10	10
85 years and over	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	44.2 ± 10.13	-
Sex: Female, Male
Units: Participants
Female	115	115
Male	315	315
Race/Ethnicity, Customized
Units: Subjects
American Indian Or Alaska Native	7	7
Asian	9	9
Black Or African American	76	76
White	336	336
Multiple	2	2

Subject analysis set title

Staff Study Participants – Enhanced Implementation Arm

Subject analysis set type

Full analysis

Subject analysis set description

SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, SWAT meeting with sponsor team and principal clinic stakeholders, on-demand SWAT meeting, monthly continuous quality improvement (CQI) calls, face-to-face injection training, monthly FRAME assessment, access to patient and HCP level toolkit and CAB + RPV medical lead site visit.

Subject analysis set title

Staff Study Participants – Standard Implementation Arm

Subject analysis set type

Full analysis

Subject analysis set description

SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.

Subject analysis set title

Staff Study Participants (SSP)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Staff Study Participants

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Staff Study Participants – Standard Implementation Arm

Subject analysis set type

Full analysis

Subject analysis set description

SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.

Subject analysis set title

Staff Study Participants (SSP)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Patient Study Participants (PSPs)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Patient Study Participants (PSPs)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis sets values	Staff Study Participants – Enhanced Implementation Arm	Staff Study Participants – Standard Implementation Arm	Staff Study Participants (SSP)	Staff Study Participants	Staff Study Participants – Standard Implementation Arm	Staff Study Participants (SSP)	Patient Study Participants (PSPs)	Patient Study Participants (PSPs)
Number of subjects	34	36	62	69	35	18	110	430
Age categorical
Units: Subjects
In utero
Preterm newborn infants (gestational age < 37 wks)
Newborns (0-27 days)
Infants and toddlers (28 days-23 months)
Children (2-11 years)
Adolescents (12-17 years)
Adults (18-64 years)
From 65-84 years
85 years and over
Age Continuous
Units: Years
arithmetic mean (standard deviation)	±	±	±	±	±	23 ±	±	93 ±
Sex: Female, Male
Units: Participants
Female
Male
Race/Ethnicity, Customized
Units: Subjects
American Indian Or Alaska Native
Asian
Black Or African American
White
Multiple

End points

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Reporting group title

Patient Study Participants

Reporting group description

Subject analysis set title

Staff Study Participants – Enhanced Implementation Arm

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Staff Study Participants – Standard Implementation Arm

Subject analysis set type

Full analysis

Subject analysis set description

SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.

Subject analysis set title

Staff Study Participants (SSP)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Staff Study Participants

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Staff Study Participants – Standard Implementation Arm

Subject analysis set type

Full analysis

Subject analysis set description

SSPs included HIV care providers (HCPs), nurses/staff performing CAB + RPV LA injections, and administrators/clinic managers at each investigational site. They provided input using surveys, semi structured interviews (SSI) and via monthly facilitation calls. SSPs did not receive oral lead-in medication or CAB+RPV LA injections. This arm contains components like investigator meeting, CAB + RPV medical lead site visit, access to patient and HCP level toolkit, virtual injection training and monthly FRAME assessment.

Subject analysis set title

Staff Study Participants (SSP)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Patient Study Participants (PSPs)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Patient Study Participants (PSPs)

Subject analysis set type

Safety analysis

Subject analysis set description

Primary: Change from Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12

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End point title

Change from Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12 ^[1]

End point description

The AIM-Imp was designed to assess the acceptability of an implementation process (i.e., perception among implementation stakeholders that a given treatment, service, practice or innovation is agreeable, palatable or satisfactory). The measure consists of four items/statements (1. The implementation support thus far meets my approval 2. The implementation support thus far is appealing to me 3. I like the implementation support I have received 4. I welcome implementation support for the CAB + RPV injection treatment), each with a five-point rating scale (1=completely disagree,2=disagree,3=neither agree nor disagree,4=agree,5=completely agree). The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Analysis was performed on Full analysis set (FAS), which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Primary

End point timeframe

Baseline (Month 1) and Month 12

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The design does not have any statistical hypothesis. Hence statistical data is not presented.

End point values	Staff Study Participants – Enhanced Implementation Arm	Staff Study Participants – Standard Implementation Arm
Number of subjects analysed	34	36
Units: Scores on a scale
arithmetic mean (standard deviation)
Baseline (Month 1)	3.8 ± 0.76	3.9 ± 0.75
Month 12	0.28 ± 0.828	0.33 ± 0.666

No statistical analyses for this end point

Primary: Change from Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12

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End point title

Change from Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12 ^[2]

End point description

The IAM-Imp is designed to assess the appropriateness of an implementation process (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer, and the perceived fit of the innovation to address a particular issue or problem). The IAM-Imp is a four-item/statement measure (1. The implementation support thus far seems fitting 2. The implementation support seems suitable for using the CAB + RPV injection treatment 3. The implementation support seems applicable for the CAB + RPV injection treatment 4. The implementation support seems like a good match) with a five-point rating scale (1=completely disagree, 2=disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Analysis was performed on FAS population.

End point type

Primary

End point timeframe

Baseline (Month 1) and Month 12

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The design does not have any statistical hypothesis. Hence statistical data is not presented.

End point values	Staff Study Participants – Enhanced Implementation Arm	Staff Study Participants – Standard Implementation Arm
Number of subjects analysed	34	36
Units: Scores on a scale
arithmetic mean (standard deviation)
Baseline (Month 1)	3.8 ± 0.78	3.9 ± 0.78
Month 12	0.22 ± 0.740	0.31 ± 0.729

No statistical analyses for this end point

Primary: Change from Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12

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End point title

Change from Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12 ^[3]

End point description

The FIM-Imp was a four-item/statement (1. The implementation support seems implementable in our clinic/practice 2. The implementation support seems possible in our clinic/practice 3. The implementation support seems doable in our clinic/practice 4. The implementation support seems easy to use in our clinic/practice) and was measured on a five-point rating scale (1 = completely disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = completely agree). The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Primary

End point timeframe

Baseline (Month 1) and Month 12

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The design does not have any statistical hypothesis. Hence statistical data is not presented.

End point values	Staff Study Participants – Enhanced Implementation Arm	Staff Study Participants – Standard Implementation Arm
Number of subjects analysed	34	36
Units: Scores on a scale
arithmetic mean (standard deviation)
Baseline (Month 1)	4.0 ± 0.66	4.0 ± 0.64
Month 12	0.06 ± 1.047	0.34 ± 0.773

No statistical analyses for this end point

Primary: Number of Staff Study Participants that discussed Facilitators for Acceptability Assessed via Semi Structured Interviews (SSIs)

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End point title

Number of Staff Study Participants that discussed Facilitators for Acceptability Assessed via Semi Structured Interviews (SSIs) ^[4]

End point description

A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs’ perspective. The results for facilitators that are integral to successful implementation are presented. Patient Perspective was abbreviated as [PP]. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Primary

End point timeframe

Up to 12 Months

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The design does not have any statistical hypothesis. Hence statistical data is not presented.

End point values	Staff Study Participants (SSP)
Number of subjects analysed	62
Units: Participants
Positive opinion	56
Treatment and Implementation better than expected	18
Patient satisfaction	30
[PP] Not worrying about taking medication	14
Discreet treatment	11
[PP] Not being reminded about HIV	11
Patient travel facilitation	10
Patient adherence	8
Innovative treatment	8
Medication efficacy	8
[PP] Gaining a sense of freedom/liberation	6
[PP]Not having to take treatment every day	6
New treatment option	6
Patient quality of life improvement	6
No resistance to implementing CAB+RPV LA	27
Administration in Other Clinical Setting	6
Home Administration by HCP-Patient Interest	16
Self-injection-Patient interest	12
Information on medication characteristics	8

No statistical analyses for this end point

Primary: Number of Staff Study Participants that discussed Barriers for Acceptability Assessed via SSIs

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End point title

Number of Staff Study Participants that discussed Barriers for Acceptability Assessed via SSIs ^[5]

End point description

A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the acceptability from the SSPs’ perspective. The results for barriers that are integral to successful implementation are presented. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Primary

End point timeframe

Up to 12 Months

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The design does not have any statistical hypothesis. Hence statistical data is not presented.

End point values	Staff Study Participants (SSP)
Number of subjects analysed	62
Units: Participants
Medication tolerability and side effects	29
Injection side effects	6
Home Administration by HCP-No patient interest	9
Self-injection-Injection site	7
Self-injection-Adherence	6

No statistical analyses for this end point

Primary: Number of Staff Study Participants that discussed Facilitators for Appropriateness Assessed via SSIs

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End point title

Number of Staff Study Participants that discussed Facilitators for Appropriateness Assessed via SSIs ^[6]

End point description

A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs’ perspective. The results for facilitators that are integral to successful implementation are presented. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Primary

End point timeframe

Up to 12 Months

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The design does not have any statistical hypothesis. Hence statistical data is not presented.

End point values	Staff Study Participants (SSP)
Number of subjects analysed	62
Units: Participants
Not being reminded of HIV status	15
Discreet treatment	14
Sense of freedom/liberation	10
Travel facilitation	10
No need to think/worry about pills	9
Adherent patients	30
No particular patient profile	13
Patients non-adherent to oral medication	13
Patients seeking discreet treatment	10
Patients with non-resistant HIV	10
Patients seeking to change oral treatment	8
Young patients	8
Frequently travelling patients	6

No statistical analyses for this end point

Primary: Number of Staff Study Participants that discussed Facilitators for Feasibility Assessed via SSIs

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End point title

Number of Staff Study Participants that discussed Facilitators for Feasibility Assessed via SSIs ^[7]

End point description

A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs’ perspective. The results for facilitators that are integral to successful implementation are presented. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Primary

End point timeframe

Up to 12 Months

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The design does not have any statistical hypothesis. Hence statistical data is not presented.

End point values	Staff Study Participants (SSP)
Number of subjects analysed	62
Units: Participants
Medication delivery from pharmacy	15
Additional staff	13
Room and/or space	13
Training	11
Responsibilities and/or multitasking	10
Specific time and/or day for injection visits	9
Scheduling strategies	8
Additional refrigerator	7
Clinic hours	7
Non-covid Oral bridging	7
Staff characteristics	14
No supplemental materials Developed	11
Supplemental materials Developed	8
No staffing and workload issues in the past	19
No current staffing and workload issues	13
No issues designated space availability	34
No current issues with space availability	7
No coordination with pharmacy issues in the past	40
No issues with medication supply	31
No current issues with medication supply	7
No issues with clinic working hours in the past	41
ViiV supportive in implementation	55
Administration in General Practitioner office	13
Administration in healthcare centers	11
Administration in private practice	6
Injection training	10

No statistical analyses for this end point

Primary: Number of Staff Study Participants that discussed Barriers for Appropriateness Assessed via SSIs

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End point title

Number of Staff Study Participants that discussed Barriers for Appropriateness Assessed via SSIs ^[8]

End point description

A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the appropriateness from the SSPs’ perspective. The results for barriers that are integral to successful implementation are presented. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Primary

End point timeframe

Up to 12 Months

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The design does not have any statistical hypothesis. Hence statistical data is not presented.

End point values	Staff Study Participants (SSP)
Number of subjects analysed	62
Units: Participants	7

No statistical analyses for this end point

Primary: Number of Staff Study Participants that discussed Barriers for Feasibility Assessed via SSIs

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End point title

Number of Staff Study Participants that discussed Barriers for Feasibility Assessed via SSIs ^[9]

End point description

A semi-structured interview guide was designed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the feasibility from the SSPs’ perspective. The results for barriers that are integral to successful implementation are presented. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Primary

End point timeframe

Up to 12 Months

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The design does not have any statistical hypothesis. Hence statistical data is not presented.

End point values	Staff Study Participants (SSP)
Number of subjects analysed	62
Units: Participants
Staffing and workload issues	15
Appointment duration	15
Appointment scheduling	9
Number of visits	7
Room and/or space issues	6
Staffing and workload issues in the past	32
Current staffing and workload issues	11
Issues with space availability in the past	20
Current issues with space availability	12
Coordination with pharmacy issues in the past	13
Current coordination with pharmacy issues	6
Issues with supply and storage in the past	12
Issues with clinic working hours in the past	6
Medication collection, cold chain, and storage	6
Injection technique	21

No statistical analyses for this end point

Secondary: Number of Modifications Reported by SSPs Assessed via FRAME-IS

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End point title

Number of Modifications Reported by SSPs Assessed via FRAME-IS

End point description

The Framework for Reporting Adaptations and Modifications to Evidence-based interventions – Implementation Strategies (FRAME-IS) was a seven-question measure (contained both open and closed categorical questions) used to record details the modifications made to the implementation of the CAB LA + RPV LA injection treatment procedures. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12

End point values	Staff Study Participants – Enhanced Implementation Arm	Staff Study Participants – Standard Implementation Arm
Number of subjects analysed	34	35
Units: Number of Modifications
Month 2	15	7
Month 3	10	2
Month 4	5	2
Month 5	1	1
Month 6	3	0
Month 7	4	0
Month 8	0	0
Month 9	3	0
Month 10	0	0
Month 11	3	1
Month 12	0	1

No statistical analyses for this end point

Secondary: Number of Plan, Do, Study, Act (PDSA) Cycles Developed During the Continuous Quality Improvement (CQI) Calls Course

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End point title

Number of Plan, Do, Study, Act (PDSA) Cycles Developed During the Continuous Quality Improvement (CQI) Calls Course

End point description

CQI were a 60 minutes calls involved working through a plan to address the identified barriers, optimize processes, and evaluate these efforts. This process of addressing barriers was guided by a series of Plan, Do, Study, Act (PDSA) cycles. Number of PDSA cycles developed are presented. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 2 to Month 7

End point values	Staff Study Participants (SSP)
Number of subjects analysed	18
Units: Cycles	23

No statistical analyses for this end point

Secondary: Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed via Questionnaire

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End point title

Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 20 Minutes, Up to 40 Minutes, Up to 60 Minutes, Up to 90 Minutes, More than 90 Minutes and missing. Missing include participants who did not provide a response for the question. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Up to Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Up to 20 Minutes	71
Up to 40 Minutes	134
Up to 60 Minutes	99
Up to 90 Minutes	48
More than 90 Minutes	19
Missing	8

No statistical analyses for this end point

Secondary: Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed via Questionnaire

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End point title

Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as: Up to 10 Minutes, 11-20 Minutes, 21-30 Minutes, 31-45 Minutes, More than 45 Minutes and Missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Up to 10 Minutes	190
11-20 Minutes	100
21-30 Minutes	54
31-45 Minutes	25
More than 45 Minutes	5
Missing	5

No statistical analyses for this end point

Secondary: Number of Participants with the Acceptability with the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed via Questionnaire

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End point title

Number of Participants with the Acceptability with the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Extremely acceptable	140
Very acceptable	151
Somewhat acceptable	72
A little acceptable	11
Not at all acceptable	0
Missing	5

No statistical analyses for this end point

Secondary: Number of Participants with Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed via Questionnaire

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End point title

Number of Participants with Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The acceptability was categorized as extremely acceptable, very acceptable, somewhat acceptable, a little acceptable, not at all acceptable and missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Extremely acceptable	163
Very acceptable	154
Somewhat acceptable	51
A little acceptable	6
Not at all acceptable	0
Missing	5

No statistical analyses for this end point

Secondary: Number of Participants Taking Time Off from Work to Attend Appointment Assessed via Questionnaire

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End point title

Number of Participants Taking Time Off from Work to Attend Appointment Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as Whole day annual leave, Half day annual leave, Whole day sick leave, Half day sick leave, Whole day unpaid, Half day unpaid, Other, No time off and missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Whole day annual leave	27
Half day annual leave	20
Whole day sick leave	5
Half day sick leave	3
Whole day unpaid	9
Half day unpaid	20
Other	64
No, I did not have to take time off	222
Missing	9

No statistical analyses for this end point

Secondary: Number of Participants who Seek Additional Care from a Dependent to Attend Appointment Assessed via Questionnaire

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End point title

Number of Participants who Seek Additional Care from a Dependent to Attend Appointment Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Yes, No, Not Applicable and Missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Yes	16
No	318
Not Applicable	39
Missing	6

No statistical analyses for this end point

Secondary: Number of Participants Taking Time Off from Work to Recover from any Injection Site Reaction Issue Assessed via Questionnaire

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End point title

Number of Participants Taking Time Off from Work to Recover from any Injection Site Reaction Issue Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The time off responses were categorized as No, On the day of receiving the treatment, One day after receiving the treatment, Two days after receiving the treatment, More than two days after receiving the treatment, Missing response for Yes, Not Applicable and Missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
No	294
Yes, on the day of receiving the treatment	45
Yes, one day after receiving the treatment	9
Yes, two days after receiving the treatment	7
Yes, more than two days receiving the treatment	5
Missing response for 'Yes'	2
Not Applicable	16
Missing	5

No statistical analyses for this end point

Secondary: Number of Participants with Appointment Reminders Received Assessed via Questionnaire

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End point title

Number of Participants with Appointment Reminders Received Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question.The responses were categorized as Phone calls, Text/SMS messages, Existing clinic app, E-mail, Reminder in the mail, Another reminder and I did not receive reminders. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Phone calls	80
Text/SMS messages	275
Existing clinic app	48
E-mail	161
Reminder in the mail	21
Another reminder	3
I did not receive reminders	14

No statistical analyses for this end point

Secondary: Number of Participants with Things Tried to Reduce Soreness Following Injections Assessed via Questionnaire

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End point title

Number of Participants with Things Tried to Reduce Soreness Following Injections Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Take over-the-counter pain relievers, Use a hot compress, Use a cold compress, Avoid sitting for long periods of time, Light stretching and exercise, None of the above, Other and I don't get sore after my injections. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Take over-the-counter pain relievers	139
Use a hot compress	20
Use a cold compress	19
Avoid sitting for long periods of time	87
Light stretching and exercise	71
None of the above	61
Other	31
I don't get sore after my injections	72

No statistical analyses for this end point

Secondary: Number of PSPs with Facilitators for Acceptability Assessed via Semi Structured Interviews (SSIs)

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End point title

Number of PSPs with Facilitators for Acceptability Assessed via Semi Structured Interviews (SSIs)

End point description

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs’ perspective. Results of number of PSPs with facilitators for acceptability are presented. Analysis was performed on patient study participants (PSPs) who participated in interviews. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Up to Month 12

End point values	Patient Study Participants (PSPs)
Number of subjects analysed	110
Units: Participants
Feeling informed about injection	105
Overall positive experience	100
Acceptable overall experience at clinic	82
In-person communication with HCP	76
Not worrying about taking medication	66
Experienced injector	64
Acceptable clinic hours to receive injections	51
injection experience met expectations	43
Patient travel facilitation	33
injection experience better than expected	32
Staff responsiveness	34
Number of visits	30
Satisfaction with rescheduling process	29
Distance to clinic	27
Not being reminded about HIV	26
Acceptable time spent in clinic	25
Treatment adherence	24
Gaining a sense of freedom	24
Discreet treatment	23
Communication with staff	22
Reduced stigma due to injection	22
Reduction in injection pain	20
PP Medication for pain management	19
Reduced stress due to injection	19
HCP advice on pain management	18
PP Activities to avoid for pain management	16
Website and/or internet	15
Characteristics of HCP communication	14
Written materials and brochures	14
Study materials	14
Time of informing	13
Collection, storage and preparation	12
Fewer side effects	12
Time-saving approach	12
Activities for injection pain management	11
Administration in other clinical setting	11

No statistical analyses for this end point

Secondary: Number of PSPs with Barriers for Acceptability Assessed via SSIs

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End point title

Number of PSPs with Barriers for Acceptability Assessed via SSIs

End point description

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs’ perspective. Results of number of PSPs with barriers for acceptability are presented. Analysis was performed on patient study participants (PSPs) who participated in interviews. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Up to Month 12

End point values	Patient Study Participants (PSPs)
Number of subjects analysed	110
Units: Participants
Injection side effects (Treatment Components)	67
Injection side effects (Treatment Challenges)	33
Injection experience worse than expected	11
Waiting time	11

No statistical analyses for this end point

Secondary: Number of PSPs with Barriers for Appropriateness Assessed via SSIs

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End point title

Number of PSPs with Barriers for Appropriateness Assessed via SSIs

End point description

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs’ perspective. Results of number of PSPs with barriers for appropriateness are presented. Analysis was performed on patient study participants (PSPs) who participated in interviews. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Up to Month 12

End point values	Patient Study Participants (PSPs)
Number of subjects analysed	110
Units: Participants
Patient fearing or squeamish about injections	22
Patients not tolerating intramuscular injection	12

No statistical analyses for this end point

Secondary: Number of PSPs with Facilitators for Appropriateness Assessed via SSIs

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End point title

Number of PSPs with Facilitators for Appropriateness Assessed via SSIs

End point description

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs’ perspective. Results of number of PSPs with Facilitators for appropriateness are presented. Analysis was performed on patient study participants (PSPs) who participated in interviews. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Up to Month 12

End point values	Patient Study Participants (PSPs)
Number of subjects analysed	110
Units: Participants	0

No statistical analyses for this end point

Secondary: Number of PSPs with Facilitators for Feasibility Assessed via SSIs

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End point title

Number of PSPs with Facilitators for Feasibility Assessed via SSIs

End point description

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs’ perspective. Results of number of PSPs with facilitators for feasibility are presented. Analysis was performed on patient study participants (PSPs) who participated in interviews. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Up to Month 12

End point values	Patient Study Participants (PSPs)
Number of subjects analysed	110
Units: Participants
Person to contact during CARISEL study	102
PP Calendar, Diary, Notes and/or Reminders	69
No missed appointment and rescheduling	65
Target date explained	57
Easy to contact	57
Contacting clinic staff during CARISEL study	52
Home administration by HCP	41
No issues due to transportation and/or parking	37
No challenges to receive injection	33
Not contacting clinic staff during CARISEL study	31
No issues due to work	28
Clinic Reminder [all types]	27
Term of target date helpful	25
[PP] Setting reminders	23
Injection administration at GP office	22
Injection administration at healthcare centers	19
No issues to attend visits due to childcare	16
[PP] Arrangements at work	16
Clinic reminder: Text and/or SMS	14
[PP] Appointment scheduling strategies	14
No issues due to clinic hours	13

No statistical analyses for this end point

Secondary: Number of PSPs with Barriers for Feasibility Assessed via SSIs

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End point title

Number of PSPs with Barriers for Feasibility Assessed via SSIs

End point description

A semi-structured interview guide was developed to support the discussion surrounding experience with for the implementation of CAB+RPV LA injection treatment. The interview guide topics were informed by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework and Proctor Outcomes to facilitate discussions on the Acceptability, Appropriateness, Feasibility, and Sustainability from the PSPs’ perspective. Results of number of PSPs with barriers for feasibility are presented. Analysis was performed on patient study participants (PSPs) who participated in interviews. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Up to Month 12

End point values	Patient Study Participants (PSPs)
Number of subjects analysed	110
Units: Participants
Target date not explained	38
Missed appointment and/or rescheduling	23
Issues due to work	21
Issues due to transportation and/or parking	14

No statistical analyses for this end point

Secondary: Change from Baseline in The Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12

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End point title

Change from Baseline in The Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12

End point description

AIM assesses the acceptability of an intervention (i.e., perception among stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory). It is a four-item (1. The CAB+RPV injection treatment meets my approval for treating my HIV, 2. The CAB+RPV injection treatment is appealing to me, 3. I like the CAB+RPV injection treatment for my HIV, 4. I welcome the CAB+RPV injection treatment for my HIV) measure with a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least acceptability and 5 the most acceptability. Analysis was performed on patient study participants (PSPs) who completed the surveys at the relevant timepoints. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Baseline (Month 1) and Month 12

End point values	Patient Study Participants
Number of subjects analysed	424
Units: Scores on a scale
arithmetic mean (standard deviation)
Baseline (Month 1)	4.55 ± 0.666
Month 12	0.10 ± 0.834

No statistical analyses for this end point

Secondary: Change from Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12

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End point title

Change from Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12

End point description

The four-item (1. The CAB+RPV injection treatment seems implementable in my life 2. The CAB+RPV injection treatment every 2 months is possible for me to use 3. The CAB+RPV injection treatment every 2 months seems doable in my life 4. The CAB+RPV injection treatment every 2 months seems easy to use in my life). FIM assesses perceived intervention feasibility. The items are measured on a five-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least feasibility and 5 the most feasibility. Analysis was performed on patient study participants (PSPs) who completed the surveys at the relevant timepoints. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Baseline (Month 1) and Month 12

End point values	Patient Study Participants
Number of subjects analysed	424
Units: Scores on a scale
arithmetic mean (standard deviation)
Baseline (Month 1)	4.51 ± 0.672
Month 12	0.07 ± 0.857

No statistical analyses for this end point

Secondary: Number of Participants with Confirmed Virologic Failure (CVF) Over Time

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End point title

Number of Participants with Confirmed Virologic Failure (CVF) Over Time

End point description

CVF was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels >=200 c/ml. Analysis was performed on Safety population, which included all enrolled participants who received at least one dose of CAB + RPV Oral or CAB LA + RPV LA.

End point type

Secondary

End point timeframe

Month 1, 2, 4, 8, 10 and 12

End point values	Patient Study Participants
Number of subjects analysed	430
Units: Participants
Month 1	0
Month 2	0
Month 4	0
Month 6	0
Month 8	0
Month 10	1
Month 12	0

No statistical analyses for this end point

Secondary: Percentage of PSP Receiving Injections within Target Window

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End point title

Percentage of PSP Receiving Injections within Target Window

End point description

The target window for participants to receive injection was from Day -7 to Day 7. Analysis was performed on Safety population, which included all enrolled participants who received at least one dose of CAB + RPV Oral or CAB LA + RPV LA.

End point type

Secondary

End point timeframe

Day -7 to Day 7

End point values	Patient Study Participants (PSPs)
Number of subjects analysed	430
Units: Percentage of Participants	93

No statistical analyses for this end point

Secondary: Number of PSPs with Adverse Events (AEs) And Serious AEs (SAEs)

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End point title

Number of PSPs with Adverse Events (AEs) And Serious AEs (SAEs)

End point description

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. Analysis was performed on Safety population, which included all enrolled participants who received at least one dose of CAB + RPV Oral or CAB LA + RPV LA.

End point type

Secondary

End point timeframe

Up to 12 Months

End point values	Patient Study Participants
Number of subjects analysed	430
Units: Participants
Any AEs	420
Any SAEs	15

No statistical analyses for this end point

Secondary: Number of PSPs Discontinuing Treatment Due to AEs

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End point title

Number of PSPs Discontinuing Treatment Due to AEs

End point description

An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Analysis was performed on Safety population, which included all enrolled participants who received at least one dose of CAB + RPV Oral or CAB LA + RPV LA.

End point type

Secondary

End point timeframe

Up to 12 Months

End point values	Patient Study Participants
Number of subjects analysed	430
Units: Participants	2

No statistical analyses for this end point

Secondary: Change from Baseline in Implementation Leadership Scale (ILS) Score at Month 12

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End point title

Change from Baseline in Implementation Leadership Scale (ILS) Score at Month 12

End point description

The ILS is a 12-item (facilitate implementation, obstacles, clear department standards, knowledge, ability to answer questions, awareness of concept, recognition, support employee efforts to learn, support employee efforts to use intervention, persevere(s) through the ups and downs, carries on through the challenges and reaction to critical issues) measure that assesses SSP understanding of the degree to which leadership in their clinic/practice setting is proactive, knowledgeable, supportive, perseverant with regards to implementing the treatment in their settings. The items are measured on a five-point rating scale (1=very great extent,2=great extent,3=moderate extent,4=slight extent,5=not at all). The mean score ranges from 1 to 5. Higher the score means less understanding in leadership. Analysis was performed on FAS, which included all SSPs who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed

End point type

Secondary

End point timeframe

Baseline (Month 1) and Month 12

End point values	Staff Study Participants
Number of subjects analysed	69
Units: Scores on a scale
arithmetic mean (standard deviation)
Baseline (Month 1)	2.1 ± 0.85
Month 12	-0.1 ± 1.19

No statistical analyses for this end point

Secondary: Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12

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End point title

Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12

End point description

The ICS is a 9 item (team’s main goals, importance of implementation, top priority, workshops, treatment training, training material, staff adaptability, flexibility, openness to new intervention) measure that assesses SSPs’ perceptions of their team (i.e., the people that they work with) while using the CAB LA + RPV LA injection treatment in their clinic/practice setting. The items were measured on a five-point rating scale (1 = very great extent, 2 = great extent, 3 = moderate extent, 4 = slight extent, and 5 = not at all). The mean score ranges from 1 to 5. Higher the score means less seriousness for implementation in staff. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 1 and Month 12

End point values	Staff Study Participants – Enhanced Implementation Arm	Staff Study Participants – Standard Implementation Arm
Number of subjects analysed	34	35
Units: Scores on a scale
arithmetic mean (standard deviation)
Month 1	2.5 ± 0.65	2.8 ± 0.80
Month 12	2.7 ± 0.72	2.6 ± 0.80

No statistical analyses for this end point

Secondary: Number of Participants with Time it took them to Get to the Clinic where they receive HIV Treatment/Check-ups Assessed via Questionnaire

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End point title

Number of Participants with Time it took them to Get to the Clinic where they receive HIV Treatment/Check-ups Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The average time was categorized as Up to 15 minutes, 16-30 minutes, 31-45 minutes, 46-60 minutes, More than 60 minutes, and missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Up to 15 minutes	66
16-30 minutes	138
31-45 minutes	87
46-60 minutes	44
More than 60 minutes	39
Missing	5

No statistical analyses for this end point

Secondary: Number of participants that endorsed type of transportation used to attend appointments

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End point title

Number of participants that endorsed type of transportation used to attend appointments

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The means of transport were categorized as Transportation service, Dropped-off, Private vehicle, Bicycle/scooter/ skateboard/ walked, Public transport and Missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Taxi-Transportation service	13
Taxi- Public transport	10
Dropped-off	12
Private vehicle	164
Bicycle/ scooter/ skateboard/ walked	49
Public transport	138
Missing	3

No statistical analyses for this end point

Secondary: Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed via Questionnaire

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End point title

Number of Participants Rating Convenience of Clinic/Practice's Procedures for Scheduling Injections Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The convenience responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, Not applicable; I did not have to schedule and Missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Extremely convenient	175
Very convenient	154
Somewhat convenient	43
A little convenient	4
Not at all convenient	0
Not applicable; I did not have to schedule	0
Missing	3

No statistical analyses for this end point

Secondary: Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed via Questionnaire

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End point title

Number of Participants Rating Convenience of Clinic/Practice's Procedures for Rescheduling Injections Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The convenience responses were categorized as Extremely convenient, Very convenient, Somewhat convenient, A little convenient, Not at all convenient, Not applicable; I did not have to reschedule and Missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Extremely convenient	158
Very convenient	153
Somewhat convenient	25
A little convenient	2
Not at all convenient	0
Not applicable; I did not have to schedule	39
Missing	2

No statistical analyses for this end point

Secondary: Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed via Questionnaire

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End point title

Number of Participants Rating Feelings About Getting CAB+RPV Injection Treatment Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely positive, Very positive, Somewhat positive, A little positive, Not at all positive and Missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Extremely positive	234
Very positive	112
Somewhat positive	23
A little positive	4
Not at all positive	0
Missing	6

No statistical analyses for this end point

Secondary: Number of Participants that Rated Perceived Knowledge about CAB+RPV Injection Treatment Assessed via Questionnaire

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End point title

Number of Participants that Rated Perceived Knowledge about CAB+RPV Injection Treatment Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely knowledgeable, Very knowledgeable, Somewhat knowledgeable, A little knowledgeable, Not at all knowledgeable and Missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Extremely knowledgeable	124
Very knowledgeable	188
Somewhat knowledgeable	57
A little knowledgeable	6
Not at all knowledgeable	0
Missing	4

No statistical analyses for this end point

Secondary: Number of Participants who rated helpfulness of Appointment outside of Typical Work Times Assessed via Questionnaire

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End point title

Number of Participants who rated helpfulness of Appointment outside of Typical Work Times Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Extremely helpful, Very helpful, Somewhat helpful, A Little helpful, Not at all helpful and Missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Extremely helpful	135
Very helpful	123
Somewhat helpful	50
A Little helpful	38
Not at all helpful	28
Missing	5

No statistical analyses for this end point

Secondary: Number of Participants that Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed via Questionnaire

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End point title

Number of Participants that Rated Agreement in Recommending the CAB+RPV Injections to Others Assessed via Questionnaire

End point description

Study-specific questions were developed to gather data on the facilitators and barriers of the CAB LA + RPV LA injection treatment. The response options are different for each question. The responses were categorized as Completely agree, Agree, Neutral, Disagree, Completely disagree and Missing. Missing include participants who did not provide a response for the question. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Completely agree	283
Agree	75
Neutral	15
Disagree	1
Completely disagree	1
Missing	4

No statistical analyses for this end point

Secondary: Change from Baseline in Intervention Appropriateness Measure (IAM) Score in PSPs at Month 12

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End point title

Change from Baseline in Intervention Appropriateness Measure (IAM) Score in PSPs at Month 12

End point description

IAM assesses the appropriateness of an intervention (i.e., the perceived fit, relevance, or compatibility of the innovation for a given practice setting, provider, or consumer; and the perceived fit of the innovation to address a particular issue or problem). It is a four-item (1.The CAB+RPV injection treatment is fitting for my life, 2.The CAB+RPV injection treatment is suitable for my life, 3.The CAB+RPV injection treatment is applicable to my life, 4.The CAB+RPV injection treatment is a good match for my life) measure with a 5-point rating scale, where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, 5=completely agree. The mean score ranges from 1 to 5 with 1 indicating the least appropriateness and 5 the most appropriateness. Analysis was performed on PSPs, which included all participants who successfully completed the survey at the relevant timepoints. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Baseline (Month 1) and Month 12

End point values	Patient Study Participants
Number of subjects analysed	423
Units: Scores on a scale
arithmetic mean (standard deviation)
Baseline (Month 1)	4.47 ± 0.762
Month 12	0.13 ± 0.928

No statistical analyses for this end point

Secondary: Associated Person Clinical Sustainability Assessment Tool (APCSAT) Total Score at Month 12

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End point title

Associated Person Clinical Sustainability Assessment Tool (APCSAT) Total Score at Month 12

End point description

The APCSAT is a 35-item measure that assesses SSP impressions of the data in their clinic. Sustainability refers to the ability to maintain and expand the CAB LA + RPV LA injection treatment and its benefits over time. SSPs were asked to rate their clinic/practice along a range of specific factors that affect sustainability, including: ‘Engages Staff & Leadership,’ ‘Engaging Stakeholders,’ ‘Monitoring and Evaluation,’ ‘Implementation & Training,’ ‘Outcomes & Effectiveness,’ ‘Workflow Integration,’ and ‘Organizational Readiness.’ Five items were presented to SSPs in each domain. The total score for the APCSAT was assessed on a scale of 1=program has sustainability to no extent to 7=program has sustainability to the full extent. Analysis was performed on FAS, which included all staff study participants (SSPs) who completed at least one survey at any timepoint. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Month 12

End point values	Staff Study Participants (SSP)
Number of subjects analysed	62
Units: Scores on a scale
number (not applicable)	5.32

No statistical analyses for this end point

Secondary: Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (C/ml)

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End point title

Percentage of PSPs With Plasma HIV-1 Ribonucleic Acid (RNA) Less Than (<)50 Copies Per Milliliter (C/ml)

End point description

Plasma samples were collected from the participant at specific time points. Analysis was performed on Safety population, which included all enrolled participants who received at least one dose of CAB + RPV Oral or CAB LA + RPV LA.

End point type

Secondary

End point timeframe

Month 1, 2, 4, 8 and 12

End point values	Patient Study Participants
Number of subjects analysed	430
Units: Percentage of Participants
number (confidence interval 95%)
Month 1	99 (97.0 to 99.5)
Month 2	96 (93.7 to 97.7)
Month 4	93 (90.5 to 95.4)
Month 8	86 (82.7 to 89.4)
Month 12	87 (83.2 to 89.8)

No statistical analyses for this end point

Secondary: Number of PSP with Preference for Therapy Assessed via Preference Questionnaire

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End point title

Number of PSP with Preference for Therapy Assessed via Preference Questionnaire

End point description

PSPs were asked to think about their experience of using the long-acting injectable medication versus the daily oral HIV medication, and to select their preferred treatment and all the reasons that support their preference. Results are categorized as: ‘long-acting injectable HIV medication’, ‘daily oral HIV medication’, ‘no preference’, Missing and Erroneous. Missing include participants who did not provide a response for the question. PSPs who completed this question incorrectly (i.e., checked reasons without a ticking a leading preference or checked more than one leading preference box) were included in Erroneous. Analysis was performed on patient study participants (PSPs), which included all participants who successfully completed the survey at Month 12. Only those participants with data available at the specified time points were analyzed.

End point type

Secondary

End point timeframe

Up to 12 Months

End point values	Patient Study Participants
Number of subjects analysed	379
Units: Participants
Daily oral HIV medication	2
Long-acting injectable HIV medication	275
No preference	0
Missing	2
Erroneous	100

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Serious adverse events (SAEs), non-serious AEs and all-cause mortality were collected up to Month 12. Data collection is still on-going and additional results will be provided after study completion.

Adverse event reporting additional description

Adverse events were reported for safety population which comprised of all participants enrolled and who received at least 1 dose of CAB LA+RPV LA. Staff Study Participants (SSP) did not receive oral lead-in medication or CAB+RPV LA injections. Adverse events for SSP were not collected because it was not required per study design.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

.23.1

Reporting group title

Patient Study Participants

Reporting group description

Participants with HIV received one tablet of Cabotegravir (CAB) 30 milligrams (mg) + Rilpivirine (RPV) 25 mg once daily from Day 1 for 1 month during the oral lead-in phase (OLI). Participants received last dose of oral regimen followed by CAB long-acting injectable (LA) 600 mg + RPV LA 900 mg injections in Month 1, one month later (Month 2), and every 2 months (Q2M) thereafter via intramuscular (IM) route.

Serious adverse events	Patient Study Participants
Total subjects affected by serious adverse events
subjects affected / exposed	15 / 430 (3.49%)
number of deaths (all causes)	0
number of deaths resulting from adverse events
Injury, poisoning and procedural complications
Subdural haemorrhage
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Clavicle fracture
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Vascular disorders
Aortic dissection
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Nervous system disorders
Orthostatic intolerance
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Gastrointestinal disorders
Appendicitis noninfective
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Abdominal pain
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Reproductive system and breast disorders
Haematospermia
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Ovarian cyst
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Respiratory, thoracic and mediastinal disorders
Pneumothorax
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Psychiatric disorders
Major depression
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Suicidal ideation
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Renal and urinary disorders
Haematuria
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Infections and infestations
Appendicitis
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Yersinia infection
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
Peritonitis
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0
COVID-19
subjects affected / exposed	1 / 430 (0.23%)
occurrences causally related to treatment / all	0 / 1
deaths causally related to treatment / all	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Patient Study Participants
Total subjects affected by non serious adverse events
subjects affected / exposed	380 / 430 (88.37%)
Nervous system disorders
Headache
subjects affected / exposed	36 / 430 (8.37%)
occurrences all number	45
General disorders and administration site conditions
Injection site pain
subjects affected / exposed	342 / 430 (79.53%)
occurrences all number	1533
Injection site induration
subjects affected / exposed	43 / 430 (10.00%)
occurrences all number	74
Injection site discomfort
subjects affected / exposed	38 / 430 (8.84%)
occurrences all number	94
Pyrexia
subjects affected / exposed	37 / 430 (8.60%)
occurrences all number	48
Injection site nodule
subjects affected / exposed	32 / 430 (7.44%)
occurrences all number	57
Injection site swelling
subjects affected / exposed	27 / 430 (6.28%)
occurrences all number	38
Asthenia
subjects affected / exposed	25 / 430 (5.81%)
occurrences all number	29
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	27 / 430 (6.28%)
occurrences all number	32
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	33 / 430 (7.67%)
occurrences all number	33
Infections and infestations
COVID-19
subjects affected / exposed	68 / 430 (15.81%)
occurrences all number	72
Nasopharyngitis
subjects affected / exposed	25 / 430 (5.81%)
occurrences all number	25

More information

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Were there any global substantial amendments to the protocol? Yes

02 Dec 2020

Changes were made to correct discrepancies in the document and to update the statistical section based on Ethics Committee requirement.

01 Jul 2021

To allow participants who become pregnant while in the study to remain in the study and not be withdrawn due to pregnancy.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase IIIb, open-label, hybrid type III trial evaluating implementation strategies for long-acting cabotegravir plus long-acting rilpivirine every two months in HIV-1 infected, virologically suppressed adults in select European healthcare settings

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12

Primary: Change from Baseline in Acceptability of Implementation Measure (AIM-Imp) Score in SSP at Month 12

Primary: Change from Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12

Primary: Change from Baseline in Implementation Appropriateness Measure (IAM-Imp) Score in SSPs at Month 12

Primary: Change from Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12

Primary: Change from Baseline in Feasibility of Implementation Measure (FIM-Imp) Score at Month 12

Primary: Number of Staff Study Participants that discussed Facilitators for Acceptability Assessed via Semi Structured Interviews (SSIs)

Primary: Number of Staff Study Participants that discussed Facilitators for Acceptability Assessed via Semi Structured Interviews (SSIs)

Primary: Number of Staff Study Participants that discussed Barriers for Acceptability Assessed via SSIs

Primary: Number of Staff Study Participants that discussed Barriers for Acceptability Assessed via SSIs

Primary: Number of Staff Study Participants that discussed Facilitators for Appropriateness Assessed via SSIs

Primary: Number of Staff Study Participants that discussed Facilitators for Appropriateness Assessed via SSIs

Primary: Number of Staff Study Participants that discussed Facilitators for Feasibility Assessed via SSIs

Primary: Number of Staff Study Participants that discussed Facilitators for Feasibility Assessed via SSIs

Primary: Number of Staff Study Participants that discussed Barriers for Appropriateness Assessed via SSIs

Primary: Number of Staff Study Participants that discussed Barriers for Appropriateness Assessed via SSIs

Primary: Number of Staff Study Participants that discussed Barriers for Feasibility Assessed via SSIs

Primary: Number of Staff Study Participants that discussed Barriers for Feasibility Assessed via SSIs

Secondary: Number of Modifications Reported by SSPs Assessed via FRAME-IS

Secondary: Number of Modifications Reported by SSPs Assessed via FRAME-IS

Secondary: Number of Plan, Do, Study, Act (PDSA) Cycles Developed During the Continuous Quality Improvement (CQI) Calls Course

Secondary: Number of Plan, Do, Study, Act (PDSA) Cycles Developed During the Continuous Quality Improvement (CQI) Calls Course

Secondary: Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed via Questionnaire

Secondary: Number of Participants Spending Average Time in the Clinic/Practice for Each Injection Visit Assessed via Questionnaire

Secondary: Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed via Questionnaire

Secondary: Number of Participants Spending Average Time in an Exam Room Waiting for a Nurse (or Other Healthcare Provider) to Get the Injection Administered Assessed via Questionnaire

Secondary: Number of Participants with the Acceptability with the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed via Questionnaire

Secondary: Number of Participants with the Acceptability with the Amount of Time Spent in The Clinic/Practice for Each Injection Visit Assessed via Questionnaire

Secondary: Number of Participants with Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed via Questionnaire

Secondary: Number of Participants with Acceptability to Come to the Clinic/Practice Every 2 Months for the Injection Visit Assessed via Questionnaire

Secondary: Number of Participants Taking Time Off from Work to Attend Appointment Assessed via Questionnaire

Secondary: Number of Participants Taking Time Off from Work to Attend Appointment Assessed via Questionnaire

Secondary: Number of Participants who Seek Additional Care from a Dependent to Attend Appointment Assessed via Questionnaire

Secondary: Number of Participants who Seek Additional Care from a Dependent to Attend Appointment Assessed via Questionnaire

Secondary: Number of Participants Taking Time Off from Work to Recover from any Injection Site Reaction Issue Assessed via Questionnaire

Secondary: Number of Participants Taking Time Off from Work to Recover from any Injection Site Reaction Issue Assessed via Questionnaire

Secondary: Number of Participants with Appointment Reminders Received Assessed via Questionnaire

Secondary: Number of Participants with Appointment Reminders Received Assessed via Questionnaire

Secondary: Number of Participants with Things Tried to Reduce Soreness Following Injections Assessed via Questionnaire

Secondary: Number of Participants with Things Tried to Reduce Soreness Following Injections Assessed via Questionnaire

Secondary: Number of PSPs with Facilitators for Acceptability Assessed via Semi Structured Interviews (SSIs)

Secondary: Number of PSPs with Facilitators for Acceptability Assessed via Semi Structured Interviews (SSIs)

Secondary: Number of PSPs with Barriers for Acceptability Assessed via SSIs

Secondary: Number of PSPs with Barriers for Acceptability Assessed via SSIs

Secondary: Number of PSPs with Barriers for Appropriateness Assessed via SSIs

Secondary: Number of PSPs with Barriers for Appropriateness Assessed via SSIs

Secondary: Number of PSPs with Facilitators for Appropriateness Assessed via SSIs

Secondary: Number of PSPs with Facilitators for Appropriateness Assessed via SSIs

Secondary: Number of PSPs with Facilitators for Feasibility Assessed via SSIs

Secondary: Number of PSPs with Facilitators for Feasibility Assessed via SSIs

Secondary: Number of PSPs with Barriers for Feasibility Assessed via SSIs

Secondary: Number of PSPs with Barriers for Feasibility Assessed via SSIs

Secondary: Change from Baseline in The Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12

Secondary: Change from Baseline in The Acceptability of Intervention Measure (AIM) Score in PSPs at Month 12

Secondary: Change from Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12

Secondary: Change from Baseline in Feasibility of Intervention Measure (FIM) Score in PSPs at Month 12

Secondary: Number of Participants with Confirmed Virologic Failure (CVF) Over Time

Secondary: Number of Participants with Confirmed Virologic Failure (CVF) Over Time

Secondary: Percentage of PSP Receiving Injections within Target Window

Secondary: Percentage of PSP Receiving Injections within Target Window

Secondary: Number of PSPs with Adverse Events (AEs) And Serious AEs (SAEs)

Secondary: Number of PSPs with Adverse Events (AEs) And Serious AEs (SAEs)

Secondary: Number of PSPs Discontinuing Treatment Due to AEs

Secondary: Number of PSPs Discontinuing Treatment Due to AEs

Secondary: Change from Baseline in Implementation Leadership Scale (ILS) Score at Month 12

Secondary: Change from Baseline in Implementation Leadership Scale (ILS) Score at Month 12

Secondary: Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12

Secondary: Absolute Values of Implementation Climate Scale (ICS) Scores at Month 1 and Month 12

Secondary: Number of Participants with Time it took them to Get to the Clinic where they receive HIV Treatment/Check-ups Assessed via Questionnaire

Secondary: Number of Participants with Time it took them to Get to the Clinic where they receive HIV Treatment/Check-ups Assessed via Questionnaire

Clinical Trial Results:
A Phase IIIb, open-label, hybrid type III trial evaluating implementation strategies for long-acting cabotegravir plus long-acting rilpivirine every two months in HIV-1 infected, virologically suppressed adults in select European healthcare settings