Study Using CABENUVA™ for the Treatment of Human Immunodeficiency Virus (HIV)-1, Administered in Infusion Centers (IC) or Alternate Sites of Administration (ASA) in the United States (U.S.)

ViiV Healthcare44 enrolled

Overview

GLACIER (Giving Long Acting CABENUVA in an Infusion center/ASA) is an interventional study examining the administration of CABENUVA (Cabotegravir long acting \[LA\] plus Rilpivirine LA) intramuscular (IM) in infusion centers/ASAs in United States. In this study, the intervention is the process of using an infusion center/ASA as the location to receive the CABENUVA IM injections. The acceptability and feasibility of the IC/ASA to deliver CABENUVA IM injections will be assessed from the perspectives of the participants, HIV care providers and IC/ASA staff. In this study, Month 1 is the Baseline visit. CABENUVA is a registered trademark of ViiV Healthcare.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria * Adults (greater than or equal to \[\>=\]18 years old) at the time of signing the informed consent. * HIV-1 infected and have been prescribed CABNEUVA per the United States Prescribing information (USPI). * Participants can be enrolled * If they have been taking oral VOCABRIA + EDURANT or other ART for approximately 1 month (at least 28 days) prior to Baseline/Month 1, or * Already taking CABENUVA prior to Baseline/Month 1 and the last injections were within a 1 month +/- 7-day window or for every 2-month injections, the timing will vary if they are receiving the initiation injections (1 month +/- 7-day) or the continuation injections (2 months +/- 7 days) per the USPI, or * Prescribed direct to inject and receive their 1st injection without an oral lead in at the Infusion Center/ASA on the last day of any other antiretroviral therapy * Agreement to receive CABENUVA IM injections at participating infusion center/ASA. Exclusion criteria * Participants are excluded from the study as dictated in the Prescribing Information (CABENUVA \[USPI\]) in consultation with the HIV care provider. * Contraindications, as per the current Prescribing Information \[CABENUVA USPI\] * New health condition / prohibited medication reported - Other Reason at the discretion of the HIV care provider or IC/ ASA staff

Locations (15)

GSK Investigational Site

Evans, Georgia, United States

GSK Investigational Site

East Lansing, Michigan, United States

GSK Investigational Site

Novi, Michigan, United States

GSK Investigational Site

Plymouth, Minnesota, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Greensboro, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Florence, South Carolina, United States

GSK Investigational Site

Summerville, South Carolina, United States

...and 5 more locations

Outcomes

Primary Outcomes

Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the Feasibility of Intervention Measure (FIM)

Feasibility of Intervention Measure (FIM) were employed to evaluate the feasibility of CABENUVA administration at Infusion Centers (IC)/ alternate sites of administration (ASA). Higher scores on FIM indicate greater feasibility, where each item can be scored from 1 to 5: Completely disagree (score=1), disagree (score=2), neither agree or disagree (score=3), agree (score=4), completely agree (score=5). This scoring looked at the number responding '4' or '5' to each question divided by the number completing all 4-items where "items" refer to the individual questions or statements that participants respond to in order to assess their perceptions of an intervention. Each item is designed to measure a specific aspect of either acceptability or feasibility.

Time frame: At Month 8

Secondary Outcomes

Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM at Month 1 and 3

Time frame: At Months 1 and 3

Number of HIV Care Providers Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM at Month 1, 4 and 8

Time frame: At Months 1, 4, and 8

Number of IC/ ASA Staff Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM Prior to Month 1 and at Months 3 and 8

Time frame: Prior to Month 1 (Baseline) and at Months 3 and 8

Change in FIM Score Over Time in Participants at Month 3 and 8

The mean score for feasibility of the intervention administration was calculated by averaging the responses from the 4 items. The responses were scored based on a scale of 1 to 5 where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree.

Time frame: From Month 1 (Baseline) to Months 3 and 8

Change in FIM Score Over Time in HIV Care Providers at Month 4 and 8

Time frame: From Month 1 (Baseline) to Months 4 and 8

Change in FIM Score Over Time in IC/ ASA Staff at Month 3 and 8

Time frame: From Month 1 (Baseline) to Months 3 and 8

Number of Participants Assessed for Feasibility of CABENUVA Administration by Other Quantitative Questionnaires at Month 1

The tailored questionnaire for participants receiving CABENUVA was developed specifically for this study and contains items regarding the reasons for switching to CABENUVA, adherence to their previous oral HIV medication, preferences and attitudes regarding their medication regimen, and perceived advantages and disadvantages of receiving injections at the IC/ASA. In this outcome measure, participants were asked about their views on the IC/ASA administration model (any/biggest concerns about receiving CABENUVA at an infusion center).

Time frame: At Month 1

Number of Participants Assessed for Feasibility of CABENUVA Administration (Concern About Continuing to Receive CABENUVA) by Other Quantitative Questionnaires at Month 3 and 8

The tailored questionnaire for participants receiving CABENUVA was developed specifically for this study and contains items regarding the reasons for switching to CABENUVA, adherence to their previous oral HIV medication, preferences and attitudes regarding their medication regimen, and perceived advantages and disadvantages of receiving injections at the IC/ASA. In this outcome measure, participants were asked about their views on the IC/ASA administration model (any concerns about continuing to receive CABENUVA at an infusion center) at Months 3 and 8.

Time frame: At Month 3 and 8

Number of Participants Assessed for Feasibility of CABENUVA Administration by Other Quantitative Questionnaires at Month 3 and 8

Participants were asked about their views on the IC/ASA administration model (biggest concerns about continuing to receive CABENUVA at an infusion center).

Time frame: At Month 3 and 8

Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 1

The tailored HIV care provider/clinical staff questionnaire was developed specifically for this study and contains items regarding the provider's practice and experience, as well as their attitudes, expectations, and concerns regarding the use of CABENUVA/long-acting injectable administered by ICs/ASAs.

Time frame: At Month 1

Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 4

Time frame: At Month 4

Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 8

Time frame: At Month 8

Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires Prior to Month 1

The tailored IC staff questionnaire was developed specifically for this study and contains items regarding the staff member's role at the IC, as well as their attitudes, concerns, and anticipated/implemented procedures regarding the use of CABENUVA/long-acting injectable administered by ICs. The IC/ASA staff members were asked to indicate their level of concern across 16 areas of potential concern, on a five-point scale from "not at all concerned" to "extremely concerned."

Time frame: Prior to Month 1 (Baseline)

Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants Assessed by Other Quantitative Questionnaires at Month 3

The IC/ASA staff members were asked to indicate their level of concern across 16 areas of potential concern, on a five-point scale from "not at all concerned" to "extremely concerned."

Time frame: At Month 3

Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Other Quantitative Questionnaires at Month 8

The IC/ASA staff members were asked to indicate their level of concern across 16 areas of potential concern, on a five-point scale from "not at all concerned" to "extremely concerned."

Time frame: At Month 8

Number of Participants Assessed for Feasibility of CABENUVA Administration by Qualitative Interviews at Month 8

Qualitative interviews were conducted at Month 8 to evaluate the opinions of participants on the feasibility of CABENUVA administration at IC/ASA.

Time frame: At Month 8

Number of HIV Care Providers Assessed for Feasibility of CABENUVA Administration in Participants by Qualitative Interviews at Month 8

Qualitative interviews were conducted at Month 8 to evaluate the general opinion of HIV care providers on the feasibility of referring participants to receive CABENUVA at the IC/ASA.

Time frame: At Month 8

Number of IC/ASA Staff Assessed for Feasibility of CABENUVA Administration in Participants by Qualitative Interviews at Month 8

Qualitative interviews were conducted at Month 8 to evaluate the general opinion of IC/ ASA staff on feasibility of CABENUVA administration at the IC/ASA.

Time frame: At Month 8

Composite Score of Feasibility Process Indications

Composite score of feasibility process was calculated as the mean of the following four scores: FIM Score, Consent Rate, Show Rate, and Return Rate at Visit, on a 0 to 100 scale, where higher numbers correspond to better feasibility.

Time frame: Up to and including Month 8

Change in Composite Score and Each Item of Composite Score Over Time

This outcome measure was planned to evaluate change in composite score from baseline to month 8 according to the protocol. The composite score was however not evaluated as a change over time but as a point in time at month 8 as the components of each of the feasibility composite score (FIM score, consent rate, show rate and return rate) were captured at different time intervals.

Time frame: Baseline (Month 1) and at Month 8

Number of HIV Care Providers Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the Acceptability of Intervention Measure (AIM)

AIM was employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, where each item was scored from 1 to 5: Completely disagree (score=1), disagree (score=2), neither agree or disagree (score=3), agree (score=4), completely agree (score=5).

Time frame: Months 1 (Baseline), 4, and 8

Number of Participants Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM

AIM were employed to evaluate the acceptability of CABENUVA administration at Infusion Centers/ ASAs. Higher scores for AIM indicate greater acceptability, where each item was scored from 1 to 5: Completely disagree (score=1), disagree (score=2), neither agree or disagree (score=3), agree (score=4), completely agree (score=5).

Time frame: Month 1 (Baseline), 3 and 8

Number of IC/ ASA Staff Who Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM

Time frame: Prior to Month 1 (Baseline), and at Month 3 and 8

Change in AIM Score Over Time in HIV Care Providers at Month 4 and 8

The mean score for acceptability of the intervention is calculated by averaging the responses from 4 items. The responses were scored based on a scale of 1 to 5 where 1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree.

Time frame: Month 1 (Baseline), at Months 4 and 8

Change in AIM Score Over Time in Participants at Month 3 and 8

Time frame: Month 1 (Baseline), at Months 3 and 8

Change in AIM Score Over Time in IC/ ASA Staff at Month 3 and 8

Time frame: Month 1 (Baseline), at Months 3 and 8

Number of HIV Care Providers Assessed for Acceptability of CABENUVA Administration in Participants at IC/ ASA by Other Quantitative Questionnaire at Months 1, 4 and 8

Time frame: At Months 1, 4 and 8

Number of Participants Assessed for Acceptability of CABENUVA Administration at IC/ ASA by Other Quantitative Questionnaire in at Months 1, 3 and 8

The participants were asked how acceptable it was to come to the IC/ASA for CABENUVA using a 7-point scale from "very acceptable" to "very unacceptable" where 1= very acceptable, 2= somewhat acceptable, 3= a little acceptable, 4= neutral, 5= a little unacceptable, 6= somewhat unacceptable and 7= very unacceptable.

Time frame: At Months 1, 3 and 8

Number of IC/ ASA Staff Assessed for Acceptability of CABENUVA Administration in Participants at IC/ ASA by Other Quantitative Questionnaire Prior to Month 1

Time frame: Prior to Month 1 (Baseline)

Number of IC/ ASA Staff Assessed for Acceptability of CABENUVA Administration in Participants at IC/ ASA by Other Quantitative Questionnaire at Months 3 and 8

Time frame: At Months 3 and 8

Number of Participants Assessed for Acceptability of CABENUVA Administration at IC/ASA by Qualitative Interviews at Month 8

Participants were asked about their opinion on acceptability of CABENUVA administration at the IC/ASA.

Time frame: At Month 8

Number of HIV Care Providers Assessed for Acceptability of CABENUVA Administration in Participants at IC/ASA by Qualitative Interviews at Month 8

HIV care providers were asked about their opinion on the acceptability of participants receiving CABENUVA at the IC/ASA.

Time frame: At Month 8

Number of IC/ASA Staff Assessed for Acceptability of CABENUVA Administration in Participants at IC/ASA by Qualitative Interviews at Month 8

IC/ASA staff were asked about their opinion on the acceptability of administering CABENUVA at an IC/ASA.

Time frame: At Month 8

Number of Expert Panel That Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the FIM Scale

Time frame: Prior to Month 1 (Baseline), and at Month 3 and 6

Number of Expert Panel That Agree or Completely Agree (a Score of 4 or Higher) Across All Items on the AIM Scale

Time frame: Prior to Month 1 (Baseline), and at Month 3 and 6

Change in FIM Score of Expert Panel Over Time Through Month 6

Time frame: Prior to Month 1 (Baseline) and Up to Month 6

Change in AIM Score of Expert Panel Over Time Through Month 6

Time frame: Prior to Month 1 (Baseline) and Up to Month 6

Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Insurance Coverage for CABENUVA Administration in Participants by Quantitative Questionnaires Prior to Month 1

Time frame: Prior to Month 1 (Baseline)

Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Communication for CABENUVA Administration in Participants by Quantitative Questionnaires Prior to Month 1

Time frame: Prior to Month 1 (Baseline)

Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of CABENUVA Administration (Interval of Time) in Participants by Quantitative Questionnaires Prior to Month 1

In this outcome measure, Expert Panel members were asked about their views on the IC/ASA administration model (for patients receiving CABENUVA injections at the infusion center, what is the preferred interval of time for patients to be seen by their HIV provider).

Time frame: Prior to Month 1 (Baseline)

Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Referring Participants for CABENUVA Administration by Quantitative Questionnaires Prior to Month 1

Time frame: Prior to Month 1 (Baseline)

Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Insurance and Communication for CABENUVA Administration in Participants by Quantitative Questionnaires at Month 3

Time frame: At Month 3

Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of Insurance and Communication for CABENUVA Administration in Participants by Quantitative Questionnaires at Month 6

Time frame: At Month 6

Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of CABENUVA Administration in Participants by Qualitative Interviews Prior to Month 1

The Expert Panel were asked about the key steps focused on the process of CABENUVA administration at IC/ASAs in order to inform the development of the blueprint.

Time frame: Prior to Month 1 (Baseline)

Number of Expert Panel Members Assessed for Feasibility, Acceptability and Process of CABENUVA Administration in Participants by Qualitative Interviews at Month 6

The Expert Panel were asked about the key steps focused on the process of CABENUVA administration at IC/ASAs in order to inform the development of the blueprint.

Time frame: At Month 6

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires at Month 1

Time frame: At Month 1

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 1) at Month 3 and 8

Time frame: At Month 3 and 8

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 2) at Months 3 and 8

Time frame: At Months 3 and 8

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 3) at Months 3 and 8

Time frame: At Months 3 and 8

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 4) at Months 3 and 8

Time frame: At Months 3 and 8

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 5) at Months 3 and 8

Time frame: At Months 3 and 8

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 6) at Months 3 and 8

Time frame: At Months 3 and 8

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 7) at Months 3 and 8

Time frame: At Months 3 and 8

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 8) at Months 3 and 8

Time frame: At Months 3 and 8

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 9) at Months 3 and 8

Time frame: At Months 3 and 8

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 10) at Months 3 and 8

Participants were asked their opinion on who did they reach out to obtain answers to their questions.

Time frame: At Months 3 and 8

Number of Participants Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration With Other Quantitative Questionnaires (Q 11) at Months 3 and 8

Time frame: At Months 3 and 8

Number of IC/ASA Staff Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Other Quantitative Questionnaires Prior to Month 1

Since CABENUVA must be administered within a two-week treatment window every month, IC/ASA staff were asked their opinion about the ease or difficulty in appointment re-scheduling and implementation of CABENUVA administration in their work-flow.

Time frame: Prior to Month 1 (Baseline)

Number of IC/ASA Staff Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Other Quantitative Questionnaires at Month 3

Since CABENUVA must be administered within a two-week treatment window (+/-)7 days relative to the target treatment date), the IC/ASA staff was asked their opinion about the ease or difficulty in appointment scheduling and re-scheduling and implementation of CABENUVA administration in their workflow.

Time frame: At Month 3

Number of IC/ASA Staff Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Other Quantitative Questionnaires at Month 8

Time frame: At Month 8

Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 1

Time frame: At Month 1

Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 4

Time frame: At Month 4

Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants With Quantitative Questionnaires at Month 8

Time frame: At Month 8

Number of Participants Assessed for Facilitators of CABENUVA Administration by Qualitative Interviews at Month 8

Participants were asked about facilitators that made the process of receiving CABENUVA at IC/ASAs easier.

Time frame: At Month 8

Number of IC/ASA Staff Assessed for Barriers/Concerns of CABENUVA Administration in Participants by Qualitative Interviews at Month 8

IC/ASA staff were asked their opinion on the infrastructure impact of administering CABENUVA.

Time frame: At Month 8

Number of HIV Care Providers Assessed for Perceptions, Facilitators and Barriers/Concerns of CABENUVA Administration in Participants by Qualitative Interviews at Month 8

HIV care providers were asked about the facilitators and challenges related to referring participants to IC/ASAs.

Time frame: At Month 8

Number of Participants Assessed for Preference on the Location to Receive CABENUVA With Other Quantitative Questionnaires at Months 1, 3 and 8

Time frame: At Month 1, 3 and 8

Number of Participants Assessed for Preference on the Location to Receive CABENUVA by Qualitative Interviews at Month 8

Time frame: At Month 8

Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Month 1

In this outcome measure, participants were asked about their views on the IC/ASA administration model (advantages of going to the infusion center to receive CABENUVA).

Time frame: At Month 1

Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Months 3 and 8

In this outcome measure, participants were asked about their views on the IC/ASA administration model (advantages of going to the infusion center to receive CABENUVA).

Time frame: At Months 3 and 8

Number of HIV Care Providers Assessed for Advantages of Referring Participants to the IC/ ASA to Receive CABENUVA by Other Quantitative Questionnaires at Month 1, 4 and 8

In this outcome measure, HIV care providers were asked about their views on the IC/ASA administration model (advantages of referring patients to an infusion center for CABENUVA).

Time frame: At Months 1, 4 and 8

Number of Participants Assessed for Advantages of Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8

Time frame: At Month 8

Number of HIV Care Providers Assessed for Advantages of Participants Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8

Time frame: At Month 8

Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Month 1

In this outcome measure, participants were asked about their views on the IC/ASA administration model (disadvantages of going to the infusion center to receive CABENUVA).

Time frame: At Month 1

Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Other Quantitative Questionnaires at Months 3 and 8

In this outcome measure, participants were asked about their views on the IC/ASA administration model (disadvantages of going to the infusion center to receive CABENUVA).

Time frame: At Months 3 and 8

Number of HIV Care Providers Assessed for Disadvantages of Referring Participants to the IC/ ASA to Receive CABENUVA by Other Quantitative Questionnaires at Month 1

In this outcome measure, HIV care providers were asked about their views on the IC/ASA administration model (potential disadvantages of referring patients to an IC for CABENUVA).

Time frame: At Month 1

Number of HIV Care Providers Assessed for Disadvantages of Referring Participants to the IC/ ASA to Receive CABENUVA by Other Quantitative Questionnaires at Months 4 and 8

In this outcome measure, HIV care providers were asked about their views on the IC/ASA administration model (disadvantages of referring patients to an IC for CABENUVA).

Time frame: At Months 4 and 8

Number of Participants Assessed for Disadvantages of Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8

Time frame: At Month 8

Number of HIV Care Providers Assessed for Disadvantages for Participants Receiving CABENUVA at IC/ ASA by Qualitative Interviews at Month 8

In this outcome measure, HIV care providers were asked about their views on the IC/ASA administration model (disadvantages for participants receiving CABENUVA at IC/ASAs).

Time frame: At Month 8

Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 1

Time frame: At Month 1

Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 3

Time frame: At Month 3

Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Other Quantitative Questionnaires at Month 8

Time frame: At Month 8

Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs (Time Spent at IC) by Other Quantitative Questionnaires at Months 3 and 8

Time frame: At Months 3 and 8

Number of HIV Care Providers Assessed for Acceptability of the Process of Referring Participants to the IC/ ASA for CABENUVA by Other Quantitative Questionnaires at Months 1, 4 and 8

HIV care providers were asked about the type of patients they found acceptable to refer to an IC to receive CABENUVA.

Time frame: At Months 1, 4 and 8

Number of Participants Assessed for Acceptability of the Process of Receiving Injections at ICs/ ASAs by Qualitative Interviews at Month 8

Participants were asked about their opinion on the acceptability of CABENUVA administration at the IC.

Time frame: At Month 8

Number of HIV Care Providers Assessed for Acceptability of the Process of Participants Receiving Injections at ICs/ ASAs by Qualitative Interviews at Month 8

Time frame: At Month 8

Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention With Other Quantitative Questionnaires Prior to Month 1

The blueprint guides IC/ASA staff on what to do with referrals to receive CABENUVA at the IC/ASA.

Time frame: Prior to Month 1 (Baseline)

Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention With Other Quantitative Questionnaires at Month 3 and 8

The blueprint guides IC/ASA staff on what to do with referrals to receive CABENUVA at the IC/ASA.

Time frame: At Months 3 and 8

Number of HIV Care Providers Assessed for Usefulness of Plan of Treatment (POT) by Other Quantitative Questionnaires at Months 4 and 8

Time frame: At Months 4 and 8

Number of IC/ASA Staff Assessed for Usefulness of the Blueprint Intervention and POT Assessed by Qualitative Interviews at Month 8

Time frame: Month 8

Number of HIV Care Providers Assessed for Usefulness of the Blueprint Intervention and POT by Qualitative Interviews at Month 8

The blueprint guides HIV care providers on what to do with referrals to receive CABENUVA at the IC/ASA.

Time frame: Month 8

Number of IC/ASA Staff Assessed for Overall Opinion of Administering the Injection at an IC/ ASA by Other Quantitative Questionnaires Prior to Month 1 and at Months 3 and 8

Time frame: Prior to Month 1 (Baseline) and Months 3 and 8

Number of Participants Assessed for Overall Opinion of Receiving the Injection at an IC/ ASA by Other Quantitative Questionnaires at Months 1, 3 and 8

Time frame: At Months 1, 3 and 8

Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 1

Time frame: At Month 1

Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 4

Time frame: At Month 4

Number of HIV Care Providers Assessed for Overall Opinion of Referring the Participant to an IC/ ASA by Other Quantitative Questionnaires at Month 8

Time frame: At Month 8

Number of HIV Care Providers Assessed for Overall Opinion of Continuing to Refer Participants to an IC/ ASA by Other Quantitative Questionnaires at Month 8

Time frame: At Month 8

Number of Participants Assessed for Overall Opinion of Receiving the Injection at an IC/ ASA by Qualitative Interview at Month 8

Participants were asked about their overall favorable and non-favorable opinion of receiving CABENUVA at the IC/ASA.

Time frame: At Month 8

Number of HIV Care Providers Assessed for Overall Opinion of Referring Patients to an IC/ ASA by Qualitative Interview at Month 8

HIV care providers were asked about their overall favoring and non-favoring opinions on referring participants to IC/ASA for CABENUVA administration.

Time frame: At Month 8

Number of IC/ASA Staff Assessed for Overall Opinion of Administering the Injection at an IC/ ASA by Qualitative Interview at Month 8

IC/ASA staff was asked about their overall opinion on the participants referral process.

Time frame: At Month 8

Number of Injections Occurring Within Target Window From Target Date

This outcome measure evaluates the fidelity to treatment and dosing window. Fidelity to treatment and dosing window was defined based on a ±7-day window from target treatment date based on the calendar date of baseline injection.

Time frame: Up to and including Month 8