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.)

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.

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.

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).

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.

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

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.

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."

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."

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."

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

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.

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.

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.

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.

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).

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).

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).

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.

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.

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.

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.

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

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

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

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).

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.

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.

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

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.

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.

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.

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

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

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

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).

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).

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).

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).

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).

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).

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).

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).

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

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

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

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

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

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

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

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

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.