A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States (PILLAR)

A Phase 4, Randomized, Open-label, Two-arm Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-volume Pre-exposure Prophylaxis (PrEP) Sites in the U.S. for HIV Uninfected MSM and Transgender Men ≥ 18

This is a two-arm study evaluating the impact of two implementation strategy conditions, dynamic implementation and routine implementation on the feasibility of delivering of Cabotegravir PrEP in low and high-volume PrEP sites in the United States for men who have sex with men (MSM) and Transgender men ≥ 18 years of age. There are two types of participants in the study. Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available Cabotegravir PrEP via prescription from the PrEP provider at the corresponding site. Staff Study Participants (SSPs) will refer to site staff who are involved in administrative and clinical aspects of offering and administering PrEP to PSPs and will participate in the staff study assessments. PSPs who choose to opt for 1-month oral lead-in (OLI) will receive cabotegravir tablets for PrEP at Month 1 followed by APPRETUDE intramuscular (IM) injections on Month 2, 3 and every two months thereafter up to Month 13. PSPs who opt for Direct to injections (DTI) will receive APPRETUDE IM injections on Month 1, 2 and every two months thereafter up to Month 12. Month 6/7 refers to Month 6 (DTI)/ Month 7 (OLI). Month 12/13 refers to Month 12 (DTI)/ Month 13 (OLI).

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: APRETUDE; Drug: Cabotegravir OLI

• Study Type: Interventional
• Enrollment (Actual): 287
• Phase: Phase 4

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90036
      • GSK Investigational Site
    • San Francisco, California, United States, 94102
      • GSK Investigational Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20005
      • GSK Investigational Site
  • Florida
    • Miami, Florida, United States, 33140
      • GSK Investigational Site
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
    • Pensacola, Florida, United States, 32503
      • GSK Investigational Site
    • Sarasota, Florida, United States, 34237
      • GSK Investigational Site
  • Kansas
    • Bridgeport, Kansas, United States, 06605
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • GSK Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65212
      • GSK Investigational Site
    • St Louis, Missouri, United States, 63117
      • GSK Investigational Site
  • New York
    • Rochester, New York, United States, 14607
      • GSK Investigational Site
    • The Bronx, New York, United States, 10467
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19123
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • GSK Investigational Site
  • Texas
    • Harlingen, Texas, United States, 78550
      • GSK Investigational Site
  • Washington
    • Seattle, Washington, United States, 98104
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
• No prior history of receiving CAB PrEP
• HIV negative test result at screening
• Capable of giving signed informed consent form

Exclusion Criteria:

• HIV indeterminate or positive test result during screening and prior to initiation of CAB PrEP
• A participant of concurrent interventional clinical or implementation science study at any time during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic Implementation (DI) - PSP; Men who have sex with men (MSM) and transgender men (TGM) who were HIV negative as PSPs received APRETUDE injection (Direct to Injection - DTI) and had the choice to receive an optional cabotegravir tablets as oral lead in (OLI). PSPs had access to enhanced toolkits and digital health implementation supports.	Drug: APRETUDE; Available as intramuscular injection.; Drug: Cabotegravir OLI; Available as marketed orally administered tablets.
Experimental: Routine Implementation (RI) - PSP; MSM and transgender men who were HIV negative as PSPs received APRETUDE injection (DTI) and had the choice to use an optional cabotegravir tablets as OLI. PSPs had access to standard toolkits for APRETUDE to use as needed.	Drug: APRETUDE; Available as intramuscular injection.; Drug: Cabotegravir OLI; Available as marketed orally administered tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Feasibility of Intervention Measure (FIM) Score Assessed for SSPs	The FIM-Intervention (INT) was a four-item measure for APRETUDE intervention (1. APRETUDE seems implementable in our clinic/practice 2. APRETUDE seems possible in our clinic/practice 3. APRETUDE seems doable in our clinic/practice 4. APRETUDE 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. Timeframe for evaluation of this outcome measure is Month (M)12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI)	At Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in FIM Score Assessed for SSPs	This outcome assesses the change in FIM-INT for SSPs over time. The FIM-INT was a four-item measure for APRETUDE intervention (1. APRETUDE seems implementable in our clinic/practice 2. APRETUDE seems possible in our clinic/practice 3. APRETUDE seems doable in our clinic/practice 4. APRETUDE 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. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI) compared to Baseline (BL).	At Month 4 and Month 12 compared to baseline (Month 1)
Number of SSPs Assessed for Perceptions of Facilitators to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12	Perception of facilitators to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, SSPs were asked about the facilitators of the overall implementation of APRETUDE into clinic infrastructure, evaluating feasibility of DI and RI study arms. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Number of SSPs Assessed for Perceptions of Barriers to RI, DI and Overall Implementation of PrEP Into Routine Care Through Month 12	Perception of barriers to RI, DI and overall implementation of PrEP measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interview. In this outcome measure, SSPs were asked about the barriers/challenges of the overall implementation of APRETUDE into clinic infrastructure, evaluating feasibility of DI and RI study arms. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Mean FIM Score Assessed for PSPs	The FIM-INT was a four-item measure for APRETUDE intervention (1. Receiving APRETUDE injection every 2 months seems workable in my life 2. Receiving APRETUDE injection every 2 months seems possible in my life 3. Receiving APRETUDE injection every 2 months seems doable in my life 4. Receiving APRETUDE injection every 2 months seems easy in my life) 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. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Baseline (Month 1), Month 6 and Month 12
Mean Acceptability of Intervention Measure (AIM) Score Assessed for PSPs	The AIM-INT was employed to evaluate the perceived intervention acceptability among PSPs. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each 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 acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Baseline (Month 1), Month 6 and Month 12
Number of PSPs With Responses to Implementation Science Questionnaire (ISQ) Regarding Their Feelings About Taking APRETUDE	The implementation science questionnaire (ISQ) used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated their feelings about taking APRETUDE. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Baseline (Month 1), Month 6 and Month 12
Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection	The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated how acceptable it was for them to go to the clinic for APRETUDE injections. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Baseline (Month 1), Month 6 and Month 12
Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE	The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated if they would recommend APRETUDE to others. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Month 6 and Month 12
Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling	The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about their opinion on the ease or difficulty of scheduling appointments at the clinic. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Month 6 and Month 12
Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling	The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about their opinion on ease or difficulty of rescheduling appointments at the clinic. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Month 6 and Month 12
Change From Baseline in AIM Score Assessed for PSPs	This outcome assesses the change in AIM-INT for PSPs over time. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each 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 acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to Baseline.	At Month 6 and Month 12 compared to baseline (Month 1)
Change From Baseline in FIM Score Assessed for PSPs	This outcome assesses the change in FIM-INT for PSPs over time. The FIM-INT was a four-item measure for APRETUDE intervention (1. Receiving APRETUDE injection every 2 months seems workable in my life 2. Receiving APRETUDE injection every 2 months seems possible in my life 3. Receiving APRETUDE injection every 2 months seems doable in my life 4. Receiving APRETUDE injection every 2 months seems easy in my life) 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. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to baseline.	At Month 6 and Month 12 compared to baseline (Month 1)
Percentage of PSPs With Change From Baseline in ISQ Responses	The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs indicated their feelings about taking APRETUDE and how acceptable it was for them to go to the clinic for APRETUDE injections. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M6 minus (-) BL, and M12-BL. Q2M = a schedule of injection administration at every 2 months.	At Month 6 and Month 12 compared to Baseline (Month 1)
Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12	Facilitators to feasibility and acceptability of APRETUDE measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, PSPs were asked about their perception of the facilitators of feasibility and acceptability of APRETUDE intervention. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of PSPs Assessed for Perception of Barriers to Feasibility and Acceptability of APRETUDE Through Month 12	Barriers to feasibility and acceptability of APRETUDE were measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, PSPs were asked about their perspectives on the barriers and challenges of feasibility and acceptability of APRETUDE intervention. Timeframe for evaluation of this outcome measure is through M12 (equivalent M13 for PSPs who received OLI).	Up to Month 12
Mean FIM Score for Telehealth Delivery Assessed for SSPs	The FIM-TEL services for SSPs were a four-item measure (1. Telehealth for APRETUDE seems implementable in our clinic/practice 2. Telehealth for APRETUDE seems possible in our clinic/practice 3. Telehealth for APRETUDE seems doable in our clinic/practice 4. Telehealth for APRETUDE 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. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).	At Baseline (Month 1), Month 4 and Month 12
Mean AIM Score for Telehealth Delivery Assessed for SSPs	The AIM-TEL services for SSPs were a four-item measure (1. The idea of telehealth for APRETUDE in our clinic/practice meets my approval 2. The idea of telehealth for APRETUDE in our clinic/practice is appealing to me 3. I like the idea of telehealth for APRETUDE in our clinic/practice 4. I welcome the idea of telehealth for APRETUDE in our clinic/practice), each 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 acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).	At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery	The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the use of telehealth services at their clinic/practice. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).	At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used	The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about which telehealth services/systems were used at their clinic/practice to deliver APRETUDE during the PILLAR study. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).	At Month 4 and Month 12
Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used	The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the helpfulness of the telehealth services/systems used at their clinic/practice. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).	At Month 4 and Month 12
Change From Baseline in FIM Score for Telehealth Delivery Assessed for SSPs	The FIM telehealth services for SSPs were a four-item measure (1. Telehealth for APRETUDE seems implementable in our clinic/practice 2. Telehealth for APRETUDE seems possible in our clinic/practice 3. Telehealth for APRETUDE seems doable in our clinic/practice 4. Telehealth for APRETUDE 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. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI) compared to Baseline (BL).	At Month 4 and Month 12 compared to baseline (Month 1)
Change From Baseline in AIM Score for Telehealth Delivery Assessed for SSPs	This outcome assesses the change in AIM telehealth services for SSPs over time. The AIM telehealth services for SSPs were a four-item measure (1. The idea of telehealth for APRETUDE in our clinic/practice meets my approval 2. The idea of telehealth for APRETUDE in our clinic/practice is appealing to me 3. I like the idea of telehealth for APRETUDE in our clinic/practice 4. I welcome the idea of telehealth for APRETUDE in our clinic/practice), each 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 acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI) compared to Baseline (BL).	At Month 4 and Month 12 compared to baseline (Month 1)
Percentage of SSPs With Change From Baseline in ISQ Responses for Telehealth Delivery	The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the use of telehealth services at their clinic/practice. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M4 minus (-) BL, and M12-BL.	At Month 4 and Month 12 compared to Baseline (Month 1)
Mean FIM Score for Telehealth Delivery Assessed for PSPs	The FIM telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services seems workable in my life 2. Using telehealth for APRETUDE services seems possible in my life 3. Using telehealth for APRETUDE services seems doable in my life 4. Using telehealth for APRETUDE services seems easy in my life) 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. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Baseline (Month 1), Month 6 and Month 12
Mean AIM Score for Telehealth Delivery Assessed for PSPs	The AIM Telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services meets my approval 2. Using telehealth for APRETUDE services is appealing to me 3. I like telehealth for APRETUDE services 4. I welcome using telehealth for APRETUDE services), each 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 acceptability and 5 the most acceptability. Timepoints during which this outcome measure was evaluated were BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI)	At Baseline (Month 1), Month 6 and Month 12
Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the use of telehealth (TEL) services such as completing forms online, video chatting with their provider, getting reminders about their injection, or scheduling injection appointments online. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Baseline (Month 1), Month 6 and Month 12
Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about how comfortable it was to use various telehealth services for APRETUDE. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Month 6 and Month 12
Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about how convenient it was to use various telehealth services for APRETUDE. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Month 6 and Month 12
Number of PSPs With Response to the ISQs Recommending Telehealth Delivery	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked if they would recommend telehealth services for APRETUDE to other people. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Month 6 and Month 12
Change From Baseline in FIM Score for Telehealth Delivery Assessed for PSPs	The FIM Telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services seems workable in my life 2. Using telehealth for APRETUDE services seems possible in my life 3. Using telehealth for APRETUDE services seems doable in my life 4. Using telehealth for APRETUDE services seems easy in my life) 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. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to BL.	At Month 6 and Month 12 compared to baseline (Month 1)
Change From Baseline in AIM Score for Telehealth Delivery Assessed for PSPs	The AIM Telehealth services for PSPs were a four-item measure (1. Using telehealth for APRETUDE services meets my approval 2. Using telehealth for APRETUDE services is appealing to me 3. I like telehealth for APRETUDE services 4. I welcome using telehealth for APRETUDE services), each 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 acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to BL.	At Month 6 and Month 12 compared to baseline (Month 1)
Percentage of PSPs With Change From Baseline in ISQ Responses Regarding Telehealth Delivery	The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the use of telehealth (TEL) services such as completing forms online, video chatting with their provider, getting reminders about their injection, or scheduling injection appointments online. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M6 minus (-) BL, and M12-BL.	At Month 6 and Month 12 compared to Baseline (Month 1)
Number of SSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery	Barriers and facilitators to the feasibility and acceptability of telehealth use for APRETUDE were measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, SSPs were asked their perceptions of these facilitators and barriers for telehealth services used. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery	Barriers and facilitators to the feasibility and acceptability of telehealth use for APRETUDE were measured from themes emerging from Proctor and Consolidated Framework for Implementation Research (CFIR) guided semi-structured qualitative interviews. In this outcome measure, PSPs were asked their perceptions of these facilitators and barriers for telehealth services used. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Mean AIM Score Assessed for SSPs	AIM score for SSPs has 2 parts- AIM-INT that evaluates perceived intervention acceptability among SSPs and consists of 4 items (1. APRETUDE in our clinic/practice meets my approval 2. APRETUDE in our clinic/practice is appealing to me 3. I like APRETUDE in our clinic/practice 4. I welcome APRETUDE in our clinic/practice), and AIM-Implementation (IMP) that evaluates perceived acceptability of DI and RI approaches among SSPs and consists of 4 items (1. The implementation support has met my approval; 2. The implementation support was appealing to me; 3. I like the implementation support I have received; 4. I welcome the implementation support I have received),each with a five-point rating scale (1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree). Mean score ranges from 1 to 5 with 1=least acceptability and 5=most acceptability. Timeframe for evaluation is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).	At Baseline (Month 1), Month 4 and Month 12
Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the perceived barriers to managing delivery of APRETUDE. Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI).	At Baseline (Month 1), Month 4 and Month 12
Change From Baseline in AIM Score Assessed for SSPs	AIM score for SSPs has 2 parts- AIM-INT that evaluates perceived intervention acceptability among SSPs and consists of 4 items (1. APRETUDE in our clinic/practice meets my approval 2. APRETUDE in our clinic/practice is appealing to me 3. I like APRETUDE in our clinic/practice 4. I welcome APRETUDE in our clinic/practice), and AIM-IMP that evaluates perceived acceptability of DI and RI approaches among SSPs and consists of 4 items (1. The implementation support has met my approval; 2. The implementation support was appealing to me; 3. I like the implementation support I have received; 4. I welcome the implementation support I have received),each with a five-point rating scale (1=completely disagree, 2=disagree, 3=neither agree nor disagree, 4=agree, and 5=completely agree). Mean score ranges from 1 to 5 with 1=least acceptability and 5=most acceptability. Timeframe for evaluation is M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI) compared to BL.	At Month 4 and Month 12 compared to baseline (Month 1)
Percentage of SSPs With Change From Baseline in ISQ Responses Regarding Managing Delivery of APRETUDE	The ISQ used a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the perceived barriers to managing delivery of APRETUDE (Item [I]1= Management of scheduling injection appointments during correct injection windows, I2= Management of rescheduling appointments during correct injection windows, I3= Ability to schedule/reschedule patients who missed APRETUDE visits, I4= Ability to identify and flag missed injection visits to providers (in a timely manner), I5= Ability to manage patients presenting to APRETUDE appointments with other care needs). Timeframe for evaluation of this outcome measure is BL, M4 and M12 (equivalent to M5 and M13 for SSPs who assessed PSPs receiving OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M4 minus (-) BL, and M12-BL.	At Month 4 and 12 compared to Baseline (Month 1)
Mean AIM Score Assessed for PSPs	The AIM-INT was employed to evaluate the perceived intervention acceptability among PSPs. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each 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 acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is BL, M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI).	At Baseline (Month 1), Month 6 and Month 12
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the helpfulness of various knowledge materials used in learning about APRETUDE.	At Baseline (Month 1)
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the helpfulness of various knowledge materials used in learning about APRETUDE. Timeframe for evaluation of this outcome measure is M6 (equivalent to M7 for PSPs who received OLI).	At Month 6
Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about the helpfulness of various knowledge materials used in learning about APRETUDE. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for PSPs who received OLI).	At Month 12
Change From Baseline in Mean AIM Score in PSPs	This outcome assesses the change in AIM-INT for PSPs over time. The measure consists of four items (1. APRETUDE meets my approval for preventing HIV 2. APRETUDE for the prevention of HIV is appealing to me 3. I like APRETUDE for the prevention of HIV 4. I welcome APRETUDE for the prevention of HIV), each 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 acceptability and 5 the most acceptability. Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI) compared to Baseline.	At Month 6 and Month 12 compared to baseline (Month 1)
Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy	In this outcome measure, usong the ISQ, PSPs were asked about the helpfulness of various knowledge materials (I1= Getting Started Brochure that gives an overview of how to get started with APRETUDE, I2 = Patient Brochure helps understand the process of receiving APRETUDE, I3 = HIV & PrEP video gives key facts about HIV and PrEP options (DI), I4 = APRETUDE Myths and Facts video, addressing common myths about APRETUDE (DI), I5 = The What to Expect video which shows what to expect during the APRETUDE process (DI), I6 = The ViiV Connect program Video and frequently asked questions (DI), I7 = The study website to access APRETDUE information (RI), I8 = The study app to access APRETUDE information (DI). Timeframe for evaluation of this outcome measure is M6 and M12 (equivalent to M7 and M13 for PSPs who received OLI). The change from baseline is calculated as a difference of percentages resulted at each timepoint as following: M6 minus (-) BL, and M12-BL.	At Month 6 and Month 12 compared to Baseline (Month 1)
Number of SSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, SSPs were asked about the usefulness of various implementation strategies used for implementing APRETUDE in their clinic/practice. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Number of PSPs That Respond in Agreement on Relevant Items on the ISQ That Each Implementation Strategy is Fit for Use	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs were asked about how useful various implementation strategies have been in supporting them while taking APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of SSPs Assessed for Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI	Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interview. In this outcome measure, SSPs provided their insights on the tools and strategies used for implementing APRETUDE during the PILLAR study. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)	Perceptions of Utility of Implementation Strategies and Facilitators and Barriers to Acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interview. In this outcome measure, PSPs provided their insights regarding the tools and strategies used for delivering APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of Injections Occurring Within Target Window From Target Date	This outcome measure evaluates the number of injections occurring within the target window. The target window is defined as ± 7 days from target date of injection for Dose 2 and subsequent injections. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of PSPs Completing Target Number of Injections	Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of PSPs With Perceptions of Facilitators to Fidelity to Injections	Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs provided their insights into how APRETUDE has been incorporated into their daily lives, including factors that supported its delivery. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of PSPs With Perceptions of Barriers to Fidelity to Injections	Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs reported several challenges related to incorporating APRETUDE into their daily lives. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of SSPs With Perceptions of Facilitators to Fidelity to Injections	Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs provided insights regarding the facilitators for adherence to APRETUDE and the support provided to enable patient adherence. These facilitators were categorized as resources, support, patient communication and patient feasibility. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Number of SSPs With Perceptions of Barriers to Fidelity to Injections	Perceptions of utility of implementation strategies and facilitators and barriers to acceptability of RI and DI measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs provided insights regarding the barriers and challenges in enabling patient adherence to APRETUDE. The barriers were categorized as patient barriers and staff challenges. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Number of SSPs Who Administer Sexual Health Assessment (SHA)	In this outcome measure, SSPs answered questions about their administration of the sexual health assessment (SHA). The SHA was only administered by SSPs at the DI sites, hence it was not assessed for RI sites. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Number of Eligible PSPs for Which SHA Are Administered	In this outcome measure, data shown below describes the number of PSPs to which the SHA was administered. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of Men Who Have Sex With Men (MSM) and Transgender Men (TGM) Who Take the SHA Through M12	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. Timeframe for evaluation of this outcome measure is M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of MSM and TGM Who Report Having Had Sex in the Last 6 Months on the SHA	In this outcome measure, data shown below describes the number of MSM and TGM who reported having had sex in the last 6 months. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of PSPs Who Expressed Interest in PrEP or Never Heard of PrEP Out of Those Who Report Having Had Sex in the Last 6 Months	In this outcome measure, data presented below shows the number of PSPs who expressed interest in PreP by responding to the question "Have you taken oral PreP in the last 6 months" and number of PSPs who had not heard of PreP.	Up to Month 12
Number of PSPs Who Initiate APRETUDE After Taking the SHA	In this outcome measure, PSPs were asked if they had taken oral PreP in the last 6 months. PSPs who answered 'No' or 'I prefer not to answer' were further asked if they had ever taken oral PreP. Timeframe for evaluation of this outcome measure is through M12(equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of PSPs With Perceptions of SHA	Perceptions of the sexual health assessment (SHA) among PSPs were measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of SSPs With Perceptions of SHA	In this outcome measure, SSPs provided insights regarding the use and implementation of SHA tool in their clinic/practice. The SHA was only administered by SSPs at the DI sites, hence it was not assessed for RI sites. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Number of Modifications Reported by SSPs Using FRAME-IS	The Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) is a measure that provides a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes. Data below summarize all modifications reported by SSPs during PILLAR study. Timeframe for evaluation of this outcome measure is from M2 to M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	At Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12
Number of Modifications for Each Category Reported by SSPs Using FRAME-IS	The FRAME-IS is a measure that provides a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes. Data below summarize the types of modifications and adaptations reported by SSPs during PILLAR study. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Number of Modifications Made for Adaptations to Implementation Reported by SSPs Using FRAME-IS	The FRAME-IS is a measure that provides a precise understanding of modifications, the process of modifying or adapting, and the relationship between different forms of modification and subsequent health and implementation outcomes. Data below summarize the perceptions and motivations of adaptations to implementation reported by SSPs using FRAME-IS. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies	PSP perceptions of adaptations to implementation strategies were measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs discussed their use of study resources and recommendations to staff for delivery of APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE	In this outcome measure, PSPs who completed the SHA and ISQ, describe the history of PrEP use and of sexual health assessment use for determination of PreP use during PILLAR study. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by Semi-Structured Interviews (SSIs)	Reasons for choosing and switching to APRETUDE were measured from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews among PSPs. In this outcome measure, PSPs shared previous oral PrEP experiences, comparisons of other forms of PrEP to APRETUDE, and reasons for preferring APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by ISQs	The ISQ uses a variety of questions to assess outcomes spanning acceptability of, feasibility of, utility of, and experiences with the intervention and the implementation approach. In this outcome measure, PSPs answered ISQ regarding reasons for choosing to take APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of PSPs Assessed for Perception of Facilitators	General perceptions of facilitators for APRETUDE delivery and use were measured among PSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs discuss views of long-term use of APRETUDE, reasons to choose APRETUDE, and experiences with clinic staff. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of PSPs Assessed for Perception of Barriers	General perceptions of barriers for APRETUDE delivery and use were measured among PSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, PSPs discuss challenging views of or experiences with APRETUDE receipt. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for PSPs who received OLI).	Up to Month 12
Number of SSPs Assessed for Perception of Facilitators	General perceptions of facilitators for APRETUDE intervention and implementation were measured among SSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs discuss clinic culture and implementation motivations. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12
Number of SSPs Assessed for Perception of Barriers	General perceptions of barriers for APRETUDE intervention and implementation were measured among SSPs from themes emerging from Proctor and CFIR guided semi-structured qualitative interviews. In this outcome measure, SSPs discuss feelings and perspectives while implementing APRETUDE. Timeframe for evaluation of this outcome measure is through M12 (equivalent to M13 for SSPs who assessed PSPs receiving OLI).	Up to Month 12

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Investigators: Study Director: GSK Clinical Trials, ViiV Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): August 8, 2024
• Study Completion (Actual): August 8, 2024

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: HIV; Pre-exposure prophylaxis; Implementation science; Cabotegravir; Long-acting injectables
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; HIV Integrase Inhibitors; Integrase Inhibitors; cabotegravir
• Other Study ID Numbers: 217710

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes