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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- Mean Feasibility of Intervention Measure (FIM) Score Assessed for SSPs
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: APRETUDE (Drug)
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.
干预措施: Cabotegravir OLI (Drug)
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.
干预措施: APRETUDE (Drug)
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.
干预措施: Cabotegravir OLI (Drug)
结局指标
主要结局
Mean Feasibility of Intervention Measure (FIM) Score Assessed for SSPs
时间窗: At Month 12
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)
次要结局
- Change From Baseline in FIM Score Assessed for SSPs(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(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(Up to Month 12)
- Mean FIM Score Assessed for PSPs(At Baseline (Month 1), Month 6 and Month 12)
- Mean Acceptability of Intervention Measure (AIM) Score Assessed for PSPs(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(At Baseline (Month 1), Month 6 and Month 12)
- Number of PSPs With Responses to the ISQs Regarding Recommending APRETUDE(At Month 6 and Month 12)
- Number of PSPs Assessed for Perception of Facilitators to Feasibility and Acceptability of APRETUDE Through Month 12(Up to Month 12)
- Mean FIM Score for Telehealth Delivery Assessed for SSPs(At Baseline (Month 1), Month 4 and Month 12)
- Number of SSPs With Responses to the ISQs Regarding Use of Telehealth Delivery(At Baseline (Month 1), Month 4 and Month 12)
- Number of SSPs With Responses to the ISQs Indicating the Helpfulness of Telehealth Services Used(At Month 4 and Month 12)
- Change From Baseline in FIM Score for Telehealth Delivery Assessed for SSPs(At Month 4 and Month 12 compared to baseline (Month 1))
- Change From Baseline in AIM Score for Telehealth Delivery Assessed for SSPs(At Month 4 and Month 12 compared to baseline (Month 1))
- Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Baseline(At Baseline (Month 1))
- Number of PSPs With Responses to ISQs Regarding Acceptability of Coming to Clinic for APRETUDE Injection(At Baseline (Month 1), Month 6 and Month 12)
- Percentage of PSPs With Change From Baseline in ISQ Responses(At Month 6 and Month 12 compared to Baseline (Month 1))
- Number of PSPs Assessed for Perception of Barriers to Feasibility and Acceptability of APRETUDE Through Month 12(Up to Month 12)
- Mean AIM Score for Telehealth Delivery Assessed for SSPs(At Baseline (Month 1), Month 4 and Month 12)
- Number of SSPs With Responses to the ISQs Indicating Which Telehealth Services Were Used(At Month 4 and Month 12)
- Number of PSPs With Responses to the ISQs Regarding Appointment Scheduling(At Month 6 and Month 12)
- Number of PSPs With Responses to the ISQs Regarding Appointment Rescheduling(At Month 6 and Month 12)
- Change From Baseline in AIM Score Assessed for PSPs(At Month 6 and Month 12 compared to baseline (Month 1))
- Change From Baseline in FIM Score Assessed for PSPs(At Month 6 and Month 12 compared to baseline (Month 1))
- Number of MSM and TGM Who Report Having Had Sex in the Last 6 Months on the SHA(Up to Month 12)
- Number of Modifications for Each Category Reported by SSPs Using FRAME-IS(Up to Month 12)
- Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by Semi-Structured Interviews (SSIs)(Up to Month 12)
- Number of PSPs With Reasons for Choosing and Switching to APRETUDE Assessed by ISQs(Up to Month 12)
- Number of PSPs Assessed for Perception of Facilitators(Up to Month 12)
- Number of PSPs Assessed for Perception of Barriers(Up to Month 12)
- Number of SSPs Assessed for Perception of Facilitators(Up to Month 12)
- Number of SSPs Assessed for Perception of Barriers(Up to Month 12)
- Percentage of SSPs With Change From Baseline in ISQ Responses for Telehealth Delivery(At Month 4 and Month 12 compared to Baseline (Month 1))
- Mean FIM Score for Telehealth Delivery Assessed for PSPs(At Baseline (Month 1), Month 6 and Month 12)
- Mean AIM Score for Telehealth Delivery Assessed for PSPs(At Baseline (Month 1), Month 6 and Month 12)
- Number of PSPs With Responses to the ISQs Regarding Telehealth Use for APRETUDE(At Baseline (Month 1), Month 6 and Month 12)
- Number of PSPs With Responses to the ISQs Regarding the Comfort of Using Telehealth Services(At Month 6 and Month 12)
- Number of PSPs With Response to the ISQs Regarding the Convenience of Telehealth Services Used(At Month 6 and Month 12)
- Number of PSPs With Response to the ISQs Recommending Telehealth Delivery(At Month 6 and Month 12)
- Change From Baseline in FIM Score for Telehealth Delivery Assessed for PSPs(At Month 6 and Month 12 compared to baseline (Month 1))
- Change From Baseline in AIM Score for Telehealth Delivery Assessed for PSPs(At Month 6 and Month 12 compared to baseline (Month 1))
- Number of PSPs With History of PrEP Use That Complete the SHA and ISQ and Start APRETUDE(Up to Month 12)
- Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 6(At Month 6)
- Percentage of PSPs With Change From Baseline in ISQ Responses Regarding Telehealth Delivery(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(Up to Month 12)
- Number of PSPs Assessed for Perception of Facilitators and Barriers to Feasibility and Acceptability for Telehealth Delivery(Up to Month 12)
- Mean AIM Score Assessed for SSPs(At Baseline (Month 1), Month 4 and Month 12)
- Number of SSPs With Responses to ISQs Regarding Managing Delivery of APRETUDE(At Baseline (Month 1), Month 4 and Month 12)
- Change From Baseline in AIM Score Assessed for SSPs(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(At Month 4 and 12 compared to Baseline (Month 1))
- Mean AIM Score Assessed for PSPs(At Baseline (Month 1), Month 6 and Month 12)
- Number of PSPs With ISQ Responses Regarding Utility of Implementation Strategy at Month 12(At Month 12)
- Change From Baseline in Mean AIM Score in PSPs(At Month 6 and Month 12 compared to baseline (Month 1))
- Percentage of PSPs With Change From Baseline in ISQ Responses Under Implementation Strategy(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(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(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(Up to Month 12)
- Number of PSPs Assessed for Perceptions of Utility of Implementation Strategies Through Semi-Structured Interviews (SSIs)(Up to Month 12)
- Number of Injections Occurring Within Target Window From Target Date(Up to Month 12)
- Number of PSPs Completing Target Number of Injections(Up to Month 12)
- Number of PSPs With Perceptions of Facilitators to Fidelity to Injections(Up to Month 12)
- Number of PSPs With Perceptions of Barriers to Fidelity to Injections(Up to Month 12)
- Number of SSPs With Perceptions of Facilitators to Fidelity to Injections(Up to Month 12)
- Number of SSPs With Perceptions of Barriers to Fidelity to Injections(Up to Month 12)
- Number of SSPs Who Administer Sexual Health Assessment (SHA)(Up to Month 12)
- Number of Eligible PSPs for Which SHA Are Administered(Up to Month 12)
- Number of Men Who Have Sex With Men (MSM) and Transgender Men (TGM) Who Take the SHA Through M12(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(Up to Month 12)
- Number of PSPs Who Initiate APRETUDE After Taking the SHA(Up to Month 12)
- Number of PSPs With Perceptions of SHA(Up to Month 12)
- Number of SSPs With Perceptions of SHA(Up to Month 12)
- Number of Modifications Reported by SSPs Using FRAME-IS(At Month 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12)
- Number of Modifications Made for Adaptations to Implementation Reported by SSPs Using FRAME-IS(Up to Month 12)
- Number of PSPs Assessed for Perceptions of Adaptations to Implementation Strategies(Up to Month 12)