A Phase 4, Randomized, Open-label, Three-arm Study to Evaluate Implementation Strategies for the Delivery of CAB for HIV Pre-exposure Prophylaxis (PrEP) Across Clinical Settings for Adult (≥18 Years) Black cis-and Transgender Women Without HIV Infection Living in the United States Ending the Epidemic (EHE) Territories
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 23
- 主要终点
- Mean Intervention Appropriateness Measure (IAM) Score in SSPs
研究概览
简要总结
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant must be ≥18 years of age, at the time of signing the informed consent.
- •HIV negative at screening. Type of HIV-1 test is per standard of care.
- •No prior history of receiving oral CAB or CAB LA injections.
- •PrEP provider deems CAB PrEP use to be appropriate per the applicable CAB PrEP prescribing information prior to enrollment in the study.
- •Female at birth or self-identified Transgender Female.
- •Self-identified as African American/Black
- •Capable of giving signed informed consent
排除标准
- •HIV indeterminate or positive test result during screening.
- •A participant of concurrent interventional clinical or implementation science study at any time during the study.
- •Cis-gender or Transgender male
研究组 & 干预措施
Standard Implementation (SI)
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as oral lead in (OLI). The SI arm receives the standard toolkits that are anticipated to be available for APRETUDE that includes information resource for PSPs and SSPs.
干预措施: APRETUDE (Drug)
Standard Implementation (SI)
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as oral lead in (OLI). The SI arm receives the standard toolkits that are anticipated to be available for APRETUDE that includes information resource for PSPs and SSPs.
干预措施: Cabotegravir tablet (Drug)
Enhanced Implementation (EI)
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The EI arm will receive all components of SI arm and additional provider-focused implementation strategies. Provider-focused strategies will include a patient-provider communication tool, Provider Education, and enhanced tool kit materials.
干预措施: APRETUDE (Drug)
Enhanced Implementation (EI)
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The EI arm will receive all components of SI arm and additional provider-focused implementation strategies. Provider-focused strategies will include a patient-provider communication tool, Provider Education, and enhanced tool kit materials.
干预措施: Cabotegravir tablet (Drug)
Enhanced Collaborative Implementation (ECI)
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The ECI arm will involve implementation strategies to support patient activation and provider awareness. Clinics randomized to ECI will receive all components of SI and additional implementation strategies to support patient activation and ensure provider awareness. ECI strategies will include a patient information and product resources and peer support.
干预措施: APRETUDE (Drug)
Enhanced Collaborative Implementation (ECI)
PSPs will receive APRETUDE injection and could receive optional Cabotegravir tablets as OLI. The ECI arm will involve implementation strategies to support patient activation and provider awareness. Clinics randomized to ECI will receive all components of SI and additional implementation strategies to support patient activation and ensure provider awareness. ECI strategies will include a patient information and product resources and peer support.
干预措施: Cabotegravir tablet (Drug)
结局指标
主要结局
Mean Intervention Appropriateness Measure (IAM) Score in SSPs
时间窗: Up to Month 13
The responses for appropriateness will be measured on a Likert scale ranging from 0 to 5 with higher values representing better outcomes.
次要结局
- Number of cis-and trans Black women who Complete a Sexual Health Assessment through Month 13 in ECI Arm based on site-level PrEP Information Questionnaire(Up to Month 13)
- Perception to Facilitators and Barriers to Implementation in SSPs Assessed by IMC(Month 4, 5, 12 and 13)
- Acceptability of Intervention Measure (AIM) Score for APRETUDE in SSPs and PSPs(Month 1, 4, 5, 12 and 13)
- Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Clinic Characteristics(Up to Month 13)
- Proportion of PSPs that have one Oral lead-in before CAB Injection(Up to Month 13)
- Appropriateness of APRETUDE Assessed by SSP Questionnaire responses at Month 1, 4, 5, 12 and 13(Month 1, 4, 5, 12 and 13)
- Perception of Appropriateness of APRETUDE Assessed by PSP Questionnaire responses at Month 1, 4, 5, 12 and 13(Month 1, 4, 5, 12 and 13)
- Proportion of Injections Occurring Within Target Window from Target Date (+-7 days of target date)(Up to Month 13)
- Proportion of PSPs completing target number of injections(Up to Month 13)
- Barriers, Facilitators, Concerns and Perception to Implementation in SSPs and PSPs Assessed by Questionnaire responses(Month 1, 4, 5, 12 and 13)
- Perception to Facilitators and Barriers to Implementation in SSPs Assessed by SSI(Month 4, 5, 12 and 13)
- Mean IAM Score in SSPs at Month 1, 4, 5, 12 and 13(Month 1, 4, 5, 12 and 13)
- Change from Baseline in Mean IAM Score in SSPs at Month 4, 5, 12 and 13(Baseline (Month 1) and Month 4, 5, 12 and 13)
- Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13(Month 4, 5 12 and 13)
- Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire(Up to Month 13)
- Mean Feasibility of Intervention Measure (FIM) score in SSPs for Implementation Strategies(Month 1 and 4, 5, 12 and 13)
- Proportion of SSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Patient Subgroups(Up to Month 13)
- Proportion of PSPs that Respond in Agreement on Relevant Items on the Implementation science questionnaire (ISQ) that each implementation tool and strategy is fit for use through Month 13 Based on Study Arm(Up to Month 13)
- Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Clinic Characteristics(Up to Month 13)
- Feasibility and Acceptability of APRETUDE in PSPs Assessed by SSIs(Month 1, 12 and 13)
- Perception on Reason for Decision to Use Oral lead-in SSPs Assessed by Survey responses(Month 1, 4, 5, 12 and 13)
- Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by Survey Responses(Month 1)
- Proportion of PSPs that Complete a Sexual Health Assessment and Start or Switch from Oral PrEP to APRETUDE(Up to Month 13)
- Reasons for Choosing or Switching from Oral PrEP to APRETUDE in PSPs Assessed by SSIs(Up to Month 13)
- Mean IAM Score in PSPs at Month 1, 4, 5, 12 and 13(Month 1, 4, 5, 12 and 13)
- Change from Baseline in Mean IAM Score in PSPs at Month 4, 5, 12 and 13(Baseline (Month 1) and Month 4, 5, 12 and 13)
- Perception of Appropriateness of APRETUDE Assessed by SSI in PSPs at Month 4, 5, 12 and 13(Month 4, 5, 12 and 13)
- Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire(Up to Month 13)
- Proportion of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Study Arm Based on Site level PrEP Information Questionnaire(Up to Month 13)
- Number of cis-and trans Black Women who Continue APRETUDE beyond a First Dose through Month 13 by study arm based on Site-level PrEP Information Questionnaire(Up to Month 13)
- Change from Baseline in FIM Score in SSPs for Implementation Strategies(Baseline (Month 1) and Month 4, 5, 12 and 13)
- Feasibility of Strategy Assessed by SSPs Questionnaire responses at Month 1, 4, 5, 12 and 13(Month 1, 4, 5, 12 and 13)
- Feasibility and Utility of Strategy Assessed in SSPs by SSI at Month 4, 5, 12 and 13(Month 4, 5, 12 and 13)
- Proportion of SSPs that Respond in Agreement on Relevant Items on the Implementation science questionnaire (ISQ) that each implementation tool and strategy is fit for use through Month 13 Based on Study Arm(Up to Month 13)
- Number of PSPs who Complete a Sexual Health Assessment through Month 13 in ECI Arm based on Site-level PrEP Information Questionnaire(Up to Month 13)
- Number of cis-and trans Black Women who Initiate APRETUDE through Month 13 by Clinic Characteristics Based on Site level PrEP Information Questionnaire(Up to Month 13)
- Number of cis-and trans Black Women who Continue APRETUDE beyond a First Dose through Month 13 by Clinic Characteristics based on Site-level PrEP Information Questionnaire(Up to Month 13)
- Perception to Facilitators and Barriers to Implementation in PSPs Assessed by SSI(Month 1, 12 and 13)
- FIM Score for APRETUDE in SSPs and PSPs(Month 1, 4, 5, 12 and 13)
- Feasibility and Acceptability of APRETUDE in SSPs and PSPs Assessed by Questionnaire Responses(Month 1, 4, 5, 12 and 13)
- Feasibility and Acceptability of APRETUDE in SSPs Assessed by SSIs(Month 4, 12 and 13)
- Proportion of PSPs that Respond in Agreement on Relevant Items on the ISQ that each implementation tool and strategy is fit for use through Month 13 Based on Patient Subgroups(Up to Month 13)
- Perceptions of Utility of Implementation tools and strategies Assessed by SSIs in PSPs through Month 13 based on Patient Subgroups(Up to Month 13)
- Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by SSIs in PSPs(Month 1, 12 and 13)
- Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Surveys in PSPs(Month 1, 4, 5, 12 and 13)
- Perception of Barriers and Facilitators to Fidelity to Injections Window Assessed by Implementation Monitoring Calls (IMC) in SSPs(Month 4, 5, 12 and 13)
- Perception on Reason for Decision to Use Oral lead-in PSPs Assessed by SSIs(Month 1)
- Perception on Reason for Decision to Use Oral lead-in in SSPs Assessed by SSI(Month 1, 4, 5, 12 and 13)
- Appropriateness of APRETUDE Assessed by Semi-structured interview (SSI) at Month 4, 5, 12 and 13(Month 1, 4, 5, 12 and 13)