ACCELERATING THE PATH TO SCALE FOR INJECTABLE HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) in MALAWI: THE PERSIST TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9,900
- 试验地点
- 1
- 主要终点
- PrEP continuation among CAB LA PrEP users of enhanced intervention verse SoC
研究概览
简要总结
The purpose of this study is to identify the effectiveness of a bundle of strategies to support continuation of clients on pre-exposure prophylaxis, including long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high priority groups.
详细描述
The study will test a package of implementation strategies to support continuation on pre-exposure prophylaxis (PrEP), with a particular focus on long-acting injectable cabotegravir (CAB LA). The study will prioritize impacts on PrEP continuation at 5-months and will secondarily consider alternate continuation endpoints, acceptability, feasibility, appropriateness and fidelity of implementation strategies among CAB LA users and providers. The study will use an efficient hybrid type 3 pragmatic cluster randomization. Clusters are defined as delivery sites, including primary health centers (PHCs) and private clinics serving the broader population and drop-in centers/community-based organizations providing CAB LA to prioritized populations including female sex workers, clients, men who have sex with men and transgender persons.
Clusters will be randomized to receive the standard of care (SoC) per Ministry of Health guidelines for PrEP continuation vs. an enhanced bundle of clinical support and provider-focused implementation strategies to promote sustained PrEP use. Variable-constrained randomization will be applied to balance allocation by facility type (drop-in centre for female sex workers, drop-in centre for men who have sex with men, primary health clinic, hospital, private), and overall clinic/PrEP volume.
PrEP users will be passively enrolled into the cluster randomized trial and a subset actively enrolled for participation in the targeted research activities. De-identified programmatic data will be utilized from OCR technology called ScanForm, which was developed by QED PrEP to identify the number and demographic characteristics (gender, age, indication for PrEP) of oral and CAB LA PrEP users initiating PrEP modalities by site, switching from oral to CAB LA PrEP (and vice versa), and continuation rates.
Outcomes of PrEP persistence will be followed for at least 5 months. Follow-up will begin at the time of injectable or oral PrEP initiation. With a 6-month passive enrollment period across sites and at least 5 months of follow-up of all clients initiating oral or injectable PrEP, this will result in 5-11 months of follow-up data per facility.
In addition to the utilization of programmatic data documenting PrEP continuation overall, and by PrEP modality (oral vs. CAB LA), a number of discrete research activities will be undertaken to evaluate the secondary objectives of the cluster randomized trial. These include: (1) serial cross-sectional surveys with PrEP clients; (2) In-depth qualitative interviews with PrEP clients; (3) Fidelity assessments of implementation strategies.
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
- 15 Years 至 110 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis will be applied per Ministry of Health guidelines. Per Ministry of Health guidelines, the following populations will be prioritized for long-acting injectable cabotegravir for pre-exposure prophylaxis distribution, following individual risk assessment:
- •Individuals who are 15+ years old AND either
- •Female sex workers (FSW) OR
- •Men who have sex with men (MSM) OR
- •Transgender individuals (TG) OR
- •Women and adolescent girls and young women (AGYW) presenting at STI services and/or family planning and/or HIV testing services OR
- •Breastfeeding women (BFW) OR
- •Male partners of female sex workers and/or Men at high risk for HIV and/or men presenting with a syndromic or lab-confirmed sexually transmitted infections. All individuals initiated on long-acting injectable cabotegravir for pre-exposure prophylaxis 15 years or above will be included in the passively enrolled sample.
排除标准
- •Per Ministry of Health guidelines, exclusion criteria for long-acting injectable cabotegravir for pre-exposure prophylaxis includes:
- •Those living with HIV-1 or evidence of possible acute HIV infection OR Those with a prior Hepatitis B diagnosis OR Those with a known history of severe side effects to Cabotegravir Long Acting OR Those unwilling or unable to return for 3-monthly HIV testing or 2-monthly counseling and safety monitoring visits OR Clients currently on multi-drug resistance tuberculosis (MDR-TB) medications OR Clients currently taking post-exposure prophylaxis.
研究组 & 干预措施
Standard of Care (SoC)
Receive the standard of care (SoC) per Ministry of Health guidelines for PrEP continuation.
干预措施: Standard of Care (SoC) (Behavioral)
Enhanced continuation support package
Enhanced bundle of clinical support and provider focused intervention package to promote sustained PrEP use.
干预措施: Standard of Care (SoC) (Behavioral)
Enhanced continuation support package
Enhanced bundle of clinical support and provider focused intervention package to promote sustained PrEP use.
干预措施: Enhanced continuation support package (Behavioral)
结局指标
主要结局
PrEP continuation among CAB LA PrEP users of enhanced intervention verse SoC
时间窗: 5 months of follow-up after enrollment
PrEP continuation among CAB LA PrEP users at 5-months in the enhanced continuation support arm verse SoC continuation support arm without a product interruption that requires PrEP re-initiation
次要结局
- PrEP continuation among oral PrEP users of enhanced intervention verse SoC(5 months of follow-up after enrollment (window period 4-6 months based on client dosing schedule))
- PrEP continuation among CAB LA PrEP users(3 months after enrollment)
- Assessment of PrEP use and intervention(Up to 12 months after enrollment)