Ongoing Dynamic Choice to Address HIV Treatment Interruption in Malawi (CHOICE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Proportion of clients with viral suppression at 12-months (<1,000 copies/ML)
研究概览
简要总结
Repeat and prolonged treatment interruption (TI) is common and the major threat to HIV epidemic control in eastern and southern Africa. The proposed project will test an innovative long-term dynamic choice intervention for ART clients experiencing TI in Malawi. Findings will provide essential information on how to improve sustained retention among TI client, a critical step to curbing the HIV epidemic. TI clients need long-term, responsive interventions. There are no one-size fits all intervention to support long-term care for TI clients because clients experience vastly different and changing barriers to care. While health facilities do have limited capacity for adding new services, existing services can be packaged differently to meet clients' needs.
Long-term, dynamic choice of services is one way to provide responsive services and promotes client ownership over care. The investigators propose to give TI clients long-term, dynamic choice of what services they receive and how they receive it (drawing from key building blocks of DSD). Long-term, dynamic choice puts clients in the driver's seat and may be the best practical strategy to provide long-term and responsive TI interventions that are tailored to clients' evolving life circumstances. Dynamic choice is frequently used for HIV prevention and family planning products, whereby clients select the type of health product that works best for them (i.e., condoms, injectables, etc.). Choice of these services is strongly associated with improved outcomes.
The goal of this clinical trial is to determine if CHOICE can improve outcomes in TI clients, compared to standard of care (SOC). Participants will be randomly assigned to either the CHOICE or SOC group, and follow them for 12 months. The primary outcome will be viral suppression at 12 months.
详细描述
Repeat and prolonged treatment interruption (TI) is common and the major threat to HIV epidemic control in eastern and southern Africa. The investigators define TI as >28 days late for last ART appointment. Each TI episode is associated with rapid viral load rebound and long-term decreases in CD4 count. Up to 46% of ART clients in the region experience TI in the first years after treatment initiation. 30-50% of clients returning from TI experience repeat TI <6 months after returning to care. TI and repeat TI account for the majority of HIV transmissions in Malawi. Strategies to provide ongoing support to TI clients are urgently needed.
Current TI services do not work in the long-term. The few evidence-based TI interventions that exist are extremely limited in duration (usually only ~1-3 intervention visits) and services offered (counseling alone or counseling + home-based initiation). Yet reasons for TI are different for each client and change over time. TI is rarely a one-time event. Short term interventions can improve return to care, but do not address repeat TI. The investigators' recent R01 (ENGAGE; R01MH122308-05, n=735) and BMGF (IDEAL; n=569) trials with men experiencing TI in Malawi show that short-term person-centered counseling + variations of short-term home-based ART dramatically improve return to care after TI (~96% re-initiated vs 67% in standard of care - SOC; p<0.001). But rates of continued ART engagement at 6-months after re-initiation (4-5 months after interventions completed) was unacceptably low (~64% were continuously in care without repeat TI vs 48% in SOC, p<0.001).
Recent trials found that clients with repeat TI had many unexpected and changing barriers that require long-term solutions. In-depth interviews with repeat TI clients in ENGAGE and IDEAL trials (n=67) showed that clients want long-term services responsive to their changing needs, and the ability to choose services.
TI clients need long-term, dynamic choice of differentiated service delivery (DSD) options. There are no one-size fits all interventions for TI clients because they experience vastly changing and different barriers to care, from distance to facility to lack of social support to limited HIV-related literacy. Ongoing person-centered counseling and choice of how services are delivered facilitates responsive services and promotes client ownership over care. Long-term and dynamic choice of DSD may be the best practical strategy to provide long-term, responsive TI interventions. There are no evidence-based dynamic choice interventions for TI clients.
The investigators piloted a novel intervention, called CHOICE, that provides person-centered counseling (building on the success of our prior trials) + ongoing, dynamic choice of DSD services to TI clients. The pilot (n=125) found that counseling + dynamic choice of DSD was feasible, acceptable, and showed signs of efficacy to reduce repeat TI (15% vs 50% at 3-months). A full trial is needed to test the impact on viral suppression long-term (at 12- and 24-months) and cost-effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15 years of age or older
- •living with HIV;
- •initiated ART for the first time>3-months ago (i.e., not a new initiate);
- •non-pregnant;
- •experienced Treatment Interuptions during their most recent ARTappointment (>28 days late).
排除标准
- •pregnant women because the ART/antenatal care (ANC) programs are integrated and require additional considerations and linkages with antenatal services.
研究组 & 干预措施
CHOICE
The CHOICE intervention will provide long-term person-centered counseling + long-term, dynamic choice of DSD services to TI clients in Malawi over a 24-month period.
干预措施: CHOICE (Behavioral)
Standard of Care
TI clients will be offered long-term person-centered counseling tailored to TI clients. The Malawi Ministry of Health adopted findings from previous trials and is incorporating short-term person-centered counseling into standard of care (SOC) for TI clients. This will be the SOC control condition.
结局指标
主要结局
Proportion of clients with viral suppression at 12-months (<1,000 copies/ML)
时间窗: 12 months after enrollment
Test the effectiveness of CHOICE versus SOC on 12-month viral suppression among TI clients. Primary outcome is viral suppression at 12-months (\<1,000 copies/ML).
次要结局
- Viral suppression at 24 months(24 months after enrollment)
- Advanced HIV at 12 and 24 months(at 12 and 24 months after enrollment)
- ART re-initiation(3 months after enrollment)
- Repeat treatment interuption(6, 12, and 24 months after enrollment.)
- Adverse Events(Ongoing after enrollment to 24 months)
研究者
Kathryn L. Dovel, PhD
Associate Professor
University of California, Los Angeles