Strengthening the Continuity of HIV Care in Tanzania With Economic Support: Phase I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 567
- 试验地点
- 2
- 主要终点
- 6-month Viral Suppression
研究概览
简要总结
This protocol describes a 2-arm cluster, randomized controlled trial designed to test the effectiveness of a conditional cash transfer on viral suppression at 6 months among people living with HIV infection (PLHIV) in Tanzania who have disengaged from HIV care. Randomization will take place at the clinic level (HIV primary care clinics). The comparison group receives standard of care standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible adult PLHIV disengaged from HIV care and living in an intervention facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time cash transfer incentive, conditional upon confirmed completion of a clinical visit if within 90 days of study enrollment. The primary endpoint is viral suppression (<1000 copies/ml) at 6 months after study enrollment.
详细描述
The overall objective of this study is to evaluate the effectiveness of a home visit plus one-time financial incentive on the proportion of out of care PLHIV with viral load suppression (<1000 copies/ml) at 6 months after study enrollment. We will use a cluster, randomized controlled trial design with a sample size of 20 PLHIV in each of the 32 health facility catchment areas (N=640 PLHIV total) to examine the effect of a home visit plus one-time financial incentive on the primary outcome of viral suppression at 6 months. The study will take place across Geita and Kagera Regions (Lake Zone) in Tanzania.
This study will follow standard of care HIV tracing services according to Tanzania's National Guidelines for the Management of HIV and the Ministry of Health to locate potential participants, including home based care (HBC) tracing of PLHIV who have disengaged from primary care, the provision of counseling to return to HIV care, and the offer to schedule an HIV primary care appointment on the spot. Eligible and consenting participants living in an intervention health facility catchment area will receive the same standard of care HIV tracing and clinical services as control participants, plus the opportunity to receive a one-time incentive of 22,500 TSH (~$10 USD), with half (11,250 TSH) delivered upon enrollment in the study and half delivered after confirmation of the completion of a clinical visit if within 90 days of study enrollment.
Primary Endpoint:
- Viral suppression (<1000 copies/ml) at 6 months after enrollment
Secondary Endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants will not be told during the consent process that as part of the study there are intervention and control clinics. Laboratory staff analyzing viral load samples will be blind to intervention/control attribution.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PLHIV living in the catchment area of a study health facility;
- •Age 18 years or older;
- •Phone ownership OR phone consistent phone access;
- •Classified as lost to follow up (LTFU) from HIV care (not attended a clinic appointment for ≥28 days since last scheduled appointment);
- •Has had a clinic appointment within the last 24 months, and
- •Provides written informed consent for participation
排除标准
- 未提供
结局指标
主要结局
6-month Viral Suppression
时间窗: 6 months
The proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 6 months following study enrollment. The primary outcome is expressed as a binary variable, defined as PLHIV who are on ART and with sufficient HIV viral suppression (\<1000 copies/ml, WHO's threshold for virologic failure in LMICs) versus not on ART or viral failure (≥1000 copies/ml).
次要结局
- Durable 12-month Viral Suppression(12 months)
- 6-month Appointment Attendance(6 months)
- 12-month Mortality(12 months)
- Incidence of re-linkage to HIV care(12 months)
- 6 month retention in care(6 months)
- 12-month Appointment Attendance(12 months)
- 12-month Viral Suppression(12 months)
- Incidence of viral suppression(12 months)
- 12 month retention in care(12 months)
- Time to re-linkage to HIV care(12 months)
研究者
Sandra McCoy
Associate Professor in Residence
University of California, Berkeley