Optimizing the Efficiency and Implementation of Cash Transfers to Improve Adherence to Antiretroviral Therapy, Phase II: Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,984
- 试验地点
- 2
- 主要终点
- 12-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 12 months post-ART initiation among PHWHIV who have initiated ART within the past 30 days. Randomization will take place at the clinic level (HIV primary care clinics), and eligible participants attending intervention clinics will have the opportunity to receive up to 6 consecutive monthly cash transfers of 22,500 TSH (~$10) each, conditional on visit attendance with the HIV care provider. The study will take place at 32 clinics across four regions in Tanzania: Gaeta, Mwanza, Kagera and Shinyanga. The primary endpoint is viral suppression at 12 months, defined as the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Facility staff will not be blinded to intervention assignment. However, all other research staff will be blinded to intervention assignment. In addition, participants will not be told during the consent process that as part of the study there are intervention and control clinics. The rationale for this is to prevent patients transferring from intervention to control clinics if they find out that there are some clinics offering cash transfers to new ART clients. Large numbers of transferring patients will compromise the integrity of the study and will create an undue burden for facility staff at intervention clinics.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Greater than or equal to 18 years of age
- •Living with HIV infection
- •Initiated on antiretroviral therapy less than or equal to 1 month prior to enrollment in the study
- •Have access to a mobile phone (ownership, shared ownership, or access to a trusted person's phone)
- •Do not intend to transfer to a different facility for HIV care within the following 12 months.
排除标准
- 未提供
结局指标
主要结局
12-month Viral Suppression
时间窗: 12 months
the proportion of people living with HIV (PLHIV) retained in HIV primary care and with suppressed HIV viral load 12 months after starting ART. 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
- Appointment Attendance(12 months)
- 6-month Viral Suppression(6 month)
- Proportion Virally Suppressed(12 months)
研究者
Sandra McCoy
Associate Professor in Residence
University of California, Berkeley