Corrections2Community: Post-release Retention in HIV Care for Ex-inmates in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Number of Participants in Care at Six Months
研究概览
简要总结
HIV remains the leading cause of death in South Africa as a result of a failure of people living with HIV to seek HIV treatment and be retained in care. After initiating antiretroviral therapy while incarcerated, most ex-inmates fail to remain engaged in care. The goal of this research is to reduce mortality, morbidity, and HIV transmission by developing an actionable approach to retaining these individuals in HIV care.
详细描述
To pilot a randomized clinical trial (RCT) of a transition adherence club (TCAC) versus traditional care, among ex-inmates receiving antiretroviral therapy in South Africa, to study feasibility, acceptability, and preliminary effectiveness using mixed methods.
Investigators will pilot an RCT of the TCAC compared to traditional care among inmates/ex-inmates measuring transition in care, six-month viral load suppression, and follow-up of participants. Feasibility will be assessed by process measures. Acceptability will be assessed using in-depth interviews among 36 participants and 10 staff. Effectiveness will be assessed by a difference in proportions in-care with an undetectable viral load at 6 months and difference in bonding social capital and care satisfaction between arms.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Intervention arm will be masked to the field researchers and the investigators until unblinding during final analysis.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently incarcerated (either an offender/sentenced inmates or awaiting trial inmate/remandee)
- •Housed at one of the study correctional facilities (including participating satellite centres)
- •Diagnosed with HIV
- •Currently receiving antiretroviral therapy
- •Anticipated release or trial date within 3 months of study enrollment
- •Self-report expected to reside within Ekurhuleni, Tshwane, or Johannesburg districts of Gauteng Province and within proximity to one of the TCAC sites (within 20 km, 45 minute travel time, or two local taxi minibus rides)
- •Agree to post-discharge follow-up
- •Medically stable based on DCS health assessment (including not pregnant)
- •On antiretroviral therapy (ART) for >3 months at the expected time of corrections release
排除标准
- •Failure to provide informed consent to be followed up by study staff after release
- •Unable to speak one of the study languages (English, Sesotho, isiXhosa, isiZulu, Setswana, Xitsonga, and Afrikaans)
结局指标
主要结局
Number of Participants in Care at Six Months
时间窗: 6 months after corrections release
Self-reported in TCAC or routine DoH clinical care
次要结局
- Proportion of Participants Verified in Care at Six Months(6 months after corrections release)
- Time to Linkage to HIV Care(6 months after corrections release)
- Proportion of Participants Linked to Care Within 90 Days of Corrections Release(90 days after corrections release)
- Difference in Bonding Social Capital Score at Six Months(6 months after corrections release)
- Feasibility of Implementation of Transition Community Adherence Clubs Per Protocol (Composite Score)(6 months after corrections release)
- Viral Suppression (HIV RNA <400 c/mL) at Six Months(6 months after corrections release)
- Acceptability of Transition Community Adherence Clubs(6 months after corrections release)
- Difference in Ex-inmate Stigma Index Score at Six Months(6 months after corrections release)
- Difference in HIV Stigma Index Score at Six Months(6 months after corrections release)
- Proportion of Participants Employed or Self-employed(6 months after corrections release)