Intervention to Improve HIV Care Retention and Antiretroviral Adherence in Stigmatized Environments
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,771
- 试验地点
- 4
- 主要终点
- Medical Records of Care Appointments
研究概览
简要总结
Retention in care and persistent adherence to antiretroviral therapy are necessary for the successful treatment of HIV infection. HIV-related stigma is a known impediment to the care and health outcomes of people living with HIV. The proposed study will test theory-based interventions designed to manage HIV stigma in order to improve care retention and medication adherence in communities with high-levels of HIV-related stigma.
详细描述
This trial is conducting a randomized test of a behavioral self-management intervention designed to improve HIV treatment outcomes in people living with HIV in stigmatized contexts. The trial includes a control arm and a non-stigma enhanced treatment adherence intervention arm. Participants living in an economically under-resourced area of South Africa are recruited through clinical care settings. The goal of the research is to examine whether directly addressing HIV stigma and medication adherence management improves treatment outcomes beyond those observed from a standard behavioral intervention without added stigma-addressing components.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study condition masking
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
- •18 years of age or older
- •current clinic visit to receive cART in differentiated care outside of an adherence club
- •unsuppressed HIV at the most recent clinical testing confirmed in run-in
- •access to a phone
排除标准
- •Not meeting inclusion
结局指标
主要结局
Medical Records of Care Appointments
时间窗: 12-months
Medical records are retrospectively collected for all scheduled care visits and coded for whether the visits were attended.The records are exclusively from the clinic where patients are initially recruited and with patient permission. The data obtained are expressed as the ratio of the number of care appointments attended relative to the number scheduled.
Blood Plasma RNA
时间窗: 12-months
Collection of dried blood spots are tested for HIV RNA (viral load) using PCR tests with results expressed as the number of RNA copies per mL of blood plasma.
次要结局
- Antiretroviral Medication Adherence(12-months)