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
- 2
- 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
研究组 & 干预措施
Uniform Standard of Care Counseling
Routine HIV counseling services available to patients with protocol delivered services. Three sessions of patient education monitored for protocol adherence.
干预措施: Uniform Standard of Care Counseling (Behavioral)
Behavioral Self-Regulation Skills Counseling
Mobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context. This is a culturally tailored adaptation of CDC disseminated Phone-Delivered Support Counseling for HIV treatment Adherence.
干预措施: Behavioral Self-Regulation Skills Counseling (Behavioral)
Behavioral Self-Regulation Skills Counseling + Stigma Management
Mobile phone-delivered counseling grounded in Behavioral Self- Regulation Theory with stigma management to improve retention in HIV care and HIV viral suppression. Counseling is delivered by lay counselors in differentiated health care context with added components directly targeting stigma-related experiences and concerns.
干预措施: Behavioral Self-Regulation Skills Counseling + Stigma Management (Behavioral)
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)