Integrating U=U Into HIV Counseling in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 5
- 主要终点
- Documented HIV Viral Load <200 Copies/mL at 3-10 Months
研究概览
简要总结
The near-elimination of HIV transmission with antiretroviral therapy (ART) has provided the world with a clear path to end the HIV epidemic through the mass provision of ART at diagnosis, i.e. test-and-treat. Despite the substantial prevention benefits of ART, the investigators found minimal knowledge of treatment-as-prevention (TasP) in two population-based surveys recently conducted in South Africa. In addition, current public health messaging and clinical HIV counselling in South Africa do not emphasize the prevention benefits of ART.
In this formative research study the investigators developed an app-based educational video intervention that provides information on Undetectable = Untransmittable (U=U) that is locally-appropriate and can be integrated into routine HIV counselling. The intervention was be piloted in a clinical trial of patients in South Africa receiving HIV post-test and adherence counselling services, to determine feasibility and acceptability, impact on U=U knowledge and attitudes, impact on stigma and psychological well being, and preliminary evidence for ART uptake and adherence.
The study builds on a longstanding collaboration between Boston University and the Health Economics and Epidemiology Research Office (HE2RO) at the University of Witwatersrand in Johannesburg, South Africa. The study is highly innovative because the investigators take a novel approach - disseminating information on the prevention benefits of ART - to improve the wellbeing of people living with HIV (PLWH) and motivate early uptake of ART in South Africa.
The investigators hypothesized that disseminating information about U=U and treatment-as-prevention could increase ART adherence, retention, and viral suppression, enabling countries to maximize the impact of test-and-treat.
详细描述
We developed a U=U-focused HIV treatment literacy App called "Undetectable & You", to integrate U=U into HIV counseling in South Africa. We then piloted the App in a randomized clinical trial.
The randomized pilot trial was conducted at three public sector clinics in Johannesburg, South Africa, to establish intervention acceptability, effects on knowledge and attitudes, and preliminary impact on ART uptake, adherence, retention, and viral suppression (n=135).
Patients completing HIV post-test or adherence counseling were referred to study staff and randomized 1:1 to no intervention (Arm A) vs. a ~20min interaction with "Undetectable & You", a tablet-based App developed to disseminate information about U=U via PLHIV testimonials (Arm B). Participants in Arm B also received monthly text messages reinforcing intervention content. The order of the messages was randomized to ascertain whether different messages were better at driving engagement with the App.
Investigators assessed feasibility and acceptability of the "Undetectable & You" App, resonance of different key messages and videos in the App, and its impact on knowledge and attitudes related to TasP. Additionally, ART uptake, appointment adherence, retention on treatment, and viral monitoring were assessed in clinical records through six months, with VL data collected through 10 months. Qualitative exit interviews were conducted with participants and clinic staff (n=30).
In addition to the primary and secondary outcomes specified below, we assessed for effect modification in the primary outcome of viral suppression by key constructs of our theoretical model and participant demographics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •receiving HIV care at a public sector health facility in South Africa
- •Speaks English, Zulu, or Sotho
排除标准
- 未提供
结局指标
主要结局
Documented HIV Viral Load <200 Copies/mL at 3-10 Months
时间窗: 3-10 months
As documented in linked clinical records. The first viral load (VL) value taken during the period 3-10 months after baseline. Outcome will be defined as documented viral suppression among all patients: 1 = VL\<200; 0 = VL\>=200 OR no documented VL. The 200 copy threshold matches WHO definition for "zero transmission risk".
次要结局
- Started ART Within 30 Days of Baseline(0-1 month)
- ART Refills Beyond 30 Days(1-6 month)
- ART Uptake and First Refill Within 60 Days (Composite Outcome)(0-2 months)
- Retained in Care at 1-2 Months(1-2 months)
- Retained in Care at 3-4 Months(3-4 months)
- Retained in Care at 5-6 Months(5-6 months)
- Viral Load Monitoring at 3-10 Months(3-10 months)
- Mean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed(after intervention (on average 6 months))