Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK.
Malawi-Liverpool-Wellcome Trust Clinical Research Unit, Blantyre, Malawi.
BMC Public Health. 2018 Nov 6;18(1):1234. doi: 10.1186/s12889-018-6120-3.
BACKGROUND: Knowledge of HIV status remains below target in sub-Saharan Africa, especially among men and adolescents. HIV self-testing (HIVST) is a novel approach that enables unique distribution strategies, with potential to be highly decentralised and to provide complementary coverage to facility-based testing approaches. However, substantial gaps in evidence remain on the effectiveness and cost-effectiveness of HIVST, particularly in rural settings, and on approaches to facilitate linkage to confirmatory HIV testing, prevention, and treatment services. This protocol describes two cluster-randomized trials (CRT) included within the UNITAID/PSI HIV Self-Testing Africa (STAR) project. METHODS: Two independent CRTs were designed around existing reproductive health programmes in rural Malawi and rural/peri-urban Zambia. Common features include use of constrained randomisation to allocate health clinic catchment areas to either standard HIV testing (SOC) or SOC plus community-based distribution of OraQuick HIV Self Tests (Bethlehem, PA USA, assembled in Thailand) by trained lay distributors selected by the community. Community-based distribution agents will be trained (3-day curriculum) to provide brief demonstration of kit use and interpretation, information and encouragement to access follow up services, and management of social harm. The primary outcome of both CRTs is the proportion of the population aged 16 years and older who tested for HIV within the 12-month intervention period. Secondary outcomes in both trials include lifetime HIV testing, antiretroviral therapy (ART) initiation and ART use. Circumcision status among males will be a secondary outcome in Zambia and clinic-level demand for ART will be a secondary outcome in Malawi. Outcomes will be measured using cross-sectional household surveys, and routine data extraction from participating clinics. Costing studies will be used to evaluate the cost-effectiveness of the intervention arm. Qualitative research will be used to guide distribution and explore reasons for testing and linkage to onward care. DISCUSSION: The STAR-Malawi and STAR-Zambia trials will provide rigorous evidence of whether community-based lay HIVST distribution is an effective and cost-effective approach to increasing coverage of HIV testing and demand for follow-on HIV services in rural and peri-urban communities in sub-Saharan Africa. TRIAL REGISTRATION: Clinicaltrials.gov, Malawi: NCT02718274 , 18 March 2016; Zambia: NCT02793804 , 3 June 2016. Protocol date: 21 February 2018.
背景：在撒哈拉以南非洲，艾滋病毒知识仍然低于目标，尤其是在男性和青少年中。艾滋病毒自我检测（HIVST）是一种新方法，能够实现独特的分发策略，具有高度分散的潜力，并为基于机构的检测方法提供补充覆盖。然而，HIVST 的有效性和成本效益，特别是在农村环境中，以及促进与确认性 HIV 检测、预防和治疗服务联系的方法方面，仍然存在大量证据差距。本方案描述了 UNITAID/PSI 艾滋病毒自我检测非洲（STAR）项目内包含的两项集群随机试验（CRT）。
方法：两项独立的 CRT 围绕马拉维农村和赞比亚农村/城市周边地区现有的生殖健康方案设计。共同特点包括使用约束随机化将卫生诊所的覆盖范围分配给标准 HIV 检测（SOC）或 SOC 加由社区选择的经过培训的非专业分发员进行社区分发OraQuick HIV 自我检测（美国宾夕法尼亚州伯利恒，在泰国组装）。社区分发代理将接受培训（3 天课程），以提供试剂盒使用和解释、信息和鼓励获得后续服务以及管理社会危害的简要演示。两项 CRT 的主要结果是在 12 个月干预期间接受 HIV 检测的 16 岁及以上人群的比例。两项试验中的次要结果均包括一生中 HIV 检测、抗逆转录病毒治疗（ART）开始和 ART 使用。在赞比亚，男性的割礼状况将是次要结果，而在马拉维，诊所一级对 ART 的需求将是次要结果。使用横断面家庭调查和参与诊所的常规数据提取来衡量结果。成本研究将用于评估干预组的成本效益。定性研究将用于指导分发并探讨检测和与后续护理联系的原因。
讨论：STAR-马拉维和 STAR-赞比亚试验将提供严格的证据，证明社区为基础的非专业 HIVST 分发是否是增加撒哈拉以南非洲农村和城市周边社区 HIV 检测覆盖率和对后续 HIV 服务需求的有效和具有成本效益的方法。
试验注册：Clinicaltrials.gov，马拉维：NCT02718274，2016 年 3 月 18 日；赞比亚：NCT02793804，2016 年 6 月 3 日。方案日期：2018 年 2 月 21 日。
Clin Infect Dis. 2018-4-3
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