Background

HIV self-testing can overcome barriers to HIV testing, but its potential as an HIV prevention strategy for women in sub-Saharan Africa has not been assessed. We examined whether sustained provision of self-tests to women promotes testing among sexual partners and reduces HIV incidence.

Methods

We conducted a pair-matched cluster-randomised trial in 66 community clusters in Siaya County, Kenya. Clusters were communities with a high prevalence of transactional sex, including beach communities along Lake Victoria and inland communities with hotspots for transactional sex such as bars and hotels. Within clusters, we recruited HIV-negative women aged 18 years or older with two or more sexual partners within the past 4 weeks. In each of the 33 cluster pairs, we randomly assigned clusters to an intervention and comparison group. In intervention clusters, we provided participants with multiple self-tests at regular intervals and encouraged secondary distribution of self-tests to sexual partners. In comparison clusters, we provided participants referral cards for facility-based testing. Follow-up visits and HIV testing occurred at 6-month intervals for up to 24 months. The primary outcome of HIV incidence among all participants who contributed at least one HIV test was analysed using discrete-time mixed effects models. This study is registered with ClinicalTrials.gov, NCT03135067.

Findings

Between June 4, 2017, and Aug 31, 2018, we enrolled 2090 participants (1033 in the 33 intervention clusters and 1057 in the 33 comparison clusters). Participants’ median age was 25 years (IQR 22–31) and 1390 (66·6%) of 2086 participants reported sex work as an income source. 1840 participants completed the 18-month follow-up and 570 participants completed the 24-month follow up, which ended on March 25, 2020, with a median follow-up duration of 17·6 months. HIV incidence was not significantly different between the intervention and comparison groups (1·2 vs 1·0 per 100 person-years; hazard ratio 1·2, 95% CI 0·6–2·3, p=0·64). Social harms related to study participation occurred in three participants (two in the intervention group and one in the comparison group).

Interpretation

Sustained provision of multiple self-tests to women at high risk of HIV infection in Kenya enabled secondary distribution of self-tests to sexual partners but did not affect HIV incidence.

Funding

National Institute of Mental Health; Center for Health Incentives and Behavioral Economics; National Institute of Allergies and Infectious Diseases; University of Pennsylvania Center for AIDS Research.

中文翻译：

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为女性提供持续的 HIV 自我检测机会对肯尼亚男性伴侣检测、夫妻检测和 HIV 发病率的影响：一项整群随机试验

背景

HIV 自我检测可以克服 HIV 检测的障碍，但其作为撒哈拉以南非洲妇女 HIV 预防策略的潜力尚未得到评估。我们检查了持续向女性提供自我检测是否会促进性伴侣之间的检测并降低 HIV 发病率。

方法

我们在肯尼亚锡亚亚县的 66 个社区集群中进行了配对配对集群随机试验。集群是性交易盛行的社区，包括维多利亚湖沿岸的海滩社区和酒吧和酒店等性交易热点的内陆社区。在集群中，我们招募了在过去 4 周内有两个或更多性伴侣的 18 岁或以上的 HIV 阴性女性。在 33 个集群对中的每一对中，我们将集群随机分配到干预组和对照组。在干预集群中，我们定期为参与者提供多项自我测试，并鼓励将自我测试二次分发给性伴侣。在比较集群中，我们为参与者提供了基于设施的测试的推荐卡。随访和 HIV 检测每隔 6 个月进行一次，持续长达 24 个月。使用离散时间混合效应模型分析了至少进行过一次 HIV 检测的所有参与者的 HIV 发病率的主要结果。本研究已在 ClinicalTrials.gov 注册，NCT03135067。

发现

2017 年 6 月 4 日至 2018 年 8 月 31 日期间，我们招募了 2090 名参与者（33 个干预群组中的 1033 人和 33 个比较群组中的 1057 人）。参与者的中位年龄为 25 岁 (IQR 22–31)，2086 名参与者中有 1390 人 (66·6%) 将性工作作为收入来源。1840 名参与者完成了 18 个月的随访，570 名参与者完成了 24 个月的随访，截至 2020 年 3 月 25 日，中位随访时间为 17·6 个月。干预组和对照组之间的 HIV 发病率没有显着差异（每 100 人年1·2对1·0；风险比 1·2，95% CI 0·6–2·3，p=0·64）。三名参与者（干预组两名，对照组一名）发生了与研究参与相关的社会危害。

解释

肯尼亚持续向 HIV 感染高危妇女提供多项自我检测，使自我检测二次分发给性伴侣成为可能，但并未影响 HIV 发病率。

资金

国家心理健康研究所；健康激励和行为经济学中心；国家过敏和传染病研究所；宾夕法尼亚大学艾滋病研究中心。