BACKGROUND Approximately 200 000 South Africans acquired HIV in 2021 despite the availability of universal HIV test and treat and pre-exposure prophylaxis (PrEP). The aim of this study was to test the effectiveness of sexual and reproductive health services or peer support, or both, on the uptake of serostatus neutral HIV services or reduction of sexually transmissible HIV. METHODS We did an open-label, 2 × 2 randomised factorial trial among young people in a mostly rural area of KwaZulu-Natal, South Africa. Inclusion criteria included being aged 16-29 years, living in the mapped geographical areas that were accessible to the area-based peer navigators, being willing and able to provide informed consent, and being willing to provide a dried blood spot for anonymous HIV testing and HIV viral load measurement at 12 months. Participants were randomly allocated by computer-generated algorithm to one of four groups: those in the standard-of-care group were referred to youth-friendly services for differentiated HIV prevention (condoms, universal HIV test and treat with antiretroviral therapy, and PrEP if eligible); those in the sexual and reproductive health services group received baseline self-collected specimens for sexually transmitted infection (STI) testing and referral to integrated sexual and reproductive health and HIV prevention services; those in the peer support group were referred to peer navigators for health promotion, condom provision, and facilitation of attendance for differentiated HIV prevention services; and those in the final group received a combination of sexual and reproductive health services and peer support. Coprimary outcomes were linkage to clinical services within 60 days of enrolment, proportion of participants who had sexually transmissible HIV at 12 months after enrolment, and proportion of sampled individuals who consented to participation and gave a dried blood spot for HIV testing at 12 months. Logistic regression was used for analyses, and adjusted for age, sex, and rural or peri-urban area of residence. This study is registered with ClinicalTrials.gov (NCT04532307) and is closed. FINDINGS Between March 2, 2020, and July 7, 2022, 1743 (75·7%) of 2301 eligible individuals were enrolled and followed up. 12-month dried blood spots were collected from 1168 participants (67·0%). The median age of the participants was 21 years (IQR 18-25), 51·4% were female, and 51·1% had secondary level education. Baseline characteristics and 12-month outcome ascertainment were similar between groups. 755 (43·3%) linked to services by 60 days. 430 (49·8%) of 863 who were in the sexual reproductive health services group were linked to care compared with 325 (36·9%) of 880 who were not in the sexual and reproductive health services group (adjusted odds ratio [aOR] 1·68; 95% CI 1·39-2·04); peer support had no effect: 385 (43·5%) of 858 compared with 370 (43·1%) of 885 (1·02, 0·84-1·23). At 12 months, 227 (19%) tested ELISA-positive for HIV, of whom 41 (18%) had viral loads of 400 copies per mL; overall prevalence of transmissible HIV was 3·5%. 22 (3·7%) of 578 participants in the sexual and reproductive health services group had transmissible HIV compared with 19 (3·3%) of 590 not in the sexual and reproductive health services group (aOR 1·12; 95% CI 0·60-2·11). The findings were also non-significant for peer support: 21 (3·3%) of 565 compared with 20 (3·3%) of 603 (aOR 1·03; 95% CI 0·55-1·94). There were no serious adverse events or deaths during the study. INTERPRETATION This study provides evidence that STI testing and sexual and reproductive health services create demand for serostatus neutral HIV prevention in adolescents and young adults in Africa. STI testing and integration of HIV and sexual health has the potential to reach those at risk and tackle unmet sexual health needs. FUNDING US National Institute of Health, Bill & Melinda Gates Foundation, and 3ie.

中文翻译：

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在南非夸祖鲁-纳塔尔省农村青少年和年轻人中，在有或没有同伴支持的情况下将 HIV 预防纳入性生殖健康服务的有效性 （Isisekelo Sempilo）：2 × 2 析因、开放标签、随机对照试验。


背景 尽管有普遍的 HIV 检测和治疗以及暴露前预防 （PrEP） 可用，但 2021 年仍有大约 200 000 名南非人感染了 HIV。本研究的目的是测试性和生殖健康服务或同伴支持或两者对接受血清状态中性 HIV 服务或减少性传播 HIV 的有效性。方法 我们在南非夸祖鲁-纳塔尔省（KwaZulu-Natal）以农村为主的年轻人中进行了一项开放标签、2 × 2 随机析因试验。纳入标准包括年龄在 16-29 岁之间，居住在基于区域的同伴导航员可以进入的地图地理区域，愿意并能够提供知情同意，并愿意在 12 个月时为匿名 HIV 检测和 HIV 病毒载量测量提供干血点。参与者通过计算机生成的算法被随机分配到四组中的一组：标准护理组的参与者被转介到青年友好型服务机构进行差异化的 HIV 预防（避孕套、普遍的 HIV 检测和抗逆转录病毒治疗，如果符合条件，还可以进行 PrEP）;性和生殖健康服务组的人接受了基线自我采集的样本，用于性传播感染 （STI） 检测，并转介到综合性和生殖健康以及 HIV 预防服务;同伴支持小组中的那些人被转介给同行导航员，以促进健康、提供避孕套和促进参加差异化的 HIV 预防服务;最后一组接受了性和生殖健康服务以及同伴支持的组合。 共同主要结局是入组后 60 天内与临床服务的联系、入组后 12 个月患有性传播 HIV 的参与者比例，以及同意参与并在 12 个月时提供干血点进行 HIV 检测的样本个体比例。使用 Logistic 回归进行分析，并根据年龄、性别和农村或城郊居住区域进行调整。这项研究已在 ClinicalTrials.gov （NCT04532307） 注册并已关闭。调查结果 在 2020 年 3 月 2 日至 2022 年 7 月 7 日期间，2301 名符合条件的个体中有 1743 名 （75·7%） 被纳入并进行了随访。从 1168 名参与者 （67·0%） 收集了 12 个月的干血斑。参与者的中位年龄为 21 岁 （IQR 18-25），51·4% 为女性，51·1% 受过中等教育。各组之间的基线特征和 12 个月结局确定相似。755 个 （43·3%） 在 60 天内与服务相关联。性生殖健康服务组的 863 名患者中有 430 名 （49·8%） 与护理有关，而非性和生殖健康服务组的 880 名患者中有 325 名 （36·9%）与护理有关（调整比值比 [aOR] 1·68;95% CI 1·39-2·04）;同伴支持没有效果：858 人中有 385 人 （43·5%） 与 885 人中有 370 人 （43·1%） （1·02， 0·84-1·23）。在 12 个月时，227 例 （19%） 的 HIV ELISA 检测呈阳性，其中 41 例 （18%） 的病毒载量为每毫升 400 个拷贝;可传播 HIV 的总体患病率为 3·5%。性和生殖健康服务组的 578 名参与者中有 22 名 （3·7%） 患有可传播的 HIV，而性与生殖健康服务组的 590 名参与者中有 19 名 （3·3%） 患有可传播的 HIV （aOR 1·12;95% CI 0·60-2·11）。 结果对同伴支持也不显著：565 人中有 21 人 （3·3%），而 603 人中有 20 人 （3·3%） （aOR 1·03;95% CI 0·55-1·94）。研究期间没有发生严重的不良事件或死亡。解释 本研究提供证据表明，STI 检测以及性和生殖健康服务在非洲青少年和年轻人中创造了对血清状态中性 HIV 预防的需求。性传播感染检测和艾滋病毒与性健康的整合有可能覆盖高危人群，并解决未满足的性健康需求。资助美国国立卫生研究院、比尔和梅琳达·盖茨基金会以及 3ie.