South Africa has the world’s largest HIV epidemic, but South African adolescent girls and young women (AGYW) acquire HIV at twice the rate of and seroconvert on average 5–7 years earlier than their male peers. Female caregivers (FC) are an untapped resource for HIV/STI prevention in South Africa and offer a novel opportunity to strengthen AGYW prevention efforts. This study will evaluate the effectiveness and cost-effectiveness of an evidence-based mother-daughter HIV/STI prevention program tested in the United States and adapted for South Africa, Informed Motivated Aware and Responsible Adolescents and Adults (IMARA), to decrease STI incident infections and increase HIV testing and counseling (HTC) and PrEP uptake in AGYW. This is a 2-arm individually randomized controlled trial comparing IMARA to a family-based control program matched in time and intensity with 525 15–19-year-old Black South African AGYW and their FC-dyads in Cape Town’s informal communities. AGYW will complete baseline, 6-, and 12-month assessments. Following randomization, AGYW-FC dyads will participate in a 2-day group workshop (total 10 h) that includes joint and separate mother and daughter activities. Primary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 6 months. Secondary outcomes are AGYW STI incidence, HTC uptake, and PrEP uptake at 12 months, sexual behavior (e.g., condom use, number of partners), HIV incidence, and ART/PrEP adherence and intervention cost-effectiveness. AGYW who test positive for a STI will receive free treatment at the study site. HIV positive participants will be referred to ART clinics. Primary prevention remains the most viable strategy to stem new STI and HIV transmissions. HIV and STI disparities go beyond individual level factors, and prevention packages that include supportive relationships (e.g., FC) may produce greater reductions in HIV-risk, improve HTC and PrEP uptake, and increase linkage, retention, and adherence to care. Reducing new HIV and STI infections among South African AGYW is global public health priority. ClinicalTrials.gov Number NCT04758390 , accepted 02/16/2021.

中文翻译：

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针对南非少女和年轻女性的母女 HIV/STI 预防计划的单独随机对照试验：IMARA-SA 研究方案

南非是世界上艾滋病毒流行最严重的国家，但南非少女和年轻女性 (AGYW) 感染艾滋病毒的速度是男性同龄人的两倍，而且血清转化时间平均比男性同龄人早 5-7 年。女性护理人员 (FC) 是南非艾滋病毒/性传播感染预防方面尚未开发的资源，并为加强 AGYW 预防工作提供了新的机会。本研究将评估基于证据的母女艾滋病毒/性传播感染预防计划的有效性和成本效益，该计划在美国进行了测试，并适用于南非知情、动机、意识和负责任的青少年和成人 (IMARA)，以减少性传播感染事件感染并增加 AGYW 中 HIV 检测和咨询 (HTC) 以及 PrEP 的采用。这是一项 2 组单独随机对照试验，将 IMARA 与在时间和强度上相匹配的基于家庭的控制计划与开普敦非正式社区的 525 名 15-19 岁南非黑人 AGYW 及其 FC 双人组进行比较。AGYW 将完成基线、6 个月和 12 个月评估。随机分组后，AGYW-FC 两人将参加为期 2 天的小组研讨会（总共 10 小时），其中包括联合和单独的母女活动。主要结局是 6 个月时 AGYW STI 发病率、HTC 摄入量和 PrEP 摄入量。次要结局是 AGYW STI 发病率、HTC 摄入量和 12 个月时 PrEP 摄入量、性行为（例如安全套使用、性伴侣数量）、HIV 发病率以及 ART/PrEP 依从性和干预成本效益。性传播感染检测呈阳性的 AGYW 将在研究中心接受免费治疗。HIV 阳性参与者将被转介至 ART 诊所。初级预防仍然是阻止新的性传播感染和艾滋病毒传播的最可行策略。HIV 和 STI 的差异超出了个人层面的因素，包括支持性关系（例如 FC）在内的预防方案可能会更大程度地降低 HIV 风险，提高 HTC 和 PrEP 的吸收率，并增加对护理的联系、保留和依从性。减少南非 AGYW 中新发的艾滋病毒和性传播感染感染是全球公共卫生的优先事项。ClinicalTrials.gov 编号 NCT04758390，于 2021 年 2 月 16 日接受。