An individually randomized controlled trial of a mother-daughter HIV/STI prevention program for adolescent girls and young women in South Africa: IMARA-SA study protocol.

An individually randomized controlled trial of a mother-daughter HIV/STI prevention program for adolescent girls and young women in South Africa: IMARA-SA study protocol.
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DOI:
10.1186/s12889-021-11727-3
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发表时间:
2021-09-20
期刊:
影响因子:
4.5
通讯作者:
Bekker LG
Bekker LG
中科院分区:
医学2区
文献类型:
--
作者:
Donenberg GR;Atujuna M;Merrill KG;Emerson E;Ndwayana S;Blachman-Demner D;Bekker LG

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南非是世界上艾滋病毒流行最多的国家,但南非少女和年轻妇女感染艾滋病毒的速度是同龄男性的两倍,血清转化平均比同龄男性早5-7年。在南非,女性护理人员是艾滋病毒/性传播感染预防工作的一个尚未开发的资源,为加强女青年预防工作提供了一个新的机会。本研究将评估在美国测试并适用于南非的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,知情、有动机、有意识和负责任的青少年和成人(IMARA),以减少性传播感染事件,增加艾滋病毒检测和咨询(HTC)和PrEP在AGYW的吸收。这是一项2臂单独随机对照试验,比较了IMARA与基于家庭的控制计划,该计划在时间和强度上与开普敦非正式社区的525名15-19岁的南非黑人AGYW及其FC-二人组相匹配。AGYW将完成基线、6个月和12个月的评估。随机分组后,AGYW-FC二人组将参加为期2天的小组研讨会(共10小时),其中包括联合和单独的母亲和女儿活动。主要结果是6个月时的AGYW STI发病率、HTC摄取率和PrEP摄取率。次要结果是AGYW STI发病率、HTC摄取率和12个月时的PrEP摄取率、性行为(例如,避孕套的使用、性伙伴的数量)、艾滋病毒的发病率、抗逆转录病毒疗法/预防前预防措施的坚持和干预措施的成本效益。性病检测呈阳性的AGYW将在研究中心接受免费治疗。艾滋病毒阳性参与者将被转介到抗逆转录病毒治疗诊所。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战略。艾滋病毒和性传播感染方面的差异超出了个人层面的因素,以及包括支持关系在内的一揽子预防措施(例如,FC)可以更大程度地降低艾滋病毒风险,改善HTC和PrEP的吸收,并增加联系,保留和坚持护理。减少南非AGYW中新的艾滋病毒和性传播感染是全球公共卫生的优先事项。ClinicalTrials.gov编号NCT 04758390,于2021年2月16日接受。
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.
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