ART-based safer conception for HIV+ South African men who want to have children

描述（由申请人提供）：背景-许多艾滋病毒感染的男子希望孩子，把未感染的合作伙伴在获得艾滋病毒的风险。男性有动机生育未感染的孩子，但大多数预防计划并不满足生育的愿望。生物医学预防的进步为降低围产期艾滋病毒传播风险创造了机会。基于在南非的形成性工作，我们开发了一个感知风险行为概念框架，我们应用它来开发一个以男性为中心的更安全的概念干预措施，以促进披露和预防干预措施，包括早期ART，为那些想要与有风险的伴侣生孩子的男性。方法-我们建议在南非一个产前诊所艾滋病流行率为42%的地区开发和试点一种综合干预措施，利用男性生育健康婴儿的动机。该干预措施草案应用我们的概念框架，并使用认知行为治疗技术，包括教育，沟通技巧，解决问题和动机访谈，以帮助男性与伴侣沟通受孕目标，支持艾滋病披露，了解血清不一致，并采取和坚持更安全的受孕行为（包括启动ART）。在第一阶段，我们将通过定性方法和参与性发展过程来完善干预措施。在第二阶段，我们将进行一个开放阶段，干预的迭代试点，以提高可接受性和保留。在第3阶段，我们将在120名希望与未感染或未知状态的女性伴侣生育子女的男性中进行最终干预的试点随机对照试验。男性将被随机分为干预组和时间匹配的工作培训对照组。两组均提供早期抗逆转录病毒治疗;主要结局为6个月时的HIV RNA抑制。次要结果包括早期ART吸收，坚持，血清状态披露，夫妇艾滋病毒咨询和检测吸收，并限制无保护的性行为，以达到生育高峰。创新-在理想的受孕情况下最大限度地减少艾滋病毒传播，对于减少性传播和围产期艾滋病毒传播至关重要。我们建议开发和试点以患者为中心的更安全的概念干预，这是良好的基础上形成的工作。我们的干预措施在以下方面是独一无二的：在我的生育目标的背景下解决艾滋病毒风险降低问题，利用男性希望生育未感染儿童的愿望来促进艾滋病毒风险降低，并探索在艾滋病毒流行的情况下接受和坚持早期抗逆转录病毒治疗以预防艾滋病毒。我们的专家团队在更安全的概念（马修斯，Smit，Bangsberg），干预开发（Safren，Psaros，Harrison，Smit），在南非的干预测试（Smit，Harrison），坚持（Bangsberg，Safren）和定性方法（Harrison，Smit，Safren）是很好的定位，成功地完成这项工作。意义-该提案将提供可接受性和可行性数据以及初步效应量估计，以设计一项随机对照疗效试验，测试一种更安全的受孕干预措施，促进希望与高危伴侣受孕的HIV感染男性的早期ART。

DESCRIPTION (provided by applicant): Background- Many HIV-infected men desire children, putting uninfected partners at risk for acquiring HIV. Men are motivated to have uninfected children, yet most prevention programs do not accommodate fertility desires. Advances in biomedical prevention create opportunities to reduce periconception HIV transmission risk. Based on formative work in South Africa, we developed a Periconception Risk Behavior Conceptual Framework that we apply to develop a male-focused safer conception intervention to promote disclosure and prevention interventions, including early ART, for men who want to have children with at-risk partners. Approach- We propose to develop and pilot a combination intervention that leverages men's motivations to have healthy babies in a South African district where antenatal clinic HIV prevalence is 42%.The draft intervention applies our conceptual framework and uses cognitive behavior therapy techniques including education, communication skills, problem-solving and motivational interviewing to help men communicate conception goals with partners, support HIV disclosure, understand serodiscordance, and adopt and adhere to safer conception behaviors (including initiating ART). In Phase 1 we will hone the intervention through qualitative methods and a participatory development process. In Phase 2 we will conduct an open phase, iterative pilot of the intervention to enhance acceptability and retention. In Phase 3 we will conduct a pilot randomized controlled trial of the final intervention among 120 men who want to have children with uninfected or unknown status female partners. Men will be randomized into the intervention versus a time- matched jobs training comparison condition. Early ART will be offered in both arms; the primary outcome will be HIV RNA suppression at 6 months. Secondary outcomes include early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility. Innovation- Minimizing HIV transmission in the context of desired conception is critical to reducing sexual and perinatal HIV transmission. We propose to develop and pilot a patient-centered safer conception intervention which is well-grounded in formative work. Our intervention is unique in addressing HIV risk reduction in the context of the fertility goals of me, leveraging the desires of men to have uninfected children to promote HIV risk reduction, and exploring uptake and adherence to early ART for prevention in an HIV-endemic setting. Our team of experts in safer conception (Matthews, Smit, Bangsberg), intervention development (Safren, Psaros, Harrison, Smit), intervention testing in South Africa (Smit, Harrison), adherence (Bangsberg, Safren), and qualitative methods (Harrison, Smit, Safren) is well positioned to successfully complete this work. Significance- This proposal will provide acceptability and feasibility data and initial effect size estimates to design a randomized controlled efficacy trialto test a safer conception intervention promoting early ART for HIV-infected men who want to conceive with at-risk partners.