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

为想要孩子的艾滋病毒南非男性提供基于 ART 的更安全受孕

• 批准号: 8795224
• 负责人: Lynn T Matthews
• 金额: $ 17.25万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-02-01 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8795224
• 关键词: AIDS prevention; Address; Adherence; Adopted; Affect; African; Anti-Retroviral Agents; Behavior; Child; Clinic; Cognitive Therapy; Communication; Communities; Conceptions; Counseling; Couples; Data; Development; Disclosure; Education; Face; Female; Fertility; Focus Groups; Gender Relations; Goals; HIV; HIV risk; Health; Health Personnel; Individual; Infection; Intervention; Interview; Knowledge; Life; Manuals; Measures; Mediator of activation protein; Motivation; Occupations; Participant; Patients; Perinatal; Phase; Positioning Attribute; Pregnancy; Prevalence; Prevention; Prevention program; Prevention strategy; Preventive Intervention; Problem Solving; Procedures; Process; Prophylactic treatment; Qualitative Methods; RNA; Randomized; Randomized Controlled Trials; Relative (related person); Reporting; Risk; Risk Behaviors; Risk Reduction; Science; Sexual Transmission; South Africa; Techniques; Testing; Time; Training; Unsafe Sex; Viral Load result; Woman; Work; arm; base; condoms; design; efficacy trial; high risk; innovation; male; men; motivational enhancement therapy; offspring; patient oriented; pilot trial; primary outcome; programs; reproductive; secondary outcome; sex; skills; therapy development; transmission process; treatment adherence; uptake

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.

描述(申请人提供)：背景-许多感染艾滋病毒的男性渴望孩子，使未感染的伴侣面临感染艾滋病毒的风险。男性的动机是生下未感染的孩子，但大多数预防计划并不满足生育愿望。生物医学预防的进步创造了降低围产期艾滋病毒传播风险的机会。基于南非的形成性工作，我们开发了一个围绝经期风险行为概念框架，我们将其应用于开发以男性为重点的更安全的受孕干预措施，以促进披露和预防干预措施，包括早期ART，适用于希望与高危伴侣生育孩子的男性。方法-我们建议在产前诊所艾滋病毒流行率为42%的南非地区开发和试验一种组合干预措施，利用男性的动机生下健康的婴儿。干预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、沟通技能、解决问题和动机访谈，以帮助男性与伴侣沟通受孕目标，支持艾滋病毒披露，了解血清不一致性，并采用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磨练干预措施。在第二阶段，我们将对干预措施进行开放阶段的迭代试点，以提高可接受性和保留率。在第三阶段，我们将在120名男性中进行最终干预的试点随机对照试验，这些男性希望与未感染或身份不明的女性伴侣生育孩子。男性将被随机分为干预组和时间匹配的工作培训比较组。双方都将提供早期抗逆转录病毒治疗；主要结果将是在6个月后抑制艾滋病毒RNA。次要结果包括早期ART摄取、坚持、血清状态披露、夫妇艾滋病毒咨询和检测摄取，以及限制无保护措施的性行为以达到生育高峰。创新--在预期受孕的情况下尽量减少艾滋病毒传播对于减少性传播和围产期传播至关重要。我们建议开发和试点以患者为中心的更安全的概念干预，这是建立在形成工作的良好基础上的。在我的生育目标背景下，我们的干预措施在解决降低艾滋病毒风险方面是独一无二的，利用男性生育未感染儿童的愿望来促进降低艾滋病毒风险，并探索在艾滋病毒流行的环境中采用和坚持早期抗逆转录病毒疗法。我们在SAFER概念(马修斯、SMIT、邦斯伯格)、干预开发(SAFREN、PSAROS、哈里森、SMIT)、南非干预测试(SMIT、哈里森)、依从性(邦斯伯格、SAFREN)和定性方法(哈里森、SMIT、SAFREN)方面的专家团队能够很好地完成这项工作。意义--这项建议将提供可接受性和可行性数据以及初步效果大小估计，以设计一项随机对照疗效试验，以测试更安全的受孕干预措施，为希望与高危伴侣怀孕的艾滋病毒感染男性推广早期抗逆转录病毒治疗。