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（由申请人提供）：背景 - 许多感染HIV的男性想要孩子，使未感染的伴侣有获取艾滋病毒的风险。男人有动力生育未感染的孩子，但是大多数预防计划都不适应生育的欲望。生物医学预防的进步创造了减少周围感受HIV传播风险的机会。基于南非的形成性工作，我们开发了一种受感受的风险行为概念概念框架，用于开发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，包括早期艺术，适合那些想要有危险的孩子合作伙伴。方法 - 我们建议开发和试行一种组合干预措施，该干预措施利用男性在产前诊所HIV患病率为42％的南非地区拥有健康婴儿的动机。该草案采用了我们的概念框架，并使用了认知行为疗法技术，包括教育，交流，交流，交流，交流，技能，解决问题和动机访谈，以帮助男性与伴侣传达概念目标，支持艾滋病毒披露，了解血清章节，并采用并遵守更安全的概念行为（包括启动艺术）。在第1阶段，我们将通过定性方法和参与性发展过程进行磨练。在第2阶段，我们将进行干预的开放阶段，迭代试验，以增强可接受性和保留率。在第3阶段，我们将对希望有未感染或未知地位的女性伴侣的儿童进行最终干预的试验随机对照试验。男性将被随机分为干预措施，而与时间匹配的工作培训比较条件。两臂都将提供早期艺术。主要结果将是6个月的HIV RNA抑制。次要结果包括早期的艺术吸收，依从性，血清披露披露，夫妻艾滋病毒咨询和测试摄取，以及将未受保护的性别限制为峰值生育力。创新 - 最大程度地减少所需概念的艾滋病毒传播对于减少性和围产期艾滋病毒的传播至关重要。我们建议开发和驾驶以患者为中心的更安全的概念干预措施，该干预措施在形成性工作中得到了良好的基础。我们的干预措施在解决我的生育目标的背景下解决艾滋病毒的风险降低方面是独一无二的，利用男人的欲望让未感染的孩子促进艾滋病毒的风险降低，并探索在艾滋病毒流行环境中预防早期艺术的吸收和遵守。我们的更安全概念专家（Matthews，Smit，Bangsberg），干预开发（Safren，Psaros，Harrison，Smit），南非的干预测试（SMIT，Harrison），Adherence（Bangsberg，Safren）和定性方法（Harrisonsonion of Harrisony Modects） ，Smit，Safren）可以成功完成这项工作。 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.