Randomized Controlled Trial to Enhance Dual Protection Among PLHIV in India

描述(由申请人提供)：这个由耶鲁大学、康涅狄格大学和印度艾滋病毒/艾滋病患者印度网络(INP+)合作的项目提供了一个独特的机会，可以进行社会和行为科学研究，旨在扩大印度已婚艾滋病毒携带者(PLHIV)的双重避孕方法(持续使用避孕套和持续使用另一种有效的避孕方法)的使用。这将防止意外怀孕和可能将艾滋病毒垂直传播给婴儿，防止从非一夫一妻制配偶那里获得性传播感染，防止将艾滋病毒传播给血清不一致的配偶，并防止血清一致的配偶之间传播抗药性或更具致病性的艾滋病毒菌株。该项目将根据信息-动机-行为技能(IMB)理论框架和激励性访谈技术，设计、实施和评估经过修改的、完全适应文化的先前验证的旨在降低艾滋病病毒性行为风险的干预措施。我们项目的具体目标是：1)设计、试行和改进一种理论驱动(IMB模式)、适应文化、由同伴辅导员提供的干预措施，以帮助印度泰米尔纳德邦INP+患者的已婚男性和女性，他们是INP+的客户，并且不打算在未来两年内开始怀孕，采用双重避孕方法。这项干预措施将提供给已婚个人，而不是夫妇；以及2)进行一项分组随机对照试验，以比较第一个特定目标中开发的干预措施与印度泰米尔纳德邦从INP+获得地区一级服务的艾滋病毒携带者已婚男女之间的常规护理(UC)。随机化的单位将是地区。干预措施将在18个月内实施，并将在6个月、12个月、18个月和24个月进行评估。主要结果将是使用双重避孕方法。次要结果将是坚持单独使用避孕套、怀孕、性传播感染症状、接受过性传播感染的治疗以及IMB组件。假设：1)与接受UC的已婚PLHIV相比，接受干预的已婚PLHIV将更多地使用双重避孕方法，更少的婚姻怀孕，更少的STI症状和更少的STI治疗；2)与UC组相比，干预组对双重避孕方法的使用将持续24个月；以及3)干预导致双重避孕方法的使用增加将通过干预对IMB模型指定的避孕行为决定因素的影响而实现。据我们所知，这将是印度第一个以理论为导向的干预研究，以推广双重避孕方法。如果这项研究证明了有效性，干预将被整合到泰米尔纳德邦和整个印度的INP+日常护理中，并将在许多利用同伴外展工作者或同伴辅导员/教育者的印度环境中广泛适用。

DESCRIPTION (provided by applicant): This collaborative project between Yale University, the University of Connecticut, and the Indian Network for People Living with HIV/AIDS (INP+) in India provides a unique opportunity to conduct social and behavioral science research aimed at expanding the use of dual contraceptive methods (consistent condom use in combination with consistent use of another effective contraceptive method) among married people living with HIV (PLHIV) in India. This will prevent unintended pregnancies and possible vertical transmission of HIV to the infant, prevent acquisition of sexually transmitted infections from a non-monogamous spouse, prevent transmission of HIV to a serodiscordant spouse, and prevent transmission of drug resistant or more pathogenic HIV strains between seroconcordant spouses. The project will design, implement, and evaluate a modified, completely culturally-adapted version of a previously validated intervention aimed at sexual risk reduction for PLHIV based upon the Information-Motivation-Behavioral Skills (IMB) theoretical framework and Motivational Interviewing techniques. The specific aims of our project are: 1) To design, pilot test, and refine a theory-driven (IMB model), culturally-adapted, peer-counselor-delivered intervention to assist married men and women living with HIV who are clients of INP+ in Tamil Nadu, India, and who do not intend to initiate a pregnancy in the next two years, to adopt dual contraceptive methods. The intervention will be delivered to married individuals, not couples; and 2) To conduct a group-randomized controlled trial to compare the intervention developed in the first specific aim with usual care (UC) among married men and women living with HIV who are accessing district-level services from INP+ in Tamil Nadu, India. The unit of randomization will be the district. The intervention will be delivered over an 18-month period and will be evaluated at 6, 12, 18, and 24 months. The primary outcome will be use of dual contraceptive methods. Secondary outcomes will be consistent use of condoms alone, pregnancy, STI symptoms, having received treatment for an STI, and IMB components. Hypotheses are: 1) Married PLHIV who receive the intervention will have increased use of dual contraceptive methods, fewer pregnancies in the marriage, fewer STI symptoms, and less STI treatment compared with married PLHIV who receive UC; 2) Increased use of dual contraceptive methods will be sustained at 24 months in the intervention group compared to the UC group; and 3) Intervention-induced increased use of dual contraceptive methods will be mediated by intervention effects on the determinants of contraceptive behavior specified by the IMB model. To our knowledge, this would be the first theory-driven intervention study among PLHIV in India to promote dual contraceptive methods. If this research demonstrates efficacy, the intervention will be integrated into INP+ usual care in Tamil Nadu and throughout India, and will also have wide applicability in many Indian settings that utilize peer outreach workers or peer counselors/educators.