Randomized Controlled Trial to Enhance Dual Protection Among PLHIV in India

描述（申请人提供）：耶鲁大学，康涅狄格大学，印度艾滋病毒/艾滋病感染者网络（INP+）为开展旨在扩大双重避孕方法使用的社会和行为科学研究提供了独特的机会在印度，已婚艾滋病毒感染者（PLHIV）中持续使用避孕套并持续使用另一种有效的避孕方法。这将防止意外怀孕和艾滋病毒可能垂直传播给婴儿，防止从非一夫一妻制配偶那里获得性传播感染，防止艾滋病毒传播给血清不一致的配偶，并防止抗药性或致病性更强的艾滋病毒菌株在血清一致的配偶之间传播。该项目将设计，实施和评估一个修改后的，完全适应文化的版本，以前验证的干预措施，旨在减少性风险的PLHIV的基础上的信息动机行为技能（IMB）的理论框架和动机访谈技术。我们的项目的具体目标是：1）设计，试点测试，并完善理论驱动（IMB模式），文化适应，同侪咨询师提供的干预，以帮助已婚男性和女性艾滋病毒感染者谁是INP+的客户在泰米尔纳德邦，印度，谁不打算在未来两年内开始怀孕，采取双重避孕方法。干预措施将提供给已婚个人，而不是夫妇;和2）进行一项分组随机对照试验，以比较在印度泰米尔纳德邦从INP+获得地区一级服务的已婚艾滋病毒感染者中第一个具体目标与常规护理（UC）中开发的干预措施。随机化单位为地区。干预措施将在18个月内实施，并将在6、12、18和24个月时进行评估。主要结局将是使用双重避孕方法。次要结局将是持续单独使用避孕套、怀孕、性传播感染症状、接受性传播感染治疗和IMB成分。假设是：1）与接受UC的已婚PLHIV相比，接受干预的已婚PLHIV将增加双重避孕方法的使用，婚姻中怀孕较少，STI症状较少，STI治疗较少; 2）与UC组相比，干预组中双重避孕方法的使用将持续24个月;干预诱导的双重避孕方法使用的增加将通过对IMB模型指定的避孕行为决定因素的干预效应来介导。据我们所知，这将是第一个理论驱动的干预研究，在印度的艾滋病毒感染者，以促进双重避孕方法。如果这项研究证明有效，干预措施将被整合到泰米尔纳德邦和整个印度的INP+常规护理中，并且在许多利用同伴外展工作者或同伴咨询师/教育者的印度环境中也具有广泛的适用性。

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.