HIV PREVENTION TRIAL UNIT (HPTU)-PUNE, INDIA

HIV 预防试验中心 (HPTU) - 印度浦那

• 批准号: 7285857
• 负责人: ROBERT C. BOLLINGER
• 金额: $ 48.97万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-07-01 至 2009-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7285857
• 关键词: AIDS; AIDS education /prevention; AIDS therapy; HIV infections; India; antiAIDS agent; antibiotics; behavior therapy; behavioral /social science research tag; clinical research; clinical trial phase I; cooperative study; human immunodeficiency virus 1; human subject; human therapy evaluation; medical outreach /case finding; prostitution; sex partner; sexually transmitted diseases; southeast Asian

This application proposes a project site in Pune, India, as a clinical trials unit to join the HIV Prevention Trials Network (HPTN) with the following four specific aims: 1. To conduct multiple Phase I, II and m clinical trials of interventions designed to prevent HIV infection. 2. To identity and address social, behavioral and logistical barriers to screening, enrollment and retention of participants for clinical trials to prevent HIV infection. 3. To identity additional potential cohorts for HPTN trials in India. 4. To participate in collaborative studies within the HPTN to facilitate the development, design and implementation of strategies to prevent "IV infection. This collaborative proposal including investigators at the National AIDS Research Institute (NARI) in Pune, India and the Johns Hopkins University (JHU) has been proposed for the following reasons: A) The success of a 7-year HIV research collaboration between NAM and JHU B) An established and experienced, local Ethical Review Board and Community Advisory Board C) Completion of three Phase I clinical trials, in cohorts of individuals at both high and low risk for HIV, including two multi-national collaborative HIVNET clinical trials. D) Follow-up rates of greater than 92%for three recent HIV clinical trials and 2 prospective cohort studies of individuals at both high- and low-risk for HIV infection. E) An established cohort of more than 2500 high-risk male and female individuals with an annual HIV incidence of 6.4%/100 person years. We have demonstrated the ability to identity, enroll and follow low-risk women, high-risk men, female sex workers, married women at risk for HIV and discordant couples, appropriate for multiple Phase I, II and III HIV prevention clinical trials. Our site is capable of undertaking clinical trials of a variety of potential HIV prevention interventions, including microbicides, barrier methods, behavioral interventions, STD control and post-exposure prophylaxis. We will also apply novel approaches for estimating HIV incidence in other targeted populations for potential HPTU expansion in Pune. We will also undertake a comprehensive behavioral science research agenda to increase community HIV prevention education, to assess the willingness of our populations to participate in HPTN trials, and to ensure adequate the follow-up and retention for HPTN trials. In light of many years of productive collaboration and our prior experience with multinational collaborative clinical trials of HIV prevention strategies, we believe our project site in Pune, India is uniquely experienced and qualified to participate in the HPTN.

本申请提议在印度浦那设立一个项目基地，作为加入艾滋病毒预防试验网络 (HPTN) 的临床试验单位，其具体目标如下： 1. 开展多项干预措施的 I、II 和 m 期临床试验，旨在预防艾滋病毒感染。 2. 识别并解决预防艾滋病毒感染的临床试验参与者筛选、招募和保留方面的社会、行为和后勤障碍。 3. 确定在印度进行 HPTN 试验的其他潜在队列。 4. 参与 HPTN 内的合作研究，以促进预防“IV 感染”策略的制定、设计和实施。这项合作提案包括印度浦那国家艾滋病研究所 (NARI) 和约翰霍普金斯大学的研究人员（提议建立约翰霍普金斯大学 (JHU) 的原因如下： A) NAM 和约翰霍普金斯大学 (JHU) 之间为期 7 年的艾滋病毒研究合作取得了成功 B) 建立了成熟且经验丰富的当地伦理审查委员会和社区咨询委员会 C) 完成了三项 I 期临床试验, D) 最近的三项 HIV 临床试验和两项针对高危和低危人群的前瞻性队列研究的随访率均超过 92%。 - 且 HIV 感染风险低。我们已经证明了识别、登记和跟踪低风险人群的能力，该队列由 2500 多名高危男性和女性个体组成，每年的 HIV 发病率为 6.4%。 -风险女性、高危男性、女性性工作者、有艾滋病风险的已婚女性和不和谐的夫妻，适合多项 I、II 和 III 期 HIV 预防临床试验。我们的中心能够开展各种潜在的艾滋病毒预防干预措施的临床试验，包括杀菌剂、屏障方法、行为干预、性病控制和暴露后预防。我们还将应用新方法来估计其他目标人群中的艾滋病毒发病率，以便 HPTU 在浦那的潜在扩展。我们还将开展全面的行为科学研究议程，以加强社区艾滋病毒预防教育，评估我们的人群参与 HPTN 试验的意愿，并确保 HPTN 试验的充分随访和保留。鉴于多年的富有成效的合作以及我们之前在艾滋病毒预防策略跨国合作临床试验方面的经验，我们相信我们位于印度浦那的项目基地拥有独特的经验和资格来参与 HPTN。

项目成果

Failure to Use and Sustain Male Condom Usage: Lessons Learned from a Prospective Study among Men Attending STI Clinic in Pune, India.

• DOI: 10.1371/journal.pone.0135071
• 发表时间: 2015
• 期刊: PloS one
• 影响因子: 3.7
• 作者: Sahay S;Deshpande S;Bembalkar S;Kharat M;Parkhe A;Brahme RG;Paranjape R;Bollinger RC;Mehendale SM
• 通讯作者: Mehendale SM