Combining PrEP with contraception: a pilot test of an intervention to increase adherence to PrEP in adolescent girls and young women in Zimbabwe

将 PrEP 与避孕相结合：一项旨在提高津巴布韦少女和年轻女性对 PrEP 依从性的干预措施试点测试

• 批准号: 10018645
• 负责人: BARBARA A FRIEDLAND
• 金额: $ 32.5万
• 依托单位: POPULATION COUNCIL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-16 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10018645
• 关键词: AIDS prevention; Adherence; Adolescent; Africa South of the Sahara; Age; Attitude; Blood; Cause of Death; Client; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Contraceptive Agents; Contraceptive methods; Contracts; Cross-Over Studies; Development; Encapsulated; Enrollment; Ensure; Epidemic; Ethinyl Estradiol; Evaluation; Face; Family; Family Planning; Feasibility Studies; Female; Female Adolescents; Female Condoms; Focus Groups; Formulation; Fright; Fumarates; Gelatin; HIV; HIV Seropositivity; HIV risk; Health; Health Personnel; Health Sciences; Incidence; Individual; Infection; Internet; Intervention; Interview; Investigational New Drug Application; Levonorgestrel; Male Condoms; Manuals; Manufacturer Name; Materials Testing; Mediation; Menstrual cycle; Methods; Modeling; Oral; Oral Contraceptives; Pilot Projects; Population; Pregnancy; Prevalence; Prevention; Prevention Research; Process; Provider; Questionnaires; Randomized; Recommendation; Recording of previous events; Regimen; Research; Research Personnel; Risk Reduction; Route; Safe Sex; Services; Sexuality; Spottings; Surveys; TMC120-R147681; Tablets; Technology; Tenofovir; Testing; Training; Universities; Vaginal Ring; Woman; Zimbabwe; aged; base; capsule; college; condoms; cost effective; design; drug market; efficacy study; emtricitabine; girls; high risk; implementation science; improved; innovation; instrument; interest; men; novel; pill; pre-exposure prophylaxis; preference; pregnancy prevention; prevent; response; safety study; service delivery; sexual relationship; social stigma; standard of care; technology development; truvada; unintended pregnancy; uptake; young woman

HIV is the leading cause of death in adolescent girls and young women (AGYW) aged 15-24 years. Despite advances in HIV treatment and prevention, AGYW remain at high risk, particularly in sub-Saharan Africa. Oral pre-exposure prophylaxis (PrEP) is highly effective and has the potential to make a dramatic impact on the HIV epidemic. Yet to date, most trials of PrEP in women have been unable to demonstrate efficacy, largely due to poor adherence among AGYW. Emerging evidence indicates that women may be more likely to use an HIV prevention method that also prevents pregnancy. We will test an intervention consisting of a single oral capsule providing both PrEP and contraception – a contraceptive multipurpose prevention technology (cMPT) – as a strategy for increasing PrEP adherence compared to oral PrEP alone. We will enroll AGYW who already use a COCs in Harare, Zimbabwe, where AGYW continue to be at high risk of HIV, more than half of contracepting women use COCs, and less than 1% of 15-35-year-old women are using PrEP. The cMPT intervention will contain two marketed products: Truvada® [emtricitabine and tenofovir disoproxil fumarate (TDF)] and a combined oral contraceptive (COC) [levonorgestrel (LNG)/ethinyl estradiol (EE)]. This research will implemented through a collaboration between the Population Council, which has global expertise in clinical trial, implementation science, feasibility studies and evaluation around female-initiated HIV prevention methods, and the University of Zimbabwe College of Health Sciences (UZCHS), which has a long history of conducting HIV clinical studies and prevention research. In Aim 1, we will conduct qualitative formative research to explore the acceptability of combining Truvada with a COC to increase PrEP adherence through focus group discussions with AGYW and in-depth interviews (IDIs) with healthcare providers. In Aim 2, we will incorporate formative research findings into the development and pre-testing of 1) cMPT packaging and client information materials; 2) adherence and acceptability questionnaires; and 3) a provider training manual. In Aim 3, we will compare the acceptability, preference, and adherence of the cMPT intervention versus standard of care (2 separate pills: Truvada® and COC). In a 6-month randomized, crossover study, 30 AGYW (16-24 years old) in Harare, Zimbabwe will be assigned in random order to the sequence of the 2 regimens: the cMPT intervention or standard of care (2 separate pills). Each regimen will be used for 3 28-day menstrual cycles (approximately 3 months per regimen). At the end of 6 months, women will be asked to state their preference for the cMPT intervention or the 2 separate pills. We will assess and compare acceptability and adherence (via dried blood spots) of the 2 regimens, and socioecological factors (e.g., individual-, partner-, family-, clinic-level) associated with adherence and acceptability. We will explore facilitators and barriers to use through IDIs with 5 AGYW who complete the study and all AGYW who withdraw early. Acquiring confirmation now on the preference for an oral cMPT from actual use with currently approved products will accelerate the availability of such a product in the marketplace. Given supportive findings in this project, we will outline a process for regulatory approval of the more cost- effective co-formulated pill.

艾滋病毒是15-24岁的青少年女孩和年轻妇女（AGYW）的主要原因 HIV治疗和预防，AGYW仍然有高风险，特别是在撒哈拉以南非洲 预防（PREP）非常有效，并且有可能对HIB的流行产生巨大影响。 女性的大多数PREP试验都具有Beenstrate的功效，这主要是由于Toor依从性Agyw。 新兴的证据表明，女性可能更有可能使用艾滋病毒 怀孕。 收缩性多功能预防技术（CMPT） - 与口服相比提高准备依从性 我们将单独使用。 艾滋病毒的风险，超过一半的避孕妇女使用COC，只有不到1％的15-35岁妇女正在使用 PREP。 富马酸盐（TDF）]和组合口服避孕药（COC） 将通过人口委员会之间的合作实施 含义科学，可行性研究和围绕女性引发的艾滋病毒的评估产生了方法，而你 津巴布韦大学健康科学学院（UZCHS） 研究与预防研究。 将Truvada与COC相结合，通过与AGYW和深入的焦点小组讨论来提高准备效果 与AIM 2的访谈（IDI）。 开发和预测试1）CMPT包装和客户信息材料； 2） 问卷和3 CMPT干预与护理标准（2个单独的药丸：Truvada®和COC）。 跨界研究的跨界研究（16-24岁）在津巴布韦的哈拉雷将以随机顺序分配给 这2个方案：CMPT间隔或护理标准（2个单独的药丸）。 月经周期（大约3个月与妇女有关 偏爱CMPT干预或2种单独的药丸。 两种方案和社会生态因素（例如，个人，伴侣，家庭，临床水平）的血液点） 与依从性和接受性相关。 谁提早撤回确认。 CMPT来自与当前批准的产品的实际使用中的CMPT将加速您在您中的可用性 市场。 有效的共同制造药。