跳至主要内容
临床试验/NCT03493555
NCT03493555已完成不适用

Optimizing PrEP Adherence for YMSM Through the Exploration of Facilitators and Barriers and by the Provision of a Culturally-Tailored Peer Navigation Program

Fenway Community Health1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Peer Navigation for PrEP Acceptability and Feasibility

研究概览

简要总结

The specific aims of this study are:

  1. To explore perceived facilitators and barriers to initiating and adhering to HIV PRE-EXPOSURE PROPHYLAXIS (PrEP) among at-risk YOUNG MEN WHO HAVE SEX WITH MEN (YMSM).
  2. To assess the acceptability and feasibility of a culturally-tailored peer navigator program to optimize adherence to PrEP among YMSM.

详细描述

New HIV infections occur at a disproportionately high rate among young men who have sex with men (YMSM).Oral pre-exposure prophylaxis (PrEP) can reduce HIV acquisition among MSM over 90% when adherence levels are high, and increasing the effective use of PrEP among YMSM is one of the highest priorities in HIV prevention. However, YMSM face multiple barriers to initiating and adhering to PrEP, including structural barriers (e.g. housing insecurity), psychosocial factors (e.g. substance use, depression), underestimation of their risk for acquiring HIV, and ambivalence about using PrEP due to medical mistrust. In an open-label study of PrEP use by 200 YMSM, only one-third of participants had protective levels of drug in their blood at 1 year despite intensive adherence counseling, and HIV incidence was high at 3% per year. When PrEP is prescribed to YMSM in care settings, where adherence support is less intensive than in clinical studies, adherence levels, and thus effectiveness, are likely to be even lower. Without strategies to optimize adherence to PrEP for these youth, PrEP is unlikely to have a major impact on HIV incidence for YMSM.

One approach to overcoming the multi-factorial barriers that prevent YMSM from adhering to PrEP is the use of peer health system navigators. Navigators are healthcare workers who are trained to support adherence and retention in care for individuals who are at risk for suboptimal adherence. For YMSM who use PrEP, peer navigators could support adherence by connecting youth with resources to address their unmet structural and psychosocial needs and by helping them to negotiate the complexities of healthcare systems. An NICHD-funded study conducted in Boston (SMILE: Strategic Multisite Initiative for the Identification, Linkage and Engagement in Care of Youth with Undiagnosed HIV) found that peer navigation was highly acceptable for newly diagnosed HIV-infected youth, so it is likely that YMSM will find peer navigation to be acceptable for PrEP. As navigators have been used for over a decade to improve adherence in HIV-infected persons, and an evaluation showed that HIV-infected persons who used navigators had higher rates of virologic suppression, it is important to test whether peer navigation can optimize adherence to PrEP for YMSM.

Our long-term goal is to optimize adherence to PrEP for YMSM and thus decrease HIV incidence. The objective of this study, the first step towards our goal, is to develop and pilot test a peer navigator program to optimize adherence to PrEP for YMSM. We will recruit at-risk YMSM from an LGBTQ Youth-focused community health center with PrEP expertise, the Sidney Borum Jr. Health Center. The Borum Center provides care to 1200 YMSM aged 12-29 annually, half of whom are Black or Latino and 20% of whom are homeless. As incidence rates for HIV (2%) and syphilis (9%) in 2015 were over 20 and 100-fold higher at this center than in the general Boston population, and its clinicians initiate PrEP for 3-4 YMSM monthly, the Borum Center is an ideal setting to explore adherence to PrEP among the highest risk YMSM. Our specific aims are:

Aim 1. To explore perceived facilitators and barriers to initiating and adhering to PrEP among at-risk YMSM. We will conduct in-depth qualitative interviews with 32 YMSM at the Borum Center, including 8 youth who have not yet discussed PrEP with clinicians, 8 who have declined PrEP when offered by clinicians, 8 who have been adherent to PrEP, and 8 with suboptimal adherence. Discussions will include in-depth exploration of YMSM attitudes and intentions regarding PrEP and PrEP peer navigators. We will use purposive sampling to recruit a diverse sample with respect to race, ethnicity, and age, including youth who are minors.

Aim 2. To assess the acceptability and feasibility of a culturally-tailored peer navigator program to optimize adherence to PrEP among YMSM. A PrEP peer navigator program will be adapted from the SMILE study and will be informed by our findings from Aim 1. We will pilot test the program for acceptability and feasibility with 15 YMSM who are newly initiating PrEP at the Borum Center. Secondary outcomes include retention in PrEP care and adherence to PrEP, as measured by dried blood spot testing, at 3 and 6 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 24 Years(Child, Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •Ages 15-24
  • •Self-identify as men who have sex with men
  • •Self-identify as sexually active
  • •Able to understand English

排除标准

  • 未提供

研究组 & 干预措施

Intervention Development

Experimental

Peer Health Navigator for PrEP

干预措施: Peer Health Navigator for PrEP (Behavioral)

结局指标

主要结局

Peer Navigation for PrEP Acceptability and Feasibility

时间窗: up to 6 months post-enrollment

For the primary outcome, the investigators will conduct qualitative interviews (using an IRB-approved semi-structured interview guide) at 3 and 6 months post-enrollment. Additionally, a question about acceptability of the intervention will be asked at 3 and 6 months post-enrollment. An affirmative response rate of 70% or higher will indicate acceptability of the intervention.

次要结局

  • PrEP Adherence Through DBS(up to 6 months post-enrollment)

研究者

发起方
Fenway Community Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas Krakower

Assistant Professor of Medicine

Beth Israel Deaconess Medical Center

研究点 (1)

Loading locations...

相似试验