Evaluation of Life-Steps to Enhance Adherence and Engagement in PrEP Care

评估提高 PrEP 护理依从性和参与度的生活步骤

基本信息

批准号：
10241375
负责人：
KENNETH H MAYER
金额：
$ 76.12万
依托单位：
UNIVERSITY OF MIAMI CORAL GABLES
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-06 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10241375
关键词：
AIDS prevention Adherence Affect African American Anti-Retroviral Agents Behavior Therapy Bisexual Boston Caring Cities Cognitive Therapy Control Groups Counseling Data Development Diphosphates District of Columbia Dose Educational Curriculum Evaluation Face Funding Gays HIV HIV Infections Health Care Costs Health Care Sector Health Services Accessibility Heavy Drinking Hispanics Incidence Individual Infection Interpersonal Violence Intervention Latino Life Maintenance Mediator of activation protein Medical Mental Depression Mental Health Modeling Monitor Moods National Institute of Mental Health Nurses Oral Participant Patient Self-Report Pharmaceutical Preparations Population Prevalence Prevention Prevention strategy Procedures Provider Publishing Qualitative Research Randomized Recording of previous events Reporting Research Resources Risk Risk Factors Sampling San Francisco Schedule Self Efficacy Service delivery model Subgroup Technology Tenofovir Testing Text Text Messaging Trauma Visit Work arm base condomless anal sex coping cost cost effective design economic impact efficacy testing emtricitabine ethnic minority population evidence base experience follow-up health service use high risk high risk men housing instability intimate partner violence men who have sex with men multiple drug use pill pre-exposure prophylaxis prevent primary outcome prospective psychosocial racial and ethnic recruit secondary outcome skills social social structure sociodemographic variables socioeconomics standard of care theories therapy development tool transgender women uptake

项目摘要

Background. Pre-exposure prophylaxis (PrEP) has dramatically changed the promise of HIV prevention, particularly for gay, bisexual, and other men who have sex with men (MSM) who account for the majority of HIV infections in the U.S. Accordingly, PrEP reduces HIV acquisition by >90% with adequate adherence. However, many MSM face multiple challenges with respect to initiating, adhering to, and staying on PrEP, with particular challenges for specific MSM subgroups, specifically those experiencing multiple psychosocial problems—also known as syndemics—including depression; heavy alcohol use; polydrug use; history of trauma or abuse; current interpersonal violence; as well as being a racial/ethnic minority MSM. Preliminary Research. Life-Steps—a cognitive-behavioral therapy-based intervention—has successfully supported ART treatment and prevention adherence in various studies. With funding from an NIMH R34, we adapted the Life- Steps intervention to support PrEP adherence for MSM and conducted a 2-arm pilot RCT that showed high participant acceptability, feasibility of implementation, and promise of the “Life-Steps for PrEP” adherence intervention. Conceptual Model. The current study is to test the efficacy of a stepped-care “adaptive” Life- Steps for PrEP adherence intervention for MSM at high-risk for HIV acquisition. Stepped care is a healthcare delivery model in which the least resource intensive part of an intervention is delivered first, and only those who continue to have problems receive the higher intensity, more resource intensive parts of an intervention. The conceptual model is based on our formative work that led to the development of a theoretically-driven intervention curriculum (“Life-Steps for PrEP”), grounded in the social and contextual realities of MSM with multiple psychosocial problems at high-risk for HIV acquisition. Overview of Intervention. Our intervention begins with 2-way daily text messaging aimed at enhancing optimal PrEP adherence via reminders. Although helpful, for many MSM (~2/3 from published research), text messaging alone is not sufficient to overcome the barriers to PrEP adherence. Those not adherent (<4 pills over a 7-day period) from text reminders, will “step up” to receive Life-Steps adherence counseling. Research Plan. 250 HIV uninfected PrEP naïve MSM (at least 50% racial/ethnic minority) at risk for adherence difficulties (≥1 syndemic condition) will be recruited in two major U.S. cities with excellent access to and research experience with the population. Participants will be equally randomized to: (1) “Life-Steps for PrEP” – a stepped care, adherence intervention with integrated technology and counseling; or (2) Standard of care control group. Participants will be followed for 18-months post-randomization. The primary outcomes are enhanced maintenance of PrEP adherence (DBS TFV-DP concentrations & self-report) and retention in PrEP care; we will also examine improvements in PrEP adherence skills and condomless anal sex acts not protected by PrEP. Lastly, the economic impact considering healthcare sector and societal benefits will be calculated compared to standard of care.