California Hub for HIV/STI/SUD Prevention Research With Reentry Populations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 318
- 试验地点
- 3
- 主要终点
- Initiate PrEP regimen
研究概览
简要总结
The California Hub for HIV/SUD Prevention Research with Reentry Populations addresses the question: "Can the evidence-based MEPS intervention be adapted and implemented at a range of organizations to effectively serve a wider range of clients?"
The Mobile Enhanced Prevention Support (MEPS) intervention was originally implemented in Los Angeles County and was proven successful in promoting biomedical HIV prevention (PrEP) uptake and preventative screenings in people who used drugs who recently left incarceration. MEPS is an evidence-based intervention for people with substance use disorders (SUD) that incorporates a client-centered planning session, including trained peer mentors, service utilization incentives, and a mobile application (GeoPass).
The study includes a randomized controlled trial (RCT) across three community partners located in Riverside and Alameda Counties. At least 300 people will be enrolled in these three counties; the first 200 will be randomized to either receive the intervention or usual care, with the final 100 all receiving the intervention. The primary implementation outcome for the study involves using an implementation science framework and assessment tools to examine MEPS's implementation. Key outcomes include how well the implementation strategies used support intervention enrollment and retention, integration with existing services in each partnering community agency, and perceived intervention acceptability, feasibility, appropriateness, and maintenance at 6- and 12-months. The primary effectiveness outcome for the study is an increase in HIV testing, PrEP uptake and adherence, and SUD service utilization at 6 months and 12 months in the MEPS compared to the usual care group. Secondary effectiveness outcomes include frequency of service use for SUDs, hepatitis C virus testing, and linkage to care for those who test positive for HIV or hepatitis C.
详细描述
The Mobile Enhanced Prevention Support (MEPS) intervention combines three evidence-based components - peer support, a smartphone app (GeoPass), and contingency management in the form of small cash incentives for access services. The overarching goal of this study is to adapt the MEPS to ensure it can achieve its intended objectives for a diverse set of beneficiaries in wider settings and to establish both the tools and an audience for its dissemination. This will include a clinical trial and documentation and dissemination of tailoring and evaluation results. Our prior RCT of the MEPS intervention has shown it to be effective at increasing PrEP uptake and HIV testing among English-speaking participants in Los Angeles County. Now, the primary goal of our Type 3 Hybrid Implementation-Effectiveness study is to examine the MEPS implementation in different settings with a greater reach into the population who could benefit, with assessing effectiveness being a secondary goal. It is essential to consider inter-agency differences and their impact in this study.
For the randomized controlled trial, the investigators aim for a sample size of 300 participants across our 3 different study sites. The first 200 individuals enrolled with be randomized to either receive the intervention or be control participants. The last 100 individuals will all receive the intervention as a single arm continuation. Additionally, investigators will recruit 15 CBO partner staff (5 per agency), plus 6 individuals who work at agencies located in the same jurisdictions as the CBO partner staff. Both the CBO partner staff and agency representatives will be asked to participate in surveys and interviews at different time points during the R33 phase.
Client-centered Planning Session/Control Arm All participants, regardless of study arm, will receive the usual care services at the partner agency plus a client-centered planning session following enrollment. This session will be conducted with the person providing clinical supervision to the Peer Mentors at each site and may be conducted by phone, video, or in person. Plans, listing participant goals and tailored referrals, will be offered to the participant in electronic and paper versions. (For MEPS intervention participants, it will also be incorporated into the GeoPass app.)
Follow-up Quantitative Survey UCLA research associates (RAs) will conduct follow-up interviews with RCT participants at 6 and 12 months-post-enrollment. Investigators will use a survey instrument largely consisting of questions developed by the Common Data Element (CDE) workgroup comprised of NIDA CONNECT Network members; this study is one of the funded projects in CONNECT. Some of the survey questions were also carried forward from the original MEPS survey. The survey has the dual purpose of collecting information for the study aims as well as for each participant's needs assessment. The survey includes a comprehensive set of domains using validated measures/scales. Surveys administered at 6 and 12 months will include a set of questions designed to assess perceptions of the intervention (RE-AIM domains: adoption, implementation, and maintenance).
PrEP Adherence Assessment Participants who initiate PrEP (using an estimate derived from the prior MEPS trial, where up to 40% of participants will initiate PrEP) will be asked to choose to provide urine samples at six and 12 months for confirmation of PrEP use and evaluation of PrEP adherence through detection of tenofovir- (TFV, RE-AIM domain: adoption). Collection will be undertaken by partner community-based organization (CBO) agency staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •RCT Participants
- •Assigned male at birth
- •Ages 18 - 59
- •Was released from incarceration in the previous 12 months (incarceration is defined as a stay in jail, prison, or detention centers for over 24 hours)
- •Reports an SUD diagnosis or seeking SUD services at any time in the 24 months prior to enrollment
- •During the 24 months prior to enrollment, either:
- •Reports intercourse with a person assigned male at birth
- •Reports injection drug use
- •Has not received an HIV diagnosis (based on self-report)
- •Possesses a smartphone or plans to obtain one
- •Plans to reside within designated jurisdictions (counties) for the 9 months following enrollment
- •CBO and agency staff participating in implementation surveys or interviews
- •>=18 years of age
- •Employed at a study site or otherwise involved with intervention implementation and/or maintenance OR works at an agency in the counties where the study is taking place (Los Angeles, Riverside, San Bernardino, and Alameda counties, California).
- •Willing to provide informed consent for participation.
排除标准
- •RCT Participants:
- •Does not have a smart phone and is not willing to obtain one
- •Is not able to speak and understand English
- •Has insufficient reading skills to operate a mobile application on a cell phone
- •CBO participating in implementation interviews
研究组 & 干预措施
MEPS Arm
Intervention arm participants receive a client-centered goal planning session following enrollment; 14 sessions with a peer mentor over a period of 6 months; cash incentives for accessing medical and non-medical services; and a smartphone app to keep track of goals, incentive earnings and provider appointments, a provider search feature, and fill-out surveys based on participant experiences with accessing services.
干预措施: Mobile Enhanced Prevention Support (MEPS) (Behavioral)
Control Arm
Control arm participants receive a client-centered goal planning session (like the intervention arm), and usual care.
干预措施: Control (Other)
结局指标
主要结局
Initiate PrEP regimen
时间窗: 6 and 12 months
Defined as the participant obtaining a prescription for PrEP and self-reporting taking the medication
Demonstrate adherence to PrEP
时间窗: 6 and 12 months
Defined as the participant self-reporting taking prescribed PrEP in the previous 3 days. Assessed with a urine test kit that detects the presence of tenofovir disoproxil fumarate.
Remain on PrEP for at least 3 months
时间窗: 6 and 12 months
Defined by self-reported PrEP use for 3 or more months
Report an HIV test within 6 months of a follow-up interview
时间窗: 6 and 12 months
Defined as the participant self-reporting having obtained HIV testing within 3 months of the follow-up
Report a test for HCV
时间窗: 6 and 12 months
Defined as the participant self-reporting having obtained HIV testing within 3 months of the follow-up
Engage in substance use treatment in the community
时间窗: 6 and 12 months
Defined by the participant self-reporting remaining engaged in treatment (i.e., continuing to attend meetings, counseling or other treatment activities) in the 3 months prior to follow-up interviews.
Reduce substance use
时间窗: 6 and 12 months
Defined as a reduction in problematic use based Texas Christian University (TCU) Drug Screen 5 for any substance identified at as a problem based on their baseline TCU 5 score
次要结局
- Receive care for newly diagnosed HCV or HIV(6 and 12 months)
- Access services for overdose prevention and infectious disease control(6 and 12 months)
- Recidivism(6 and 12 months)
- Frequency of arrests among those who recividate(12 months)
研究者
Nina T. Harawa, MPH, PhD
Professor
University of California, Los Angeles