Clinical trial NCT04036396: Prevention Support for People Leaving Jail
Official title: Prevention Support for People Leaving Jail Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Diseases, Bacterial
Hepatitis C
Substance Use Disorders
Keywords: HIV prevention and testing
sexually transmitted disease (STD) prevention and testing
HIV pre-exposure prophylaxis (PrEP)
Incarceration
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Los Angeles Centers For Alcohol and Drug Abuse
name: Charles Drew University of Medicine and Science
name: California HIV/AIDS Research Program
name: Friends Research Institute, Inc.
First posted: 2019-07-29
Enrollment: 215
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Mobile Enhanced Prevention Support (MEPS) intervention is designed to support, motivate, and facilitate engagement in preventive health care activities in the period of community reentry following jail. Three components: support from a selected Peer Mentor (PM), incentives, and a developed mobile application. Client-driven approach, in which participants are encouraged to address priorities and immediate needs for that they identify a client-centered needs assessment, prioritization, and wellness planning process, especially social determinants of health that may discourage or undermine preventive health measures.
Primary purpose: PREVENTION

Brief summary: This study will provide HIV prevention and related support services to men who have sex with men and transgender women who have substance use disorders and are either leaving jail or recently released from jail. The researchers will compare the utilization of HIV prevention and other support services between individuals who receive routine case management provided following enrollment to those who have access to GeoPassport, a global position service (GPS)-based mobile app, incentives, and peer mentor support.

Detailed description: The investigators will enroll 200 people in jail or within 12 months post-release from incarceration. During the trial, half of participants will be randomized into a control group that will receive usual care consistent with the setting in which they live, along with referrals customized to their needs and preferences to share with a case manager. They will be compared to the other half of participants randomized to the intervention group that, in addition to receiving customized referral sources, will also receive the GeoPassport App, incentives, and the support of a trained Peer Mentor for six months. The GeoPassport App will provide participants with tools for tracking goals and progress toward meeting them, assistance in locating services, appointment and medication reminders, opportunities to provide feedback on service providers, and built-in tracking and distribution of rewards (incentives) for service utilization. GeoPassport will assist Peer Mentors in monitoring participants' service utilization. The Peer Mentors will provide encouragement, role modeling, accompaniment to appointments, and assistance with goal setting, problem-solving, and reducing logistical and psychosocial barriers to service engagement. The intervention can be delivered in person or remotely in order to comply with necessary social distancing during the COVID-19 pandemic. Participants in both groups will be followed to assess whether those offered the intervention are more likely to meet the specific prevention targets described in the Specific Aims. The intervention lasts 6 months from the start of participation. Participants are interviewed at 3, 6, and 9 months from the same point as the intervention.

Eligibility criteria: Inclusion Criteria:

1. housed in K6G unit or within 12 months post-release from incarceration
2. ages 18-49 years
3. screens positive for Substance Use Disorder (SUD), or has sought or received SUD treatment at any time starting 12 months before the most recent incarceration until the present day.
4. reports sexual intercourse with a male or a male-to-female transgender woman in the six months prior to jail entry
5. if recruited in jail, is likely to be remain either in custody for at least four more days, but less than three more months based on scheduled court dates, current sentence, treatment plan, etc.
6. has not received an HIV diagnosis (based on self-report)
7. plans to reside in Los Angeles County for the 12 months following enrollment

Exclusion Criteria:

1. does not have a smartphone and is not willing to obtain one post-release,
2. is not able to speak and understand English, and
3. does not have sufficient reading skills to operate a mobile app

Primary outcomes:
measure: Number of participants establishing a primary care provider who can prescribe PrEP (pre-exposure prophylaxis)
timeFrame: 9 months
measure: Number of participants obtaining screening for PrEP
timeFrame: 9 months
measure: Number of participants who initiate PrEP regimen
timeFrame: 9 months
measure: Number of participants who demonstrate minimal adherence to PrEP
timeFrame: 30 days
measure: Number of participants who remain on PrEP for at least 3 months.
timeFrame: 3 months
measure: Number of participants who undergo a HIV test every 3 months
timeFrame: 9 months
measure: Number of participants who undergo a test for gonorrhea, syphilis, and chlamydia every 6 months
timeFrame: 9 months
measure: Number of participants who undergo a test for hepatitis C
timeFrame: 9 months
measure: Number of participants obtaining treatment for substance use disorders (SUDs) in the community
timeFrame: 3 months
measure: Number of participants who remain engaged in treatment for substance use disorders (SUDs) in the community,
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants in each arm receiving care and treatment for newly diagnosed HIV or STD infections.
timeFrame: 9 months
measure: Number of participants in each arm experiencing recidivism
timeFrame: 9 months
measure: Temporal service utilization patterns of intervention arm participants
timeFrame: 9 months
measure: Geographic service utilization patterns of intervention arm participants
timeFrame: 9 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: God's Property
state: California
city: Los Angeles
country: United States
facility: Los Angeles County Men's Central Jail
state: California
city: Santa Fe Springs
country: United States
facility: Los Angeles Center for Alcohol and Drug Abuse
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Nina T Harawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edwards GG, Reback CJ, Cunningham WE, Hilliard CL, McWells C, Mukherjee S, Weiss RE, Harawa NT. Mobile-Enhanced Prevention Support Study for Men Who Have Sex With Men and Transgender Women Leaving Jail: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Sep 22;9(9):e18106. doi: 10.2196/18106.