Mobile Enhanced Prevention Support for People Leaving Jail
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 233
- Locations
- 3
- Primary Endpoint
- Number of Participants Establishing a Primary Care Provider Who Can Prescribe PrEP (Pre-exposure Prophylaxis)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •housed in K6G unit or within 12 months post-release from incarceration
- •ages 18-49 years
- •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.
- •reports sexual intercourse with a male or a male-to-female transgender woman in the six months prior to jail entry
- •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.
- •has not received an HIV diagnosis (based on self-report)
- •plans to reside in Los Angeles County for the 12 months following enrollment
Exclusion Criteria
- •does not have a smartphone and is not willing to obtain one post-release,
- •is not able to speak and understand English, and
- •does not have sufficient reading skills to operate a mobile app
Arms & Interventions
Mobile Enhanced Prevention Support
Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Intervention: Usual Care plus Customized Referrals (Behavioral)
Standard of Care
A client-centered assessment of priorities and needs and customized prevention and testing referrals.
Intervention: Usual Care plus Customized Referrals (Behavioral)
Mobile Enhanced Prevention Support
Standard of Care in addition to a client-centered assessment of priorities and needs and customized prevention and testing referrals, and the Mobile Enhanced Prevention Support Program
Intervention: Mobile Enhanced Prevention Support (Behavioral)
Outcomes
Primary Outcomes
Number of Participants Establishing a Primary Care Provider Who Can Prescribe PrEP (Pre-exposure Prophylaxis)
Time Frame: 9 months
Defined as the participant identifying and completing an appointment with a primary care provider who is willing and able to prescribe HIV pre-exposure prophylaxis.
Number of Participants Who Initiate PrEP Regimen
Time Frame: 9 months
Defined as the participant obtaining a prescription for PrEP, providing documentation, reporting taking the medication
Number of Participants Who Demonstrate Minimal Adherence to PrEP
Time Frame: 3, 6, or 9 months
Defined as the participant self-reporting taking prescribed PrEP at least 4 days per week at first instance of reporting taking PrEP
Number of Participants Who Remain on PrEP for at Least 3 Months.
Time Frame: 9 months
The outcomes is defined by self-reported PrEP use for 3 or more months
Number of Participants Who Report an HIV Test Within 3 Months of a Follow-up
Time Frame: 3, 6, and 9 months
Defined as the participant self-reporting having obtained HIV testing within 3 months of the follow-up
Number of Participants Who Undergo a Test for Gonorrhea, Syphilis, and Chlamydia Within 6 Months of a Follow-up
Time Frame: 6 and 9 months
Defined by the participant self-reporting having obtained testing for these sexually transmitted diseases (STDs) within the 6 months prior to a follow-up over the 9 month follow-up period
Number of Participants Who Undergo a Test for Hepatitis C
Time Frame: 9 months
Defined by the participant self-reporting having obtained at least one test for Hepatitis C
Number of Participants Obtaining Treatment for Substance Use Disorders (SUDs) in the Community
Time Frame: 3 months
Defined by the participant self-report of completing SUD appointments within the 3 months following enrollment
Number of Participants Who Remain Engaged in Treatment for Substance Use Disorders (SUDs) in the Community,
Time Frame: 9 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 the final follow-up interview.
Secondary Outcomes
- Number of Participants in Each Arm Receiving Care and Treatment for Newly Diagnosed HIV or HCV Infections.(3, 6, or 9 months)
- Number of Participants Who Recidivate(9 months)
- Number of Reincarcerations Among Those Who Recidivate(9 months)
Investigators
Nina T. Harawa, MPH, PhD
Professor-in-Residence
University of California, Los Angeles