Prevention Support for People Leaving Jail

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.

Official Title
-----------------
Prevention Support for People Leaving Jail Study

Conditions
-----------------
HIV Infections, Sexually Transmitted Diseases, Bacterial, Hepatitis C, Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: Mobile Enhanced Prevention Support
* Behavioral: Usual Care plus Customized Referrals


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>A client-centered assessment of priorities and needs and customized prevention and testing referrals. | Behavioral: Usual Care plus Customized Referrals<br>* Participants in the control arm will continue to receive services they would normally receive consistent with the setting in which they were recruited. This includes substance use treatment in jail, substance use treatment at a residential recovery facility, and/or supportive housing services. The study will provide referrals customized to their needs and preferences.<br>|
| Experimental: Mobile Enhanced Prevention Support<br>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 | Behavioral: Mobile Enhanced Prevention Support<br>* Access to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor.<br>* Other names: MEPS;Behavioral: Usual Care plus Customized Referrals<br>* Participants in the control arm will continue to receive services they would normally receive consistent with the setting in which they were recruited. This includes substance use treatment in jail, substance use treatment at a residential recovery facility, and/or supportive housing services. The study will provide referrals customized to their needs and preferences.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants establishing a primary care provider who can prescribe PrEP (pre-exposure prophylaxis) | 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. Provide documentation of the appointment. | 9 months | 
| Number of participants obtaining screening for PrEP | Defined as the participant completing the screening process for PrEP with an eligible provider or PrEP navigator. Provide documentation of the appointment. | 9 months | 
| Number of participants who initiate PrEP regimen | Defined as the participant obtaining a prescription for PrEP, providing documentation, reporting taking the medication | 9 months | 
| Number of participants who demonstrate minimal adherence to PrEP | Defined as the participant self-reporting taking prescribed PrEP at least 4 days per week over the prior 30 days | 30 days | 
| Number of participants who remain on PrEP for at least 3 months. | The participant will provide documentation of filled PrEP prescriptions for 3 or more months | 3 months | 
| Number of participants who undergo a HIV test every 3 months | Defined as the participant self-reporting having obtained HIV testing every 3 months over the 9 month follow-up period | 9 months | 
| Number of participants who undergo a test for gonorrhea, syphilis, and chlamydia every 6 months | Defined by the participant self-reporting having obtained testing for these 3 bacterial sexually transmitted diseases (STDs) approximately every 6 months over the 9 month follow-up period | 9 months | 
| Number of participants who undergo a test for hepatitis C | Defined by the participant self-reporting having obtained at least one test for Hepatitis C | 9 months | 
| Number of participants obtaining treatment for substance use disorders (SUDs) in the community | Defined by the participant self-report of completing initial recommended SUD appointments within 3 months of jail release, consistent with each participant's recommended American Society of Addiction Medicine (ASAM) level of care | 3 months | 
| Number of participants who remain engaged in treatment for substance use disorders (SUDs) in the community, | Defined by the participant self-reporting remaining engaged in treatment (i.e., continuing to attend meetings, counseling or other treatment activities) as defined by the recommended ASAM level of care in the 3 months prior to each follow-up interview. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants in each arm receiving care and treatment for newly diagnosed HIV or STD infections. | Self-report of whether or not participants received follow-up care and treatment for HIV, STD, and hepatitis C infections diagnosed during study follow-up (n=200) | 9 months | 
| Number of participants in each arm experiencing recidivism | Measure the comparative effectiveness of each intervention arm on reducing recidivism (n=200), quantified as the number of respondents who are reincarcerated and the total number of reincarcerations per arm over the study period. | 9 months | 
| Temporal service utilization patterns of intervention arm participants | Describe the temporal distribution of PrEP uptake and supportive social service utilization patterns of the participants in the MEPS intervention arm using data collected via the GeoPassport mobile app (n=100). | 9 months | 
| Geographic service utilization patterns of intervention arm participants | Report the geographic distribution of PrEP uptake and supportive social service utilization patterns of the participants in the MEPS intervention arm using data collected via the GeoPassport mobile app (n=100). | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV prevention and testing, sexually transmitted disease (STD) prevention and testing, HIV pre-exposure prophylaxis (PrEP), Incarceration