Mobile Enhanced Prevention Support for People Leaving Jail

NCT04036396 | Completed Results

• 2 other identifiers: 19-000165OS17-LA-003
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

HIV prevention and testing; sexually transmitted disease (STD) prevention and testing; HIV pre-exposure prophylaxis (PrEP); Incarceration

Outcome Measures

Primary Outcomes (9)

• 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.

  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 at first instance of reporting taking PrEP

  3, 6, or 9 months

• Number of Participants Who Remain on PrEP for at Least 3 Months.

  The outcomes is defined by self-reported PrEP use for 3 or more months

  9 months

• Number of Participants Who Report an HIV Test Within 3 Months of a Follow-up

  Defined as the participant self-reporting having obtained HIV testing within 3 months of the follow-up

  3, 6, and 9 months

• Number of Participants Who Undergo a Test for Gonorrhea, Syphilis, and Chlamydia Within 6 Months of a Follow-up

  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

  6 and 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 SUD appointments within the 3 months following enrollment

  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) in the 3 months prior to the final follow-up interview.

  9 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

A client-centered assessment of priorities and needs and customized prevention and testing referrals.

Behavioral: Usual Care plus Customized Referrals

Mobile Enhanced Prevention Support

EXPERIMENTAL

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; Behavioral: Usual Care plus Customized Referrals

Interventions

Mobile Enhanced Prevention Support BEHAVIORAL

Access to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor.

Also known as: MEPS

Mobile Enhanced Prevention Support

Usual Care plus Customized Referrals BEHAVIORAL

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.

Mobile Enhanced Prevention Support; Standard of Care

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Self-identifies as a man or a male-to-female trans woman.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Los Angeles Centers For Alcohol and Drug Abuse: collaborator
• Charles Drew University of Medicine and Science: collaborator
• California HIV/AIDS Research Program: collaborator
• Friends Research Institute, Inc.: collaborator

Study Sites (3)

God's Property

Los Angeles, California, 90003, United States

Location

Los Angeles County Men's Central Jail

Los Angeles, California, 90012, United States

Location

Los Angeles Center for Alcohol and Drug Abuse

Santa Fe Springs, California, 90670, United States

Location

Related Publications (2)

• Schrode KM, Edwards GG, Moghanian B, Weiss RE, Reback CJ, McWells C, Hilliard CL, Harawa NT. Randomized Controlled Trial Testing an HIV/STI Prevention Intervention Among People Leaving Incarceration Who Were Assigned Male at Birth, Have Sex with Men and A Substance Use Disorder. AIDS Behav. 2025 Dec;29(12):3806-3821. doi: 10.1007/s10461-025-04818-4. Epub 2025 Jul 10.

  PMID: 40634829 DERIVED

• 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.

  PMID: 32959786 DERIVED

MeSH Terms

Conditions

HIV Infections; Sexually Transmitted Diseases, Bacterial; Hepatitis C; Substance-Related Disorders; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Nina Harawa
• Organization: University of California, Los Angeles

nharawa@mednet.ucla.edu

310-794-8078

Study Officials

• Nina T Harawa, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-in-Residence

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: July 29, 2019
• Study Start: November 14, 2019
• Primary Completion: January 11, 2024
• Study Completion: March 31, 2024
• Last Updated: May 20, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)