Mobile Enhanced Prevention Support for People Leaving Jail (MEPS)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90003
- God's Property
-
Los Angeles, California, United States, 90012
- Los Angeles County Men's Central Jail
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Santa Fe Springs, California, United States, 90670
- Los Angeles Center for Alcohol and Drug Abuse
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Standard of Care
A client-centered assessment of priorities and needs and customized prevention and testing referrals.
|
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.
|
|
Experimental: 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
|
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.
Access to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
9 months
|
|
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
|
9 months
|
|
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
|
3, 6, or 9 months
|
|
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
|
9 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
|
3, 6, and 9 months
|
|
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
|
6 and 9 months
|
|
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
|
9 months
|
|
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
|
3 months
|
|
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.
|
9 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants in Each Arm Receiving Care and Treatment for Newly Diagnosed HIV or HCV Infections.
Time Frame: 3, 6, or 9 months
|
Self-report of whether or not participants received follow-up care and treatment for HIV or hepatitis C infections diagnosed during study follow-up (n=200)
|
3, 6, or 9 months
|
|
Number of Participants Who Recidivate
Time Frame: 9 months
|
Measure the comparative effectiveness of each intervention arm on reducing recidivism (n=200), quantified as the number of respondents who are reincarcerated.
|
9 months
|
|
Number of Reincarcerations Among Those Who Recidivate
Time Frame: 9 months
|
Measure the comparative effectiveness of the intervention reducing recidivism (n=200), quantified as total number of reincarcerations over the study period among those who recidivate.
|
9 months
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Nina T Harawa, PhD, University of California, Los Angeles
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Mental Disorders
- Pathologic Processes
- Disease Attributes
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Digestive System Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Chemically-Induced Disorders
- Flaviviridae Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Hepatitis
- Pathological Conditions, Signs and Symptoms
- HIV Infections
- Substance-Related Disorders
- Sexually Transmitted Diseases
- Sexually Transmitted Diseases, Bacterial
- Hepatitis C
Other Study ID Numbers
Other Study ID Numbers
- 19-000165
- OS17-LA-003 (Other Grant/Funding Number: California HIV/AIDS Research Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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