HIV InfectionsMEPSNCT04036396

Mobile Enhanced Prevention Support for People Leaving Jail

A study testing Mobile Enhanced Prevention Support in people with HIV Infections and Sexually Transmitted Diseases, Bacterial, run by University of California, Los Angeles at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 49 years, men onlyHealthy volunteers can take part
Conditions the study is for: HIV Infections, Sexually Transmitted Diseases, Bacterial, Hepatitis C
What is being tested?: Mobile Enhanced Prevention Support
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 233 participants
Where: 3 sitesUnited States
Study dates: 14 Nov 2019to 31 Mar 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

God's Property
Los Angeles, California, 90003
Los Angeles County Men's Central Jail
Los Angeles, California, 90012
Los Angeles Center for Alcohol and Drug Abuse
Santa Fe Springs, California, 90670

Other trials in United States

About this study

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.

Read the 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.

Conditions: HIV Infections, Sexually Transmitted Diseases, Bacterial, Hepatitis C, Substance Use Disorders
Being tested: Mobile Enhanced Prevention Support, Usual Care plus Customized Referrals
Keywords: HIV prevention and testing, sexually transmitted disease (STD) prevention and testing, HIV pre-exposure prophylaxis (PrEP), Incarceration
Medical subject headings: HIV Infections, Sexually Transmitted Diseases, Bacterial, Hepatitis C, Substance-Related Disorders, Sexually Transmitted Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mobile Enhanced Prevention SupportBehavioural
Also called MEPS
Access to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor.
Usual Care plus Customized ReferralsBehavioural
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.

Study groups in NCT04036396
Study group	Role	What they receive
Standard of Care	Active comparator	A client-centered assessment of priorities and needs and customized prevention and testing referrals. Receives: 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 Receives: Behavioral: Mobile Enhanced Prevention Support; Behavioral: Usual Care plus Customized Referrals

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 9 months
Number of Participants Who Initiate PrEP Regimen
Defined as the participant obtaining a prescription for PrEP, providing documentation, reporting taking the medication
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 9 months

Secondary outcomes (3)

Number of Participants in Each Arm Receiving Care and Treatment for Newly Diagnosed HIV or HCV Infections.
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)
Measured: 3, 6, or 9 months
Number of Participants Who Recidivate
Measure the comparative effectiveness of each intervention arm on reducing recidivism (n=200), quantified as the number of respondents who are reincarcerated.
Measured: 9 months
Number of Reincarcerations Among Those Who Recidivate
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.
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 201931 Mar 2024

First posted29 Jul 2019
Study start14 Nov 2019
Primary completion11 Jan 2024
Study completion31 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04036396
Sponsor's protocol ID: 19-000165
Other IDs: OS17-LA-003
Acronym: MEPS
Status last verified: May 2026
First submitted: 29 Mar 2019
Last updated: 20 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40634829
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.
PubMed 32959786

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mobile Enhanced Prevention Support for People Leaving Jail
ClinicalTrials.gov ID: NCT04036396
Acronym / sponsor ID: MEPS / 19-000165
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 233 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: Los Angeles Centers For Alcohol and Drug Abuse, Charles Drew University of Medicine and Science, California HIV/AIDS Research Program, Friends Research Institute, Inc.
Study start: 14 Nov 2019 (actual)
Primary completion: 11 Jan 2024 (actual)
Study completion: 31 Mar 2024 (actual)
First posted: 29 Jul 2019 (actual)
Results: Posted 2 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Standard of Care	Active comparator	Behavioral: Usual Care plus Customized ReferralsA client-centered assessment of priorities and needs and customized prevention and testing referrals.
Mobile Enhanced Prevention Support	Experimental	Behavioral: Mobile Enhanced Prevention Support, Behavioral: Usual Care plus Customized ReferralsStandard 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

Who may qualify

Ages: 18 to 49 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mobile Enhanced Prevention SupportAlso: MEPSAccess to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor.	Behavioural	Mobile Enhanced Prevention Support
Usual Care plus Customized ReferralsParticipants 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.	Behavioural	Mobile Enhanced Prevention Support, Standard of Care

Primary outcome

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.

3 secondary outcomes

Number of Participants in Each Arm Receiving Care and Treatment for Newly Diagnosed HIV or HCV Infections.
Time frame: 3, 6, or 9 months
Number of Participants Who Recidivate
Time frame: 9 months
Number of Reincarcerations Among Those Who Recidivate
Time frame: 9 months

Results and safety

Results posted to the registry on 2 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	117	86
Mobile Enhanced Prevention Support	116	87

Primary outcome: Number of Participants Establishing a Primary Care Provider Who Can Prescribe PrEP (Pre-exposure Prophylaxis)

Time frame: 9 months. Count of participants. Unit: Participants

Measure	Standard of Care n = 93	Mobile Enhanced Prevention Support n = 99
Value	82	90

Standard of Care vs Mobile Enhanced Prevention Support: Risk Ratio (RR): 1.07 (95% CI 0.66 to 1.74), p = 0.780, Poisson regression

Primary outcome: Number of Participants Who Initiate PrEP Regimen

Time frame: 9 months. Count of participants. Unit: Participants

Measure	Standard of Care n = 86	Mobile Enhanced Prevention Support n = 87
Value	12	28

Standard of Care vs Mobile Enhanced Prevention Support: Odds Ratio (OR): 3.8 (95% CI 1.8 to 8.0), p = 0.0006, Longitudinal trajectory model

Primary outcome: Number of Participants Who Demonstrate Minimal Adherence to PrEP

Time frame: 3, 6, or 9 months. Count of participants. Unit: Participants

Measure	Standard of Care n = 11	Mobile Enhanced Prevention Support n = 26
Value	10	26

Standard of Care vs Mobile Enhanced Prevention Support: p = 0.1191, Chi-squared

Population analysed: Sample is based on the number of people who reported taking PrEP (14 for Standard of care; 28 for MEPS) but excludes those who declined to respond to the adherence question.

Primary outcome: Number of Participants Who Remain on PrEP for at Least 3 Months.

Time frame: 9 months. Count of participants. Unit: Participants

Measure	Standard of Care n = 11	Mobile Enhanced Prevention Support n = 27
Value	7	17

Standard of Care vs Mobile Enhanced Prevention Support: p = 0.9689, Chi-squared

Population analysed: Sample is based on the number of people who reported taking PrEP (14 for Standard of care; 28 for MEPS) but excludes those who declined to respond to the this question.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	0 of 117 (0%)	0 of 117 (0%)	2 of 117
Mobile Enhanced Prevention Support	0 of 116 (0%)	0 of 116 (0%)	2 of 116

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40634829Schrode 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.
Derived from this study: PubMed 32959786Edwards 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.
Individual participant dataSharing planned: No

Related trials for HIV Infections

RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nina T Harawa, PhD principal investigator

University of California, Los Angeles

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Establishing a Primary Care Provider Who Can Prescribe PrEP (Pre-exposure Prophylaxis) (time frame: 9 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04036396, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.