- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04036396
Prevention Support for People Leaving Jail (MEPS)
April 1, 2024 updated by: Nina T. Harawa, MPH, PhD, University of California, Los Angeles
Prevention Support for People Leaving Jail 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
215
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
Santa Fe Springs, California, United States, 90670
- Los Angeles Center for Alcohol and Drug Abuse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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
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.
Provide documentation of the appointment.
|
9 months
|
Number of participants obtaining screening for PrEP
Time Frame: 9 months
|
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
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: 30 days
|
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.
Time Frame: 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
Time Frame: 9 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
Time Frame: 9 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
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 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,
Time Frame: 3 months
|
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.
Time Frame: 9 months
|
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
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 and the total number of reincarcerations per arm over the study period.
|
9 months
|
Temporal service utilization patterns of intervention arm participants
Time Frame: 9 months
|
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
Time Frame: 9 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Nina T Harawa, PhD, University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 14, 2019
Primary Completion (Actual)
January 11, 2024
Study Completion (Actual)
March 31, 2024
Study Registration Dates
First Submitted
March 29, 2019
First Submitted That Met QC Criteria
July 25, 2019
First Posted (Actual)
July 29, 2019
Study Record Updates
Last Update Posted (Actual)
April 3, 2024
Last Update Submitted That Met QC Criteria
April 1, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Disease Attributes
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Bacterial Infections
- Bacterial Infections and Mycoses
- Hepatitis
- Urogenital Diseases
- Genital Diseases
- Substance-Related Disorders
- Hepatitis C
- Sexually Transmitted Diseases
- Sexually Transmitted Diseases, Bacterial
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)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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