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Prevention Support for People Leaving Jail (MEPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04036396
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : January 9, 2020
Sponsor:
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.
Information provided by (Responsible Party):
Nina T. Harawa, MPH, PhD, University of California, Los Angeles

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 upon departure from jail or a residential recovery facility for treatment of substance use disorders. 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.

Condition or disease Intervention/treatment Phase
HIV Infections Sexually Transmitted Diseases, Bacterial Hepatitis C Substance Use Disorders Behavioral: Mobile Enhanced Prevention Support Behavioral: Substance Treatment And Re-entry Transition program Not Applicable

Detailed Description:
The investigators will enroll 300 people in jail or immediately post-release from custody for those who transfer to a residential recovery facility. During the trial, half of participants will be randomized into a control group that receives customized prevention referrals and substance abuse-focused case management. They will be compared to the other half of participants randomized to the intervention group that, in addition to receiving customized referrals, 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. Participants in both groups will be followed to assess whether those offered the GeoPassport intervention are more likely to meet the specific prevention targets described in the Specific Aims. The intervention lasts 6 months following departure from jail or residential recovery facility. Participants are interviewed at 3, 6, and 9 months from the same point as the intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Prevention Support for People Leaving Jail Study
Actual Study Start Date : November 14, 2019
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Standard of Care Case Management
A client-centered assessment of priorities and needs, substance abuse-focused transitional case management, and customized prevention and testing referrals.
Behavioral: Substance Treatment And Re-entry Transition program
Client-centered needs assessment and prioritization, customized referrals, and substance abuse focused transitional case management.
Other Name: Project START

Experimental: Mobile Enhanced Prevention Support
Standard of Care in addition to the Mobile Enhanced Prevention Support Program
Behavioral: Mobile Enhanced Prevention Support
Access to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor.
Other Name: MEPS

Behavioral: Substance Treatment And Re-entry Transition program
Client-centered needs assessment and prioritization, customized referrals, and substance abuse focused transitional case management.
Other Name: Project START




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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 12 month follow-up period

  7. 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) every 6 months over the 12 month follow-up period

  8. 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. 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

  10. 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.


Secondary Outcome Measures :
  1. 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=300)

  2. Number of participants in each arm experiencing recidivism [ Time Frame: 9 months ]
    Measure the comparative effectiveness of each intervention arm on reducing recidivism (n=300), quantified as the number of respondents who are reincarcerated and the total number of reincarcerations per arm over the study period.

  3. 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=150).

  4. 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=150).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identifies as a man Self-identifies as a woman or a transgender woman (Note all participants will be recruited from a correctional facility for men and will have been labeled male at birth.)
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. housed in K6G unit or in a residential facility with substance use services (i.e., residential treament or recovery bridge housing)
  2. ages 18-44 years,
  3. screens positive for substance use disorders via Project START
  4. Reports sexual intercourse with a male or a male-to-female transgender woman in the six months prior to jail entry
  5. is likely to be remain either in custody if in jail or at a residential recovery facility for at least four more days, but less than 3 more months based on scheduled court dates, current sentence, treatment plan, etc.
  6. has not received an HIV diagnosis (based on self-report)
  7. plans to reside in Los Angeles County for the 12 months following enrollment

Exclusion Criteria:

  1. does not have a smartphone and is not willing to obtain one post-release,
  2. is not able to speak and understand English, and
  3. does not have sufficient reading skills to operate a mobile app

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036396


Contacts
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Contact: Gabriel Edwards, M.D. 310-267-0609 GEdwards@mednet.ucla.edu
Contact: Charles L Hilliard, Ph.D 323-563-5865 charleshilliard@cdrewu.edu

Locations
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United States, California
Los Angeles County Men's Central Jail Recruiting
Los Angeles, California, United States, 90012
Contact: Lauren Wolchok, MD         
Los Angeles Center for Alcohol and Drug Abuse Recruiting
Santa Fe Springs, California, United States, 90670
Contact: Charles McWells         
Sponsors and Collaborators
University of California, Los Angeles
Los Angeles Centers For Alcohol and Drug Abuse
Charles Drew University of Medicine and Science
California HIV/AIDS Research Program
Friends Research Institute, Inc.
Investigators
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Principal Investigator: Nina T Harawa, PhD University of California, Los Angeles
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Responsible Party: Nina T. Harawa, MPH, PhD, Professor-in-Residence, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04036396    
Other Study ID Numbers: 19-000165
OS17-LA-003 ( Other Grant/Funding Number: California HIV/AIDS Research Program )
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nina T. Harawa, MPH, PhD, University of California, Los Angeles:
HIV prevention and testing
sexually transmitted disease (STD) prevention and testing
HIV pre-exposure prophylaxis (PrEP)
Incarceration
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Hepatitis C
Substance-Related Disorders
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Chemically-Induced Disorders
Mental Disorders
Infection
Genital Diseases, Male
Genital Diseases, Female
Bacterial Infections