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Prevention Support for People Leaving Jail (MEPS)

Primary Purpose

HIV Infections, Sexually Transmitted Diseases, Bacterial, Hepatitis C

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Enhanced Prevention Support
Usual Care plus Customized Referrals
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV prevention and testing, sexually transmitted disease (STD) prevention and testing, HIV pre-exposure prophylaxis (PrEP), Incarceration

Eligibility Criteria

18 Years - 49 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. housed in K6G unit or within 12 months post-release from incarceration
  2. ages 18-49 years
  3. 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.
  4. reports sexual intercourse with a male or a male-to-female transgender woman in the six months prior to jail entry
  5. 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.
  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

Sites / Locations

  • God's Property
  • Los Angeles County Men's Central Jail
  • Los Angeles Center for Alcohol and Drug Abuse

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Mobile Enhanced Prevention Support

Arm Description

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

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

Outcomes

Primary Outcome Measures

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. Provide documentation of the appointment.
Number of participants obtaining screening for PrEP
Defined as the participant completing the screening process for PrEP with an eligible provider or PrEP navigator. Provide documentation of the appointment.
Number of participants who initiate PrEP regimen
Defined as the participant obtaining a prescription for PrEP, providing documentation, reporting taking the medication
Number of participants who demonstrate minimal adherence to PrEP
Defined as the participant self-reporting taking prescribed PrEP at least 4 days per week over the prior 30 days
Number of participants who remain on PrEP for at least 3 months.
The participant will provide documentation of filled PrEP prescriptions for 3 or more months
Number of participants who undergo a HIV test every 3 months
Defined as the participant self-reporting having obtained HIV testing every 3 months over the 9 month follow-up period
Number of participants who undergo a test for gonorrhea, syphilis, and chlamydia every 6 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
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
Number of participants obtaining treatment for substance use disorders (SUDs) in the community
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
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) as defined by the recommended ASAM level of care in the 3 months prior to each follow-up interview.

Secondary Outcome Measures

Number of participants in each arm receiving care and treatment for newly diagnosed HIV or STD infections.
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)
Number of participants in each arm experiencing recidivism
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.
Temporal service utilization patterns of intervention arm participants
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).
Geographic service utilization patterns of intervention arm participants
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).

Full Information

First Posted
March 29, 2019
Last Updated
January 3, 2023
Sponsor
University of California, Los Angeles
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.
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1. Study Identification

Unique Protocol Identification Number
NCT04036396
Brief Title
Prevention Support for People Leaving Jail
Acronym
MEPS
Official Title
Prevention Support for People Leaving Jail Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 14, 2019 (Actual)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
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.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
A client-centered assessment of priorities and needs and customized prevention and testing referrals.
Arm Title
Mobile Enhanced Prevention Support
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Mobile Enhanced Prevention Support
Other Intervention Name(s)
MEPS
Intervention Description
Access to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care plus Customized Referrals
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants establishing a primary care provider who can prescribe PrEP (pre-exposure prophylaxis)
Description
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.
Time Frame
9 months
Title
Number of participants obtaining screening for PrEP
Description
Defined as the participant completing the screening process for PrEP with an eligible provider or PrEP navigator. Provide documentation of the appointment.
Time Frame
9 months
Title
Number of participants who initiate PrEP regimen
Description
Defined as the participant obtaining a prescription for PrEP, providing documentation, reporting taking the medication
Time Frame
9 months
Title
Number of participants who demonstrate minimal adherence to PrEP
Description
Defined as the participant self-reporting taking prescribed PrEP at least 4 days per week over the prior 30 days
Time Frame
30 days
Title
Number of participants who remain on PrEP for at least 3 months.
Description
The participant will provide documentation of filled PrEP prescriptions for 3 or more months
Time Frame
3 months
Title
Number of participants who undergo a HIV test every 3 months
Description
Defined as the participant self-reporting having obtained HIV testing every 3 months over the 9 month follow-up period
Time Frame
9 months
Title
Number of participants who undergo a test for gonorrhea, syphilis, and chlamydia every 6 months
Description
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
Time Frame
9 months
Title
Number of participants who undergo a test for hepatitis C
Description
Defined by the participant self-reporting having obtained at least one test for Hepatitis C
Time Frame
9 months
Title
Number of participants obtaining treatment for substance use disorders (SUDs) in the community
Description
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
Time Frame
3 months
Title
Number of participants who remain engaged in treatment for substance use disorders (SUDs) in the community,
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of participants in each arm receiving care and treatment for newly diagnosed HIV or STD infections.
Description
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)
Time Frame
9 months
Title
Number of participants in each arm experiencing recidivism
Description
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.
Time Frame
9 months
Title
Temporal service utilization patterns of intervention arm participants
Description
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).
Time Frame
9 months
Title
Geographic service utilization patterns of intervention arm participants
Description
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).
Time Frame
9 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-identifies as a man or a male-to-female trans woman.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina T Harawa, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
God's Property
City
Los Angeles
State/Province
California
ZIP/Postal Code
90003
Country
United States
Facility Name
Los Angeles County Men's Central Jail
City
Los Angeles
State/Province
California
ZIP/Postal Code
90012
Country
United States
Facility Name
Los Angeles Center for Alcohol and Drug Abuse
City
Santa Fe Springs
State/Province
California
ZIP/Postal Code
90670
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32959786
Citation
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.
Results Reference
derived

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Prevention Support for People Leaving Jail

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