Prevention Support for People Leaving Jail

HIV Infections Clinical Trial

— MEPS  

Official title:

Prevention Support for People Leaving Jail Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036396
• Other study ID #: 19-000165
• Secondary ID: OS17-LA-003
• Status: Completed
• Phase: N/A
• Start date: November 14, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: April 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: March 31, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• HIV Infections
• Sexually Transmitted Diseases
• Sexually Transmitted Diseases, Bacterial
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Mobile Enhanced Prevention Support
Access to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor.
• Usual Care plus Customized 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.

Locations

Country	Name	City	State
United States	God's Property	Los Angeles	California
United States	Los Angeles County Men's Central Jail	Los Angeles	California
United States	Los Angeles Center for Alcohol and Drug Abuse	Santa Fe Springs	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, Los Angeles	California HIV/AIDS Research Program, Charles Drew University of Medicine and Science, Friends Research Institute, Inc., Los Angeles Centers For Alcohol and Drug Abuse

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 months
Primary	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.	9 months
Primary	Number of participants who initiate PrEP regimen	Defined as the participant obtaining a prescription for PrEP, providing documentation, reporting taking the medication	9 months
Primary	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	30 days
Primary	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	3 months
Primary	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	9 months
Primary	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	9 months
Primary	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	9 months
Primary	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	3 months
Primary	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.	3 months
Secondary	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)	9 months
Secondary	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.	9 months
Secondary	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).	9 months
Secondary	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).	9 months