Hepatitis C, HIV Infections, Sexually Transmitted Diseases, Bacterial, Substance Use Disorders
Conditions
Keywords
HIV prevention and testing, sexually transmitted disease (STD) prevention and testing, HIV pre-exposure prophylaxis (PrEP), Incarceration
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.
Interventions
BEHAVIORALMobile Enhanced Prevention Support
Access to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor.
BEHAVIORALUsual 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.
Sponsors
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.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Establishing a Primary Care Provider Who Can Prescribe PrEP (Pre-exposure Prophylaxis) | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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, | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Each Arm Receiving Care and Treatment for Newly Diagnosed HIV or HCV Infections. | 3, 6, or 9 months | 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) |
| Number of Participants Who Recidivate | 9 months | Measure the comparative effectiveness of each intervention arm on reducing recidivism (n=200), quantified as the number of respondents who are reincarcerated. |
| Number of Reincarcerations Among Those Who Recidivate | 9 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNina T Harawa, PhD
University of California, Los Angeles
Participant flow
Recruitment details
Participants were recruited through a variety of methods, including direct recruitment at supportive housing facilities in LA County and in MCJ, referrals from community partners, participant referrals, and flyers posted by community organizations.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 7.6 |
| Race/Ethnicity, Customized Race/ethnicity American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race/ethnicity Asian | 4 Participants |
| Race/Ethnicity, Customized Race/ethnicity Black or African American | 53 Participants |
| Race/Ethnicity, Customized Race/ethnicity Hispanic or Latino | 40 Participants |
| Race/Ethnicity, Customized Race/ethnicity Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race/Ethnicity, Customized Race/ethnicity Other (usually multiple) | 6 Participants |
| Race/Ethnicity, Customized Race/ethnicity White | 44 Participants |
| Region of Enrollment United States | 103 participants |
| Sex/Gender, Customized Gender identity Cisgender male | 178 Participants |
| Sex/Gender, Customized Gender identity Gender non-binary or non-conforming | 9 Participants |
| Sex/Gender, Customized Gender identity Other | 1 Participants |
| Sex/Gender, Customized Gender identity Trans female | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 117 | 2 / 116 |
| other Total, other adverse events | 0 / 117 | 0 / 116 |
| serious Total, serious adverse events | 0 / 117 | 0 / 116 |
Outcome results
None listed