J-RISE: Relevant Implementation Strategies to Eliminate the Social and Structural Barriers to HIV Services Among Justice-involved Black Men Who Have Sex With Men and Other Key Populations

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

The goal of this clinical trial is to compare two interventions - Health Navigation and Health Navigation Plus among individuals who have been impacted by the criminal legal system.

The main question it aims to answer is:

• Compared with the Health Navigation group, are participants in the Health Navigation Plus group more likely to a) access HIV care, treatment, and prevention services and employment services and b) access employment services and be employed in community?

Participants on the study will be:

* Randomly assigned (like a flip of a coin) to participate in either Health Navigation or Health Navigation Plus. Participants will have an equal chance of being placed in either group. * Complete three surveys over the course of 13 months * Participants in the Health Navigation group will have two in person meetings and seven check-ins with the health navigator over 6 months * Participants in the Health Navigation Plus group will have two in person meetings and seven check-ins with the health navigator over 6 months, two in person and 10 check ins with the employment navigator over 12 months and up to $200 to support employment and career development needs and receive up to $140 to support health goals. Samples of blood, urine and swabs may be collected to meet the health goals.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

be at least 18 years of age;

currently reside or intend to reside in one of the study communities (i.e., Cook County, Baton Rouge, and the New Orleans area);

be currently incarcerated in jail or prison and report an expected release within 90 days, or under community supervision or drug court, or report a recent incarceration within the last three years, or in the last 12 months has had an interaction with law enforcement that did not lead to an arrest or jail or prison time, AND has not already been linked and/or retained in HIV or PrEP care in the community;

report needing employment-related services; and

Disqualifiers

unwilling/unable to provide informed consent,

does not live or intend to live in one of the study locations,

unable to confirm HIV status,

unable to conduct the study in English, and

Trial design

Design model

Parallel

Treatments tested in this trial

  • Health Navigation

    Behavioral

    Participants meet with Health Navigator twice in-person and receive 7 check-ins from the Health Navigator over a 6 month period. The health navigator provides participants with referrals and support to HIV, mental health, substance use, and other supportive services

  • Health Navigation, Employment Navigation plus Contingency Management Intervention

    Behavioral

    Participants meet with health navigator twice in-person and receive 7 check-ins from the health navigator over a 6 month period. The health navigator provides participants with referrals and support to HIV, mental health, substance use, and other supportive services. Participants meeting with the employment navigator twice in-person and receive 10 check-ins from the employment navigator over 12 months. The employment navigator provides participants with referrals to employment and career development opportunities in the community and up to $200 for employment and career development support (e.g., transportation to interview, GED preparation course). Participants also receive up to $140 for HIV/STI care, treatment, and prevention milestones as part of the contingency management interview over a period of 12 months.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Health NavigationActive comparator 1 intervention
Group B: Health Navigation, Employment Navigation plus Contingency Management InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Linkage to HIV care

Number of participants who visit a provider for HIV care and receive a prescription based on medical reports

Time frame
Baseline through 90 days in community
2

Linkage to PrEP care

Number of participants who visit a provider for PrEP care ranging from PrEP information only to the receipt of a prescription based on medical reports

Time frame
Baseline through 90 days in community
3

Linkage to employment-related services in community

Number of referred participants who receive employment-related service in the community based on referral reports completed by the interventionists

Time frame
Baseline through 90 days in community

Secondary outcomes

1

Retention in HIV care

Number of participants who attend two HIV care visits at least 90 days apart based on medical reports

Time frame
12 months
2

HIV viral suppression

Number of participants with an HIV viral load \< 200 copies/ml based on medical reports

Time frame
Baseline through 12 months
3

Retention in PrEP care

Number of participants with at least two PrEP care visits in a 12-month period based on medical reports

Time frame
12 months
4

Receipt of mental health services

Number of participants with a mental health service visit within 180 days based on referrals reported complete by interventionists.

Time frame
Baseline through 180 days in community

Other outcomes

1

Receipt of other HIV prevention services

Number of participants who self-report in surveys receiving a HIV/STI Test, nonoccupational HIV post-exposure prophylaxis (nPEP), and/or Doxycycline post-exposure prophylaxis (DoxyPEP)

Time frame
Baseline through 12 months
2

Changes in employer and temporary staffing agency policies and practices

Number and types of observed policies and practices related to hiring returned citizens over the course of the study based on email correspondence and informal conversations with employers and temporary staffing agencies.

Time frame
Baseline through 12 months
3

Changes in housing status

Number of participants who self-report stable housing

Time frame
Baseline through 12 months
4

Changes in substance use behaviors

Number of participants who self-report substance use behaviors

Time frame
Baseline through 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Northwestern University

Collaborator

NORC at the University of Chicago

Collaborator

Frontline Legal Services

Collaborator

Capitol Area Reentry Program Inc.

Collaborator

National Institute of Mental Health (NIMH)

Collaborator

Cook County Health

Collaborator