Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

able to provide written informed consent in English or Spanish;

living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);

Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);

willing to have HIV testing to determine negative or positive status;

Disqualifiers

severe medical or psychiatric disability making participation unsafe;

unable to provide consent.

persons self-reporting pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard PN

    Behavioral

    Standard of care

  • Patient Choice

    Behavioral

    Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Standard Patient Navigation (PN)Active comparator 1 intervention
Group B: PN + Patient Choice (PC) (PN+PC)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants who initiate or re-initiate PrEP

Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report

Time frame
6 months
2

Percentage of participants who initiate or re-initiate ART

Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report

Time frame
6 months

Secondary outcomes

1

Percentage of participants that adhere to PrEP

Percentage of participants that adhere to PrEP

Time frame
6 and 12 months
2

Percentage of participants retaining on PrEP

Percentage of participants retaining on PrEP

Time frame
6 and 12 months
3

HIV incidence

HIV incidence \[binary\] for those testing negative using rapid point of care (POC) test over time

Time frame
6 and 12 months
4

Percentage of participants that adhere to ART

Percentage of participants that adhere to ART

Time frame
6 and 12 months

Other outcomes

Sponsors and contacts

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Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator