Decentralized, Status Neutral, Stakeholder-engaged, Post-incarceration Intervention for People Living With and at Risk for HIV

The goal of this proposal is to test the DEST2nation model (an effective, person-centered, low-barrier, comprehensive model of post-incarceration medical care) with people with criminal legal system involvement (PCLSI) living with HIV or related risk factors. Peer navigation interventions, while an evidence-based strategy for HIV care engagement post-incarceration, have only been moderately effective. Additionally, strengths-based case management and motivational enhancement counseling plus text message adherence reminders also did not improve viral suppression over standard care. A common limitation of these interventions is their inability to meet complex social needs PWH face post-incarceration. While peer engagement and navigation assistance are important to link PWH to medical care, more attention is needed to address unmet social needs.

A Community Health Advocate (CHA) will meet with participants once a month for six months, with two phone check-ins per month, to provide: rapid HIV testing every 3 months for participants who are HIV-negative or of unknown status; HIV and substance use education; substance use assessment and counseling; help finding and scheduling HIV, PrEP, substance use, and mental health care; accompaniment to medical appointments; connection to community-based organization (CBO) resources; and supportive counseling to discuss health and life concerns. Participants also receive the standard-of-care referral to community care.

Behavioral: DEST2nation model · Behavioral: Standard of care referral

Participants receive a referral to a community clinic for HIV-related care, with follow-up contacts at 1.5 and 3 months after enrollment to confirm whether an appointment was made and kept. Participants also have access to the CBO's usual case management services.

Behavioral: Standard of care referral

A decentralized, status-neutral post-incarceration model delivered entirely through community-based organizations that serve people with criminal legal system involvement, so that people living with HIV and HIV-negative people with risk factors receive the same model. CHAs are certified through the New York State Peer Worker Certification Program and trained in HIV and substance use education, harm reduction, PrEP, and point-of-care HIV testing. CHAs, CBO project managers, and the research team hold regular case huddles to coordinate care. The model was co-developed with a community advisory board and piloted and refined before this trial.

Referral to community care delivered by a study project manager rather than a CHA. The clinic is chosen for convenience and participant preference, and the project manager does not offer navigation, accompaniment, or HIV testing.

Time frame: 12 months post-enrollment

Proportion of participants living with HIV who achieve viral suppression (HIV RNA \<200 copies/mL). Viral load will be obtained from a study blood draw at the 12-month visit or a clinical result within 1 month before the 12-month visit.

Time frame: From enrollment through 12 months post-enrollment

Proportion of participants without HIV who initiate PrEP at any time from enrollment through 12 months post-enrollment. Initiation is assessed as a binary (yes/no) variable, defined as dispensing of oral PrEP or initiation of at least one long-acting injectable PrEP. Initiation is based on medical record review.

Time frame: 12 months post-enrollment

Proportion of participants who report use of one or more of the following illicit substances (cocaine, methamphetamine, non-prescribed opioids and/or non-prescribed benzodiazepines) on at least 1 day during the 30 days preceding the 12-month research visit, based on self-reported days of use from the drug-use item of the modified Addiction Severity Index (ASI).

Time frame: Baseline, 3-, 6-, and 9 months post-enrollment

Proportion of participants who report use of one or more of the following illicit substances (cocaine, methamphetamine, non-prescribed opioids and/or non-prescribed benzodiazepines) on at least 1 day during the 30 days preceding each of the research visits, based on self-reported days of use from the drug use item of the modified ASI.

Time frame: 6 months post-enrollment

Proportion of participants living with HIV who achieve viral suppression (HIV RNA \<200 copies/mL). Viral load will be obtained from a study blood draw at the 6-month visit or a clinical result within 1 month before the 6-month visit.

Time frame: From baseline to 6 months and 12 months post-enrollment

Mean change from Baseline in log10 HIV RNA (copies/mL) among participants living with HIV (PWH). Viral load will be obtained from a study blood draw at the 6-month and 12-month visits or a clinical result within 1 month before those visits.

Time frame: 6 months post-enrollment

Proportion of participants without HIV who initiate PrEP at any time from enrollment through 6 months post-enrollment. Initiation is assessed as a binary (yes/no) variable, defined as dispensing of oral PrEP or initiation of at least one long-acting injectable PrEP. Initiation is based on medical record review.

Decentralized, Status Neutral, Stakeholder-engaged, Post-incarceration Intervention for People Living With and at Risk for HIV