An interventional study of DEST2nation model and Standard of care referral in Substance Use Disorder (SUD), HIV (Human Immunodeficiency Virus) and Viral Suppression of HIV Infection, sponsored by Montefiore Medical Center. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Montefiore Medical Center · Not applicable, Interventional, and Health services research
One out of six people with HIV (PWH) in the U.S. are incarcerated annually; two-thirds of individuals who are incarcerated meet criteria for substance use disorder (SUD) and many more in carceral settings have risk factors for HIV. Ending the U.S. HIV epidemic hinges on linking and engaging people with criminal legal system involvement (PCLSI) with HIV or related risk factors, especially those with SUDs, to optimize antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) uptake and adherence.
In this study, the investigator team will pursue Aim 1 (R33): Test the DEST2nation model in a multisite randomized control trial; and Aim 2 (R33): Estimate the cost of implementing and sustaining a decentralized, status neutral model and estimate its economic value from healthcare sector, state-policymaker, and societal perspectives.
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.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 420 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Montefiore Medical Center is the lead sponsor of 416 studies on the registry; 69 are open to participants now.
Of its 87 completed or terminated interventional studies of FDA-regulated products, 76 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Onsite point of care (O-PoC)
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.
Proportion of Participants Living with HIV (PWH) with viral suppression (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: 12 months post-enrollment
Proportion of Participants without HIV who Initiate PrEP (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: From enrollment through 12 months post-enrollment
Proportion of Participants with Illicit substance use in the past 30 Days (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: 12 months post-enrollment
Proportion of Participants with Illicit substance use in the past 30 Days (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: Baseline, 3-, 6-, and 9 months post-enrollment
Proportion of Participants living with HIV (PWH) who achieve Viral Suppression (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: 6 months post-enrollment
Change from Baseline in log₁₀ HIV RNA (copies/mL) (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: From baseline to 6 months and 12 months post-enrollment
Proportion of Participants without HIV who Initiate PrEP (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.
Time frame: 6 months post-enrollment
Plan to share: Undecided — Personal identifiers will be obtained for all research participants for follow-up and to be leveraged for intervention research; however, de-identified datasets will also be created to share with qualified investigators whose research protocols have been IRB-approved by their institutions. Even though the final dataset will be stripped of any potential identifiers prior to release for sharing, there could remain the possibility of deductive disclosure of subjects with unusual characteristics. Individuals requesting data must demonstrate: 1) training in human subjects research, 2) completion of a data request form that includes a clearly-defined research question, variables requested, analytic plan, mock tables, and a dissemination plan, 3) IRB approval from their institution. Study data will remain on Einstein's secure, encrypted, HIPAA-compliant web-based platform.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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