Decentralized, Status Neutral, Stakeholder-engaged, Post-incarceration Intervention for People Living With and at Risk for HIV
NCT07927673, Not applicable, Not yet recruiting, Montefiore Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Decentralized, Status Neutral, Stakeholder-engaged, Post-incarceration Intervention for People Living With and at Risk for HIV | ClinicalTrials.gov |
| NCT number | NCT07927673 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 420 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Montefiore Medical Center | ClinicalTrials.gov |
| Conditions | Substance Use Disorder (SUD), HIV (Human Immunodeficiency Virus), Viral Suppression of HIV Infection | ClinicalTrials.gov |
| Interventions | DEST2nation model, Standard of care referral | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of Participants Living with HIV (PWH) with viral suppression (12 months post-enrollment) | 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. | ClinicalTrials.gov |
| Primary | Proportion of Participants without HIV who Initiate PrEP (From enrollment through 12 months post-enrollment) | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants with Illicit substance use in the past 30 Days (12 months post-enrollment) | 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). | ClinicalTrials.gov |
| Secondary | Proportion of Participants with Illicit substance use in the past 30 Days (Baseline, 3, 6, and 9 Months post-enrollment) | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants living with HIV (PWH) who achieve Viral Suppression (6 months post-enrollment) | 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. | ClinicalTrials.gov |
| Secondary | Change from Baseline in log₁₀ HIV RNA (copies/mL) (from baseline to 6 months and 12 months post-enrollment) | 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. | ClinicalTrials.gov |
| Secondary | Proportion of Participants without HIV who Initiate PrEP (6 months post-enrollment) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 5
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)