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Gemensamt beslutsfattande för att behandla eller förebygga (STOP) HIV i rättsväsendets populationer (R33)

16 oktober 2026 uppdaterad av: Yale University

STOP (Delat Beslutsfattande för att Behandla eller Förebygga) HIV hos Rättsväsendets Populationer

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.

The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.

Studietyp

Interventionell

Inskrivning (Beräknad)

400

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Connecticut
      • New Haven, Connecticut, Förenta staterna, 06510
        • Rekrytering
        • Yale School of Medicine
        • Huvudutredare:
          • Sandy Springer, MD
    • Kentucky
      • Lexington, Kentucky, Förenta staterna, 40506
        • Rekrytering
        • College of Medicine at the University of Kentucky
        • Huvudutredare:
          • Michele Staton, PhD, MSW
    • Texas
      • Dallas, Texas, Förenta staterna, 75390
        • Rekrytering
        • University of Texas Southwestern Medical Center (UTSW)
        • Huvudutredare:
          • Ank Nijhawan, MD, MPH
      • Fort Worth, Texas, Förenta staterna, 76109
        • Rekrytering
        • Texas Christian University's (TCU) School of Medicine
        • Huvudutredare:
          • Kevin Knight,, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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;
  • persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and;
  • Having a history of opioid and/or stimulant use in the last 12 months within the community.

Exclusion Criteria:

  • severe medical or psychiatric disability making participation unsafe;
  • unable to provide consent.
  • persons self-reporting pregnancy

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Standard Patient Navigation (PN)

PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides a complete assessment of participant needs, goal setting, and help with appointment scheduling.
Beteende: Standard PN

Standard of care
Experimentell: PN + Patient Choice (PC) (PN+PC)

PNs working in the PN + PC arm will be trained to engage participants in selecting from a menu of service options in their community. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our Community Advisory Boards (CAB). PNs will also be trained to discuss sexual and substance use history with participants in order to provide education and motivation towards starting PrEP/ART and SUD treatment.
Beteende: Standard PN

Standard of care

Beteende: Patient Choice

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of participants who initiate or re-initiate PrEP
Tidsram: 6 months

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

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of participants that adhere to PrEP
Tidsram: 6 and 12 months

Percentage of participants that adhere to PrEP
6 and 12 months
Percentage of participants retaining on PrEP
Tidsram: 6 and 12 months

Percentage of participants retaining on PrEP
6 and 12 months
HIV incidence
Tidsram: 6 and 12 months

HIV incidence [binary] for those testing negative using rapid point of care (POC) test over time
6 and 12 months
Percentage of participants that adhere to ART
Tidsram: 6 and 12 months

Percentage of participants that adhere to ART
6 and 12 months
ART retention
Tidsram: 6 and 12 months

For persons living with HIV (PLH), ART retention [binary]
6 and 12 months
Substance use treatment
Tidsram: 6 and 12 months

Percentage of participants engaged in substance use disorder (SUD) treatment
6 and 12 months
HIV viral suppression
Tidsram: 6 months

For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load < 200 copies/mL at 6 months
6 months
Retention in HIV PrEP/ART
Tidsram: 6 months

Retention in HIV PrEP/ART care [binary]: defined as attending 2 or more visits in 6-months
6 months
Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior
Tidsram: 6 and 12 months

Number of Participants Who Had Any Needle Sharing Activity
6 and 12 months
Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior
Tidsram: 6 and 12 months

Number of Participants Who Had Vaginal or Anal Sex Without a Condom
6 and 12 months
Days of using opioids
Tidsram: 6 and 12 months

Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use
6 and 12 months
Number of participants with with overdose events
Tidsram: 6 and 12 months

Number of participants with non-fatal and fatal overdose events
6 and 12 months
Percentage of participants with retention in SUD treatment
Tidsram: 6 and 12 months

Retention in SUD treatment including but not exclusive to Medication for Opioid Use Disorder (MOUD) for Opioid Use Disorder (OUD)
6 and 12 months
Quality of Life assessed using PROMIS-PROPr
Tidsram: 6 and 12 months

PROMIS-PROPr assesses general societal health. Total summary score ranges from -0.022, worse than dead, to 1, perfect health.
6 and 12 months
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
Tidsram: 6 and 12 months

Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety.
6 and 12 months
Recidivism: Reasons
Tidsram: 6 and 12 months

Number of participants per reason for arrest/ incarceration/return-to-custody
6 and 12 months
Recidivism: Mean days in custody/incarcerated
Tidsram: 6 and 12 months

Mean days in custody/incarcerated
6 and 12 months
Recidivism: Mean days to return
Tidsram: 6 and 12 months

Mean days to return to custody/incarcerated
6 and 12 months
HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS)
Tidsram: 6 and 12 months

Mean score for Enacted (6 items), Anticipated (6 items), and Internalized (6 items) scales. Each scale is scored 1-5, with higher scores indicating greater endorsement of substance use stigma
6 and 12 months
Percentage of participants diagnosed with SUD
Tidsram: Baseline and 12 months

Percentage of participants diagnosed with SUD using DSM-5
Baseline and 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Yale University

Samarbetspartners

National Institute on Drug Abuse (NIDA)

Utredare

  • Huvudutredare: Sandra Springer, MD, Yale University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 november 2025

Primärt slutförande (Beräknad)

30 december 2027

Avslutad studie (Beräknad)

1 juni 2028

Studieregistreringsdatum

Först inskickad

30 oktober 2025

Först inskickad som uppfyllde QC-kriterierna

30 oktober 2025

Första postat (Faktisk)

31 oktober 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2000037052_a
  • 4R33DA060625-02 (U.S.S. NIH-anslag/kontrakt)

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