Shared Decision Making per Trattare o Prevenire (STOP) l'HIV nelle Popolazioni Giudiziarie (R33)
STOP (Decisioni Condivise per Trattare o Prevenire) HIV nelle Popolazioni Giudiziarie
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Alysse Schultheis, MA
- Numero di telefono: 203-231-2454
- Email: alysse.schultheis@yale.edu
Backup dei contatti dello studio
- Nome: Sandra Springer, MD
- Numero di telefono: 203-231-2454
- Email: Sandra.springer@yale.edu
Luoghi di studio
-
-
Connecticut
-
New Haven, Connecticut, Stati Uniti, 06510
- Reclutamento
- Yale School of Medicine
-
Investigatore principale:
- Sandy Springer, MD
-
-
Kentucky
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Lexington, Kentucky, Stati Uniti, 40506
- Reclutamento
- College of Medicine at the University of Kentucky
-
Investigatore principale:
- Michele Staton, PhD, MSW
-
-
Texas
-
Dallas, Texas, Stati Uniti, 75390
- Reclutamento
- University of Texas Southwestern Medical Center (UTSW)
-
Investigatore principale:
- Ank Nijhawan, MD, MPH
-
Fort Worth, Texas, Stati Uniti, 76109
- Reclutamento
- Texas Christian University's (TCU) School of Medicine
-
Investigatore principale:
- Kevin Knight,, PhD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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. |
Standard of care |
|
Sperimentale: 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. |
Standard of care Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of participants who initiate or re-initiate PrEP
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of participants that adhere to PrEP
Lasso di tempo: 6 and 12 months
|
Percentage of participants that adhere to PrEP |
6 and 12 months
|
|
Percentage of participants retaining on PrEP
Lasso di tempo: 6 and 12 months
|
Percentage of participants retaining on PrEP |
6 and 12 months
|
|
HIV incidence
Lasso di tempo: 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
Lasso di tempo: 6 and 12 months
|
Percentage of participants that adhere to ART |
6 and 12 months
|
|
ART retention
Lasso di tempo: 6 and 12 months
|
For persons living with HIV (PLH), ART retention [binary] |
6 and 12 months
|
|
Substance use treatment
Lasso di tempo: 6 and 12 months
|
Percentage of participants engaged in substance use disorder (SUD) treatment |
6 and 12 months
|
|
HIV viral suppression
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 and 12 months
|
Number of Participants Who Had Vaginal or Anal Sex Without a Condom |
6 and 12 months
|
|
Days of using opioids
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6 and 12 months
|
Mean days in custody/incarcerated |
6 and 12 months
|
|
Recidivism: Mean days to return
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline and 12 months
|
Percentage of participants diagnosed with SUD using DSM-5 |
Baseline and 12 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Sandra Springer, MD, Yale University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Disturbi indotti chimicamente
- Disturbi Correlati a Sostanze
- Amministrazione dei servizi sanitari
- Consegna dell'assistenza sanitaria
- Economia e organizzazioni sanitarie
- Gestione dell'assistenza al paziente
- Controllo sociale, formale
- Finanziamento, organizzato
- Economia
- Assicurazione sanitaria
- Assicurazione
- Programmi di Assistenza Sanitaria Gestita
- Legislazione come Argomento
- Leggi sulla Libertà di Scelta del Paziente
Altri numeri di identificazione dello studio
- 2000037052_a
- 4R33DA060625-02 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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