Substance Use Disorders
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStandard PN
Standard of care
BEHAVIORALPatient Choice
Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants who initiate or re-initiate PrEP | 6 months | Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report |
| Percentage of participants who initiate or re-initiate ART | 6 months | Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants that adhere to PrEP | 6 and 12 months | Percentage of participants that adhere to PrEP |
| Percentage of participants retaining on PrEP | 6 and 12 months | Percentage of participants retaining on PrEP |
| HIV incidence | 6 and 12 months | HIV incidence \[binary\] for those testing negative using rapid point of care (POC) test over time |
| Percentage of participants that adhere to ART | 6 and 12 months | Percentage of participants that adhere to ART |
| ART retention | 6 and 12 months | For persons living with HIV (PLH), ART retention \[binary\] |
| Substance use treatment | 6 and 12 months | Percentage of participants engaged in substance use disorder (SUD) treatment |
| HIV viral suppression | 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 |
| Retention in HIV PrEP/ART | 6 months | Retention in HIV PrEP/ART care \[binary\]: defined as attending 2 or more visits in 6-months |
| Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior | 6 and 12 months | Number of Participants Who Had Any Needle Sharing Activity |
| Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior | 6 and 12 months | Number of Participants Who Had Vaginal or Anal Sex Without a Condom |
| Days of using opioids | 6 and 12 months | Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use |
| Number of participants with with overdose events | 6 and 12 months | Number of participants with non-fatal and fatal overdose events |
| Percentage of participants with retention in SUD treatment | 6 and 12 months | Retention in SUD treatment including but not exclusive to Medication for Opioid Use Disorder (MOUD) for Opioid Use Disorder (OUD) |
| Quality of Life assessed using PROMIS-PROPr | 6 and 12 months | PROMIS-PROPr assesses general societal health. Total summary score ranges from -0.022, worse than dead, to 1, perfect health. |
| Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9) | 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. |
| Recidivism: Reasons | 6 and 12 months | Number of participants per reason for arrest/ incarceration/return-to-custody |
| Recidivism: Mean days in custody/incarcerated | 6 and 12 months | Mean days in custody/incarcerated |
| Recidivism: Mean days to return | 6 and 12 months | Mean days to return to custody/incarcerated |
| HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS) | 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 |
| Percentage of participants diagnosed with SUD | Baseline and 12 months | Percentage of participants diagnosed with SUD using DSM-5 |
Countries
United States
Contacts
CONTACTSandra Springer, MD
CONTACTAlysse Schultheis, MA
PRINCIPAL_INVESTIGATORSandra Springer, MD
Yale University
Outcome results
None listed