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. Phase 1 the R61 portion of the project will be a Pilot Study, and Phase 2 the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot (NCT07223398). The focus of this registration is the pilot study. In Year 1 (R61; Aim 1) the intervention of the patient choice menu of options of PrEP/ART and SUD treatment services for justice involved people who use drugs (PWUD) to supplement established peer navigation (PN +PC) will be developed and pilot tested in Western Connecticut only (Fairfield, Litchfield, Southern New Haven Counties). Implementation procedures for this study include needs assessment survey and focus groups consisting of CAB members and PNs to assess the types of services available in their community, as well as gaps in services and ideas of how services can be improved. These needs assessment surveys and focus groups will occur 3 times throughout 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 6 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 and have a viral load \>200 copies/mL in past 6 months OR persons who test negative for HIV who report not taking PrEP that meet CDC PrEP eligibility criteria in past 6 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 within 12 months prior to being in a controlled setting and/or in the last 6 months within the community Implementation portion/CAB members: * able to provide written informed consent in English or Spanish; * working with persons with a history of justice involvement and substance use in the areas targeted for this project PN Participants: * able to provide written informed consent in English or Spanish; * be employed at a project research site as a Patient Navigator
Exclusion criteria
* severe medical or psychiatric disability making participation unsafe; * unable to provide consent. * persons self-reporting pregnancy Implementation portion/CAB members: * persons self-reporting pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility/Acceptability Will be Assessed Using the CAB Community Needs Assessment | 3 months | Attitudes toward acceptability and feasibility of the PN and PN+PC menu of options will be surveyed from CAB members using the needs assessment created during project ACTION as a foundation. Total score range is 5-20 for each category. Higher scores indicate increased acceptability, appropriateness, and feasibility. Assessed only in CAB members. |
| Feasibility/Acceptability Will be Assessed Using the Organizational Readiness for Implementing Change (ORIC) From the JCOIN Common Measure Survey | 3 months | Organizational readiness for implementing change (ORIC) will be surveyed at start of preparation and sustainment phases with CAB members to evaluate confidence and commitment to using the PN+PC approach. Total scores range from 12 to 60, with higher scores indicating greater readiness. This survey was administered to CAB members only. |
| Mean Score for Participant Attitudes Toward the Interventions Will be Assessed Using the Scales for Participant Alliance With Recovery Coach (SPARC) | 3 months | Participant attitudes toward the PN and PN+PC implementation approach (rapport, satisfaction, linkage to services, engagement) will be collected at 3 months using the Scales for Participant Alliance with Recovery Coach; SPARC. The SPARC is scored on a Likert scale (1 = strongly disagree to 5 = strongly agree), higher scores indicate a high perception of the recovery coach alliance. There are six domains (engagement, satisfaction, rapport, motivation and encouragement, role model, and community linkage), and each domain score is between 10 and 50. |
| Number of Participants That Utilized Access of PrEP/ART Services | 3 months | Utilization of Services and PN Engagement data will be used to assess the number of participants that utilized access of PrEP/ART services. |
| Number of Participants With Receipt of Treatment | 3 months | Defined as participants that have received a prescription for PrEP/ART |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Substance Use Treatment | 3 months | Number of participants engaged in substance use disorder (SUD) treatment |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSandra Springer, MD
Yale University
Participant flow
Pre-assignment details
32 participants signed consent but one was lost to follow up prior to randomization. 31 patient participants were randomized.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48 years |
| Education 1 or more years of college credit, but no degree | 0 Participants |
| Education Associate's Degree (e.g., AA or AS) | 2 Participants |
| Education Bachelor's degree | 1 Participants |
| Education Did not complete high school | 0 Participants |
| Education GED or equivalent | 8 Participants |
| Education Graduate degree (MSW, MA, MS, JD, MD, DSW, EdD, Ph.D, etc.) | 3 Participants |
| Education Regular high school diploma | 1 Participants |
| Education Some college credit, but less than 1 year of college credit | 2 Participants |
| Education Trade School | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Had Insurance, last 30 days | 15 Participants |
| Hepatitis C (HCV) Rapid Testing Results Non-Reactive | 8 Participants |
| Hepatitis C (HCV) Rapid Testing Results Previous HCV diagnosis | 2 Participants |
| Hepatitis C (HCV) Rapid Testing Results Reactive | 1 Participants |
| HIV Rapid Testing Results Non-Reactive | 15 Participants |
| HIV Rapid Testing Results Previous HIV diagnosis | 1 Participants |
| HIV Rapid Testing Results Reactive | 0 Participants |
| Housing In a shelter | 1 Participants |
| Housing Other residential facility or institution (e.g. healthcare facility, halfway house) | 1 Participants |
| Housing Rent an apartment /house | 9 Participants |
| Housing Staying with family/ friends | 3 Participants |
| Housing Transitional ( time-limited) single room occupancy | 3 Participants |
| Housing Unhoused | 5 Participants |
| Injection Drug Use, last 30 days | 3 Participants |
| Participants with Moderate to Severe Substance Use Disorder Diagnoses by Substance Alcohol | 3 Participants |
| Participants with Moderate to Severe Substance Use Disorder Diagnoses by Substance Opioids | 18 Participants |
| Participants with Moderate to Severe Substance Use Disorder Diagnoses by Substance Stimulants | 21 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Received public assistance, last 12 months | 12 Participants |
| Region of Enrollment United States | 15 participants |
| Self-perceived HIV risk High risk | 3 Participants |
| Self-perceived HIV risk Living with HIV | 1 Participants |
| Self-perceived HIV risk Low risk | 7 Participants |
| Self-perceived HIV risk Medium risk | 2 Participants |
| Self-perceived HIV risk No response | 0 Participants |
| Self-perceived HIV risk No risk | 6 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 1 / 15 |
| other Total, other adverse events | 3 / 16 | 0 / 15 |
| serious Total, serious adverse events | 1 / 16 | 0 / 15 |
Outcome results
None listed