Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06439329
Other study ID # 2000037052
Secondary ID 1R61DA060625-01
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date January 2025

Study information

Verified date May 2024
Source Yale University
Contact Sandra Springer, MD
Phone 203-687-6680
Email Sandra.springer@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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; - have a current DSM-5 SUD (opioid and/or stimulant). 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Standard PN
Standard of care
Patient Choice
Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services.

Locations

Country Name City State
United States 135 College St., Suite 280 New Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility/acceptability will be assessed using the CAB Community Needs Assessment 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. 3 months
Primary Feasibility/acceptability will be assessed using the Organizational Readiness for Implementing Change (ORIC) from the JCOIN Common Measure survey 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. 3 months
Primary Participant attitudes toward the interventions will be assessed using the Scales for Participant Alliance with Recovery Coach (SPARC) 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. 3 months
Primary Percentage of participants with access to PrEP/ART services Utilization of Services and PN Engagement data will be used to assess the percentage of participants with access to PrEP/ART services. 3 months
Primary Percentage of participants with receipt of treatment Defined as participants that have received a prescription for PrEP/ART 3 months
Secondary Substance use treatment Percentage of participants engaged in substance use disorder (SUD) treatment 3 months
See also
  Status Clinical Trial Phase
Completed NCT05660434 - Using Aromatherapy in Substance Use Disorder N/A
Active, not recruiting NCT05338268 - Substance Use and Loneliness N/A
Completed NCT04098614 - Barriers to Substance Use Disorder Recovery N/A
Completed NCT03954184 - E-health Implementation (Iowa) N/A
Completed NCT03590106 - Cardiac Surgery Peer Recovery Support Program N/A
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Recruiting NCT05327504 - Written Exposure Therapy for Veterans With SUD and PTSD N/A
Terminated NCT03517111 - The Impact of a Parenting Intervention on Latino Youth Health Behaviors N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT04401215 - Technologically-Augmented Referrals to Mitigate Addiction Consequences N/A
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Not yet recruiting NCT06187701 - Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients N/A
Recruiting NCT04296604 - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations N/A
Active, not recruiting NCT02382042 - Intensive Referral Intervention to Improve Substance Use Disorder Treatment Outcomes Among Rural and Highly Rural Veterans N/A
Terminated NCT01356667 - Drum-Assisted Therapy for Native Americans N/A
Completed NCT01237366 - Study Targeting Affect Regulation Phase 1/Phase 2
Completed NCT00708890 - Twelve Step Based Self-help Groups for Substance Related Disorders N/A
Active, not recruiting NCT04048850 - Zepatier in Patients With Substance Use
Recruiting NCT05976646 - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion Phase 1/Phase 2