Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations

NCT05286879 | Completed DMC

• 2 other identifiers: 20000293461U01DA053039-01
• Study Type: interventional
• Target: 601
• Locations: 1 country
• Sites: 3

Brief Summary

This is a 5-year Hybrid Type 1 Effectiveness-Implementation Randomized Control Trial (RCT) that compares two models of linking and retaining individuals recently released from justice involvement to the continuum of community-based HIV prevention and treatment, HCV treatment, STI treatment, and opioid use disorder (OUD) prevention and treatment, medication for opioid use disorder (MOUD) service cascades of care.

Conditions

Opioid Use Disorder; Infectious Disease; Substance Abuse; Stimulant Use Disorder; Risk Reduction Behavior; Substance Use

Keywords

Justice involvement; HIV Prevention; Hepatitis C Prevention

Outcome Measures

Primary Outcomes (2)

• Time to post-release initiation of ART medication

  Time to post-release initiation of ART for persons living with HIV. Measured by self-reported initiation within 6-months. ART initiation will be measured as the date of self-reported initiation within the 6-month intervention period.

  From the day of release/randomization to initiation of ART up to 6 months

• Time to post-release initiation of PrEP medication

  Time to post-release initiation of PrEP for participants not living with HIV. Measured by self-reported initiation within 6-months. PrEP initiation will be measured as the date of self-reported initiation within the 6-month intervention period.

  From the day of release/randomization to initiation of PrEP up to 6 months

Secondary Outcomes (13)

• Proportion of participants that initiate PrEP

  From the day of release/randomization to initiation of PrEP up to 6 months

• Proportion of participants prescribed PrEP at end of intervention.

  6 months

• PrEP adherence by self-report

  6 months

• Change in HIV status

  Baseline and 12 months

• ART adherence by self-report

  6 months

Other Outcomes (26)

• PrEP adherence by dried blood spot (DBS) testing

  6 months

• PrEP adherence by urine sample analysis

  6 months

• PrEP adherence assessed by prescription refill data

  up to 6 months

Study Arms (2)

Patient Navigator

OTHER

Navigators will assist linking study participants to appropriate community service providers

Behavioral: Patient Navigator

Mobile Health Unit

OTHER

Study participants will be linked to a MHU within their community

Behavioral: Mobile Health Unit

Interventions

Patient Navigator BEHAVIORAL

Linkage to services for OUD/SUD treatment including MOUD, Hepatitis C virus (HCV) testing and treatment; those not living with HIV infection will be provided access to PrEP services, and those living with HIV will receive assistance with gaining initial or continued access to ART services during the 6-month post-release intervention period

Patient Navigator

Mobile Health Unit BEHAVIORAL

Participants will receive HIV PrEP/ HIV ART, MOUD, harm reduction services on the MHU and or assistance from a community health worker in linking to appropriate community-based OUD and other medical and behavioral health providers across the 6 month post-release intervention period

Mobile Health Unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in one of our research areas
• Age 18 or older
• Able to provide written informed consent in English or Spanish
• Involvement with the criminal justice system within the last 6 months
• Living with HIV or being at risk of acquiring HIV and willing to learn about PrEP
• Willing to be tested for HIV (unless already confirmed via medical record)
• 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
• Having a history of condomless sexual intercourse, STI diagnosis, and/or IDU within 6 months prior to being in a controlled setting and/or in the last 6 months within the community

You may not qualify if:

• Severe medical or psychiatric disability making participation unsafe
• Unable to provide consent
• Not remaining in the local area after release from custody
• Being released to inpatient care
• Potential risk to research staff

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Texas Christian University

Fort Worth, Texas, 76129, United States

Location

Related Publications (2)

• Villaire S, Sease T, Pankow J, Bennett A, Pulitzer Z, Hansen L, Frank C, Di Paola A, Lehman W, Sanchez M, McQuaid A, Schultheis A, Stein B, Springer SA, Nijhawan AE, Knight K. A qualitative examination of barriers and facilitators to HIV prevention and treatment for people involved with the criminal justice system. Health Justice. 2025 Jun 6;13(1):37. doi: 10.1186/s40352-025-00344-6.

  PMID: 40478391 DERIVED

• Springer SA, Nijhawan AE, Knight K, Kuo I, Di Paola A, Schlossberg E, Frank CA, Sanchez M, Pankow J, Proffitt RP, Lehman W, Pulitzer Z, Thompson K, Violette S, Harding KK; ACTION Cooperative Group. Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons. BMC Infect Dis. 2022 Apr 15;22(1):380. doi: 10.1186/s12879-022-07354-x.

  PMID: 35428213 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Communicable Diseases; Risk Reduction Behavior; Substance-Related Disorders

Interventions

Patient Navigation; Mobile Health Units

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Hospitals; Health Facilities; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Health Services

Study Officials

• Sandra A Springer, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 18, 2022
• Study Start: March 31, 2022
• Primary Completion: July 31, 2025
• Study Completion: December 12, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)