Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06501781
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 88 Years
Healthy Volunteers
Accepted

Interventions

  • Peer Activate-LAI — BEHAVIORAL
    Peer Activate-LAI is a Peer Recovery Specialist-delivered behavioral activation and problem solving intervention, based on our team's formative work. The intervention focuses on problem-solving skills to improve adherence to ART and/or PrEP both at the individual level and environmental barriers to care (i.e., transportation, housing).
  • Standard of Care HIV treatment or prevention with LAI-PrEP/ART — OTHER
    Standard of care HIV treatment or prevention with LAI-PrEP/ART

Study Details

This randomized Type 1 hybrid effectiveness-implementation trial (N=186) will evaluate the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART ("Peer Activate-LAI") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV. Specific aims are to: Aim 1: Evaluate the effectiveness of Peer Activate-LAI over 12-months on: a) LAI-PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); and b) substance use (secondary; WHOASSIST, urine toxicology); and c) Explore the moderating role of SRD-related factors (exploratory) Aim 2: To evaluate the implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,12,13 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation. Aim 3: To evaluate the economic viability of Peer Activate-LAI, including a) cost of implementation and sustainment, and b) cost-effectiveness from multiple stakeholder perspectives. This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of PrEP/ART within Black, substance-using populations with multiple minority identities who to date have had limited support for improving LAI adherence for HIV treatment and prevention.

Key Dates

Start date
Mar 18, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
186 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Peer Activate-LAI
    Peer Activate-LAI, is a peer recovery specialist-delivered (PRS) behavioral activation (BA) and problem solving intervention aimed at improving adherence to LAI-PrEP/ART. BA was originally developed as an efficacious treatment for depression, with accumulating empirical support for SUD outcomes, including SUD treatment retention and HIV medication adherence, particularly when integrated with problem solving strategies. BA offers important advantages compared to other psychosocial interventions by being feasible and potentially sustainable for PRS delivery, appropriate for low-income individuals with OUD and other non-opioid SUD, and focused on building positive reinforcement in the current environment through engagement in adaptive, valued behaviors.
  • Active Comparator: Enhanced Treatment As Usual
    Participants in the Enhanced Treatment As Usual (ETAU) arm receive access to standard clinical care, including access to a clinician with expertise in HIV and PrEP, opportunity for co-located treatment of OUD, and STI testing and treatment, and general peer support. Enhanced treatment includes reminder phone calls and facilitated referrals to psychosocial, housing, financial benefits and legal services.

Primary Outcome Measure

LAI-PrEP/ART Complete Adherence [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
HIPS (Harm reduction drop-in center)Washington D.C.District of Columbia20002
Phyllis Bijole Clinic Manager
[email protected]
202.834.3289
Elana Rosenthal, MD (PRINCIPAL_INVESTIGATOR)
Meredith Zoltick, NP (SUB_INVESTIGATOR)
Ashley Davis, NP (SUB_INVESTIGATOR)
Baltimore Safe HavenBaltimoreMaryland21218
Onyinyechi Ogbumbadiugha, MPH
[email protected]
(443)-635-4943
Claire Tindula, NP
[email protected]
443-897-3435
Claire Tindula, NP (SUB_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By condition
HIVSubstance use disorder
By specialty
Infectious diseaseBehavioral healthAddiction medicine
By research site
HIPS (Harm reduction drop-in center)· Washington D.C., DCBaltimore Safe Haven· Baltimore, MD

Related Studies