Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)
University of Maryland, Baltimore
Summary
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.
Description
Background. Substance use continues to be a major driver of HIV acquisition and has been associated with suboptimal ART adherence, treatment interruption, and inability to achieve or maintain viral suppression. Use of PrEP, a key tool for HIV prevention, is disproportionately lower in racial/ethnic minorities, as well as people who inject drugs. Factors related to structural racism and discrimination (SRD) may contribute to low rates of adherence in these populations. New long-acting injectable (LAI) formulations of PrEP/ART provide a potential biomedical intervention to overcome adherence cha…
Eligibility
- Age range
- 18–88 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age 18 years or older * Able and willing to sign informed consent * HIV status: HIV negative with a negative HIV antibody/antigen test and meeting CDC(center for disease control and prevention) criteria for PrEP HIV positive with a positive antibody/antigen test * Meeting indications for treatment based on Cabotegravir-LA (HIV negative) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV positive) prescribing information * Moderate substance use, defined as a (World Health Organization Alcohol, Smoking and Substance Involvement Screening Test) WHO-ASSIST score of ≥4 fo…
Interventions
- BehavioralPeer Activate-LAI
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).
- OtherStandard of Care HIV treatment or prevention with LAI-PrEP/ART
Standard of care HIV treatment or prevention with LAI-PrEP/ART
Locations (2)
- HIPS (Harm reduction drop-in center)Washington D.C., District of Columbia
- Baltimore Safe HavenBaltimore, Maryland