Peer Behavioral Intervention for HIV

(PUSH Trial)

Recruiting at 1 trial location

Overseen By Emade Ebah Edongole, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: Cabotegravir, Rilpivirine

Disqualifiers: Pregnant, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 months

186 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 who are living with or at high risk for HIV and use substances moderately. They must be able to consent, meet the criteria for Cabotegravir-LA if HIV negative, or CAB and RPV-LA if positive, based on CDC guidelines.

Inclusion Criteria

Moderate substance use, defined as a WHO-ASSIST score of ≥4 for certain drugs (cocaine, amphetamines, inhalants, sedatives, hallucinogens, or opioids) or ≥11 for alcohol

Able and willing to sign informed consent

HIV negative with a negative HIV antibody/antigen test and meeting CDC criteria for PrEP or HIV positive with a positive antibody/antigen test

Exclusion Criteria

I have no medical conditions that would prevent me from using Cabotegravir or Rilpivirine.

Pregnant or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Peer Activate-LAI intervention or Enhanced Treatment As Usual (ETAU) for adherence to LAI-PrEP/ART over 12 months

12 months

6 visits for LAI maintenance injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Peer Activate-LAI

Trial Overview The study compares a peer-delivered problem-solving intervention ('Peer Activate-LAI') aimed at improving adherence to long-acting injectable PrEP/ART against standard care. It will assess effectiveness in maintaining treatment schedules, reducing substance use, and explore economic viability.

Participant Groups

Group I: Peer Activate-LAI Experimental Treatment 2 Interventions

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.

Group II: Enhanced Treatment As Usual Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+