← Back to Search

Behavioural Intervention

Peer Behavioral Intervention for HIV (PUSH Trial)

Washington, United States

N/A

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Meeting indications for treatment based on Cabotegravir-LA (HIV negative) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV positive) prescribing information

Must not have

Contraindications to Cabotegravir-LA (HIV-) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV+) use based on prescribing information or other medical/psychiatric conditions that may interfere with study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effectiveness and implementation of a peer-delivered problem solving and behavioral intervention called "Peer Activate-LAI" for improving adherence to HIV medication in a Black, substance-using population. The

See full description

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, LAI-PrEP/ART treatments can include reactions at the injection site, potential liver issues, sleep problems, and changes in body fat distribution among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

show original

Select...

I am eligible for Cabotegravir-LA or CAB and RPV-LA based on my HIV status.

show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

show original

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

LAI-PrEP/ART Complete Adherence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Peer Activate-LAIExperimental Treatment2 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 UsualActive Control1 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.

0 / 3Eligibility criteria met