Peer Behavioral Intervention for HIV

(PUSH Trial)

Recruiting at 2 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a peer-supported approach to help individuals adhere to their HIV medication routine, focusing on those using long-acting injectable treatments (LAI-PrEP/ART). The researchers aim to determine if this new method, called Peer Activate-LAI, is more effective than usual care, particularly for Black individuals who use substances and are living with or at high risk for HIV. The trial will also evaluate how well this approach can be implemented and its cost-effectiveness. Suitable candidates for the trial include those who are either HIV positive or at high risk for HIV, use substances moderately, and are ready to engage in a new treatment strategy. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance HIV care for many.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Peer Activate-LAI intervention is safe?

Research shows that the Peer Activate-LAI treatment is generally easy for people to handle. This method involves peer recovery specialists assisting individuals in staying on track with their long-acting injectable medications for preventing and treating HIV. Previous studies suggest that this approach is practical and easy to use, with few side effects. The focus on behavioral activation, successful in treating depression, also seems promising for helping people adhere to their medication and manage substance use disorders. Although specific safety data for this trial is not yet available, a peer-driven model has proven effective and well-accepted in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Peer Activate-LAI because it offers a fresh approach to improving adherence to HIV medication. Unlike standard treatments that focus primarily on medical interventions, this method combines behavioral activation with problem-solving techniques delivered by peer recovery specialists. This unique strategy is particularly promising for individuals with substance use disorders, as it not only targets HIV medication adherence but also supports sustained recovery and positive lifestyle changes. By integrating peer support, it makes the treatment more accessible and sustainable for low-income individuals.

What evidence suggests that the Peer Activate-LAI intervention is effective for improving adherence to LAI-PrEP/ART in individuals at high risk for HIV?

Studies have shown that long-acting injectable (LAI) treatments for HIV, such as LAI ART and PrEP, effectively treat and prevent the virus. Research indicates that these treatments often lead to better adherence, as people are more likely to follow their medication schedule compared to taking daily pills. In this trial, participants in the Peer Activate-LAI arm will receive peer support, which employs strategies to help individuals adhere to their treatment plan. One strategy, called behavioral activation, was originally used to treat depression and has successfully helped people stay on track with substance use treatment and HIV medications. This approach is particularly beneficial for those who might not have regular access to healthcare resources. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. trialx.com trialx.com/clinical-trials/listings/310931/peer-behavioral-activation-utilization-to-improve-substance-use-and-hiv-outcomes-in-people-receiving-long-acting-injectable-prepart-push/

Peer Behavioral Activation Utilization to Improve ... This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of ART/PrEP within ...

2. withpower.com withpower.com/trial/phase-hiv-infections-2025-88f93

Peer Behavioral Intervention for HIV (PUSH Trial) This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of PrEP/ART within Black, substance ...

3. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R01DA061324&arg_ProgOfficeCode=114

Award Information | HHS TAGGS Peer Behavioral Activation Utilization to Address Structural Racism and Discrimination and Improve HIV Outcomes in High-Risk, Substance-Using Populations- ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12264424/

Willingness to Take Long-Acting Injectable Preexposure ... LAI CAB shows higher efficacy and better adherence than oral PrEP and could ... LAI PrEP among PWID were qualitative, and quantitative data are limited.

5. academic.oup.com academic.oup.com/ofid/article/12/2/ofaf029/7961917

Real-world Rollout of Injectable Antiretrovirals for HIV ... In clinical trials, LAI ART and PrEP demonstrated efficacy at treating and preventing HIV, respectively, and emerging data suggest that LAI ART may even be ...

6. reporter.nih.gov reporter.nih.gov/search/C4k7PgF3TEiIr1g6tNPHQA/project-details/10986307

Peer Behavioral Activation Utilization to ... - NIH RePORTER Implementing an evidence-based, peer delivered approach to support adherence to LAI interventions may be a feasible, acceptable, and sustainable way to improve ...

7. academic.oup.com academic.oup.com/ofid/article/12/7/ofaf389/8185534

Willingness to Take Long-Acting Injectable Preexposure ... Of 402 PWID, 69.1% reported being extremely likely/likely to take LAI PrEP; 52.4% preferred LAI PrEP over daily oral PrEP.

8. reporter.nih.gov reporter.nih.gov/project-details/8996204

Preparing for Implementation of Sustained Release Long-acting injectable (LAI) ARVs for PrEP have the potential to address several key barriers inherent in daily oral PrEP, including obviating the need for ...