Acceptance-Based Behavior Therapy for HIV/AIDS

Overseen By Debra Herman, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Cognitively impaired

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Acceptance-Based Behavior Therapy (ABBT) to help people with HIV remain committed to their medical care. Researchers compare ABBT to a standard HIV education program. Participants will receive either two sessions of ABBT or two sessions of HIV education. This trial suits individuals newly diagnosed with HIV who are beginning medical care for the first time. As an unphased trial, it allows participants to contribute to innovative research that could improve HIV care strategies.

Do I have to stop taking my current medications for this 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Acceptance-Based Behavior Therapy (ABBT) is generally safe for people with HIV/AIDS. In past studies, ABBT helped patients stay engaged in their medical care without major safety issues.

Participants handled ABBT well, experiencing no harmful side effects. This therapy helps people accept their thoughts and feelings, making it easier to follow treatment plans. Tested with HIV-positive patients before, there were no significant reports of negative effects.

Overall, ABBT appears safe and well-tolerated for people with HIV, based on previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance-Based Behavior Therapy (ABBT) for HIV/AIDS because it focuses on psychological acceptance and behavior change, which is a refreshing approach compared to the typical antiretroviral medications. Unlike standard treatments that primarily target the virus itself, ABBT aims to help individuals manage the emotional and mental challenges associated with living with HIV/AIDS. This therapy is delivered efficiently in just two sessions, one in-person and one via telephone, making it accessible and potentially easier to integrate into patients' lives. By addressing the psychological aspects, ABBT could enhance overall well-being and treatment adherence, offering a holistic complement to existing medical treatments.

What evidence suggests that this trial's treatments could be effective for improving HIV patients' commitment to medical care?

Research has shown that Acceptance-Based Behavior Therapy (ABBT), one of the treatments studied in this trial, might help people with HIV/AIDS maintain their medical care. One study found that ABBT can assist patients in accepting their HIV status, feeling more comfortable discussing it with others, and staying engaged in their treatment. ABBT encourages patients to accept their feelings and thoughts without judgment, potentially leading to better health. Previous studies also suggest that this therapy can help individuals adhere to their medical care, which is crucial for effective HIV management. While researchers continue to study ABBT, early results are promising for those seeking to improve their commitment to HIV treatment. Another treatment arm in this trial, Enhanced-Treatment-as-Usual (ETAU), includes a 2-session program of HIV education alongside standard care. ^{1 2 4 5 6}

Who Is on the Research Team?

Ethan Moitra, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have recently been diagnosed with HIV and are starting medical care for it. Participants must speak and read English well enough to follow the study procedures and have access to a telephone. People with cognitive impairments cannot join.

Inclusion Criteria

HIV+

Entering HIV medical care services for the first time (that is, not transferring HIV care from another location)

Able to speak and read English at the level to be able to complete the study procedures

Exclusion Criteria

Cognitively impaired

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 2-session Acceptance-Based Behavior Therapy (ABBT) intervention, with the first session in-person and the second session by telephone

2 weeks

1 visit (in-person), 1 visit (telephone)

Control

Participants in the control group receive an Enhanced-Treatment-as-Usual (ETAU) condition, including a 2-session HIV education program

2 weeks

1 visit (in-person), 1 visit (telephone)

Follow-up

Participants are monitored for retention in care, virologic suppression, ART adherence, and other secondary outcomes

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acceptance-Based Behavior Therapy (ABBT)
• Enhanced-Treatment-as-Usual (ETAU)

Trial Overview The trial is testing Acceptance-Based Behavior Therapy (ABBT) against an Enhanced-Treatment-as-Usual (ETAU) control condition, aiming to improve commitment to medical care among new HIV patients. It's a randomized study, meaning participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

Group I: Acceptance-Based Behavior Therapy (ABBT) Experimental Treatment 1 Intervention

The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.

Group II: Enhanced-Treatment-as-Usual (ETAU) Placebo Group 1 Intervention

In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5522179/

Open Trial of an Acceptance-Based Behavior Therapy ... The interventionist acknowledged that informed disclosure was a common concern for all people living with HIV/AIDS and that there is no “right way” to approach ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28451891/

Pilot Randomized Controlled Trial of Acceptance-Based ... Pilot Randomized Controlled Trial of Acceptance-Based Behavior Therapy to Promote HIV Acceptance, HIV Disclosure, and Retention in Medical Care. AIDS Behav.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421002500

HIV Engage—A randomized controlled efficacy trial of an ... Pilot randomized controlled trial of acceptance-based behavior therapy to promote HIV acceptance, HIV disclosure, and retention in medical care. AIDS Behav.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06648629

Acceptance and Commitment Therapy for HIV+ Hazardous ... Study Overview. Brief Summary. Alcohol consumption is a critical factor in HIV treatment that significantly contributes to poor treatment-related outcomes.

5. clinicaltrial.be clinicaltrial.be/en/details/59391?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Brief Acceptance-Based Retention Intervention for Newly D... Always speak to your doctor to see if you are a potential candidate for this trial. Jump toI am interestedLocations. Conditions. HIV/AIDS.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5659953/

Pilot randomized controlled trial of acceptance-based ... Relative to TAU, ABBT had significant positive effects on retention, as well as putativ mechanisms of action, including experiential avoidance of HIV, ...