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Behavioral Intervention

ACT + Exercise + Social Support for Women with HIV (WE RISE Trial)

N/A

Recruiting

Led By Maile Karris, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Is female sex at birth (cis-women)

HIV-seropositive

Must not have

Not willing or not able to comply with study advisory board group participation agreement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 0, 8, 24 and 48.

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effects of a combination of acceptance and commitment therapy (ACT), exercise, and social support on women living with HIV. The goal is to see if this intervention can improve medication adherence

Who is the study for?

This trial is for women living with HIV who struggle with substance use, have experienced trauma, and may have difficulty sticking to their medication regimen. Participants should be connected to community organizations in the four target counties.

What is being tested?

The study tests a peer-delivered program combining Acceptance and Commitment Therapy (ACT), exercise routines, and empathetic social support. It aims to see if this approach helps improve medication adherence among women with HIV.

What are the potential side effects?

Since the interventions are non-pharmaceutical, typical drug side effects aren't expected. However, participants might experience emotional discomfort during therapy or physical strain from exercise.

Eligibility Criteria

Inclusion Criteria

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

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I was assigned female at birth.

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I am HIV positive.

Exclusion Criteria

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

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I am unable or unwilling to follow the study's participation rules.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 0, 8, 24 and 48.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 0, 8, 24 and 48.

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 8, 24 and 48. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Antiretroviral therapy (ART) adherence by drug levels

Secondary study objectives

Antiretroviral therapy (ART) adherence by visual analog scale

Generalized Anxiety Disorder-7

International trauma questionnaire

+2 more

Other study objectives

Fitbit data

HIV Stigma Scale 12-short form

Loneliness (UCLA-3 item)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: WE RISE InterventionExperimental Treatment3 Interventions

Participants will undergo WE RISE intervention: twice a week for 8 week combination delivery of acceptance and commitment therapy + exercise + social suppot.

Group II: ObservationalExperimental Treatment3 Interventions

Observational study of participants undergoing WE RISE adapted for sustainability.

Group III: ControlActive Control1 Intervention

Participants will receive standard of care which would be referrals to local opportunites for therapy, exercise and social support.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acceptance and Commitment Therapy (ACT)

2016

Completed Phase 3

~1470