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Behavioral Intervention

WE RISE Intervention for Human Immunodeficiency Virus Infection (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 0, 8, 24 and 48.

Awards & highlights

WE RISE Trial 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.Check my eligibility

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.See study design

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.

WE RISE Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I was assigned female at birth.

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I am HIV positive.

WE RISE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Antiretroviral therapy (ART) adherence by drug levels

Secondary outcome measures

Antiretroviral therapy (ART) adherence by visual analog scale

Generalized Anxiety Disorder-7

International trauma questionnaire

+2 more

Other outcome measures

Fitbit data

HIV Stigma Scale 12-short form

Loneliness (UCLA-3 item)

WE RISE 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

~1460

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

By His StripesUNKNOWN

Christie's PlaceOTHER

1 Previous Clinical Trials

210 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,122 Previous Clinical Trials

1,520,744 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this study currently open?

"According to the information available on clinicaltrials.gov, this particular trial is not currently seeking participants. The trial was originally posted on February 1st, 2024 and last updated on January 11th, 2024. However, it is worth noting that there are presently 894 other studies actively enrolling patients at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Women Focused Encounters for Resilience Independence Strength and Eudaimonia

Maile Young Karris 2024. "Women Focused Encounters for Resilience Independence Strength and Eudaimonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06216600.