RecruitingNot ApplicableNCT06463886

Striving Towards EmPowerment and Medication Adherence R01

A Randomized Control Trial of Striving Towards EmPowerment and Medication Adherence (STEP-AD)

Sponsor

University of Miami

Enrollment

250 participants

Start Date

Aug 19, 2024

Study Type

INTERVENTIONAL

Conditions

Mental Health Issue HIV

Summary

This is a study for Black women living with HIV to test a counseling program for Black women living with HIV. This participant may be a good fit if the participant is a Black woman, living with HIV, has a history of trauma, and is currently taking Antiretroviral Therapy (ART) medicines

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a program designed to help Black women living with HIV better manage their medication and cope with past trauma. The goal is to improve how consistently participants take their HIV medications so their viral load becomes undetectable. **You may be eligible if...** - You identify as Black and cisgender female - You are 18 or older and living with HIV - Your HIV viral levels have not been fully suppressed in the last year, or you have not had a viral load test in 6 or more months - You have a history of trauma or abuse - You speak English **You may NOT be eligible if...** - You are unable to understand or complete the consent process Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSTEP-AD

This in-person STEP-AD intervention will consist of 10 sessions. Session 1: Life Steps Adherence Session 2: Psychoeducation on the treatment model Session 3: Substance Use and Enhancing Resilience Session 4: Trauma Impact Session 5: Cognitive Restructuring Session 6: Racial Discrimination Impact and Coping Session 7: HIV Stigma Impact and Coping Session 8: Gender-related Stressors and Coping Session 9: Body Image and Healthy Relationships Session 10: Practice, Review, and Relapse Prevention. Each session lasts for about 40 to 60 minutes.

BEHAVIORALEnhanced treatment as usual (E-TAU)

Participants assigned to the E-TAU condition will receive 10 in person sessions to ensure comparable contact time with study staff and identical incentives. The first session will consist of a session on healthy living with HIV (CDC content on HIV 101 \[highlights importance of engaging in care, adhering to medication, finding support\], nutrition, and physical activity. The remaining 9 sessions will consist of neutral (daily events) writing. Women will be asked to write a description of their plans for the next 24 hours.

Locations(1)

University of Miami

Miami, Florida, United States

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NCT06463886

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