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Striving Towards EmPowerment and Medication Adherence R01

NCT06463886 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-09-19

No results posted yet for this study

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

Conditions

  • Hiv
  • Mental Health Issue

Interventions

BEHAVIORAL

STEP-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.

BEHAVIORAL

Enhanced 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.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Miami

    lead OTHER

Principal Investigators

  • Sannisha Dale, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-19
Primary Completion
2029-06-01
Completion
2029-06-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06463886 on ClinicalTrials.gov