Recruiting

Empowerment & Adherence

Sponsor:

University of Miami

Code:

NCT06463886

Conditions

Hiv

Mental Health Issue

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STEP-AD

Enhanced treatment as usual (E-TAU)

Study Details

Brief 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

Study ID

NCT06463886

Start date

Aug 19, 2024

Status verified date

Sep, 2025

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

1. Black
2. Living with HIV
3. Cis-gender female
4. Age 18 or older
5. English speaking
6. Viral load non-suppression (>200 ml) within the past year or a lack of HIV viral load measure for 6 consecutive months or more during the past 12 months
7. History of trauma/abuse
8. Capable of completing and fully understanding the informed consent process and study procedures

Exclusion criteria:

1. Unable to completely and fully understand the informed consent process and the study procedures
2. Significantly interfering mental health symptoms (e.g., active psychosis that is untreated)

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: STEP-AD

Participants in this arm will receive the manualized 10 session behavioral medicine intervention titled "Striving Towards EmPowerment and Medication Adherence". Participants will be in this group for a total of up to 1.5 years.

active comparator: Enhanced treatment as usual

Participants in the comparison condition will also complete 10 in person sessions. The first session will consist of a session on healthy living with HIV. The remaining 9 sessions will consist of neutral (daily events) writing. Participants will be in this group for a total of up to 1.5 years.

Interventions

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.

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.

Primary outcome measure

  • Change in viral suppression [ Time Frame: Baseline up to 1.5 years ]

Central Contacts and Locations

Central contacts

Sannisha Dale, PhD

3052841991sdale@med.miami.edu

Shine Research

3052436714shineresearch@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Sannisha Dale, PhD

305-284-1991sdale@med.miami.edu

SHINE Research

3052436714shineresearch@miami.edu

Principal Investigator:

Sannisha Dale, PhD

More Information

Sponsor

University of Miami

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Keywords

  • HIV
  • Black women
  • Trauma
  • Intersectional
  • Discrimination
  • Stigma
  • Medication adherence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-09-19.