Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Counseling program for Black women living with HIV

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

Run by University of Miami · NCT06463886 · Data updated 2026-11-12

This study tests a counseling program for Black women living with HIV to see if it helps them stick to their medication and cope with trauma better than standard care.

Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment250 (estimated)
SponsorUniversity of Miami
Academic / other
Locations1 site (Miami, Florida)
StatusRecruiting
StartedAugust 19, 2024
Main results expectedJune 1, 2029
Study endsJune 1, 2029
Registry record updatedOctober 15, 2026
Trial IDNCT06463886 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Black women aged 18 or older, living with HIV, who have a history of trauma and are currently taking antiretroviral therapy.

Probably not a fit

Patients with significantly interfering mental health symptoms or those unable to understand the informed consent process may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on Black women living with HIV to evaluate the effectiveness of a counseling program designed to enhance medication adherence and address trauma-related issues. Participants will receive either the STEP-AD intervention or enhanced treatment as usual (E-TAU). The study aims to empower these women by providing tailored support that acknowledges their unique experiences and challenges. The approach combines mental health support with medical adherence strategies to improve overall health outcomes.

Why it matters

Potential benefit: If successful, this program could significantly improve medication adherence and mental health outcomes for Black women living with HIV.

How similar studies have gone: Other studies have shown success in using counseling and support programs to improve health outcomes in similar populations, indicating a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria:

1. Black
2. Living with HIV
3. Female
4. Age 18 or older
5. English speaking
6. Viral load non-suppression (\>200 ml) within the past year OR a detectable HIV viral load (\>/= 20 within the past year) OR a lack of HIV viral load measure for 6 consecutive months or more during the past 12 months OR missed HIV care visits greater than 6 months within the past year
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)

Where it's running

  • University of Miami
    Miami, Florida, United States
    Recruiting

Study contacts

  • Principal investigator: Sannisha Dale, PhD — University of Miami
  • Study coordinator: Sannisha Dale, PhD
  • Email: sdale@med.miami.edu
  • Phone: 3052841991

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.