Counseling program for Black women living with HIV
A Randomized Control Trial of Striving Towards EmPowerment and Medication Adherence (STEP-AD)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06463886 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown success in using counseling and support programs to improve health outcomes in similar populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.