NIH-funded research R01 grant

STEP-AD: empowerment and medication support for Black women living with HIV

Official title: A Randomized Control Trial of Striving Towards EmPowerment and Medication Adherence (STEP-AD) among Black Women Living with HIV

Funded at University of Miami Coral Gables · NIH-11245762 · Data updated 2026-11-12

A 10-session program that combines trauma-informed therapy, adherence coaching, and empowerment skills to help Black women living with HIV take their medications and improve mental health.

More Medication Adherence research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of Miami Coral Gables
NIH-funded
Lab location1 site (Coral Gables, United States)
Project startMarch 1, 2024
Project endNovember 30, 2028
Funding year2026
Award (this year)$676,686
NIH project number5R01MH135833-03
Project IDNIH-11245762 on NIH RePORTER

Who could benefit from this research

Could help

Black women living with HIV who are adults and who experience challenges with medication adherence, trauma symptoms, or related psychosocial stressors are the ideal candidates.

Less likely to help

People who are not Black women, are already stably virally suppressed with good adherence and no trauma-related issues, or cannot attend the required sessions are less likely to benefit.

What this research studies

You would be randomly assigned to receive the STEP-AD program or usual care and followed over time. STEP-AD includes ten one-on-one sessions that mix cognitive behavioral therapy for trauma, a LifeSteps medication-adherence module, and community-informed strategies to boost empowerment, body image, relationships, and resilience. The research team will collect measures like medication adherence, viral load, CD4 counts, and mental health symptoms at scheduled visits. Sessions are tailored to address adversities commonly experienced by Black women with HIV and to make daily medication-taking easier and more sustainable.

Why it matters

Potential benefit: If successful, this could help Black women with HIV achieve better medication adherence and higher rates of viral suppression while reducing trauma-related symptoms.

How similar studies have gone: Previous pilot testing of STEP-AD and single-session LifeSteps adherence work showed promising feasibility and adherence signals, but trauma-focused interventions for women with HIV have not consistently improved adherence, so this combined approach is partly novel and built on encouraging preliminary data.

Where this research is happening

  • University of Miami Coral Gables
    Coral Gables, United States
    Active

Researchers

  • Principal investigator: Dale, Sannisha K — University of Miami Coral Gables
  • Study coordinator: Dale, Sannisha K

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
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.