Striving Towards EmPowerment and Medication Adherence R01

September 15, 2025 updated by: Sannisha K Dale, University of Miami

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Sannisha Dale, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in viral suppression
Time Frame: Baseline up to 1.5 years
HIV viral load <200 copies/ml time averaged. Measured by blood specimen.
Baseline up to 1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in engagement in HIV care
Time Frame: Baseline up to 1.5 years
Number of kept versus number of scheduled visits verified by self-report.
Baseline up to 1.5 years
Change in PTSD as measured by PCL-5
Time Frame: Baseline up to 1.5 years
Measured by the Posttraumatic Stress Disorder Checklist (PCL)-5, a 20-item self-report measure of PTSD symptoms. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Higher scores indicate higher PTSD severity.
Baseline up to 1.5 years
Change in Post-traumatic cognitions measured by PTCI
Time Frame: Baseline up to 1.5 years
The Posttraumatic Cognitions Inventory (PTCI) is a 36-item, self-report questionnaire, and each item is rated on a 7-point Likert scale that ranges from 1 (totally agree) to 7 (totally disagree).
Baseline up to 1.5 years
Change in Post-traumatic Stress Disorder Diagnosis
Time Frame: Baseline up to 1.5 years
A structured mental health diagnostic interview will be administered to evaluate participants' mental health symptoms and whether they meet criteria for mental health diagnoses (e.g. Post-traumatic Stress Disorder).
Baseline up to 1.5 years
Change in antiretroviral (ART) adherence
Time Frame: Baseline up to 1.5 years
A 3-item self-report instrument that will measure reported adherence to ART. Responses range from 1 to 6. Responses will be averaged (min average of 1, max average of 6) across items with higher scores indicating higher adherence to ART medication.
Baseline up to 1.5 years
Change in adherence to anti-retroviral medications questionnaire
Time Frame: Baseline up to 1.5 years
A list of 12 reasons why individuals may miss taking their ART (e.g., forgot, change in routine) will be used from the AIDS Clinical Trials Group. The minimum score is 0 (no endorsed reasons for missing medication) and maximum score is 36 (endorsing more reasons for missing ART medication).
Baseline up to 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Sannisha Dale, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2024

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230854
  • R01MH135833 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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