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NCT Number: NCT06463886

Striving Towards EmPowerment and Medication Adherence R01

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

Recruiting

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Health Behavior Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Medication Adherence Mental Health Issue Patient Acceptance of Health Care Patient Compliance RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Social Behavior Social Stigma Treatment Adherence and Compliance Urogenital Diseases Virus Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Black
  • Living with HIV
  • Cis-gender female
  • Age 18 or older
  • English speaking
  • 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
  • History of trauma/abuse
  • Capable of completing and fully understanding the informed consent process and study procedures

Exclusion criteria

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

Treatment and study plan

STEP-AD

Behavioral

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)

Behavioral

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 outcomes

  1. Change in viral suppression

    Time frame: Baseline up to 1.5 years

    HIV viral load <200 copies/ml time averaged. Measured by blood specimen.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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).

  6. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sannisha Dale, PhD

CONTACT

[email protected]

3052841991

Shine Research

CONTACT

[email protected]

3052436714

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jun 18, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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