Striving Towards EmPowerment and Medication Adherence R01

NCT06463886 | Recruiting DMC

• 2 other identifiers: 20230854R01MH135833
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hiv; Mental Health Issue

Keywords

HIV; Black women; Trauma; Intersectional; Discrimination; Stigma; Medication adherence

Outcome Measures

Primary Outcomes (1)

• Change in viral suppression

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

  Baseline up to 1.5 years

Secondary Outcomes (6)

• Change in antiretroviral (ART) adherence

  Baseline up to 1.5 years

• Change in adherence to anti-retroviral medications questionnaire

  Baseline up to 1.5 years

• Change in engagement in HIV care

  Baseline up to 1.5 years

• Change in PTSD as measured by PCL-5

  Baseline up to 1.5 years

• Change in Post-traumatic cognitions measured by PTCI

  Baseline up to 1.5 years

Study Arms (2)

STEP-AD

EXPERIMENTAL

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

Enhanced treatment as usual

ACTIVE COMPARATOR

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)

Interventions

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.

STEP-AD

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.

Enhanced treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Wounds and Injuries; Social Stigma; Medication Adherence

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Sannisha Dale, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sannisha Dale, PhD

CONTACT

3052841991; sdale@med.miami.edu

Shine Research

CONTACT

3052436714; shineresearch@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 18, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)