Recruiting NCT06463886
Striving Towards EmPowerment and Medication Adherence R01
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: STEP-AD, Enhanced treatment as usual (E-TAU).
- Who it may be relevant to
- Registry conditions: Hiv, Mental Health Issue. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized Control Trial of Striving Towards EmPowerment and Medication Adherence (STEP-AD)
Overview
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
Interventions
- 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. Eac - 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 p
Primary outcome measures
- Change in viral suppression [Time frame: Baseline up to 1.5 years]
Secondary outcome measures (6)
- Change in antiretroviral (ART) adherence [Time frame: Baseline up to 1.5 years]
- Change in adherence to anti-retroviral medications questionnaire [Time frame: Baseline up to 1.5 years]
- Change in engagement in HIV care [Time frame: Baseline up to 1.5 years]
- Change in PTSD as measured by PCL-5 [Time frame: Baseline up to 1.5 years]
- Change in Post-traumatic cognitions measured by PTCI [Time frame: Baseline up to 1.5 years]
- Change in Post-traumatic Stress Disorder Diagnosis [Time frame: Baseline up to 1.5 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT06463886 · 20230854 · R01MH135833