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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
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.
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.
University of Miami
Miami, Florida, United States
RECRUITINGChange in viral suppression
HIV viral load \<200 copies/ml time averaged. Measured by blood specimen.
Time frame: Baseline up to 1.5 years
Change in antiretroviral (ART) adherence
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.
Time frame: Baseline up to 1.5 years
Change in adherence to anti-retroviral medications questionnaire
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).
Time frame: Baseline up to 1.5 years
Change in engagement in HIV care
Number of kept versus number of scheduled visits verified by self-report.
Time frame: Baseline up to 1.5 years
Change in PTSD as measured by PCL-5
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.
Time frame: Baseline up to 1.5 years
Change in Post-traumatic cognitions measured by PTCI
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).
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Time frame: Baseline up to 1.5 years
Change in Post-traumatic Stress Disorder Diagnosis
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).
Time frame: Baseline up to 1.5 years