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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06463886
Other study ID # 20230854
Secondary ID R01MH135833
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date June 1, 2029

Study information

Verified date June 2024
Source University of Miami
Contact Sannisha Dale, PhD
Phone 3052841991
Email sdale@med.miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date June 1, 2029
Est. primary completion date June 1, 2029
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in viral suppression HIV viral load <200 copies/ml time averaged. Measured by blood specimen. Baseline up to 1.5 years
Secondary Change in antiretroviral (ART) adherence A 3-item self-report instrument that will measure reported adherence to ART. Baseline up to 1.5 years
Secondary Change in adherence to anti-retroviral medications questionnaire HIV medication adherence will be measured via self-report, using the AIDS Clinical Trials Group Medication Questionnaire. Participants are asked to give the number of doses taken of each of the HIV medications per day, and to note how many doses were missed. Baseline up to 1.5 years
Secondary Change in engagement in HIV care Number of kept versus number of scheduled visits verified by self-report. Baseline up to 1.5 years
Secondary 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. Baseline up to 1.5 years
Secondary 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). Baseline up to 1.5 years
Secondary 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). Baseline up to 1.5 years
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