Striving Towards EmPowerment and Medication Adherence R01

Not Applicable

Recruiting

• Conditions: Mental Health Issue; Hiv
• Interventions: Behavioral: STEP-AD; Behavioral: Enhanced treatment as usual (E-TAU)

• Registration Number: NCT06463886
• Lead Sponsor: University of Miami

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-10
• Study First Posted: 2024-06-18
• Status Verified: 2024-08
• Study Start: 2024-08-19
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-22
• Primary Completion: 2029-06-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STEP-AD	STEP-AD	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.
Enhanced treatment as usual	Enhanced treatment as usual (E-TAU)	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.

Primary Outcome Measures

Name	Time	Method
Change in viral suppression	Baseline up to 1.5 years	HIV viral load \<200 copies/ml time averaged. Measured by blood specimen.

Secondary Outcome Measures

Name	Time	Method
Change in Post-traumatic cognitions measured by PTCI	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).
Change in antiretroviral (ART) adherence	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.
Change in PTSD as measured by PCL-5	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.
Change in adherence to anti-retroviral medications questionnaire	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).
Change in engagement in HIV care	Baseline up to 1.5 years	Number of kept versus number of scheduled visits verified by self-report.
Change in Post-traumatic Stress Disorder Diagnosis	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).

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States