Striving Towards EmPowerment and Medication Adherence R01

Hiv Clinical Trial

Official title:

A Randomized Control Trial of Striving Towards EmPowerment and Medication Adherence (STEP-AD)

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
• 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
• 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)

Related Conditions & MeSH terms

• Hiv
• Mental Health Issue

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