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

University of Miami1 site in 1 country250 target enrollmentAugust 19, 2024

ConditionsHiv Mental Health Issue

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hiv
Sponsor: University of Miami
Enrollment: 250
Locations: 1
Primary Endpoint: Change in viral suppression
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 19, 2024

End Date

June 1, 2029

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Miami

Responsible Party

Principal Investigator

Sannisha K Dale

Associate Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Change in viral suppression

Time Frame: Baseline up to 1.5 years

HIV viral load \<200 copies/ml time averaged. Measured by blood specimen.

Secondary Outcomes

Change in Post-traumatic cognitions measured by PTCI(Baseline up to 1.5 years)
Change in antiretroviral (ART) adherence(Baseline up to 1.5 years)
Change in PTSD as measured by PCL-5(Baseline up to 1.5 years)
Change in adherence to anti-retroviral medications questionnaire(Baseline up to 1.5 years)
Change in engagement in HIV care(Baseline up to 1.5 years)
Change in Post-traumatic Stress Disorder Diagnosis(Baseline up to 1.5 years)