Striving Towards EmPowerment and Medication Adherence R01

University of Miami

Status: Enrolling

Conditions: Mental Health Issue; Hiv

Treatments: Behavioral: Enhanced treatment as usual (E-TAU); Behavioral: STEP-AD

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06463886

R01MH135833 (U.S. NIH Grant/Contract)

20230854

Details and patient eligibility

About

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

Enrollment: 250 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 or a lack of HIV viral load measure for 6 consecutive months or more during the past 12 months
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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

STEP-AD

Experimental group

Description:

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.

Treatment:

Behavioral: STEP-AD

Enhanced treatment as usual

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced treatment as usual (E-TAU)