RecruitingNot ApplicableNCT06463886

Striving Towards EmPowerment and Medication Adherence R01

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


Sponsor

University of Miami

Enrollment

250 participants

Start Date

Aug 19, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

  • Black
  • Living with HIV
  • Cis-gender female
  • Age 18 or older
  • English speaking
  • 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
  • History of trauma/abuse
  • Capable of completing and fully understanding the informed consent process and study procedures

Exclusion Criteria2

  • Unable to completely and fully understand the informed consent process and the study procedures
  • Significantly interfering mental health symptoms (e.g., active psychosis that is untreated)

Interventions

BEHAVIORALSTEP-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.

BEHAVIORALEnhanced 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(1)

University of Miami

Miami, Florida, United States

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NCT06463886


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