Striving Towards EmPowerment and Medication Adherence R01

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06463886
Status
Recruiting
Apply to this trial

Conditions

  • Hiv
  • Mental Health Issue

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STEP-AD — BEHAVIORAL
    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) — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Aug 19, 2024
Status verified
Sep 2025
Primary completion
Jun 1, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: Enhanced treatment as usual
    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 Measure

Change in viral suppression [ Time Frame: Baseline up to 1.5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Sannisha Dale, PhD
[email protected]
305-284-1991
SHINE Research
[email protected]
3052436714
Sannisha Dale, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
HIV
By specialty
Infectious disease
By research site
University of Miami· Miami, FL

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