Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT05509959
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Women SHINE — BEHAVIORAL
    Minimum of nine weekly one-on-one peer navigation sessions and 7 weekly psychoeducation support group sessions.
  • Control — BEHAVIORAL
    Single group session and access to website

Study Details

A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV/AIDS (WLHA) with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent (\< 90% ART adherent in the last 4 weeks) will be enrolled in the study. WLHA will be randomized (1:1) into one of the following conditions: 1) Women SHINE intervention arm (n=180) or 2) Control arm (n=180). The Women SHINE intervention arm will receive a four-month intervention including peer navigator (PN) one-on-one sessions, phone/text-based check-ins, 7 psychoeducation weekly support group sessions (120 mins.) co-facilitated by a licensed therapist and PN, and access to a static website with resources for HIV care, interpersonal violence, trauma, mental health, and substance use. The control arm will receive one group session (60 mins.) on self-care and well-being and access to the aforementioned website with resources. Women will complete a video-based survey and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization, to evaluate improvements in ART adherence (Aim 1), emotion regulation, and PTSD symptoms (Aim 2). Investigators will examine the mediating effect of individual (retention in HIV care, coping self-efficacy, social support, ancillary support services use) and socio-structural (stigma, medical mistrust) mechanisms of change on the efficacy of Women SHINE (Aim 3).

Key Dates

Start date
Nov 15, 2022
Status verified
Oct 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Placebo Comparator: Control Arm
    Women assigned to the control arm (n=180) will receive one 60-minute group session facilitated by the licensed clinical therapist (LCT) on self-care and well-being as it relates to HIV, interpersonal violence, trauma, adverse mental health, and substance use. During this session, women will be provided with resources to HIV care, interpersonal violence, trauma, mental health, and substance use, through a static website created for Women SHINE. The content will include: 1) names and locations of clinics and organizations, services provided, and contact information; 2) links to support websites and hotlines and 3) testimonials from WLHA.
  • Experimental: Women SHINE
    Women SHINE consists of a four-month intervention that includes video-based one-on-one peer navigation and 7 weekly psycho-education support group sessions co-facilitated by a licensed clinical therapist (LCT) and peer navigator (PN). 180 women will be enrolled in the Women SHINE intervention and will remain in their assigned psycho-education support group sessions with the same members over the course of the intervention.

Primary Outcome Measure

Change in ART Adherence [ Time Frame: 4-, 8-, and 12-month post-randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Regents of the Univ. of Calif., U.C. San DiegoLa JollaCalifornia92093
Jamila K Stockman, PhD
[email protected]
8588224652
Jamila K Stockman, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By condition
HIV
By specialty
Infectious disease
By research site
The Regents of the Univ. of Calif., U.C. San Diego· La Jolla, CA

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