Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05509959

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

Led by University of California, San Diego · Updated on 2025-10-20

360

Participants Needed

1

Research Sites

198 weeks

Total Duration

On this page

Sponsors

U

University of California, San Diego

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Cisgender female
  • Diagnosed with HIV by a physician, healthcare provider, or community health worker
  • Aged 18 years or older
  • Able to speak and read English or Spanish
  • Experienced interpersonal violence during adulthood
  • Currently prescribed antiretroviral therapy (ART)
  • Self-reported less than 90% adherence to ART in the past month
  • Not currently participating in another adherence intervention
  • Access to an internet browser
Not Eligible

You will not qualify if you...

  • Unwilling to participate in the intervention
  • Transgender female
  • No diagnosis of HIV by a physician, healthcare provider, or community health worker
  • Under 18 years of age
  • Unable to speak or read English or Spanish
  • Not currently prescribed ART
  • Self-reported 90% or greater adherence to ART in the past month
  • Currently participating in another adherence intervention
  • No access to an internet browser
  • Cognitive impairment that limits ability to give informed consent
  • Experienced only childhood interpersonal violence
  • Unable to safely participate in the study based on secondary screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Regents of the Univ. of Calif., U.C. San Diego

La Jolla, California, United States, 92093

Actively Recruiting

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Research Team

C

Cassandra Cyr, MPH

CONTACT

J

Jamila K Stockman, PhD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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