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

Recruiting now · Not applicable

Conditions studied: HIV/AIDS

In brief

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 facts

Study ID

NCT05509959

Run by

University of California, San Diego

People needed

360

Starts

2022-11-15

Expected to finish

2026-09-01

Last updated by the study team

2025-10-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Cisgender female
• Diagnosis of HIV by a physician, healthcare provider, or community health worker
• Aged 18 years or older
• Speaking and reading English or Spanish
• Adulthood experiences of interpersonal violence
• Currently prescribed ART
• Self-report of <90% past-month ART adherence
• Not currently participating in another adherence intervention
• Access to an internet browser

You may not qualify if…

• Unwillingness to participate in the intervention
• Transgender female
• No diagnosis of HIV by a physician, healthcare provider, or community health worker
• Aged less than 18 years
• Not speaking and reading English or Spanish
• Not currently prescribed ART
• Self-report of >= 90% past-month ART adherence
• Currently participating in another adherence intervention
• No access to an internet browser
• Cognitive impairment limiting the ability to provide informed consent
• Experiencing only childhood experiences of interpersonal violence
• Inability to safely participate in the study based on secondary screener

Where it is running

• The Regents of the Univ. of Calif., U.C. San Diego — La Jolla, California, United States (enrolling)

Full record on ClinicalTrials.gov

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