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RECRUITING
NCT05509959
NA

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

Sponsor: University of California, San Diego

View on ClinicalTrials.gov

Summary

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 Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2022-11-15

Completion Date

2026-09-01

Last Updated

2025-10-20

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

Women SHINE

Minimum of nine weekly one-on-one peer navigation sessions and 7 weekly psychoeducation support group sessions.

BEHAVIORAL

Control

Single group session and access to website

Locations (1)

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

La Jolla, California, United States