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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
The Regents of the Univ. of Calif., U.C. San Diego
RECRUITING
La Jolla
Contact Information
Primary
Cassandra Cyr, MPH
clcyr@health.ucsd.edu
(858) 534-7979
Backup
Jamila K Stockman, PhD, MPH
jstockman@health.ucsd.edu
(858) 822-4652
Time Frame
Start Date: 2022-11-15
Estimated Completion Date: 2025-11-28
Participants
Target number of participants: 360
Treatments
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.
Sponsors
Collaborators: National Institute of Mental Health (NIMH)
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov