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

NCT05509959 | Recruiting DMC

• 2 other identifiers: 210509R01MH125785
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

HIV/AIDS

Keywords

HIV Care Continuum; Psychoeducation

Outcome Measures

Primary Outcomes (10)

• Change in ART Adherence

  Adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples

  4-, 8-, and 12-month post-randomization

• Change in ART Adherence

  Validated self-report measure of ART adherence (3 items)

  4-, 8-, and 12-month post-randomization

• Change in PTSD Symptoms

  Validated self-report measure of PTSD (9 items;PCL-5)

  4-, 8-, and 12-month post-randomization

• Change in Emotion Regulation

  Validated self-report measure of emotion regulation (16 items; DERS-16)

  4-, 8-, and 12-month post-randomization

• Change in Individual and Socio-Structural Mechanisms of Change

  Validated self-report measure of retention in HIV care

  4-, 8-, and 12-month post-randomization

• Change in Individual and Socio-Structural Mechanisms of Change

  Validated self-report measure of coping self-efficacy (26 items; CSE)

  4-, 8-, and 12-month post-randomization

• Change in Individual and Socio-Structural Mechanisms of Change

  Validated self-report measure of social support (8 items; mMOS-SS)

  4-, 8-, and 12-month post-randomization

• Change in Individual and Socio-Structural Mechanisms of Change

  Validated self-report measure of ancillary support utilization (26 items; adapted from CDC medical monitoring project), HIV stigma (30 items), and medical mistrust (12 items; GBMMS)

  4-, 8-, and 12-month post-randomization

• Change in Individual and Socio-Structural Mechanisms of Change

  Validated self-report measure of HIV stigma (30 items), and medical mistrust (12 items; GBMMS)

  4-, 8-, and 12-month post-randomization

• Change in Individual and Socio-Structural Mechanisms of Change

  Validated self-report measure of medical mistrust (12 items; GBMMS)

  4-, 8-, and 12-month post-randomization

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

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.

Behavioral: Control

Women SHINE

EXPERIMENTAL

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.

Behavioral: Women SHINE

Interventions

Women SHINE BEHAVIORAL

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

Women SHINE

Control BEHAVIORAL

Single group session and access to website

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

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

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jamila K Stockman, PhD, MPH

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Cyr, MPH

CONTACT

(858) 534-7979; clcyr@health.ucsd.edu

Jamila K Stockman, PhD, MPH

CONTACT

(858) 822-4652; jstockman@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chief, Global Public Health Section

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 22, 2022
• Study Start: November 15, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)