Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05509959

Conditions

HIV/AIDS

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Women SHINE

Control

Study Details

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

Study ID

NCT05509959

Start date

Nov 15, 2022

Status verified date

Oct, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Women SHINE

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

Control

Single group session and access to website

Primary outcome measure

  • Change in ART Adherence [ Time Frame: 4-, 8-, and 12-month post-randomization ]
  • Change in ART Adherence [ Time Frame: 4-, 8-, and 12-month post-randomization ]
  • Change in PTSD Symptoms [ Time Frame: 4-, 8-, and 12-month post-randomization ]
  • Change in Emotion Regulation [ Time Frame: 4-, 8-, and 12-month post-randomization ]
  • Change in Individual and Socio-Structural Mechanisms of Change [ Time Frame: 4-, 8-, and 12-month post-randomization ]
  • Change in Individual and Socio-Structural Mechanisms of Change [ Time Frame: 4-, 8-, and 12-month post-randomization ]
  • Change in Individual and Socio-Structural Mechanisms of Change [ Time Frame: 4-, 8-, and 12-month post-randomization ]
  • Change in Individual and Socio-Structural Mechanisms of Change [ Time Frame: 4-, 8-, and 12-month post-randomization ]
  • Change in Individual and Socio-Structural Mechanisms of Change [ Time Frame: 4-, 8-, and 12-month post-randomization ]
  • Change in Individual and Socio-Structural Mechanisms of Change [ Time Frame: 4-, 8-, and 12-month post-randomization ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

La Jolla, California, United States, 92093

Contacts

Jamila K Stockman, PhD

8588224652jstockman@ucsd.edu

Principal Investigator:

Jamila K Stockman, PhD

More Information

Sponsor

University of California, San Diego

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • HIV Care Continuum
  • Psychoeducation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-10-20.