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

NCT ID: NCT05509959

Last Updated: 2025-10-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2026-09-01

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).

Detailed Description

In the US, women living with HIV/AIDS (WLHA) are less likely to be adherent to antiretroviral therapy (ART) and virally suppressed compared to men living with HIV/AIDS. Concurrently, WLHA experience high rates of interpersonal violence - physical, sexual, and/or psychological abuse in childhood or adulthood - which often results in trauma (e.g., post-traumatic stress disorder [PTSD]) and other adverse mental health, further contributing to ART non-adherence. Additionally, the confluence of syndemic or co-occurring adverse mental health, substance use, and socio-structural factors (e.g., HIV stigma, medical mistrust) further contribute to poor HIV outcomes. Social support through peer navigation and networks has been shown to counter these effects and improve HIV outcomes among WLHA. Likewise, psychoeducation addressing affective distress to improve mood and emotion management and relationship skills has been shown to reduce PTSD and depression. However, limited resources at HIV service agencies combined with socio-structural barriers (e.g., social isolation, lack of transportation) impede the potential effectiveness of in-person peer navigation. A scalable and sustainable solution is the use of technology in the form of web-based video interaction. Building on these promising pilot findings, investigators propose to conduct a randomized clinical trial of Women SHINE (new name) to improve ART adherence among WLHA affected by interpersonal violence in California, Arizona, and Nevada. Participants will be randomized to either: a) the intervention arm (n=180) where they will receive a 4-month program comprised of video-based peer navigation support via one-on-one sessions, 7 psychoeducation weekly support group sessions, and access to a static Women SHINE website with statewide resources for HIV care, interpersonal violence, trauma, mental health, and substance use; or b) the control arm (n=180) where they will receive a single group session on self-care and well-being, with access to the static Women SHINE website. Women will complete video-based survey assessments and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization. Compared to the control arm, investigators will determine if Women SHINE is associated with improvements in ART adherence (Aim 1) and PTSD symptoms and emotion regulation (Aim 2). Investigators will also examine individual (e.g., self-efficacy for coping, social support networks) and socio-structural (e.g., HIV stigma, medical mistrust) mechanisms of change in the efficacy of Women SHINE (Aim 3). If efficacious, investigators will conduct subsequent research to determine effective and feasible methods for intervention implementation nationwide to improve HIV outcomes among WLHA.

Conditions

HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Single group session and access to website

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.

Group Type: EXPERIMENTAL

Women SHINE

Intervention Type: BEHAVIORAL

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

Interventions

Women SHINE

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

Intervention Type: BEHAVIORAL

Control

Single group session and access to website

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Jamila K. Stockman

Professor and Vice Chief, Global Public Health Section

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jamila K Stockman, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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

La Jolla, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cassandra Cyr, MPH

Role: CONTACT

clcyr@health.ucsd.edu

(858) 534-7979

Jamila K Stockman, PhD, MPH

Role: CONTACT

jstockman@health.ucsd.edu

(858) 822-4652

Facility Contacts

Jamila K Stockman, PhD

Role: primary

jstockman@ucsd.edu

8588224652

Other Identifiers

R01MH125785

Identifier Type: NIH

Identifier Source: secondary_id

View Link

210509

Identifier Type: -

Identifier Source: org_study_id