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NCT Number: NCT05509959

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

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).

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

La Jolla, California, 92093, United States

Location status: Recruiting

Location contact

Jamila K Stockman, PhD

CONTACT

[email protected]

8588224652

Jamila K Stockman, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Women SHINE

Behavioral

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

Control

Behavioral

Single group session and access to website

Primary outcomes

  1. Change in ART Adherence

    Time frame: 4-, 8-, and 12-month post-randomization

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

  2. Change in ART Adherence

    Time frame: 4-, 8-, and 12-month post-randomization

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

  3. Change in PTSD Symptoms

    Time frame: 4-, 8-, and 12-month post-randomization

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

  4. Change in Emotion Regulation

    Time frame: 4-, 8-, and 12-month post-randomization

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

  5. Change in Individual and Socio-Structural Mechanisms of Change

    Time frame: 4-, 8-, and 12-month post-randomization

    Validated self-report measure of retention in HIV care

  6. Change in Individual and Socio-Structural Mechanisms of Change

    Time frame: 4-, 8-, and 12-month post-randomization

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

  7. Change in Individual and Socio-Structural Mechanisms of Change

    Time frame: 4-, 8-, and 12-month post-randomization

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

  8. Change in Individual and Socio-Structural Mechanisms of Change

    Time frame: 4-, 8-, and 12-month post-randomization

    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)

  9. Change in Individual and Socio-Structural Mechanisms of Change

    Time frame: 4-, 8-, and 12-month post-randomization

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

  10. Change in Individual and Socio-Structural Mechanisms of Change

    Time frame: 4-, 8-, and 12-month post-randomization

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

Study contacts

Contact information is provided by the study sponsor or research team.

Cassandra Cyr, MPH

CONTACT

[email protected]

(858) 534-7979

Jamila K Stockman, PhD, MPH

CONTACT

[email protected]

(858) 822-4652

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2022
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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