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

• ClinicalTrials.gov Identifier: NCT05509959
• Recruitment Status: Recruiting
• First Posted: August 22, 2022
• Last Update Posted: March 17, 2023
• Sponsor: University of California, San Diego
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Jamila K. Stockman, University of California, San Diego

Study Description

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).

Condition or disease	Intervention/treatment	Phase
HIV/AIDS	Behavioral: Women SHINE; Behavioral: Control	Not Applicable

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. 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 360 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
• Actual Study Start Date: November 15, 2022
• Estimated Primary Completion Date: November 28, 2025
• Estimated Study Completion Date: November 28, 2025

Arms and Interventions

Arm	Intervention/treatment
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.	Behavioral: Control; Single group session and access to website
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.	Behavioral: Women SHINE; Minimum of nine weekly one-on-one peer navigation sessions and 7 weekly psychoeducation support group sessions.

Outcome Measures

Primary Outcome Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Alexandra Fernandez DeSoto, MPH; (858) 354-0381; alf013@health.ucsd.edu

Contact: Jamila K Stockman, PhD, MPH; (858) 822-4652; jstockman@health.ucsd.edu

Locations

United States, California

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

La Jolla, California, United States, 92093

Contact: Jamila K Stockman, PhD 858-822-4652 jstockman@ucsd.edu

Principal Investigator: Jamila K Stockman, PhD

Sponsors and Collaborators

University of California, San Diego

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Jamila K Stockman, PhD, MPH; University of California, San Diego

More Information

• Responsible Party: Jamila K. Stockman, Professor and Vice Chief, Global Public Health Section, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT05509959
• Other Study ID Numbers: 210509; R01MH125785 ( U.S. NIH Grant/Contract )
• First Posted: August 22, 2022
• Last Update Posted: March 17, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jamila K. Stockman, University of California, San Diego:

HIV Care Continuum; Psychoeducation

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; 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