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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509959
• Other study ID #: 210509
• Secondary ID: R01MH125785
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: November 28, 2025

Study information

• Verified date: March 2023
• Source: University of California, San Diego
• Contact: Alexandra Fernandez DeSoto, MPH
• Phone: (858) 354-0381
• Email: alf013[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: November 28, 2025
• Est. primary completion date: November 28, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	The Regents of the Univ. of Calif., U.C. San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in ART Adherence	Validated self-report measure of ART adherence (3 items)	4-, 8-, and 12-month post-randomization
Primary	Change in PTSD Symptoms	Validated self-report measure of PTSD (9 items;PCL-5)	4-, 8-, and 12-month post-randomization
Primary	Change in Emotion Regulation	Validated self-report measure of emotion regulation (16 items; DERS-16)	4-, 8-, and 12-month post-randomization
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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