NCT05509959 Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
| NCT ID | NCT05509959 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | HIV/AIDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2022-11-15 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2022-11-15 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Jamila K Stockman, PhD, MPH
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT05509959 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HIV/AIDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05509959 currently recruiting?
Yes, NCT05509959 is actively recruiting participants. Contact the research team at clcyr@health.ucsd.edu for enrollment information.
Where is the NCT05509959 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT05509959 clinical trial?
NCT05509959 is sponsored by University of California, San Diego. The principal investigator is Jamila K Stockman, PhD, MPH at University of California, San Diego. The trial plans to enroll 360 participants.
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