NCT05509959Recruiting
Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
Source: ClinicalTrials.gov · Last updated 20 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 26 Jul 2022
- Start date
- 15 Nov 2022
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- University of California, San Diego
- Diseases
- HIV
- NCT number
- NCT05509959
What you commit to
- Study type: Interventional
- Planned participants: 360
- From 15 Nov 2022 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- No diagnosis of HIV by a physician, healthcare provider, or community health worker
- Cognitive impairment limiting the ability to provide informed consent
Age
- Aged less than 18 years
Other
- Unwillingness to participate in the intervention
- Transgender female
- 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
- Experiencing only childhood experiences of interpersonal violence
- Inability to safely participate in the study based on secondary screener
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Regents of the Univ. of Calif., U.C. San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.