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NCT05509959 · ClinicalTrials.gov registry record · NA
Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
A NA study of HIV/AIDS, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- NA
- Development phase
- 360
- Enrollment target
- 1
- Study location
NCT05509959: Recruiting NA study of HIV/AIDS, sponsored by University of California, San Diego.
NCT05509959 is a NA study of HIV/AIDS that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 360 participants, below the 33,175-participant average among 61 other HIV/AIDS trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05509959, a NA study of HIV/AIDS, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- NA
- Development phase
- 360 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples
Conditions Studied
Interventions
- BEHAVIORAL Control
- BEHAVIORAL Women SHINE
Study Locations (1)
California
- The Regents of the Univ. of Calif., U.C. San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2022-11-15 |
| Est. Completion | 2026-09-01 |
| Phase | NA |
What NCT05509959 shows while recruiting
NCT05509959 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 33,175-participant average among 61 other HIV/AIDS trials with a reported enrollment target (99% lower).
The record links to 1 condition, with HIV/AIDS appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT05509959 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05509959 about?
NCT05509959 is a clinical study titled "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-adhere...
What is the current status of trial NCT05509959?
This trial is currently recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2022-11-15. Estimated completion is 2026-09-01.
What conditions does trial NCT05509959 study?
This clinical trial studies the following conditions: HIV/AIDS.
What interventions are being tested in trial NCT05509959?
The interventions under investigation include: Control (BEHAVIORAL), Women SHINE (BEHAVIORAL).
Who is sponsoring clinical trial NCT05509959?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05509959 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05509959's enrollment target sits among peer trials
360 16th of 61 higher than 46 of 61 other HIV/AIDS trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV/AIDS trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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