RecruitingNot ApplicableNCT05509959

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


Sponsor

University of California, San Diego

Enrollment

360 participants

Start Date

Nov 15, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The Women SHINE study uses technology and peer support to help women living with HIV who have also experienced interpersonal violence (such as domestic abuse or assault). The program is delivered remotely via smartphone or computer and is offered in English and Spanish. **You may be eligible if...** - You identify as a cisgender woman - You are 18 or older - You have been diagnosed with HIV - You speak and read English or Spanish - You have experienced interpersonal violence as an adult - You are currently prescribed HIV medication (antiretroviral therapy) - You have missed doses — taking your HIV meds less than 90% of the time in the past month **You may NOT be eligible if...** - You do not identify as a cisgender woman - You are not living with HIV - You are fully adherent to your HIV medications (taking them more than 90% of the time) - You do not speak English or Spanish - You do not have access to a phone or internet for remote participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALWomen SHINE

Minimum of nine weekly one-on-one peer navigation sessions and 7 weekly psychoeducation support group sessions.

BEHAVIORALControl

Single group session and access to website


Locations(1)

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

La Jolla, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05509959


Related Trials