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Women SHINE Intervention for HIV/AIDS

N/A

Recruiting

Led By Jamila K Stockman, PhD, MPH

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-, 8-, and 12-month post-randomization

Summary

This trial will test an intervention to help women living with HIV/AIDS with a history of violence increase their adherence to HIV treatment, regulate emotions and reduce PTSD symptoms.

Who is the study for?

This trial is for cisgender women over 18 living with HIV/AIDS who have experienced interpersonal violence as adults and are not fully adherent to their antiretroviral therapy (ART). Participants must speak English or Spanish, have internet access, and cannot be involved in another adherence intervention.

What is being tested?

The study compares the Women SHINE web-based peer support program against a control group. The Women SHINE group receives one-on-one sessions, check-ins, support groups with therapists, and resource access. The control gets a single self-care session and similar resources.

What are the potential side effects?

Since this is a tech-based social support intervention rather than a drug trial, traditional side effects like those seen with medications aren't expected. However, participants may experience emotional discomfort when discussing personal experiences.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-, 8-, and 12-month post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-, 8-, and 12-month post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-, 8-, and 12-month post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ART Adherence

Change in Emotion Regulation

Change in Individual and Socio-Structural Mechanisms of Change

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Women SHINEExperimental Treatment1 Intervention

Women SHINE consists of a four-month intervention that includes video-based one-on-one peer navigation and 7 weekly psycho-education support group sessions co-facilitated by a licensed clinical therapist (LCT) and peer navigator (PN). 180 women will be enrolled in the Women SHINE intervention and will remain in their assigned psycho-education support group sessions with the same members over the course of the intervention.

Group II: Control ArmPlacebo Group1 Intervention

Women assigned to the control arm (n=180) will receive one 60-minute group session facilitated by the licensed clinical therapist (LCT) on self-care and well-being as it relates to HIV, interpersonal violence, trauma, adverse mental health, and substance use. During this session, women will be provided with resources to HIV care, interpersonal violence, trauma, mental health, and substance use, through a static website created for Women SHINE. The content will include: 1) names and locations of clinics and organizations, services provided, and contact information; 2) links to support websites and hotlines and 3) testimonials from WLHA.

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