Your session is about to expire
← Back to Search
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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in ART Adherence
Change in Emotion Regulation
Change in Individual and Socio-Structural Mechanisms of Change
+1 moreTrial 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.
Find a Location
Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,047 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,784 Previous Clinical Trials
2,688,915 Total Patients Enrolled
Jamila K Stockman, PhD, MPHPrincipal InvestigatorUniversity of California, San Diego
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a transgender female.I am under 18 years old.I have taken my ART medication as prescribed 90% of the time in the past month.I cannot speak or read English or Spanish.I am 18 years old or older.I identify as a cisgender female.I am currently on antiretroviral therapy.I have never been diagnosed with HIV.I am not currently taking antiretroviral therapy.I am able to understand and give consent for my treatment.I have been diagnosed with HIV.I am not willing to participate in the study treatment.I am considered safe to participate in the study according to a secondary evaluation.I can speak and read in English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Women SHINE
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots available in this clinical experiment?
"Correct. According to information found on clinicaltrials.gov, this medical research is actively seeking participants as of March 15th 2023; the study was initially posted on November 15th 2022. 360 patients from 1 site are needed for the trial's completion."
Answered by AI
How many volunteers are participating in this trial?
"Affirmative. The information on clinicaltrials.gov displays that this experiment is now recruiting candidates. It was originally posted on November 15th 2022 and has been recently updated as of March 15th 2023 - with the aim to enrol 360 people in a single location."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger