What are the benefits of participating in the WomenSHINE study?
As part of your participation, you will receive up to $465 in compensation for your time and effort. Participants in both the intervention and control groups are expected to benefit from resources and support relating to HIV care, which may help participants stay healthy or become healthier. Additionally, participants assigned to the intervention, Women SHINE, are expected to have significant benefits, specifically improved ART adherence, PTSD symptoms, and emotion regulation. Participants in the control arm may benefit from receiving a guided introduction to statewide resources for HIV care, interpersonal violence, trauma, mental
health, and substance use, that can be accessed any time through a static website that has
been created specifically for Women SHINE
What are the potential risks of participating in the research study?
Participation in this study may involve some added risks or discomforts. These may include
the following:
- Emotional discomfort during survey completion, group sessions, or one-on-one sessions, due to difficult topic areas such as violence, substance use, mental health, and HIV.
- There is a risk of discomfort self-collecting hair samples. However, the amount of hair collected is equivalent to the daily amount of hair strands that are lost, and the hair sample collection procedure itself is considered noninvasive. All research staff members will be trained in instructing participants in sample collection procedures to decrease the likelihood of discomfort.
- We take every precaution to protect participant confidentiality and privacy. With that said, there may be a potential for loss of confidentiality.
How long does my participation in the study last?
The study will last for a total of one year (12 months). If you are in the Standard of Care
(control) group, your participation will be for five hours over one year (4 one-hour study
visits, 1 one-hour education session). If you are in the HIV care support group
(intervention group), your participation will be for 24 hours over one year (4 one-hour
study visits, six one-hour peer navigation sessions, seven two-hour psycho-education
social support sessions).
What is Women SHINE trying to learn about?
The purpose of the Women SHINE study is to test a program to help women living with HIV to engage and stay in HIV care. The goal of the program is to provide skills to help women deal with challenges to improve engagement in HIV care.
Who is conducting the Women SHINE study?
Dr. Jamila K. Stockman, at the University of California San Diego, is conducting the Women SHINE study.
Are study visits confidential?
Yes, all study visits are confidential. No information regarding your participation will be shared outside of the study staff, and all your information and study data will be stored securely.
How many study visits are there, and how long do they last?
There are four study visits. The first visit will last about 2 hours, and the following ones will last about an hour and a half, each. There is also a hair sample collection at each visit, in which you will be mailed a hair sample collection kit and asked to mail it back to us.
Why do I need to collect hair samples?
The hair samples help us measure your HIV medication (ART) adherence and how often you
took your medication.
I screened ineligible, is it possible I could be eligible at another time?
Yes. Some of the criteria that we judge eligibility may change over time. Feel free to take the screening survey again if your answers change at a later time.
Can I refer a friend or family member to join Women SHINE?
Yes, if they would like to see if they are eligible to participate they can complete the online survey on our “see if you qualify” page.
Do I need to have internet access to participate?
Yes, all study activities will be virtual and will require internet access to participate.
Do I need to have a computer to participate?
No, a computer is not required to participate. You may participate if you have internet access on any other device such as a smartphone or tablet.
Will there be compensation for participating in the study?
Yes, enrolled women may earn up to $465 in the form of e-gift cards for their time.
How does Women SHINE protect my information?
- All research data will be kept in locked file cabinets and will only be available to research staff directly involved in the project
- Data will be de-identifiable; each participant will be assigned a personal identification number.
- HIV status will not appear along with any personal identifying information such as the contact sheet.
- Contact information sheets with participant’s name, and contact phone number, and email, will be stored separately from research data.
Why can’t I choose to be in the Women SHINE intervention group?
All participants will be assigned to one of two study groups, by random chance, in a process similar to flipping a coin. There is an equal (50%) chance of being put into each study group. Half of the participants will be randomly chosen to be in the Standard of Care (Control) group and half will be randomly chosen to be in the intervention group.
What are the differences between the intervention and control groups?
The intervention will attend more sessions relating to the study, but both groups will receive resources and support.