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Study Title: Care and Treatment Services NOLA - CATS NOLA
Principal Investigator:      Kim Mosby, Ph.D.

Background

In partnership with the Institute of Women & Ethnic Studies (IWES), Priority Health Care (Priority) has been selected as one of 12 sites across the country for a study to improve the health and wellbeing of Black women living with HIV. The study is funded by the federal government through the Health Resources and Services Administration (HRSA). A research team at the University of Massachusetts, Lowell (UMass) and Boston University (BU) is evaluating the strategies used at each site to improve health outcomes. The strategies combine changing clinic culture through staff training on trauma, domestic or intimate partner violence, and gender-affirming care while providing extra support to clients through health navigation services. Health navigators provide clients with an additional person to help connect them to services and show them now to move through complex health care systems.

Purpose

The purpose of this study is to understand how using several strategies to change clinic culture and increase client support and access to services at the same time impacts the health and wellbeing of Black women living with HIV. The information from this study will be useful to help researchers, program and clinic directors, and policy makers identify ways to improve the care for Black women living with HIV.

What Will Happen in This Research Study

Approximately 1,500 women across the country will be asked to participate in this study from April 1, 2021 to August 31, 2023. If you decide to not participate, we will ask you about your reason for choosing not to participate. We will record your reason if you choose to give one, but we will not record any other information about you.

If you decide to participate, a staff person from Priority or IWES will have a face-to-face or phone interview with you to complete a questionnaire. The interview may take 1.5 to 2 hours to complete. During the interview, you will be asked about your experiences getting HIV services and medical care, your needs, your experiences with COVID-19, and your overall health and quality of life. You will be asked to complete follow-up interviews 6 months and one year later. Similar questions will be asked across the interviews to track changes in your health over time.

After the first interview, you will meet twice a month with a health navigator from Priority. After the first meeting, which will be in-person, you will be able to decide if the meetings are in-person, over the phone, or through tele-health services. You will meet with the health navigator for 6 to 18 months depending on your needs. You will also have the choice to attend support group meetings with other participants in the study. The health navigators and case managers at Priority will complete forms about the services you receive as a part of the program. These forms will record if meetings took place in-person, over the phone, or through tele-health services. They will also record how long meetings lasted, topics discussed, and any referrals made. This will be done to understand what parts of the program lead to changes in your health over time.

In addition to the interview and meetings with the health navigator, a staff member at Priority will review your medical records when you enroll, after 6 months, and after 12 months in the program. This will be done to document changes in your health over time.

Risks and Discomforts

While there is little to no chance of being injured or harmed by participating in the study, there is a possibility that you may feel uncomfortable answering some of the questions during the interviews. You do not have to answer any questions that make you feel uncomfortable or that you do not want to answer. If you need help, we can offer the help of someone to talk to that is not a part of the study. All staff members are trained to protect your privacy and rights as a study participant.

Potential Benefits

The main benefit of participating in the study is that you will receive additional support to connect you to services and assistance with moving through health care systems. Your participation may help the research team learn how using many strategies at once can help Black women living with HIV obtain care, address needs, and improve health and wellbeing. Your participation may also help HIV/AIDS policy research and others that may draw upon this knowledge to serve other Black women living with HIV.

Costs

There are no costs to participate in this research study. The only costs to you will be costs related to receiving HIV care that you would normally have such as co-payments, deductibles, and transportation/parking.

Compensation

As a participant in the study, you will receive a $25 gift card when you achieve important milestones and health screenings. You will also receive a gift ($25 value) when you complete the health navigation program.

For participating in the interviews to complete the questionnaire(s):

• You will receive a $50 gift card for completing the first interview and the 6-month follow-up interview.
• You will receive a $75 gift card for the 12 month follow-up interview.

Confidentiality

Your participation in the study is confidential. You will be assigned a random study ID number. All information collected about you will be stored using only your study ID number. A small group of staff at Priority, IWES, and the UMass and BU evaluation team will be the only ones with access to the key that links your name to your study ID number. HRSA and other researchers involved with the national study will not be able to link your name to your information. Information from this study may be used for research purposes and may be published, but your name will not be used in any publications. Only the results of the study group as a whole will be presented or published. Federal and state agencies, if they are required by law or are involved in research oversight, may access information about you from this study. Such agencies may include the U.S. Department of Health and Human Services, the Food and Drug Administration, the National Institutes of Health, and the Massachusetts Department of Public Health.

We will never share information that could identify you. All identifying information, including the key that links study ID numbers with names, will be deleted five years after the study ends.

Participant’s Rights

By consenting, or agreeing, to be in this study, you maintain your legal rights. Signing this form means you have been given information about this study, had your questions answered to your satisfaction, and that you are voluntarily agreeing to participate. You will be given a signed copy of this form to keep.

If you choose not to participate or decide later that you want to stop participating in the study, you will not face any negative consequences. You will be able to keep any gift cards that you earned and will still be able to receive any and all health care and support services Priority provides to their clients. If the study is stopped for any reason or we decide your participation in the study is bad or harmful to you, we will end your participation in the study.

If you feel that you have not been treated fairly or have questions about your rights as a study participant, contact the IWES Institutional Review Board via Jen Latimer at jlatimer@iwesnola.org or 504-941-0488.

Questions

The research team will try to answer all of your questions. If you have additional questions or concerns about this study either now or in the future, you can contact the project director, Dr. Kim Mosby at 504-599-7712 or kmosby@iwesnola.org at any time.

The following medical information will be collected in the course of this study:

• Pregnancy
• HIV and/or AIDS diagnosis dates
• HIV Primary Care Medical Visits including last visit prior to study enrollment
• CD4 and Viral Load Lab values including last values prior to study enrollment
• HIV Antiretroviral Therapy and other medications
• Routine Preventative Care (Hepatitis C, Osteoporosis, and Cervical, Breast, or Colon Cancer Screenings)
• Mental Health and Substance Abuse Disorders and/or Referrals
• Hospital or Emergency Room Visits including any within the last 12 months prior to study enrollment
• Intimate Partner Violence screener responses
• Opportunistic Infections or Other Diagnoses including but not limited to: Asthma, Respiratory Disease, Autoimmune Disease, High Blood Pressure, Hepatitis C, Diabetes, Heart Disease, Cancer, Depression, Lupus, Obesity, etc.

By signing this consent form, you are indicating that you have read this form (or it has been read to you), that your questions have been answered to your satisfaction, and that you voluntarily agree to participate in this research study.