IMARA for Black Male Caregivers and Girls Empowerment (IMAGE) (NCT06266416) | Clinical Trial Compass
RecruitingNot Applicable
IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)
United States612 participantsStarted 2024-09-02
Plain-language summary
The scientific premise of this research is that individual, interpersonal, and structural factors impact Black girls' sexual reproductive health outcomes (sexually transmitted infection (STI) and Human Immunodeficiency Virus (HIV)) and experience of sexual violence. This study expands STI/HIV prevention programs to include Black male caregivers, a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STI/HIV and sexual violence.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
AIM 1:
* Self-identify as African American, Black, or mixed race with African American or Black
* Speak English
* Males must identify as a current caregiver to girl enrolled in the study
AIM 2: All Community Based Organizations (CBO) directors and IMAGE liaisons will be eligible.
Exclusion Criteria:
AIM 1:
* Girl refuses to participate
* Inability to understand the consent/assent process
* Non-English speaking
* Does not self-identify as African American, Black, or mixed race with African American or Black
* If the primary caregiver (female caregiver/mother) does not consent to the girls' participation with the male caregiver the girl chooses, the girl will not be able to participate
* Girls will be excluded if they participated in other phases of the research
AIM 2:
• Inability to understand the consent process, and non-employment at a partnering CBO.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.