NCT06266416 · University of Illinois at Chicago
IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)
(IMAGE)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
IMARA for Black Male Caregivers and Girls Empowerment
IMAGE is delivered by trained Black female facilitators to improve girls' SRH outcomes, prevention HIV/STIs, and reduce sexual violence. Over the two days, some components of the curriculum are delivered separately to male caregivers and girls, covering parallel content, and other sections are delivered jointly in a single group. The curriculum, extensively tailored for the target population and pilot tested, addresses Black girls' sexual development, risk for sexual violence, female anatomy, body positivity, HIV/STI knowledge and attitudes, and condom use. IMAGE is designed to strengthen bonds and communication between male caregivers and girls by encouraging perspective-taking (i.e., reverse role play) and conflict resolution.
BEHAVIORAL
Time-matched control program
FUEL will engage Black male caregivers and girls to promote good nutrition, exercise, and informed consumer behavior. Topics include the impact of media on body image, evaluating nutritional labels to make healthy food choices, eating balanced meals, establishing regular exercise routines, and how families and communities can support healthy behavior. FUEL includes a brief video about HIV/AIDS and other STIs but otherwise does not otherwise address sexual health. Like IMAGE, FUEL is delivered in groups of 6-8 dyads over two workshop days (\~10 hours total) in one weekend. Parts of the curriculum are delivered separately to girls and male caregivers covering parallel content and other components are delivered jointly.
Primary outcome measures
STI Incidence in Participants
Time frame: 6 and 12 months post treatment
Sexually Transmitted Infection (STI) incidence from the 14-18 year old girls dyad
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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.
Where
- Chicago, Illinois
Collaborators
University of Michigan, National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 17, 2026 · Source of record for eligibility and locations