IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13+
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
IMARA for Black Male Caregivers and Girls Empowerment
BehavioralIMAGE 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.
Time-matched control program
BehavioralFUEL 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.
Treatment groups
612 Participants
are divided into 2 treatment groupsGroup A: Experimental (IMAGE) GroupExperimental treatment 1 intervention
Group B: Control (FUEL) GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
STI Incidence in Participants
Sexually Transmitted Infection (STI) incidence from the 14-18 year old girls dyad
Time frame
6 and 12 months post treatmentSecondary outcomes
1
Rate of STI History among Participants
History of STI in 14-18 year old girls dyad. The investigators will ask the about a history of STI and how they have been treated.
Time frame
Baseline, 6 and 12 months2
Number of Participants Using Condoms
Use and frequency of condom use in 14-18 year old girls dyad
Time frame
baseline, 6, and 12 months3
Number of Sexual Partners of Participants
Number of sexual partners by 14-18 year old girls dyad
Time frame
baseline, 6, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Chicago
Lead sponsor
University of Michigan
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov