IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT06266416
Status
Recruiting
Apply to this trial

Conditions

  • HIV Infections
  • Sexual Behavior
  • Sexually Transmitted Infections (Not HIV or Hepatitis)

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • IMARA for Black Male Caregivers and Girls Empowerment — BEHAVIORAL
    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.
  • Time-matched control program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 2, 2024
Status verified
Apr 2026
Primary completion
Jul 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
612 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Experimental (IMAGE) Group
    The IMAGE group will receive an 8-10-hour HIV/STI group-based (6-8 dyads) prevention program delivered to Black male caregivers and girls over 2-days.
  • Active Comparator: Control (FUEL) Group
    The FUEL group will receive a caregiver-adolescent general health promotion program identical in length and intensity to IMAGE.

Primary Outcome Measure

STI Incidence in Participants [ Time Frame: 6 and 12 months post treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois ChicagoChicagoIllinois60612
LIsa Sharp, PhD
[email protected]
312.966.1819
Sue Littau
[email protected]
312.996.3932

Find similar trials in Chicago, IL

By condition
HIV
By specialty
Infectious disease
By research site
University of Illinois Chicago· Chicago, IL

Related Studies