Recruiting

IMAGE

Sponsor:

University of Illinois at Chicago

Code:

NCT06266416

Conditions

Sexually Transmitted Infections (Not HIV or Hepatitis)

HIV Infections

Sexual Behavior

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Interventions

IMARA for Black Male Caregivers and Girls Empowerment

Time-matched control program

Study Details

Brief 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.

Conditions

Sexually Transmitted Infections (Not HIV or Hepatitis)

HIV Infections

Sexual Behavior

Study ID

NCT06266416

Start date

Sep 2, 2024

Status verified date

Apr, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

612 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

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 measure

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

Central Contacts and Locations

Central contacts

Natasha Crooks, PhD

312-996-5801ncrooks@uic.edu

Jessica Ogwumike, MPH

7739839980oogwumik@uic.edu

Locations

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

LIsa Sharp, PhD

312.966.1819sharpl@uic.edu

Sue Littau

312.996.3932slittau@uic.edu

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • Sexual Health
  • HIV Prevention
  • Community Based
  • Sexually Transmitted Infections

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-04-17.