IMARA for Black Male Caregivers and Girls Empowerment (IMAGE) (IMAGE)

April 13, 2026 updated by: Natasha Crooks, University of Illinois at Chicago

A Family-Based HIV Prevention Program for Black Men to Protect Black Girls

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sexually transmitted infections (STIs) continue to be a major public health problem for Black girls in the United States. Each year 1 in 4 Black girls, 14-19 years old acquires an STI, placing them at risk for poor sexual and reproductive health outcomes (SRH) (i.e., pelvic inflammatory disease, infertility, Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS)). In Chicago, STI rates are highest among 13- to 29-year-old Black girls, and they represent 56% of new HIV diagnoses compared to other racial groups, making adolescence an exceptionally vulnerable period. These racial disparities require new and innovative strategies to reduce Black girls' negative SRH outcomes. Familial protection is seen as critical to mitigating risk, particularly exposure to sexual violence, which is linked to girls' STI/HIV risk. Interventions that strengthen family relationships and communication as strategies to protect Black girls have demonstrated success in improving Black girls' SRH outcomes. Yet, with few exceptions, these programs engage only female caregivers, whereas male caregivers may amplify the protective effects of families on Black girls' SRH. The investigators systematically adapted IMARA (an evidence-based program designed for Black girls and their female caregivers) to create Informed, Motivated, Aware, and Responsible about AIDS (IMARA) for Black Male caregivers and Girls Empowerment (IMAGE), adding drivers of structural violence (i.e., stereotype messaging and lack of protection) aligning with the Becoming a Sexual Black Woman framework and the Health Disparities Research Framework. Preliminary data (interviews, focus groups, theatre, and pilot testing) with Black girls and male and female caregivers justify the proposed randomized control trial (RCT). The investigators will rigorously evaluate IMAGE's efficacy in a randomized control trial while carefully documenting implementation determinants and processes to inform adoption and sustainability. Aim 1 is to conduct a 2-arm RCT (IMAGE vs. a health promotion control) with 300 13-24-year old Black teens and young women and their male caregivers and compare girls' sexual risk behavior (condom use, sexual debut, and sexual partners) and STI incidence at baseline, 6- and 12-months. The investigators hypothesize that girls in IMAGE will have lower STI incidence at 6- and 12- months (primary outcome) and report more condom use and fewer sexual partners (secondary outcomes) compared to the control group. The investigators will also explore change in the theoretical mechanisms posited by the Becoming a Sexual Black Woman framework. Aim 2 is to identify processes, barriers, and constraints associated with primary outcomes to inform future sustainability in community-based organizations. The long-term significance and impact of this application are high. By including Black male caregivers in the protection of girls, this study leverages a long-neglected yet important resource in Black girls' SRH, thereby amplifying the protective effects of family-based programs and pushing the science of health disparities forward.

Study Type

Interventional

Enrollment (Estimated)

612

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Natasha Crooks, PhD
  • Phone Number: 312-996-5801
  • Email: ncrooks@uic.edu

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois Chicago
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • IMAGE
Active Comparator: Control (FUEL) Group
The FUEL group will receive a caregiver-adolescent general health promotion program identical in length and intensity to IMAGE.
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.
Other Names:
  • FUEL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 and 12 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of STI History among Participants
Time Frame: Baseline, 6 and 12 months
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.
Baseline, 6 and 12 months
Number of Participants Using Condoms
Time Frame: baseline, 6, and 12 months
Use and frequency of condom use in 14-18 year old girls dyad
baseline, 6, and 12 months
Number of Sexual Partners of Participants
Time Frame: baseline, 6, and 12 months
Number of sexual partners by 14-18 year old girls dyad
baseline, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)
University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115207
  • R01MD018929 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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