IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)

NCT06266416 | Recruiting DMC

• 2 other identifiers: 115207R01MD018929
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• STI Incidence in Participants

  Sexually Transmitted Infection (STI) incidence from the 14-18 year old girls dyad

  6 and 12 months post treatment

Secondary Outcomes (3)

• Rate of STI History among Participants

  Baseline, 6 and 12 months

• Number of Participants Using Condoms

  baseline, 6, and 12 months

• Number of Sexual Partners of Participants

  baseline, 6, and 12 months

Study Arms (2)

Experimental (IMAGE) Group

EXPERIMENTAL

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

Control (FUEL) Group

ACTIVE COMPARATOR

The FUEL group will receive a caregiver-adolescent general health promotion program identical in length and intensity to IMAGE.

Behavioral: Time-matched control program

Interventions

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.

Also known as: FUEL

Control (FUEL) Group

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.

Also known as: IMAGE

Experimental (IMAGE) Group

Eligibility Criteria

• Age: 13 Years+
• Gender Eligibility Details: AIM 1: Girls aged 13-24 years old; Male caregivers \> 18 years old. AIM 2: \>18 years old.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• University of Michigan: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (1)

• Crooks N, Donenberg G, Ogwumike J, Silva J, Udeogu E, Pela E, Patil C. A randomized controlled trial of a family-based HIV/STI prevention program for Black girls and male caregivers in Chicago: IMAGE study protocol paper. PLoS One. 2025 Mar 28;20(3):e0320164. doi: 10.1371/journal.pone.0320164. eCollection 2025.

  PMID: 40153378 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Hepatitis; HIV Infections; Sexual Behavior

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavior

Central Study Contacts

Natasha Crooks, PhD

CONTACT

312-996-5801; ncrooks@uic.edu

Jessica Ogwumike, MPH

CONTACT

7739839980; oogwumik@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will evaluate the efficacy of IMAGE with 13-24-year-old Black girls (n=300) and male caregivers (n=300) in a 2-arm individually randomized controlled trial. The researchers will compare SRH outcomes (STI incidence, self-reported sexual behavior) at 6- and 12-months among girls randomized to IMAGE or a time-matched general health promotion control program (FUEL). The researchers will simultaneously evaluate implementation determinants (barriers, facilitators, constraints) and processes at Community Based Organizations working through the 3 steps of the implementation model (Prepare, Roll out, and Sustain).

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 20, 2024
• Study Start: September 2, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)