Sexually Transmitted Infections (Not HIV or Hepatitis)IMAGENCT06266416
IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)
A study testing IMARA for Black Male Caregivers and Girls Empowerment in people with Sexually Transmitted Infections (Not HIV or Hepatitis) and HIV Infections, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Infections (Not HIV or Hepatitis), HIV Infections, Sexual Behavior
- What is being tested?
- IMARA for Black Male Caregivers and Girls Empowerment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 612 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2024to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Chicago
Chicago, Illinois, 60612
LIsa Sharp, PhD, 312.966.1819, sharpl@uic.edu
Sue Littau, 312.996.3932, slittau@uic.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- IMARA for Black Male Caregivers and Girls Empowerment, Time-matched control program
- Keywords
- Sexual Health, HIV Prevention, Community Based, Sexually Transmitted Infections
- Medical subject headings
- Sexually Transmitted Diseases, Hepatitis, HIV Infections, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMARA for Black Male Caregivers and Girls EmpowermentBehavioural
Also called IMAGE
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 programBehavioural
Also called FUEL
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Time-matched control program |
What is being measured
The primary outcome is the main question the study is designed to answer.
STI Incidence in Participants
Sexually Transmitted Infection (STI) incidence from the 14-18 year old girls dyad
Measured: 6 and 12 months post treatment
Secondary outcomes (3)
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.
Measured: Baseline, 6 and 12 months
Number of Participants Using Condoms
Use and frequency of condom use in 14-18 year old girls dyad
Measured: baseline, 6, and 12 months
Number of Sexual Partners of Participants
Number of sexual partners by 14-18 year old girls dyad
Measured: baseline, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start2 Sep 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted Infections (Not HIV or Hepatitis)Studies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Natasha Crooks, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266416
- Sponsor's protocol ID
- 115207
- Other IDs
- R01MD018929
- Acronym
- IMAGE
- Status last verified
- Apr 2026
- First submitted
- 26 Jan 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40153378
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family-Based HIV Prevention Program for Black Men to Protect Black Girls
- ClinicalTrials.gov ID
- NCT06266416
- Acronym / sponsor ID
- IMAGE / 115207
- Keywords
- Sexual Health, HIV Prevention, Community Based, Sexually Transmitted Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- University of Michigan, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Experimental (IMAGE) Group | Experimental | Behavioral: IMARA for Black Male Caregivers and Girls EmpowermentThe 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. |
| Control (FUEL) Group | Active comparator | Behavioral: Time-matched control programThe FUEL group will receive a caregiver-adolescent general health promotion program identical in length and intensity to IMAGE. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMARA for Black Male Caregivers and Girls EmpowermentAlso: IMAGEIMAGE 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. | Behavioural | Experimental (IMAGE) Group |
| Time-matched control programAlso: FUELFUEL 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. | Behavioural | Control (FUEL) Group |
Primary outcome
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
3 secondary outcomes
Rate of STI History among Participants
Time frame: Baseline, 6 and 12 months
Number of Participants Using Condoms
Time frame: baseline, 6, and 12 months
Number of Sexual Partners of Participants
Time frame: baseline, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Derived from this study: PubMed 40153378Crooks 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMARA for Black Male Caregivers and Girls Empowerment in people with Sexually Transmitted Infections (Not HIV or Hepatitis) and HIV Infections, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha Crooks, PhD (312-996-5801, ncrooks@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STI Incidence in Participants (time frame: 6 and 12 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06266416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.