IMARA Program for Sexual Health in Black Girls

(IMAGE Trial)

Overseen By Jessica Ogwumike, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 2 days

612 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment IMARA for sexual health in Black girls?

Research shows that the IMARA program, a mother-daughter intervention, helped reduce the likelihood of new sexually transmitted infections (STIs) by 43% among Black/African-American girls over a 12-month period. This suggests that IMARA is effective in improving sexual health outcomes for this group. ^{1 2 3 4 5}

Is the IMARA Program for Sexual Health in Black Girls safe?

The IMARA program, which focuses on reducing sexually transmitted infections (STIs) among African American girls, has been tested in several studies. While these studies primarily assess its effectiveness, they do not report any specific safety concerns, suggesting it is generally safe for participants. ^{1 2 3 4 6}

How is the IMARA treatment unique for sexual health in Black girls?

IMARA is unique because it is a group-based mother-daughter intervention specifically designed to reduce sexually transmitted infections (STIs) among African American girls by addressing both sexual health and mental health symptoms. Unlike other treatments, it involves psychosocial support and education over two consecutive Saturdays, focusing on informed decision-making and responsible behavior. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for Black male caregivers and their daughters, focusing on preventing STIs, HIV, and sexual violence. Participants must be willing to engage in programs aimed at improving girls' sexual reproductive health outcomes.

Inclusion Criteria

AIM 2: All Community Based Organizations (CBO) directors and IMAGE liaisons will be eligible.

I am a male caregiver to a girl participating in the study.

AIM 1: Self-identify as African American, Black, or mixed race with African American or Black

Exclusion Criteria

My female caregiver agrees to my participation with my chosen male caregiver.

AIM 1: Inability to understand the consent/assent process

I am a girl and I refuse to participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

The IMAGE group receives an 8-10-hour HIV/STI group-based prevention program delivered over 2 days

2 days

1 visit (in-person)

Follow-up

Participants are monitored for STI incidence and sexual behavior outcomes

12 months

Assessments at 6 and 12 months

Treatment Details

Interventions

• IMARA

Trial Overview The study tests the IMARA program for Black male caregivers paired with a Girls Empowerment initiative against a control program. It aims to understand how these interventions can influence health outcomes related to STIs/HIV and prevent sexual violence.

Participant Groups

Group I: Experimental (IMAGE) Group Experimental Treatment 1 Intervention

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.

Group II: Control (FUEL) Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

The IMARA intervention significantly reduced externalizing symptoms in African American female adolescents with initially high symptom levels, suggesting it may help improve behavioral issues related to mental health.

Participants who showed improvement in externalizing symptoms after the IMARA program were also less likely to acquire new STIs, indicating a potential link between mental health and STI prevention that warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in externalizing and internalizing symptoms among African American female adolescents over 1 year following a mother-daughter sexual health intervention. Kendall, AD., Young, CB., Bray, BC., et al.[2023]

The Imara intervention, designed for African American girls in juvenile detention, effectively addresses sexual health risks by providing tailored one-on-one sessions that consider individual needs and circumstances.

Key lessons from implementing Imara highlight the importance of logistical support, ongoing contact post-release, and addressing competing priorities to enhance the intervention's effectiveness in reducing STIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned From Delivering Imara, an HIV/STI Risk Reduction Intervention for African American Girls in Juvenile Detention. Davis, TL., Boyce, LS., Rose, E., et al.[2022]

The Imara intervention, which included individual and phone sessions, significantly improved condom use self-efficacy, HIV/STI knowledge, and condom use skills among 188 African American adolescent girls in juvenile detention, compared to those receiving usual care.

Despite these improvements in knowledge and skills, the intervention did not lead to a significant reduction in incident Chlamydia or gonorrhea infections, highlighting the ongoing need for effective strategies to reduce sexual risk in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an HIV/STI sexual risk-reduction intervention for African American adolescent girls in juvenile detention centers: a randomized controlled trial. DiClemente, RJ., Davis, TL., Swartzendruber, A., et al.[2022]

The IMARA program, a mother-daughter psychosocial intervention, significantly reduced the likelihood of new STIs in Black/African-American girls by 43% compared to a control program over a 12-month period, based on a study involving 199 participants.

Retention in the study was high at 86%, indicating strong participant engagement, and the results suggest that IMARA could be an effective strategy for STI prevention in this demographic, warranting further research into its mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IMARA: A mother-daughter group randomized controlled trial to reduce sexually transmitted infections in Black/African-American adolescents. Donenberg, GR., Kendall, AD., Emerson, E., et al.[2022]

The systematic review identified 15 interventions aimed at preventing poor sexual health outcomes and drug use among Black adolescent females, a group particularly affected by these issues.

Most interventions focused on sexual health, with only two incorporating drug use education, highlighting a gap in comprehensive approaches to address both sexual health and substance use in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on Sexual Health and Drug Use Prevention Interventions for Black Girls. Opara, I., Pierre, K., Assan, MA., et al.[2023]

The 'I Am Men's Health' program successfully improved adherence to PrEP among 23 young men of color at high risk for HIV, achieving an average adherence rate of 73% over a 28-week period.

This innovative approach to promoting PrEP adherence may serve as a model for future large-scale HIV prevention efforts, particularly in communities with high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I Am Men's Health: Generating Adherence to HIV Pre-Exposure Prophylaxis (PrEP) in Young Men of Color Who Have Sex with Men. Daughtridge, GW., Conyngham, SC., Ramirez, N., et al.[2022]

The Sister-to-Sister intervention significantly reduced sexual risk behaviors and STD incidence among African American women, demonstrating its effectiveness as a skill-building program.

Self-efficacy for condom use was identified as the key factor mediating the intervention's success, indicating that empowering women to feel confident in their ability to use condoms is crucial for improving sexual health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediation analysis of an effective sexual risk-reduction intervention for women: the importance of self-efficacy. O'Leary, A., Jemmott, LS., Jemmott, JB.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Changes in externalizing and internalizing symptoms among African American female adolescents over 1 year following a mother-daughter sexual health intervention. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Lessons Learned From Delivering Imara, an HIV/STI Risk Reduction Intervention for African American Girls in Juvenile Detention. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of an HIV/STI sexual risk-reduction intervention for African American adolescent girls in juvenile detention centers: a randomized controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

IMARA: A mother-daughter group randomized controlled trial to reduce sexually transmitted infections in Black/African-American adolescents. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Review on Sexual Health and Drug Use Prevention Interventions for Black Girls. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

I Am Men's Health: Generating Adherence to HIV Pre-Exposure Prophylaxis (PrEP) in Young Men of Color Who Have Sex with Men. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Mediation analysis of an effective sexual risk-reduction intervention for women: the importance of self-efficacy. [2022]