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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the sexual reproductive health of Black girls by involving their male caregivers in a prevention program called IMARA. It examines how individual, family, and societal factors affect health outcomes such as sexually transmitted infections (STIs) and experiences of sexual violence. Participants will either join a two-day program focused on STI/HIV prevention or a general health promotion program. This trial suits Black girls with a male caregiver willing to participate alongside them. As an unphased trial, it offers a unique opportunity to contribute to important research that could enhance community health and well-being.

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 prior data suggests that the IMARA program is safe?

Research has shown that the IMARA program has been tested in various settings to assess its effectiveness and safety. In earlier studies with mother-daughter pairs, girls who participated in the IMARA program were significantly less likely to contract new sexually transmitted infections (STIs). No major negative effects have been reported from participating in the program, suggesting it is well-tolerated.

The current study is adapting IMARA for Black male caregivers and girls, which could provide crucial support in preventing STIs and improving sexual health. Although specific data on negative effects for this new version is not yet available, the program's history indicates it is designed to be a safe educational and preventive tool. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IMARA program because it focuses on strengthening sexual health in Black girls by involving their male caregivers in a group-based educational setting. Unlike typical health programs that often center solely on individual education, IMARA brings caregivers and adolescents together, fostering open communication and mutual understanding over two days. This approach not only targets knowledge but also builds supportive relationships, which could lead to better prevention of HIV/STIs. By addressing the community aspect, this program offers a fresh perspective that could enhance the effectiveness of sexual health education in this demographic.

What evidence suggests that this trial's treatments could be effective for improving sexual health in Black girls?

Research has shown that the IMARA program, which participants in this trial may receive, can help lower the risk of sexually transmitted infections (STIs) among Black girls. One study found that girls who participated in IMARA were 43% less likely to contract an STI within a year compared to those who did not participate. This program includes Black male caregivers and focuses on preventing health issues related to sexual and reproductive health. Past trials demonstrated that IMARA also empowers girls and reduces their risk of experiencing sexual violence. These findings suggest that IMARA can play an important role in protecting and empowering Black girls in their communities. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10022073/

Preliminary effectiveness and implementation outcomes of ... An efficacy trial in Chicago found that girls (aged 14–18 years) who received IMARA were 43% less likely to contract a STI during one year of follow-up compared ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06266416

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7605636/

IMARA: A mother-daughter group randomized controlled trial ... This study tested the efficacy of IMARA, a mother-daughter psychosocial STI/HIV prevention program, on adolescent Black/African-American girls' incident STIs ...

4. journals.plos.org journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0001092

A pilot randomized trial | PLOS Global Public Health An efficacy trial in Chicago found that girls (aged 14–18 years) who received IMARA were 43% less likely to contract a STI during one year of ...

5. uicollaboratory.uic.edu uicollaboratory.uic.edu/6848-erin-emerson/publications

Erin Emerson | Publications 014). Findings provide early evidence for IMARA's efficacy, such that IMARA protected against STIs at 12-months among adolescent Black/African-American girls.

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0239650

IMARA: A mother-daughter group randomized controlled trial ... This study tested the efficacy of IMARA, a mother-daughter psychosocial STI/HIV prevention program, on adolescent Black/African-American girls' incident STIs ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04758390

A Comprehensive HIV Prevention Package for South ... The study will test whether AGYW receiving IMARA will have fewer sexually-transmitted infections (STI) and greater acceptance of HIV testing and counseling (HTC) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11952266/

A randomized controlled trial of a family-based HIV/STI ... This study will evaluate the efficacy and implementation of an HIV/STI prevention program delivered to Black girls and male caregivers in community settings.