Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266416
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-01-26
Brief Title:
IMARA for Black Male Caregivers and Girls Empowerment IMAGE
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
A Family-Based HIV Prevention Program for Black Men to Protect Black Girls
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAGE
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 STIHIV prevention programs to include Black male caregivers a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STIHIV 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 ie pelvic inflammatory disease infertility Human Immunodeficiency Virus HIVAcquired 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 STIHIV 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 ie 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 IMAGEs 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 14-18-year old Black girls 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None