IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)
- Conditions
- HIV InfectionsSexually Transmitted Infections (Not HIV or Hepatitis)Sexual Behavior
- Interventions
- Behavioral: IMARA for Black Male Caregivers and Girls EmpowermentBehavioral: Time-matched control program
- Registration Number
- NCT06266416
- Lead Sponsor
- University of Illinois at Chicago
- 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.
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 612
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental (IMAGE) Group IMARA for Black Male Caregivers and Girls Empowerment 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. Control (FUEL) Group Time-matched control program The FUEL group will receive a caregiver-adolescent general health promotion program identical in length and intensity to IMAGE.
- Primary Outcome Measures
Name Time Method STI Incidence in Participants 6 and 12 months post treatment Sexually Transmitted Infection (STI) incidence from the 14-18 year old girls dyad
- Secondary Outcome Measures
Name Time Method Rate of STI History among Participants Baseline, 6 and 12 months 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.
Number of Participants Using Condoms baseline, 6, and 12 months Use and frequency of condom use in 14-18 year old girls dyad
Number of Sexual Partners of Participants baseline, 6, and 12 months Number of sexual partners by 14-18 year old girls dyad
Trial Locations
- Locations (1)
University of Illinois Chicago
🇺🇸Chicago, Illinois, United States