Clinical trial NCT06266416: IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)
Official title: A Family-Based HIV Prevention Program for Black Men to Protect Black Girls
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexually Transmitted Infections (Not HIV or Hepatitis)
HIV Infections
Sexual Behavior
Keywords: Sexual Health
HIV Prevention
Community Based
Sexually Transmitted Infections
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-02-20
Enrollment: 612
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will evaluate the efficacy of IMAGE with 14-18-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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: STI Incidence in Participants
timeFrame: 6 and 12 months post treatment
Secondary outcomes:
measure: Rate of STI History among Participants
timeFrame: Baseline, 6 and 12 months
measure: Number of Participants Using Condoms
timeFrame: baseline, 6, and 12 months
measure: Number of Sexual Partners of Participants
timeFrame: baseline, 6, and 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
Study officials:
References: