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临床试验/NCT06266416
NCT06266416招募中不适用

A Family-Based HIV Prevention Program for Black Men to Protect Black Girls

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 612 人开始时间: 2024年9月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
612
试验地点
2
主要终点
STI Incidence in Participants

研究概览

简要总结

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.

详细描述

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 13-24-year old Black teens and young women 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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
  • Inability to understand the consent process, and non-employment at a partnering CBO.

研究组 & 干预措施

Experimental (IMAGE) Group

Experimental

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.

干预措施: IMARA for Black Male Caregivers and Girls Empowerment (Behavioral)

Control (FUEL) Group

Active Comparator

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

干预措施: Time-matched control program (Behavioral)

结局指标

主要结局

STI Incidence in Participants

时间窗: 6 and 12 months post treatment

Sexually Transmitted Infection (STI) incidence from the 14-18 year old girls dyad

次要结局

  • Rate of STI History among Participants(Baseline, 6 and 12 months)
  • Number of Participants Using Condoms(baseline, 6, and 12 months)
  • Number of Sexual Partners of Participants(baseline, 6, and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natasha Crooks

Principal Investigator

University of Illinois at Chicago

研究点 (2)

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