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临床试验/NCT02958813
NCT02958813已完成不适用

An Integrated HIV Prevention Model for African American Mothers and Daughters

University of Illinois at Chicago0 个研究点目标入组 514 人开始时间: 2012年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
514
主要终点
Change in Incident STI infection

研究概览

简要总结

This study has three specific aims:

  1. To conduct a 2-arm randomized controlled trial comparing IMARA to a family-based health program (FUELTM). The investigators will:

a. Randomly assign 300 14-18 year-old AA or black girls and their primary female caregivers to IMARA (N=150) or FUELTM (N=150). Women and girls will be recruited four ways: 1) from mental health clinics using clinic liaisons, 2) flyers will be posted in clinic recruitment sites and other agencies instructing interested families to call our recruiter, 3) IMARA participants will hand flyers to interested women and girls they know, and 4) COIP field station staff will pass out flyers and recruit interested women and girls at the field stations and in the community. Investigators will examine the effects of IMARA on women and girls' sexual behavior at 6- and 12-months. 2. To evaluate the impact of IMARA on theoretical mediators posited by the Theory of Gender and Power and the Social-Personal framework associated with AA women and girls' risky sex. Investigators will:

  1. Assess changes in women and girls' Individual Attributes (HIV/AIDS knowledge, attitudes, and beliefs, mental health/emotion regulation, ethnic identity); Peer and Partner Processes (partner characteristics, relationship power dynamics, peer influences, partner communication); and Family Context (mother-daughter relationship and communication, parental monitoring) at baseline and follow-ups.

  2. Evaluate mediation and moderation of theoretical mechanisms on women and girls' sexual behavior.

  3. To assess the impact of IMARA compared to FUELTM on sexually transmitted infections (STIs). Investigators will:

  4. Test women and girls' urine for three common STIs at baseline and 12-month follow up.

  5. Explore linkages between biological outcomes and targeted mediators and moderators of change.

详细描述

Disproportionate rates of mental illness and HIV/STIs among African Americans (AA) reflect significant health disparities. AAs account for more HIV/AIDS cases, people living with HIV/AIDS, and HIV-related deaths than any other racial group in the US. In 2004, HIV was the 3rd leading cause of death among Black women, and in 2006, AA women accounted for 66% of new AIDS cases among women. AA youth ages 13 - 19 comprise approximately 16% of US teens but 69% of new AIDS cases. Most infections among AA women and girls occur through sexual activity, and AA girls report more risky sex, less condom use, and lower perceived HIV risk than AA boys. Racial disparities also exist for AAs in rates of gonorrhea, chlamydia, and syphilis. Among 15 - 19 year old AA girls, gonorrhea rates are higher than any other race/age/gender group, and almost half of AA women have an STI. Important linkages exist between HIV/STIs and mental health; Mental illness is linked to HIV through greater risk taking, poor health promotion, and reduced effects of behavioral interventions for teens and adults.

HIV-risk factors extend beyond individual women or girls, yet few family-based, gender-specific, Afrocentric programs simultaneously address AA women, AA girls, mental health, and the mother-daughter dyad, thereby missing a critical opportunity to address HIV in a broader social context. Interventions that are sensitive to gender and culture focus on women (SISTA) or girls (SiHLE) and lack a mental health and family component. Family-based HIV prevention programs rarely address gender and culture or the adult family member's HIV risks (Project STYLE). Simultaneously targeting multiple levels in an integrated program -- the mother-daughter dyad, women, and girls -- capitalizes on the reciprocal impact of mothers and daughters, and facilitates mutual reinforcement of prevention attitudes and behavior, thereby reducing intervention decay and sustaining positive outcomes over time.

IMARA (Informed, Motivated, Aware, and Responsible about AIDS) blends gender and ethnic components of SISTA and SiHLE (gender roles, ethnic pride, relationship power) with family and mental health components from Project STYLE (affect management, parental monitoring, adolescent development, parent-child communication) to create a culturally relevant, multi-level, integrated, family-based, HIV and mental health prevention program that simultaneously targets AA women and their daughters. Based on the Theory of Gender and Power, the Social-Personal model of HIV-risk, and findings from the investigator's research, IMARA emphasizes the interplay of family, peer, partner, and individual mechanisms as mediators of sexual risk taking for women and girls. Pilot testing (N=22 dyads) revealed strong feasibility, acceptability, and tolerability: >95% consent/assent rates, 96% retention at 2-month follow-up, and very positive feedback. Promising outcome data for mothers and daughters in targeted mediators (e.g., positive attitudes about HIV/AIDS, greater intentions to use condoms, increased parental monitoring, more open mother-daughter communication, more relationship power) and sexual risk outcomes (e.g., increased condom use, fewer partners) justify a randomized controlled trial.

This study has three specific aims:

  1. To conduct a 2-arm randomized controlled trial comparing IMARA to a family-based health program (FUELTM). Investigators will:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Adolescent girls between 14-18 years of age, African American or Black.
  • •Women who are primary female caregivers and self-identify as African American or Black, and are over the age of
  • •Women and daughters must agree to participate as a dyad.

排除标准

  • •If either participant is unable to understand the consent/assent process, do not speak English, are actively psychotic or severely mentally ill, or girls do not live with participating female caregiver.

研究组 & 干预措施

IMARA

Experimental

IMARA blends three programs with the most relevance for AA women (SISTA) and girls (SiHLE) and families in psychiatric care (Project STYLE). Separate mother and daughter groups cover parallel content and run simultaneously, and joint activities enhance mothers' credibility as a resource for HIV/STI prevention, practice new communication skills, negotiate conflict, and strengthen the mother-daughter relationship. Activities reinforce the reciprocal impact of mothers and daughters, and enhance safe sex knowledge, attitudes, and skills. Woven throughout IMARA is the impact of alcohol and drug use on risk behavior, including condom use while high.

干预措施: IMARA (Behavioral)

FUEL

Placebo Comparator

FUEL Health Promotion Control combines two programs, FUEL and Project Balance Health Promotion. FUEL™ promotes healthy activities by encouraging good nutrition, exercise, and informed consumer behavior. FUEL™ does not explicitly address HIV/STI prevention. Investigators will present information from Balance's session about HIV/AIDS, condoms, and other STIs. Investigators will also insert the following sessions from Balance into FUEL: alcohol use, drug/marijuana use, nutrition, exercise, and violence to increase program length.

干预措施: FUEL (Behavioral)

结局指标

主要结局

Change in Incident STI infection

时间窗: From Baseline to 12 month followup

Investigators will measure women's and girls' STIs using biological endpoints (yes/no) to evaluate intervention effects. Investigators will screen urine for three sexually transmitted pathogens at baseline and 12- month follow up; N. gonorrhoeae, C. trachomatis, and T.vaginalis. Investigators will use nucleic acid amplification technologies (NAAT) for STI testing.

Change in Risky Sexual Behavior

时间窗: From Baseline to 12 month followup

The AIDS-Risk Behavior Assessment (ARBA) is a computer-assisted interview of sexual behavior and drug use. The ARBA was derived from five established measures used in large-scale studies to examine HIV/AIDS-risk in youth and adults. The ARBA assesses substance use, sexual behavior, and needle use. Investigators will assess mothers and daughters' condom use, sex with high-risk partners, sex while using drugs/alcohol, number of partners, sexual debut -- and relative frequency and count-based indicators.

Change in Individual Attributes

时间窗: From Baseline to 12 month followup

Investigators will measure changes in women and girls' Individual Attributes such as HIV/AIDS knowledge, attitudes, and beliefs, mental health/emotion regulation, and ethnic identity.

Change in Family Context

时间窗: From Baseline to 12 month followup

Investigators will measure changes in women and girls' Individual Attributes such as Family Context (mother-daughter relationship and communication, and parental monitoring)

Change in Peer and Partner Processes

时间窗: From Baseline to 12 month followup

Investigators will measure changes in women and girls' Peer and Partner Processes such as partner characteristics, relationship power dynamics, peer influences, and partner communication.

Change in Risky Sexual Behavior

时间窗: From Baseline to 6 month followup

The AIDS-Risk Behavior Assessment (ARBA) is a computer-assisted interview of sexual behavior and drug use. The ARBA was derived from five established measures used in large-scale studies to examine HIV/AIDS-risk in youth and adults. The ARBA assesses substance use, sexual behavior, and needle use. Investigators will assess mothers and daughters' condom use, sex with high-risk partners, sex while using drugs/alcohol, number of partners, sexual debut -- and relative frequency and count-based indicators.

Change in Peer and Partner Processes

时间窗: From Baseline to 6 month followup

Investigators will measure changes in women and girls' Peer and Partner Processes such as partner characteristics, relationship power dynamics, peer influences, and partner communication.

Change in Individual Attributes

时间窗: From Baseline to 6 month followup

Investigators will measure changes in women and girls' Individual Attributes such as HIV/AIDS knowledge, attitudes, and beliefs, mental health/emotion regulation, and ethnic identity.

Change in Family Context

时间窗: From Baseline to 6 month followup

Investigators will measure changes in women and girls' Individual Attributes such as Family Context (mother-daughter relationship and communication, and parental monitoring)

次要结局

未报告次要终点

研究者

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

Geri Donenberg

Associate Dean of Research, School of Public Health Professor, Department of Medicine Director, Community Outreach Intervention Projects and Healthy Youths Program

University of Illinois at Chicago

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