An Integrated HIV Prevention Model for African American Mothers and Daughters
NCT02958813 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 514
Last updated 2019-04-18
Summary
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:
1. Test women and girls' urine for three common STIs at baseline and 12-month follow up.
2. Explore linkages between biological outcomes and targeted mediators and moderators of change.
Conditions
- HIV Prevention
Interventions
- BEHAVIORAL
-
IMARA
Morning and afternoon sessions begin with an icebreaker and/or poem to enhance ethnic and gender pride. IMARA's goals and motto are presented to emphasize strong mother-daughter relationships, foster sisterhood, build group cohesion, and increase motivation. Ground rules are reviewed, and each woman and girl signs the IMARA pact to confirm her commitment to the program. At the end of day 1, mothers and daughters receive homework for the week. Woven throughout IMARA is the impact of alcohol and drug use on risk behavior, including condom use while high.
- BEHAVIORAL
-
FUEL
FUEL™ Health Promotion Control Group: mothers and daughters randomly assigned to FUEL™ will participate in separate 2-day workshops identical in length and intensity to IMARA. FUEL™ promotes healthy activities by encouraging good nutrition, exercise, and informed consumer behavior. Investigators will also insert the following sessions from Balance into FUEL: alcohol use, drug/marijuana use, nutrition, exercise, and violence to increase program length.
Sponsors & Collaborators
-
Rush University
collaborator OTHER -
University of Illinois at Chicago
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-11-01
- Primary Completion
- 2018-01-31
- Completion
- 2018-01-31
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