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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02958813 on ClinicalTrials.gov