An Integrated HIV Prevention Model for African American Mothers and Daughters

NCT02958813 | Completed DMC

• 1 other identifier: 2011-01627
• Study Type: interventional
• Target: 514
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study has three specific aims:

1. 1.To conduct a 2-arm randomized controlled trial comparing IMARA to a family-based health program (FUELTM). The investigators will:
2. 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:
3. 3.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.
4. 4.Evaluate mediation and moderation of theoretical mechanisms on women and girls' sexual behavior.
5. 5.To assess the impact of IMARA compared to FUELTM on sexually transmitted infections (STIs). Investigators will:
6. 6.Test women and girls' urine for three common STIs at baseline and 12-month follow up.
7. 7.Explore linkages between biological outcomes and targeted mediators and moderators of change.

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (9)

• Change in Risky Sexual Behavior

  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.

  From Baseline to 6 month followup

• Change in Incident STI infection

  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.

  From Baseline to 12 month followup

• Change in Risky Sexual Behavior

  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.

  From Baseline to 12 month followup

• Change in Peer and Partner Processes

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

  From Baseline to 6 month followup

• Change in Peer and Partner Processes

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

  From Baseline to 12 month followup

• Change in Individual Attributes

  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.

  From Baseline to 6 month followup

• Change in Individual Attributes

  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.

  From Baseline to 12 month followup

• Change in Family Context

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

  From Baseline to 6 month followup

• Change in Family Context

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

  From Baseline to 12 month followup

Study Arms (2)

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.

Behavioral: IMARA

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.

Behavioral: FUEL

Interventions

IMARA BEHAVIORAL

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.

IMARA

FUEL BEHAVIORAL

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.

FUEL

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 18.
• Women and daughters must agree to participate as a dyad.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Rush University: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Research, School of Public Health Professor, Department of Medicine Director, Community Outreach Intervention Projects and Healthy Youths Program

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 8, 2016
• Study Start: November 1, 2012
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04