A Risky Sex Prevention Intervention for Minority Middle School Age Girls (GEMM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of North Carolina, Greensboro
Sponsor:
Information provided by (Responsible Party):
Dr. Tracy R. Bartlett, University of North Carolina, Greensboro
ClinicalTrials.gov Identifier:
NCT02103218
First received: March 31, 2014
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

African American adolescent females are more likely to have sex at an early age, to have older sex partners that have had multiple sexual experiences, and are less likely to use a condom than their white counterparts. Lack of sexual assertiveness is a factor in the risky sex behaviors of young African American women. African American girls at the greatest risk for contracting HIV are the ones that report that their partners could convince them to have sex and report trouble communicating their wishes related to sex. Thus far no intervention has addressed the disparate rate of HIV infection in young African American girls. This study is unique in promoting increases in racial pride as a component of empowerment to help African American girls self-protect against HIV. The study has the potential to empower young African American girls to delay sex initiation or reduce risky sex behaviors and thus reduce their risk of contracting HIV.


Condition Intervention
HIV
Risky Sex Prevention
Behavioral: Education, activity, empowerment, racial pride building
Behavioral: General Health education, activities

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Risky Sex Prevention Intervention for Middle School Age Minority Girls

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Greensboro:

Primary Outcome Measures:
  • Risky Sex Behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Girls' self report of risky sex behavior assessed at Time 1-4 data collection points. Measured using the Adolescent Sexual Activity Index (Female) and Sex Behavior Questionnaire.

  • HIV Knowledge [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Girls' self report HIV knowledge assessed at Time 1-4 data collection points. Measured using HIV-Knowledge Questionnaire for Adolescent Girls.

  • Mother-Daughter Communication/Bonding [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Girls' and moms' self report of communication/bonding assessed at Time 1-4 data collection points. Measured using the Mother-Adolescent Communication Scale, the Maternal Monitoring Scale, Mother-Teen Sexual Risk Communication Scale and the Maternal Bonding Scale.

  • Racial Pride [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Girls' self report of racial pride assessed at Time 1-4 data collection points. Measured using the Racial Pride Scale (RP).

  • Self-Esteem [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Girls self report of self-esteem assessed at Time 1-4 data collection points. Measured using the Rosenberg Self-Esteem Scale.

  • Empowerment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Girls' self report of empowerment assessed at Time 1-4 data collection points. Measured using Empowerment Scale.

  • Sexual Assertiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Girls' self report of sexual assertiveness assessed at Time 1-4 data collection points. Sexual Assertiveness Scale.

  • Mother Sexual Self-Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Moms' self report of sexual self-efficacy assessed at Time 1-4 data collections points. Measured using the Communication about Sex Self-Efficacy Scale.


Estimated Enrollment: 192
Study Start Date: November 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Risky sex prevention
education, activity, empowerment, racial pride building
Behavioral: Education, activity, empowerment, racial pride building
Active Comparator: Healthy behaviors
General health education, activities
Behavioral: General Health education, activities

Detailed Description:

This is a longitudinal intervention study with a study condition intervention and a control condition intervention. Potential participants will be invited to a recruitment meeting. If they choose to participate, they will be asked to sign informed consent or assent. There are 4 data collections for moms and girls - 1 after recruitment but before the start of the intervention, 1 at the end of the intervention (after the girls 12 week intervention), 1 three months after the end of the intervention (about 6 months after recruitment), and the final data collection 9 months after the end of the intervention (about 12 months from recruitment). Girls are asked to attend 12 group intervention sessions of about 2 hours each, once weekly, and then a final termination session that is followed by a celebration session to which their mothers are invited and then an evaluation session. Moms are asked to participate in 3 one hour education sessions over the 12 weeks that their daughters are in the weekly sessions, the celebration with their daughters, and then their evaluation session. Moms will also be asked to give their daughter empowering messages 5-7 times/week and girls asked to receive them. Finally, moms will be asked to receive calls from the study team once per month or 1 year to be asked about the empowering messages they have been sending their daughters.

  Eligibility

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Mother Inclusion Criteria:

  • Must be 21 years or older.
  • Must be daughter's primary female guardian/caregiver and she lives with me at least 50% of the time.
  • Must understand spoken and written English.
  • Must be able to provide a phone number where they can be reached and will be able to maintain contact with researchers for one year after start of study.
  • Must be able to provide or arrange reliable transportation for their daughter after each session or data collection.

Mother Exclusion Criteria:

  • Must not be incarcerated at the time of recruitment
  • Must not have a physical or mental health condition that may affect my or my daughter's participation in the study.

Daughter Inclusion Criteria:

  • Must be in middle school (grades 6-8) at the time of recruitment.
  • Must be between the ages of 11-14 at the time of recruitment.
  • Must self-identify as Black, African-American, or a mixed race that includes black or African-American.
  • Must be able to understand written and spoken English.

Daughter Exclusion Criteria:

  • Must not be in a classroom for developmentally delayed students in school.
  • Must not be currently pregnant at the time of recruitment.
  • Must not have a mental or physical health condition that may affect her participation in the study.
  • Must not be suspended or expelled from school at the time of recruitment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02103218

Contacts
Contact: Tracy R Bartlett, PhD 336-334-5840 ext 45840 trbartle@uncg.edu

Locations
United States, North Carolina
University of North Carolina, Greensboro Recruiting
Greensboro, North Carolina, United States, 27402
Sponsors and Collaborators
University of North Carolina, Greensboro
Investigators
Principal Investigator: Tracy R Bartlett, PhD University of North Carolina, Greensboro
Study Chair: Debra C Wallace, PhD Univeristy of North Carolina, Greensboro
  More Information

Publications:
Responsible Party: Dr. Tracy R. Bartlett, Associate Professor, University of North Carolina, Greensboro
ClinicalTrials.gov Identifier: NCT02103218     History of Changes
Other Study ID Numbers: P20MD002289-1
Study First Received: March 31, 2014
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Greensboro:
HIV
risky sex prevention
intervention

ClinicalTrials.gov processed this record on July 24, 2014