A Risky Sex Prevention Intervention for Middle School Age Minority Girls

NCT ID: NCT02103218

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2018-02-13

Brief Summary

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.

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.

Conditions

HIV; Risky Sex Prevention

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Risky sex prevention

education, activities, empowerment, racial pride building

Group Type: EXPERIMENTAL

Education, activities, empowerment, racial pride building

Intervention Type: BEHAVIORAL

Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females.

Healthy behaviors

General health education, activities

Group Type: ACTIVE_COMPARATOR

General Health education, activities

Intervention Type: BEHAVIORAL

Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex).

Interventions

Education, activities, empowerment, racial pride building

Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females.

Intervention Type: BEHAVIORAL

General Health education, activities

Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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.

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.

• 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.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Greensboro

OTHER

Sponsor Role: lead

Responsible Party

Dr. Tracy R. Bartlett

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracy R Bartlett, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Greensboro

Debra C Wallace, PhD

Role: STUDY_CHAIR

Univeristy of North Carolina, Greensboro

Locations

University of North Carolina, Greensboro

Greensboro, North Carolina, United States

Countries

United States

References

Wallace DC, Bartlett R. Recruitment and retention of African American and Hispanic girls and women in research. Public Health Nurs. 2013 Mar;30(2):159-66. doi: 10.1111/phn.12014. Epub 2012 Nov 22.

Reference Type: BACKGROUND

PMID: 23452110 (View on PubMed)

Bartlett R, Johnson A, Randolph I, McCoy TP. Communication and Bonding Between African-American Middle School Girls and Their Maternal Figures. J Natl Black Nurses Assoc. 2016 Jul;27(1):18-23.

Reference Type: RESULT

PMID: 29932539 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

P20MD002289

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P20MD002289-1

Identifier Type: -

Identifier Source: org_study_id