A Risky Sex Prevention Intervention for Middle School Age Minority Girls

HIV Clinical Trial

— GEMM  

Official title:

A Risky Sex Prevention Intervention for Middle School Age Minority Girls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103218
• Other study ID #: P20MD002289-1
• Secondary ID: P20MD002289
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: February 13, 2018

Study information

• Verified date: May 2021
• Source: University of North Carolina, Greensboro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: February 13, 2018
• Est. primary completion date: February 13, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV
• Risky Sex Prevention

Intervention

Behavioral:
• Education, activities, empowerment, racial pride building
Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females.
• General Health education, activities
Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex).

Locations

Country	Name	City	State
United States	University of North Carolina, Greensboro	Greensboro	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Greensboro

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mother Adolescent Communication: Open Family Communication (Mother)	Mother Adolescent Communication: Open Family Communication (Mother). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.	12 months
Other	Maternal Monitoring Scale (Mother)	Maternal Monitoring Scale (Mother). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.	12 months
Other	Communication About Sex Self-Efficacy Scale	Communication about Sex Self-Efficacy Scale. The theoretical minimum and maximum scores are min=12 and max=60. Higher scores indicate greater self-efficacy (better outcome).	12 months
Primary	Adolescent Sexual Activity Index	Adolescent Sexual Activity Index (Female). The theoretical minimum and maximum values are min=0 and max=10 (Hansen, Paskett, & Carter, 1999). A higher index value indicates more activity (worse outcome).	12 months
Primary	Any Sex no Condom, Past 3 Months	Any sex no condom, past 3 months	12 months
Primary	Sex With Multiple Partners, Ever	Sex with multiple partners, ever	12 months
Primary	Drugs/Alcohol Use During Sex, Past 3 Months	Drugs/Alcohol use during sex, past 3 months	12 months
Secondary	HIV Knowledge	HIV-Knowledge Questionnaire for Adolescent Girls. The theoretical minimum and maximum values are min=0 and max=18. Higher scores indicate higher HIV knowledge which is a better outcome.	12 month
Secondary	Maternal Bond Scale	Maternal Bond Scale. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate stronger maternal bonds which is a better outcome.	12 months
Secondary	Mother-Teen Sexual Risk Communication	Mother-Teen Sexual Risk Communication. The theoretical minimum and maximum are min=8 to max=40. Higher scores indicate greater mother-teen communication about sexual risk which is a better outcome.	12 months
Secondary	Mother-Adolescent Communication: Open Family Communication (Girl)	Mother-Adolescent Communication: Open Family Communication (Girl). The theoretical minimum and maximum values are min=10 and max=50. A higher value indicates greater mother-adolescent open family communication which is a better outcome.	12 months
Secondary	Maternal Monitoring Scale (Girl)	Maternal Monitoring Scale (Girl). The theoretical minimum and maximum values are min=8 and max=40. A higher value indicates greater maternal monitoring which is a better outcome.	12 months
Secondary	Rosenberg Self-Esteem	Rosenberg Self-Esteem Scale. The theoretical minimum and maximum values are min=10 and max=40. A higher value indicates higher self-esteem which is a better outcome.	12 months
Secondary	Racial Pride	Racial Pride Scale. The theoretical minimum and maximum values are min=7 and max=28. A higher value indicates stronger feelings of racial pride which is a better outcome.	12 months
Secondary	Empowerment: Interpersonal	Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=4 and max=20. A higher value indicates greater personal influence on relationship decisions.	12 months
Secondary	Empowerment: Relationship	Empowerment Scale: Interpersonal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater influence over a partner.	12 months
Secondary	Empowerment: Personal	Empowerment Scale: Personal. The theoretical minimum and maximum values are min=3 and max=21. A higher value indicates greater personal empowerment.	12 months
Secondary	Sexual Assertiveness: Refusal	Sexual Assertiveness Refusal subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in refusing sexual activity (better outcome).	12 months
Secondary	Sexual Assertiveness: Prevent	Sexual Assertiveness Prevent subscale. The theoretical minimum and maximum scores are min=6 and max=30. Higher scores indicate greater assertiveness in taking measures to prevent pregnancy (better outcome).	12 months