Clinical trial NCT02103218: A Risky Sex Prevention Intervention for Middle School Age Minority Girls
Official title: A Risky Sex Prevention Intervention for Middle School Age Minority Girls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Risky Sex Prevention
Keywords: HIV
risky sex prevention
intervention
Lead sponsor: University of North Carolina, Greensboro
Sponsor class: OTHER
First posted: 2014-04-03
Enrollment: 212
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Adolescent Sexual Activity Index
timeFrame: 12 months
measure: Any Sex no Condom, Past 3 Months
timeFrame: 12 months
measure: Sex With Multiple Partners, Ever
timeFrame: 12 months
measure: Drugs/Alcohol Use During Sex, Past 3 Months
timeFrame: 12 months
Secondary outcomes:
measure: HIV Knowledge
timeFrame: 12 month
measure: Maternal Bond Scale
timeFrame: 12 months
measure: Mother-Teen Sexual Risk Communication
timeFrame: 12 months
measure: Mother-Adolescent Communication: Open Family Communication (Girl)
timeFrame: 12 months
measure: Maternal Monitoring Scale (Girl)
timeFrame: 12 months
measure: Rosenberg Self-Esteem
timeFrame: 12 months
measure: Racial Pride
timeFrame: 12 months
measure: Empowerment: Interpersonal
timeFrame: 12 months
measure: Empowerment: Relationship
timeFrame: 12 months
measure: Empowerment: Personal
timeFrame: 12 months
measure: Sexual Assertiveness: Refusal
timeFrame: 12 months
measure: Sexual Assertiveness: Prevent
timeFrame: 12 months
Other outcomes:
measure: Mother Adolescent Communication: Open Family Communication (Mother)
timeFrame: 12 months
measure: Maternal Monitoring Scale (Mother)
timeFrame: 12 months
measure: Communication About Sex Self-Efficacy Scale
timeFrame: 12 months
Locations:
city: Greensboro
country: United States
facility: University of North Carolina, Greensboro
state: North Carolina
Study officials:
affiliation: University of North Carolina, Greensboro
name: Tracy R Bartlett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Univeristy of North Carolina, Greensboro
name: Debra C Wallace, PhD
role: STUDY_CHAIR
References:
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.
citation: 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.