A Risky Sex Prevention Intervention for Middle School Age Minority Girls
Phase: NA
Conditions: HIV, Risky Sex Prevention
Sponsor: University of North Carolina, Greensboro

Cover Page: 
 
Study Protocol 
 
 
Title of the study: 
 
A Risky Sex Prevention Intervention for Middle School Age Minority Girls 
 
 
NCT number: 
 
NCT02103218 
 
 
Date of the document: 
 
January 28, 2019 
 
 
 
 

The study objectives were to address the following research questions (RQs): 
 
RQ1. What is the efficacy of the intervention in delaying initiation of sex or reducing 
risky sex behaviors by young Black girls? 
 
RQ2. Does the intervention produce changes in black middle school girls’ knowledge of 
HIV, communication with mothers (including bonding and monitoring), self-esteem, 
racial pride, empowerment and sexual assertiveness? 
 
RQ3. Does the intervention produce changes in mothers’ mother-daughter 
communication, bonding, and maternal monitoring? 
 
Study design 
 
A quasi-experimental, longitudinal design was used to test the efficacy of a family-level 
HIV preventive intervention for young Black girls relative to girls in a comparison group 
to assess HIV knowledge, communication and bonds with their mothers, racial/ethnic 
pride, self-esteem, and assertiveness and to empower girls. Data were collected for all 
participants at baseline (prior to the intervention), immediately post-intervention (three 
months post-baseline), and at three- and nine-month follow-up. 
 
The study statistical analysis plan is uploaded as a separate document to  
clinicaltrials.gov.