N/A
N=212
A Risky Sex Prevention Intervention for Middle School Age Minority Girls
HIV · Risky Sex Prevention
Bottom Line
View on ClinicalTrials.gov: NCT02103218 ↗Enrolled (actual)
212
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Adolescent Sexual Activity Index — 1.39; 1.45; 2.12; 1.90 score on a scale — p=0.62
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education, activities, empowerment, racial pride building (Behavioral); General Health education, activities (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 11+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Greensboro
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adolescent Sexual Activity Index |
1.39; 1.45; 2.12; 1.90 | 0.62 |
| PRIMARY Any Sex no Condom, Past 3 Months |
7.1; 1.3; 8.4; 2.4 | 0.15 |
| PRIMARY Sex With Multiple Partners, Ever |
0.0; 0.0; 1.0; 2.2 | 0.47 |
| PRIMARY Drugs/Alcohol Use During Sex, Past 3 Months |
4.4; 0.0; 1.3; 5.1 | 0.29 |
| SECONDARY HIV Knowledge |
9.8; 8.5; 13.1; 10.4 | <0.001 sig |
| SECONDARY Maternal Bond Scale |
26.9; 27.8; 26.8; 28.9 | 0.02 sig |
| SECONDARY Mother-Teen Sexual Risk Communication |
22.8; 22.0; 25.4; 26.1 | 0.67 |
| SECONDARY Mother-Adolescent Communication: Open Family Communication (Girl) |
39.1; 39.5; 37.8; 39.2 | 0.45 |
| SECONDARY Maternal Monitoring Scale (Girl) |
34.4; 35.0; 34.7; 35.1 | 0.70 |
| SECONDARY Rosenberg Self-Esteem |
20.6; 21.7; 21.8; 22.8 | 0.42 |
| SECONDARY Racial Pride |
20.9; 21.2; 22.7; 22.3 | 0.63 |
| SECONDARY Empowerment: Interpersonal |
14.7; 14.8; 14.2; 15.2 | 0.05 |
| SECONDARY Empowerment: Relationship |
17.1; 16.6; 16.0; 15.0 | 0.50 |
| SECONDARY Empowerment: Personal |
18.2; 18.3; 18.6; 18.3 | — |
| SECONDARY Sexual Assertiveness: Refusal |
23.2; 24.4; 25.0; 25.3 | 0.86 |
| SECONDARY Sexual Assertiveness: Prevent |
26.8; 25.8; 27.1; 26.4 | 0.46 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02103218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.