e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls (eSiHLE)
The purpose of this study is to evaluate the efficacy of an online pregnancy prevention intervention that was adapted from the evidence based small group intervention SiHLE.
Sexually Transmitted Infections
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls|
- Percent change from baseline in the use of reliable contraceptives [ Time Frame: Change from baseline measured at 3 and 7 and 13 months post baseline ] [ Designated as safety issue: No ]Women who receive the BUtiful intervention will have a 35% increase in the use of reliable contraceptives compared to the DIVAS intervention. Reliable contraceptive use is defined as the consistent use of a condom with all sex partners, a hormonal birth control method, or an intrauterine device.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Intervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention
8 website sessions include themes that teach: gender empowerment, assertive communication skills, goal setting, pregnancy and STI/HIV risk, safer sex behaviors, proper condom use, positive attitudes and norms towards consistent condom use, contraception, partner involvement in safer sex, and responsibility for their own health.
Other Name: BUtiful
Attention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition
Attention control arm: 8 website sessions that include topics on: healthy eating, choosing nutritional snacks, sugar and salt intake, physical activity, stress management, foods for beauty.
Other Name: DIVAS
The investigators will test the hypothesis that by the end of the study, women who receive the e-SIHLE intervention will have a 35% increase in reliable contraception use compared to attention control website, DIVAS, which is a health and nutrition education program.
Both arms of the study were designed for African-American women who are 18-19 years old.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579617
|Contact: Patricia Kissinger, BSN MPH PhD||(504) firstname.lastname@example.org|
|Contact: Norine Schmidt, MPHemail@example.com|
|United States, Louisiana|
|Delgado Community College||Recruiting|
|New Orleans, Louisiana, United States, 70119|
|Tulane Drop In Clinic at Covenant House||Recruiting|
|New Orleans, Louisiana, United States, 70116|
|Southern University of New Orleans||Recruiting|
|New Orleans, Louisiana, United States, 70126|
|New Orleans, Louisiana, United States, 70112|
|New Orleans, Louisiana, United States, 70122|
|New Orleans, Louisiana, United States, 70125|
|Contact: Charles A Gramlich, PhD|
|Principal Investigator:||Patricia Kissinger, BSN MPH PhD||Tulane University Health Sciences Center, School of Public Health and Tropical Medicine|