e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls

Not Applicable

Completed

• Conditions: Pregnancy; Sexually Transmitted Infections
• Interventions: Behavioral: BUtiful.; Behavioral: DIVAS.

• Registration Number: NCT01579617
• Lead Sponsor: Tulane University Health Sciences Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Study Start: 2012-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-16
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 637

Inclusion Criteria

• Age 18 or 19 at enrollment
• Female
• Not currently pregnant or intending to become pregnant in the next 12 months
• Live in Orleans or Jefferson Parish in Louisiana
• English is your primary language
• Access to a computer and internet connection
• Does not have sex with women exclusively

Exclusion Criteria

• Age younger than 18 or older than 19
• Male
• Currently pregnant or intend to become pregnant in the next 12 months
• Live outside of Orleans or Jefferson Parish
• Hearing impairments that prevent listening to videos

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BUtiful	BUtiful.	Intervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention
DIVAS	DIVAS.	Attention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition

Primary Outcome Measures

Name	Time	Method
Percent change from baseline in the use of reliable contraceptives	Change from baseline measured at 3 and 7 and 13 months post baseline	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.

Trial Locations

Locations (6)

Community Intercept; 🇺🇸 New Orleans, Louisiana, United States

Delgado Community College; 🇺🇸 New Orleans, Louisiana, United States

Tulane Drop In Clinic at Covenant House; 🇺🇸 New Orleans, Louisiana, United States

Dillard University; 🇺🇸 New Orleans, Louisiana, United States

Southern University of New Orleans; 🇺🇸 New Orleans, Louisiana, United States

Xavier University; 🇺🇸 New Orleans, Louisiana, United States