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

Primary Purpose

Pregnancy, Sexually Transmitted Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BUtiful.
DIVAS.
Sponsored by
Tulane University Health Sciences Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring pregnancy, STI, STD

Eligibility Criteria

18 Years - 19 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Community Intercept
  • Tulane Drop In Clinic at Covenant House
  • Delgado Community College
  • Dillard University
  • Xavier University
  • Southern University of New Orleans

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

BUtiful

DIVAS

Arm Description

Intervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention

Attention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition

Outcomes

Primary Outcome Measures

Percent change from baseline in the use of reliable contraceptives
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.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2012
Last Updated
December 16, 2016
Sponsor
Tulane University Health Sciences Center
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT01579617
Brief Title
e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls
Acronym
eSiHLE
Official Title
e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tulane University Health Sciences Center
Collaborators
Department of Health and Human Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Sexually Transmitted Infections
Keywords
pregnancy, STI, STD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
637 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BUtiful
Arm Type
Experimental
Arm Description
Intervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention
Arm Title
DIVAS
Arm Type
Other
Arm Description
Attention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition
Intervention Type
Behavioral
Intervention Name(s)
BUtiful.
Other Intervention Name(s)
BUtiful
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DIVAS.
Other Intervention Name(s)
DIVAS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent change from baseline in the use of reliable contraceptives
Description
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.
Time Frame
Change from baseline measured at 3 and 7 and 13 months post baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Kissinger, BSN MPH PhD
Organizational Affiliation
Tulane University Health Sciences Center, School of Public Health and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Intercept
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Tulane Drop In Clinic at Covenant House
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70116
Country
United States
Facility Name
Delgado Community College
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Dillard University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70122
Country
United States
Facility Name
Xavier University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125
Country
United States
Facility Name
Southern University of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70126
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls

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