Home
Clinical Trials
NCT01579617

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

Last Updated: 2016-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

637 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Sexually Transmitted Infections

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pregnancy STI STD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BUtiful

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

Group Type EXPERIMENTAL

BUtiful.

Intervention Type BEHAVIORAL

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.

DIVAS

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

Group Type OTHER

DIVAS.

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BUtiful.

Intervention Type BEHAVIORAL

DIVAS.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BUtiful DIVAS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Patricia Kissinger

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Patricia Kissinger, BSN MPH PhD

Role: PRINCIPAL_INVESTIGATOR

Tulane University Health Sciences Center, School of Public Health and Tropical Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.