ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01579617
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : December 19, 2016
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Patricia Kissinger, Tulane University Health Sciences Center

March 6, 2012
April 18, 2012
December 19, 2016
August 2012
December 2015   (Final data collection date for primary outcome measure)
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 ]
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.
Number of participants who become pregnant after a baseline status of not pregnant [ Time Frame: Change from baseline in pregnancy status measured at 6 and 12 months ]
Women who receive the BUtiful intervention will have a 35% reduction in pregnancy compared to the DIVAS intervention
Complete list of historical versions of study NCT01579617 on ClinicalTrials.gov Archive Site
Not Provided
  • Percent change from baseline in knowledge regarding pregnancy prevention [ Time Frame: Change from baseline measured at 6 and 12 months post baseline ]
    Women who receive the BUtiful intervention will have a 35% increase in knowledge regarding pregnancy prevention compared to the DIVAS intervention.
  • Percent change from baseline of attitudes regarding pregnancy prevention [ Time Frame: Change from baseline measured at 6 and 12 months post baseline ]
    Women who receive the BUtiful intervention will have a 35% increase in attitudes regarding pregnancy prevention compared to the DIVAS intervention.
  • Number of participants who have a new diagnosis from baseline with either Neisseria gonorrhoeae and/or Chlamydia trachomatis. [ Time Frame: Measured at 6 and 12 months post baseline ]
    Women who receive the BUtiful intervention will be less likely to be infected with the STIs Neisseria gonorrhoeae and/or Chlamydia trachomatis compared to the DIVAS intervention.
Not Provided
Not Provided
 
e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls
e-SiHLE: An Internet Pregnancy Prevention for Older Teenage Girls
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Pregnancy
  • Sexually Transmitted Infections
  • Behavioral: BUtiful.
    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
  • 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.
    Other Name: DIVAS
  • Experimental: BUtiful
    Intervention arm, 'BUtiful. Be yoU! Talented, Informed, Fearless, Uncompromised, Loved', has 8 website sessions focused on pregnancy and STI prevention
    Intervention: Behavioral: BUtiful.
  • DIVAS
    Attention control arm, 'DIVAS. Diversity, Individuality, Vitality, Activity and Strong', has 8 website sessions focused on general health and nutrition
    Intervention: Behavioral: DIVAS.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
637
700
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 19 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01579617
261904-1
TP2AH000013 ( Other Grant/Funding Number: Department of Health and Human Services )
No
Not Provided
Plan to Share IPD: No
Patricia Kissinger, Tulane University Health Sciences Center
Tulane University Health Sciences Center
Department of Health and Human Services
Principal Investigator: Patricia Kissinger, BSN MPH PhD Tulane University Health Sciences Center, School of Public Health and Tropical Medicine
Tulane University
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP