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CyberSenga: Internet-based HIV Prevention in Uganda

This study has been completed.
Sponsor:
Collaborators:
Mbarara University of Science and Technology
Harvard University
University of Colorado, Denver
Internet Solutions for Kids Uganda, Limited
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Center for Innovative Public Health Research
ClinicalTrials.gov Identifier:
NCT00906178
First received: May 20, 2009
Last updated: June 29, 2016
Last verified: June 2016
  Purpose
The investigators propose to design and test an Internet-based HIV prevention program for adolescents in Uganda.

Condition Intervention Phase
Sexual Abstinence
Condom Use
Behavioral: CyberSenga
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: CyberSenga: Harnessing the Power of the Internet to Prevent HIV in Ugandan Youth

Resource links provided by NLM:


Further study details as provided by Center for Innovative Public Health Research:

Primary Outcome Measures:
  • Sex Without a Condom as Assessed by Self-report [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
    Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months

  • Sexual Abstinence [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
    Not having had vaginal or anal sex in the past three months


Secondary Outcome Measures:
  • Abstinence at Three-month Follow-up [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
    Sexual abstinence (i.e., not having vaginal or anal sex) in the past 90 days

  • Unprotected Sex at Three-month Follow-up [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
    Ever had vaginal or anal sex without a condom in the past 90 days


Enrollment: 366
Study Start Date: August 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyberSenga
6-module HIV prevention program tailored for adolescents in Uganda
Behavioral: CyberSenga
Internet-based HIV prevention program
No Intervention: Control
"treatment as usual" - the sexual health education adolescents currently receive in secondary school

Detailed Description:

HIV/AIDS is a major contributor to morbidity and mortality in Uganda. Despite aggressive advances in HIV prevention efforts, recent data suggest that HIV prevalence is increasing generally, and HIV knowledge, a direct contributor to behavior, is on the decline among young people specifically as compared to a decade ago.

The Internet is a promising mode of intervention delivery in resource poor-settings because the costs associated with scaling up are minimal; dissemination online is the same if one person or 100,000 people use the program. Just as important, it provides access to important health information in a stigma-free, anonymous atmosphere. Our recent data indicate that 45% of adolescents in Mbarara, Uganda have used the Internet, 78% of whom went online at least once in the previous week. Eighty-one percent of respondents in the same survey indicated they would go to an HIV prevention web site if it existed. Based upon these data, we propose to develop a culturally appropriate, Internet-based HIV prevention program designed specifically for Ugandan adolescents between the ages of 12 and 18 years. Our specific aims are as follows:

Specific Aim 1: Design a 6-hour, Internet-based HIV prevention program for adolescents. Content will be culturally tailored to the HIV preventive information, motivation, and behavioral skills needs of Ugandan adolescents.

Specific Aim 2: Test the intervention in a randomized controlled trial (n=500) among adolescents attending grades Secondary 1-4 (similar to US high school grades 8th - 11th) at day schools in Mbarara.

This project has the potential to develop low-cost and salable interventions to HIV transmission risk behaviors among adolescents in Uganda.

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Enrollment in grades Secondary 1 through 4 at a partner secondary school
  • Having used a computer or the Internet at least once in the past year
  • Not having been part of the intervention development activities
  • Caregiver informed permission and adolescent informed assent

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906178

Locations
Uganda
Internet Solutions for Kids Uganda, Limited
Mbarara, Uganda
Sponsors and Collaborators
Center for Innovative Public Health Research
Mbarara University of Science and Technology
Harvard University
University of Colorado, Denver
Internet Solutions for Kids Uganda, Limited
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Michele Ybarra, MPH PhD Center for Innovative Public Health
  More Information

Additional Information:
Publications:

Study Data/Documents: Intervention website  This link exits the ClinicalTrials.gov site
Informed Consent Form  This link exits the ClinicalTrials.gov site
All study documents (consent form, surveys, etc) are available for free download at the study site

Responsible Party: Center for Innovative Public Health Research
ClinicalTrials.gov Identifier: NCT00906178     History of Changes
Other Study ID Numbers: ISK-NIH-MH080662  5R01MH080662 
Study First Received: May 20, 2009
Results First Received: March 29, 2016
Last Updated: June 29, 2016
Health Authority: United States: Institutional Review Board
Uganda: National Council for Science and Technology
Uganda: Research Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Center for Innovative Public Health Research:
HIV prevention
technology
adolescent
developing countries

ClinicalTrials.gov processed this record on December 05, 2016