Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

May 20, 2009
June 29, 2016
August 2007
October 2011   (final data collection date for primary outcome measure)
  • 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
Our main outcome measure is the frequency of unprotected sex [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00906178 on ClinicalTrials.gov Archive Site
  • 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
The secondary outcome will be sexual abstinence [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
CyberSenga: Internet-based HIV Prevention in Uganda
CyberSenga: Harnessing the Power of the Internet to Prevent HIV in Ugandan Youth
The investigators propose to design and test an Internet-based HIV prevention program for adolescents in Uganda.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Sexual Abstinence
  • Condom Use
Behavioral: CyberSenga
Internet-based HIV prevention program
  • Experimental: CyberSenga
    6-module HIV prevention program tailored for adolescents in Uganda
    Intervention: Behavioral: CyberSenga
  • No Intervention: Control
    "treatment as usual" - the sexual health education adolescents currently receive in secondary school

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
366
October 2011
October 2011   (final data collection date for primary outcome measure)

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:

Both
12 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Uganda
 
NCT00906178
ISK-NIH-MH080662, 5R01MH080662
No
No
Not Provided
Center for Innovative Public Health Research
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)
Principal Investigator: Michele Ybarra, MPH PhD Center for Innovative Public Health
Center for Innovative Public Health Research
June 2016

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