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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00906178
Other study ID # ISK-NIH-MH080662
Secondary ID 5R01MH080662
Status Completed
Phase Phase 1
First received May 20, 2009
Last updated January 18, 2012
Start date August 2007
Est. completion date October 2011

Study information

Verified date January 2012
Source Center for Innovative Public Health Research
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUganda: National Council for Science and TechnologyUganda: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

We propose to design and test an Internet-based HIV prevention program for adolescents in Uganda.


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 scalable interventions to HIV transmission risk behaviors among adolescents in Uganda.


Recruitment information / eligibility

Status Completed
Enrollment 374
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Attendance at a partner secondary school

- Enrollment in grades Secondary 1 through 4

- Caregiver informed permission and adolescent informed assent

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
CybereSenga
Internet-based HIV prevention program

Locations

Country Name City State
Uganda Internet Solutions for Kids Uganda, Lmtd Mbarara

Sponsors (5)

Lead Sponsor Collaborator
Center for Innovative Public Health Research Harvard University, Internet Solutions for Kids Uganda, Limited, Mbarara University of Science and Technology, University of Colorado, Denver

Country where clinical trial is conducted

Uganda, 

References & Publications (2)

Bull S, Nabembezi D, Birungi R, Kiwanuka J, Ybarra M. Cyber-Senga: Ugandan youth preferences for content in an internet-delivered comprehensive sexuality education programme. East Afr J Public Health. 2010 Mar;7(1):58-63. — View Citation

Mitchell KJ, Bull S, Kiwanuka J, Ybarra ML. Cell phone usage among adolescents in Uganda: acceptability for relaying health information. Health Educ Res. 2011 Oct;26(5):770-81. doi: 10.1093/her/cyr022. Epub 2011 May 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Our main outcome measure is the frequency of unprotected sex 6-months post-intervention No
Secondary The secondary outcome will be sexual abstinence 6-months post-intervention No
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