NCT00906178

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
366

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

August 11, 2016

Completed
Last Updated

August 11, 2016

Status Verified

June 1, 2016

Enrollment Period

4.2 years

First QC Date

May 20, 2009

Results QC Date

March 29, 2016

Last Update Submit

June 29, 2016

Conditions

Sexual AbstinenceCondom Use

Keywords

HIV preventiontechnologyadolescentdeveloping countries

Outcome Measures

Primary Outcomes (2)

  • Sex Without a Condom as Assessed by Self-report

    Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months

    6-months post-intervention

  • Sexual Abstinence

    Not having had vaginal or anal sex in the past three months

    6-months post-intervention

Secondary Outcomes (2)

  • Abstinence at Three-month Follow-up

    3 months post-intervention

  • Unprotected Sex at Three-month Follow-up

    3 months post-intervention

Study Arms (2)

CyberSenga

EXPERIMENTAL

6-module HIV prevention program tailored for adolescents in Uganda

Behavioral: CyberSenga

Control

NO INTERVENTION

"treatment as usual" - the sexual health education adolescents currently receive in secondary school

Interventions

CyberSengaBEHAVIORAL

Internet-based HIV prevention program

CyberSenga

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Internet Solutions for Kids Uganda, Limited

Mbarara, Uganda

Location

Related Publications (12)

  • 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.

    PMID: 21536715BACKGROUND

  • 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.

    PMID: 21413574BACKGROUND

  • Ybarra ML, Biringi R, Prescott T, Bull SS. Usability and navigability of an HIV/AIDS internet intervention for adolescents in a resource-limited setting. Comput Inform Nurs. 2012 Nov;30(11):587-95; quiz 596-7. doi: 10.1097/NXN.0b013e318266cb0e.

    PMID: 22918136BACKGROUND

  • Hampanda K, Ybarra M, Bull S. Perceptions of health care services and HIV-related health-seeking behavior among Uganda adolescents. AIDS Care. 2014;26(10):1209-17. doi: 10.1080/09540121.2014.894612. Epub 2014 Mar 13.

    PMID: 24625122BACKGROUND

  • Ybarra ML, Korchmaros J, Kiwanuka J, Bangsberg DR, Bull S. Examining the applicability of the IMB model in predicting condom use among sexually active secondary school students in Mbarara, Uganda. AIDS Behav. 2013 Mar;17(3):1116-28. doi: 10.1007/s10461-012-0137-x.

    PMID: 22350827BACKGROUND

  • Katz IT, Ybarra ML, Wyatt MA, Kiwanuka JP, Bangsberg DR, Ware NC. Socio-cultural and economic antecedents of adolescent sexual decision-making and HIV-risk in rural Uganda. AIDS Care. 2013;25(2):258-64. doi: 10.1080/09540121.2012.701718. Epub 2012 Jul 27.

    PMID: 22835224BACKGROUND

  • Ybarra ML, Bull SS, Kiwanuka J, Bangsberg DR, Korchmaros J. Prevalence rates of sexual coercion victimization and perpetration among Uganda adolescents. AIDS Care. 2012;24(11):1392-400. doi: 10.1080/09540121.2011.648604. Epub 2012 Feb 2.

    PMID: 22299764BACKGROUND

  • Birungi R, Nabembezi D, Kiwanuka J, Ybarra M, Bull S. Adolescents' perceptions of sexual coercion in Uganda. Afr J AIDS Res. 2011 Dec;10(4):487-94. doi: 10.2989/16085906.2011.646664.

    PMID: 25865380BACKGROUND

  • Ybarra ML, Emenyonu N, Nansera D, Kiwanuka J, Bangsberg DR. Health information seeking among Mbararan adolescents: results from the Uganda Media and You survey. Health Educ Res. 2008 Apr;23(2):249-58. doi: 10.1093/her/cym026. Epub 2007 Jul 16.

    PMID: 17639121BACKGROUND

  • Ybarra ML, Korchmaros JD, Prescott TL, Birungi R. A Randomized Controlled Trial to Increase HIV Preventive Information, Motivation, and Behavioral Skills in Ugandan Adolescents. Ann Behav Med. 2015 Jun;49(3):473-85. doi: 10.1007/s12160-014-9673-0.

    PMID: 25633626RESULT

  • Ybarra ML, Bull SS, Prescott TL, Birungi R. Acceptability and feasibility of CyberSenga: an Internet-based HIV-prevention program for adolescents in Mbarara, Uganda. AIDS Care. 2014 Apr;26(4):441-7. doi: 10.1080/09540121.2013.841837. Epub 2013 Oct 4.

    PMID: 24093828RESULT

  • Ybarra ML, Bull SS, Prescott TL, Korchmaros JD, Bangsberg DR, Kiwanuka JP. Adolescent abstinence and unprotected sex in CyberSenga, an Internet-based HIV prevention program: randomized clinical trial of efficacy. PLoS One. 2013 Aug 14;8(8):e70083. doi: 10.1371/journal.pone.0070083. eCollection 2013.

    PMID: 23967069RESULT

MeSH Terms

Conditions

Sexual Abstinence

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Limitations and Caveats

Sexual activity in adolescence is a stigmatized behavior in Uganda, especially for females. Youth may have under-reported their sexual experiences, which in the intervention group would have led to them being triaged to the incorrect content.

Results Point of Contact

Title
Dr. Michele Ybarra
Organization
Center for Innovative Public Health Reserch
michele@innovativepublichealth.org
877-302-6858

Study Officials

  • Michele Ybarra, MPH PhD

    Center for Innovative Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 21, 2009

Study Start

August 1, 2007

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

August 11, 2016

Results First Posted

August 11, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Intervention website Access

Locations

UG(1)