AzTrials
AzTrials

Sexual AbstinencePhase 1NCT00906178

CyberSenga: Internet-based HIV Prevention in Uganda

A Phase 1 study testing CyberSenga in people with Sexual Abstinence and Condom Use, run by Center for Innovative Public Health Research at 1 site in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The investigators propose to design and test an Internet-based HIV prevention program for adolescents in Uganda. Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Sexual Abstinence, Condom Use
What is being tested?
CyberSenga
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
1 siteUganda
Study dates
Aug 2007to Oct 2011
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • Internet Solutions for Kids Uganda, Limited

    Mbarara

Other trials in Uganda

About this study

Official title: 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.

Read the 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.

Being tested
CyberSenga
Keywords
HIV prevention, technology, adolescent, developing countries
Medical subject headings
Sexual Abstinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyberSengaBehavioural

    Internet-based HIV prevention program

Study groups in NCT00906178
Study groupRoleWhat they receive
CyberSengaExperimental6-module HIV prevention program tailored for adolescents in Uganda
Receives: Behavioral: CyberSenga
ControlNo intervention"treatment as usual" - the sexual health education adolescents currently receive in secondary school

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6-months post-intervention

  2. Sexual Abstinence

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

    Measured: 6-months post-intervention

Secondary outcomes (2)

  1. Abstinence at Three-month Follow-up

    Sexual abstinence (i.e., not having vaginal or anal sex) in the past 90 days

    Measured: 3 months post-intervention

  2. Unprotected Sex at Three-month Follow-up

    Ever had vaginal or anal sex without a condom in the past 90 days

    Measured: 3 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2009 (estimated)
  2. Study startAug 2007
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00906178
Sponsor's protocol ID
ISK-NIH-MH080662
Other IDs
5R01MH080662
Status last verified
Jun 2016
First submitted
20 May 2009
Last updated
11 Aug 2016
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21536715

  • 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.

    PubMed 21413574

  • 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.

    PubMed 22918136

  • 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.

    PubMed 24625122

  • 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.

    PubMed 22350827

  • 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.

    PubMed 22835224

  • 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.

    PubMed 22299764

  • 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.

    PubMed 25865380

  • 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.

    PubMed 17639121

  • 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.

    PubMed 25633626

  • 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.

    PubMed 24093828

  • 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.

    PubMed 23967069

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CyberSenga in people with Sexual Abstinence and Condom Use, run by Center for Innovative Public Health Research at 1 site in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sex Without a Condom as Assessed by Self-report (time frame: 6-months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00906178, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in