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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
Results First Received: March 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Sexual Abstinence
Condom Use
Intervention: Behavioral: CyberSenga

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We aimed to screen all 382 female students enrolled in the two mixed-sex schools and 772 of the 2,264 male students enrolled across the four schools to identify 400 eligible youth. Many youth were out of school trying to secure school fees or had changed schools. As a result, 740 of the youth were screened, 416 of whom were eligible (56%).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HIV Prevention

6-module HIV prevention program tailored for adolescents in Uganda

CybereSenga: Internet-based HIV prevention program

Control

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

CybereSenga: Internet-based HIV prevention program


Participant Flow:   Overall Study
    HIV Prevention   Control
STARTED   183   183 
COMPLETED   168   167 
NOT COMPLETED   15   16 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HIV Prevention

6-module HIV prevention program tailored for adolescents in Uganda

CybereSenga: Internet-based HIV prevention program

Control

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

CybereSenga: Internet-based HIV prevention program

Total Total of all reporting groups

Baseline Measures
   HIV Prevention   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 183   183   366 
Age 
[Units: Years]
Mean (Standard Deviation)
 16.0  (1.4)   16.2  (1.5)   16.1  (1.4) 
Gender 
[Units: Participants]
     
Female   31   28   59 
Male   152   155   307 
Grade 
[Units: Participants]
     
Secondary 2   47   50   97 
Secondary 3   73   58   131 
Secondary 4   63   75   138 
Maternal Education 
[Units: Participants]
     
Primary School or Less/Don't Know   60   63   123 
More Than Primary School   123   120   243 
Paternal Education 
[Units: Participants]
     
Primary School or Less/Don't Know   48   50   98 
More Than Primary School   135   133   268 
Internet Use 
[Units: Participants]
     
Infrequent   101   102   203 
Frequent   82   81   163 
Ever Had Oral Sex 
[Units: Participants]
     
Yes   19   17   36 
No   164   166   330 
Ever Had Vaginal Sex 
[Units: Participants]
     
Yes   58   55   113 
No   125   128   253 
Ever Had Anal Sex 
[Units: Participants]
     
Yes   4   5   9 
No   179   178   357 
Ever Been Tested for HIV 
[Units: Participants]
     
Yes   75   64   139 
No   108   119   227 
Ever known someone who died from AIDS 
[Units: Participants]
     
Yes   67   71   138 
No   116   112   228 
Tired of hearing about HIV prevention information 
[Units: Participants]
     
Somewhat/strongly agree   45   49   94 
Do not Somewhat/strongly agree   138   134   272 
Above average change of getting HIV [1] 
[Units: Participants]
     
Yes   12   12   24 
No   171   171   342 
[1] Self-appraisal of one's likelihood of getting HIV
Beliefs supportive of HIV Stigma [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.1  (.9)   1.2  (1.1)   1.1  (1.0) 
[1] This measure has a range from 0 to 4 with higher scores reflecting greater HIV stigma
Ever had a boyfriend/girlfriend 
[Units: Participants]
     
Yes   141   137   278 
No   42   46   88 
Ever been a victim of teen dating violence 
[Units: Participants]
     
Yes   35   43   78 
No   148   140   288 
Ever been a perpetrator of teen dating violence 
[Units: Participants]
     
Yes   28   37   65 
No   155   146   301 
Beliefs consistent with female empowerment in relationships [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 8.2  (2.8)   8.0  (2.8)   8.1  (2.8) 
[1] This measure has scores that can range from 2 to 10 with higher scores being higher in these beliefs
Fair or poor health 
[Units: Participants]
     
Yes   35   24   59 
No   148   159   307 
Bright future somewhat/very unlikely [1] 
[Units: Participants]
     
Yes   20   15   35 
No   163   168   331 
[1] subject chose between somewhat likely and very likely
Wish to have more self-respect 
[Units: Participants]
     
Yes   149   144   293 
No   34   39   73 
The Multidimensional Scale of Perceived Social Support : Social support from "special person" [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 16.7  (2.8)   16.2  (4.1)   16.5  (4.0) 
[1] This measure has scores possibly ranging form 1 to 20 with higher scores reflecting more support
The Multidimensional Scale of Perceived Social Support: Social support from family [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 17.1  (3.1)   17.7  (3.0)   17.4  (3.1) 
[1] This measure has scores possibly ranging form 1 to 20 with higher scores reflecting more support
Information [1] 
[Units: Participants]
     
Yes   86   97   183 
No   97   86   183 
[1] 80% or more answers about HIV correct
Motivation: Attitudes towards HIV preventive acts [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.6  (.9)   3.5  (.9)   3.6  (.9) 
[1] This measure has scores possibly ranging form 1 to 5 with higher scores reflecting more motivation
Motivation: Subjective norms regarding HIV preventive acts [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.6  (.9)   3.5  (.9)   3.6  (.9) 
[1] This measure has scores possibly ranging form 1 to 5 with higher scores reflecting more motivation
Motivation: Behavioral intentions for HIV prevention [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.5  (.9)   3.5  (.9)   3.5  (.9) 
[1] This measure has scores possibly ranging form 1 to 5 with higher scores reflecting more motivation
Behavioral Skills [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.9  (.7)   2.9  (.7)   2.9  (.7) 
[1] This measure has scores possibly ranging form 1 to 5 with higher scores reflecting more skills


  Outcome Measures
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1.  Primary:   Sex Without a Condom as Assessed by Self-report   [ Time Frame: 6-months post-intervention ]

2.  Primary:   Sexual Abstinence   [ Time Frame: 6-months post-intervention ]

3.  Secondary:   Abstinence at Three-month Follow-up   [ Time Frame: 3 months post-intervention ]

4.  Secondary:   Unprotected Sex at Three-month Follow-up   [ Time Frame: 3 months post-intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michele Ybarra
Organization: Center for Innovative Public Health Reserch
phone: 877-302-6858 ext 1-801#
e-mail: michele@innovativepublichealth.org


Publications of Results:
Other Publications:


Responsible Party: Center for Innovative Public Health Research
ClinicalTrials.gov Identifier: NCT00906178     History of Changes
Other Study ID Numbers: ISK-NIH-MH080662
5R01MH080662 ( US NIH Grant/Contract Award Number )
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