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  
Number of Participants  
[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  
Beliefs supportive of HIV Stigma [2]
[units: units on a scale]
Mean (Standard Deviation)
  1.1  (.9)     1.2  (1.1)     1.1  (1.0)  
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 [3]
[units: units on a scale]
Mean (Standard Deviation)
  8.2  (2.8)     8.0  (2.8)     8.1  (2.8)  
Fair or poor health  
[units: participants]
     
Yes     35     24     59  
No     148     159     307  
Bright future somewhat/very unlikely [4]
[units: participants]
     
Yes     20     15     35  
No     163     168     331  
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" [5]
[units: units on a scale]
Mean (Standard Deviation)
  16.7  (2.8)     16.2  (4.1)     16.5  (4.0)  
The Multidimensional Scale of Perceived Social Support: Social support from family [5]
[units: units on a scale]
Mean (Standard Deviation)
  17.1  (3.1)     17.7  (3.0)     17.4  (3.1)  
Information [6]
[units: participants]
     
Yes     86     97     183  
No     97     86     183  
Motivation: Attitudes towards HIV preventive acts [7]
[units: units on a scale]
Mean (Standard Deviation)
  3.6  (.9)     3.5  (.9)     3.6  (.9)  
Motivation: Subjective norms regarding HIV preventive acts [7]
[units: units on a scale]
Mean (Standard Deviation)
  3.6  (.9)     3.5  (.9)     3.6  (.9)  
Motivation: Behavioral intentions for HIV prevention [7]
[units: units on a scale]
Mean (Standard Deviation)
  3.5  (.9)     3.5  (.9)     3.5  (.9)  
Behavioral Skills [8]
[units: units on a scale]
Mean (Standard Deviation)
  2.9  (.7)     2.9  (.7)     2.9  (.7)  
[1] Self-appraisal of one's likelihood of getting HIV
[2] This measure has a range from 0 to 4 with higher scores reflecting greater HIV stigma
[3] This measure has scores that can range from 2 to 10 with higher scores being higher in these beliefs
[4] subject chose between somewhat likely and very likely
[5] This measure has scores possibly ranging form 1 to 20 with higher scores reflecting more support
[6] 80% or more answers about HIV correct
[7] This measure has scores possibly ranging form 1 to 5 with higher scores reflecting more motivation
[8] 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