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

History of Changes

Results First Received: March 29, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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

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

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

366

Age
[Units: Years]
Mean (Standard Deviation)

16.0 (1.4)

16.2 (1.5)

16.1 (1.4)

Gender
[Units: Participants]

Female

Male

152

155

307

Grade
[Units: Participants]

Secondary 2

Secondary 3

131

Secondary 4

138

Maternal Education
[Units: Participants]

Primary School or Less/Don't Know

123

More Than Primary School

123

120

243

Paternal Education
[Units: Participants]

Primary School or Less/Don't Know

More Than Primary School

135

133

268

Internet Use
[Units: Participants]

Infrequent

101

102

203

Frequent

163

Ever Had Oral Sex
[Units: Participants]

Yes

164

166

330

Ever Had Vaginal Sex
[Units: Participants]

Yes

113

125

128

253

Ever Had Anal Sex
[Units: Participants]

Yes

179

178

357

Ever Been Tested for HIV
[Units: Participants]

Yes

139

108

119

227

Ever known someone who died from AIDS
[Units: Participants]

Yes

138

116

112

228

Tired of hearing about HIV prevention information
[Units: Participants]

Somewhat/strongly agree

Do not Somewhat/strongly agree

138

134

272

Above average change of getting HIV ^[1]
[Units: Participants]

Yes

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

Ever been a victim of teen dating violence
[Units: Participants]

Yes

148

140

288

Ever been a perpetrator of teen dating violence
[Units: Participants]

Yes

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

148

159

307

Bright future somewhat/very unlikely ^[1]
[Units: Participants]

Yes

163

168

331

^[1]	subject chose between somewhat likely and very likely

Wish to have more self-respect
[Units: Participants]

Yes

149

144

293

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

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)

^[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)

^[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 ]

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2. Primary:

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

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3. Secondary:

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

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4. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

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.

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.

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.

Other 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.

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.

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.

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.

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.

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.

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.

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.

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. Epub 2007 Jul 16.

Responsible Party:	Center for Innovative Public Health Research
ClinicalTrials.gov Identifier:	NCT00906178 History of Changes
Other Study ID Numbers:	ISK-NIH-MH080662 5R01MH080662 ( U.S. NIH Grant/Contract )
Study First Received:	May 20, 2009
Results First Received:	March 29, 2016
Last Updated:	June 29, 2016

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