CyberSenga: Internet-based HIV Prevention in Uganda
Sponsor
Center for Innovative Public Health Research (Other)
Overall Status
Completed
CT.gov ID
NCT00906178
Collaborator
Mbarara University of Science and Technology (Other), Harvard University (Other), University of Colorado, Denver (Other), Internet Solutions for Kids Uganda, Limited (Other), National Institute of Mental Health (NIMH) (NIH)
366
1
2
50
7.3
Study Details
Study Description
Brief Summary
The investigators propose to design and test an Internet-based HIV prevention program for adolescents in Uganda.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
366 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
CyberSenga: Harnessing the Power of the Internet to Prevent HIV in Ugandan Youth
Study Start Date
:
Aug 1, 2007
Actual Primary Completion Date
:
Oct 1, 2011
Actual Study Completion Date
:
Oct 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CyberSenga 6-module HIV prevention program tailored for adolescents in Uganda |
Behavioral: CyberSenga
Internet-based HIV prevention program
|
| No Intervention: Control "treatment as usual" - the sexual health education adolescents currently receive in secondary school |
Outcome Measures
Primary Outcome Measures
- Sex Without a Condom as Assessed by Self-report [6-months post-intervention]
Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months
- Sexual Abstinence [6-months post-intervention]
Not having had vaginal or anal sex in the past three months
Secondary Outcome Measures
- Abstinence at Three-month Follow-up [3 months post-intervention]
Sexual abstinence (i.e., not having vaginal or anal sex) in the past 90 days
- Unprotected Sex at Three-month Follow-up [3 months post-intervention]
Ever had vaginal or anal sex without a condom in the past 90 days
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
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
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Internet Solutions for Kids Uganda, Limited | Mbarara | Uganda |
Sponsors and Collaborators
- Center for Innovative Public Health Research
- Mbarara University of Science and Technology
- Harvard University
- University of Colorado, Denver
- Internet Solutions for Kids Uganda, Limited
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Michele Ybarra, MPH PhD, Center for Innovative Public Health
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Center for Innovative Public Health Research
ClinicalTrials.gov Identifier:
NCT00906178
Other Study ID Numbers:
- ISK-NIH-MH080662
- 5R01MH080662
First Posted:
May 21, 2009
Last Update Posted:
Aug 11, 2016
Last Verified:
Jun 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Center for Innovative Public Health Research
Study Results
Participant Flow
| Recruitment Details | 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 Detail |
| Arm/Group Title | HIV Prevention | Control |
|---|---|---|
| Arm/Group Description | 6-module HIV prevention program tailored for adolescents in Uganda CybereSenga: Internet-based HIV prevention program | "treatment as usual" - the sexual health education adolescents currently receive in secondary school CybereSenga: Internet-based HIV prevention program |
| Period Title: Overall Study | ||
| STARTED | 183 | 183 |
| COMPLETED | 168 | 167 |
| NOT COMPLETED | 15 | 16 |
Baseline Characteristics
| Arm/Group Title | HIV Prevention | Control | Total |
|---|---|---|---|
| Arm/Group Description | 6-module HIV prevention program tailored for adolescents in Uganda CybereSenga: Internet-based HIV prevention program | "treatment as usual" - the sexual health education adolescents currently receive in secondary school CybereSenga: Internet-based HIV prevention program | Total of all reporting groups |
| Overall Participants | 183 | 183 | 366 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
16.0
(1.4)
|
16.2
(1.5)
|
16.1
(1.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
31
16.9%
|
28
15.3%
|
59
16.1%
|
| Male |
152
83.1%
|
155
84.7%
|
307
83.9%
|
| Grade (participants) [Number] | |||
| Secondary 2 |
47
25.7%
|
50
27.3%
|
97
26.5%
|
| Secondary 3 |
73
39.9%
|
58
31.7%
|
131
35.8%
|
| Secondary 4 |
63
34.4%
|
75
41%
|
138
37.7%
|
| Maternal Education (participants) [Number] | |||
| Primary School or Less/Don't Know |
60
32.8%
|
63
34.4%
|
123
33.6%
|
| More Than Primary School |
123
67.2%
|
120
65.6%
|
243
66.4%
|
| Paternal Education (participants) [Number] | |||
| Primary School or Less/Don't Know |
48
26.2%
|
50
27.3%
|
98
26.8%
|
| More Than Primary School |
135
73.8%
|
133
72.7%
|
268
73.2%
|
| Internet Use (participants) [Number] | |||
| Infrequent |
101
55.2%
|
102
55.7%
|
203
55.5%
|
| Frequent |
82
44.8%
|
81
44.3%
|
163
44.5%
|
| Ever Had Oral Sex (participants) [Number] | |||
| Yes |
19
10.4%
|
17
9.3%
|
36
9.8%
|
| No |
164
89.6%
|
166
90.7%
|
330
90.2%
|
| Ever Had Vaginal Sex (participants) [Number] | |||
| Yes |
58
31.7%
|
55
30.1%
|
113
30.9%
|
| No |
125
68.3%
|
128
69.9%
|
253
69.1%
|
| Ever Had Anal Sex (participants) [Number] | |||
| Yes |
4
2.2%
|
5
2.7%
|
9
2.5%
|
| No |
179
97.8%
|
178
97.3%
|
357
97.5%
|
| Ever Been Tested for HIV (participants) [Number] | |||
| Yes |
75
41%
|
64
35%
|
139
38%
|
| No |
108
59%
|
119
65%
|
227
62%
|
| Ever known someone who died from AIDS (participants) [Number] | |||
| Yes |
67
36.6%
|
71
38.8%
|
138
37.7%
|
| No |
116
63.4%
|
112
61.2%
|
228
62.3%
|
| Tired of hearing about HIV prevention information (participants) [Number] | |||
| Somewhat/strongly agree |
45
24.6%
|
49
26.8%
|
94
25.7%
|
| Do not Somewhat/strongly agree |
138
75.4%
|
134
73.2%
|
272
74.3%
|
| Above average change of getting HIV (participants) [Number] | |||
| Yes |
12
6.6%
|
12
6.6%
|
24
6.6%
|
| No |
171
93.4%
|
171
93.4%
|
342
93.4%
|
| Beliefs supportive of HIV Stigma (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
1.1
(.9)
|
1.2
(1.1)
|
1.1
(1.0)
|
| Ever had a boyfriend/girlfriend (participants) [Number] | |||
| Yes |
141
77%
|
137
74.9%
|
278
76%
|
| No |
42
23%
|
46
25.1%
|
88
24%
|
| Ever been a victim of teen dating violence (participants) [Number] | |||
| Yes |
35
19.1%
|
43
23.5%
|
78
21.3%
|
| No |
148
80.9%
|
140
76.5%
|
288
78.7%
|
| Ever been a perpetrator of teen dating violence (participants) [Number] | |||
| Yes |
28
15.3%
|
37
20.2%
|
65
17.8%
|
| No |
155
84.7%
|
146
79.8%
|
301
82.2%
|
| Beliefs consistent with female empowerment in relationships (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
8.2
(2.8)
|
8.0
(2.8)
|
8.1
(2.8)
|
| Fair or poor health (participants) [Number] | |||
| Yes |
35
19.1%
|
24
13.1%
|
59
16.1%
|
| No |
148
80.9%
|
159
86.9%
|
307
83.9%
|
| Bright future somewhat/very unlikely (participants) [Number] | |||
| Yes |
20
10.9%
|
15
8.2%
|
35
9.6%
|
| No |
163
89.1%
|
168
91.8%
|
331
90.4%
|
| Wish to have more self-respect (participants) [Number] | |||
| Yes |
149
81.4%
|
144
78.7%
|
293
80.1%
|
| No |
34
18.6%
|
39
21.3%
|
73
19.9%
|
| The Multidimensional Scale of Perceived Social Support : Social support from "special person" (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
16.7
(2.8)
|
16.2
(4.1)
|
16.5
(4.0)
|
| The Multidimensional Scale of Perceived Social Support: Social support from family (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
17.1
(3.1)
|
17.7
(3.0)
|
17.4
(3.1)
|
| Information (participants) [Number] | |||
| Yes |
86
47%
|
97
53%
|
183
50%
|
| No |
97
53%
|
86
47%
|
183
50%
|
| Motivation: Attitudes towards HIV preventive acts (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3.6
(.9)
|
3.5
(.9)
|
3.6
(.9)
|
| Motivation: Subjective norms regarding HIV preventive acts (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3.6
(.9)
|
3.5
(.9)
|
3.6
(.9)
|
| Motivation: Behavioral intentions for HIV prevention (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3.5
(.9)
|
3.5
(.9)
|
3.5
(.9)
|
| Behavioral Skills (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
2.9
(.7)
|
2.9
(.7)
|
2.9
(.7)
|
Outcome Measures
| Title | Sex Without a Condom as Assessed by Self-report |
|---|---|
| Description | Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months |
| Time Frame | 6-months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT - Intention to Treat |
| Arm/Group Title | HIV Prevention | Control |
|---|---|---|
| Arm/Group Description | 6-module HIV prevention program tailored for adolescents in Uganda CybereSenga: Internet-based HIV prevention program | "treatment as usual" - the sexual health education adolescents currently receive in secondary school CybereSenga: Internet-based HIV prevention program |
| Measure Participants | 183 | 183 |
| Number [participants] |
26
14.2%
|
24
13.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HIV Prevention, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.05 | |
| Confidence Interval |
(2-Sided) 95% .57 to 1.94 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Sexual Abstinence |
|---|---|
| Description | Not having had vaginal or anal sex in the past three months |
| Time Frame | 6-months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT - Intention to Treat |
| Arm/Group Title | HIV Prevention | Control |
|---|---|---|
| Arm/Group Description | 6-module HIV prevention program tailored for adolescents in Uganda CybereSenga: Internet-based HIV prevention program | "treatment as usual" - the sexual health education adolescents currently receive in secondary school CybereSenga: Internet-based HIV prevention program |
| Measure Participants | 183 | 183 |
| Number [participants] |
138
75.4%
|
137
74.9%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HIV Prevention, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.01 | |
| Confidence Interval |
(2-Sided) 95% .62 to 1.65 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Abstinence at Three-month Follow-up |
|---|---|
| Description | Sexual abstinence (i.e., not having vaginal or anal sex) in the past 90 days |
| Time Frame | 3 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT--Intention to Treat |
| Arm/Group Title | HIV Prevention | Control |
|---|---|---|
| Arm/Group Description | 6-module HIV prevention program tailored for adolescents in Uganda CybereSenga: Internet-based HIV prevention program | "treatment as usual" - the sexual health education adolescents currently receive in secondary school CybereSenga: Internet-based HIV prevention program |
| Measure Participants | 183 | 183 |
| Number [participants] |
135
73.8%
|
149
81.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HIV Prevention, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.56 | |
| Confidence Interval |
(2-Sided) 95% .93 to 2.62 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Unprotected Sex at Three-month Follow-up |
|---|---|
| Description | Ever had vaginal or anal sex without a condom in the past 90 days |
| Time Frame | 3 months post-intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT--Intention to Treat |
| Arm/Group Title | HIV Prevention | Control |
|---|---|---|
| Arm/Group Description | 6-module HIV prevention program tailored for adolescents in Uganda CybereSenga: Internet-based HIV prevention program | "treatment as usual" - the sexual health education adolescents currently receive in secondary school CybereSenga: Internet-based HIV prevention program |
| Measure Participants | 183 | 183 |
| Number [participants] |
21
11.5%
|
28
15.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HIV Prevention, Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | .70 | |
| Confidence Interval |
(2-Sided) 95% .37 to 1.30 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Adverse event data were collected through the study period (i.e., from baseline to 6 month follow-up). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | HIV Prevention | Control | ||
| Arm/Group Description | 6-module HIV prevention program tailored for adolescents in Uganda CybereSenga: Internet-based HIV prevention program | "treatment as usual" - the sexual health education adolescents currently receive in secondary school CybereSenga: Internet-based HIV prevention program | ||
All Cause Mortality |
||||
| HIV Prevention | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| HIV Prevention | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/183 (0%) | 0/183 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| HIV Prevention | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/183 (0%) | 0/183 (0%) | ||
Limitations/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.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Michele Ybarra |
|---|---|
| Organization | Center for Innovative Public Health Reserch |
| Phone | 877-302-6858 ext 1-801# |
| michele@innovativepublichealth.org |
Responsible Party:
Center for Innovative Public Health Research
ClinicalTrials.gov Identifier:
NCT00906178
Other Study ID Numbers:
- ISK-NIH-MH080662
- 5R01MH080662
First Posted:
May 21, 2009
Last Update Posted:
Aug 11, 2016
Last Verified:
Jun 1, 2016