Trial Outcomes & Findings for CyberSenga: Internet-based HIV Prevention in Uganda (NCT NCT00906178)
NCT ID: NCT00906178
Last Updated: 2016-08-11
Results Overview
Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
366 participants
Primary outcome timeframe
6-months post-intervention
Results posted on
2016-08-11
Participant Flow
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%).
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
183
|
183
|
|
Overall Study
COMPLETED
|
168
|
167
|
|
Overall Study
NOT COMPLETED
|
15
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CyberSenga: Internet-based HIV Prevention in Uganda
Baseline characteristics by cohort
| Measure |
HIV Prevention
n=183 Participants
6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program
|
Control
n=183 Participants
"treatment as usual" - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program
|
Total
n=366 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.0 years
STANDARD_DEVIATION 1.4 • n=99 Participants
|
16.2 years
STANDARD_DEVIATION 1.5 • n=107 Participants
|
16.1 years
STANDARD_DEVIATION 1.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
152 Participants
n=99 Participants
|
155 Participants
n=107 Participants
|
307 Participants
n=206 Participants
|
|
Grade
Secondary 2
|
47 participants
n=99 Participants
|
50 participants
n=107 Participants
|
97 participants
n=206 Participants
|
|
Grade
Secondary 3
|
73 participants
n=99 Participants
|
58 participants
n=107 Participants
|
131 participants
n=206 Participants
|
|
Grade
Secondary 4
|
63 participants
n=99 Participants
|
75 participants
n=107 Participants
|
138 participants
n=206 Participants
|
|
Maternal Education
Primary School or Less/Don't Know
|
60 participants
n=99 Participants
|
63 participants
n=107 Participants
|
123 participants
n=206 Participants
|
|
Maternal Education
More Than Primary School
|
123 participants
n=99 Participants
|
120 participants
n=107 Participants
|
243 participants
n=206 Participants
|
|
Paternal Education
Primary School or Less/Don't Know
|
48 participants
n=99 Participants
|
50 participants
n=107 Participants
|
98 participants
n=206 Participants
|
|
Paternal Education
More Than Primary School
|
135 participants
n=99 Participants
|
133 participants
n=107 Participants
|
268 participants
n=206 Participants
|
|
Internet Use
Infrequent
|
101 participants
n=99 Participants
|
102 participants
n=107 Participants
|
203 participants
n=206 Participants
|
|
Internet Use
Frequent
|
82 participants
n=99 Participants
|
81 participants
n=107 Participants
|
163 participants
n=206 Participants
|
|
Ever Had Oral Sex
Yes
|
19 participants
n=99 Participants
|
17 participants
n=107 Participants
|
36 participants
n=206 Participants
|
|
Ever Had Oral Sex
No
|
164 participants
n=99 Participants
|
166 participants
n=107 Participants
|
330 participants
n=206 Participants
|
|
Ever Had Vaginal Sex
Yes
|
58 participants
n=99 Participants
|
55 participants
n=107 Participants
|
113 participants
n=206 Participants
|
|
Ever Had Vaginal Sex
No
|
125 participants
n=99 Participants
|
128 participants
n=107 Participants
|
253 participants
n=206 Participants
|
|
Ever Had Anal Sex
Yes
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Ever Had Anal Sex
No
|
179 participants
n=99 Participants
|
178 participants
n=107 Participants
|
357 participants
n=206 Participants
|
|
Ever Been Tested for HIV
Yes
|
75 participants
n=99 Participants
|
64 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
Ever Been Tested for HIV
No
|
108 participants
n=99 Participants
|
119 participants
n=107 Participants
|
227 participants
n=206 Participants
|
|
Ever known someone who died from AIDS
Yes
|
67 participants
n=99 Participants
|
71 participants
n=107 Participants
|
138 participants
n=206 Participants
|
|
Ever known someone who died from AIDS
No
|
116 participants
n=99 Participants
|
112 participants
n=107 Participants
|
228 participants
n=206 Participants
|
|
Tired of hearing about HIV prevention information
Somewhat/strongly agree
|
45 participants
n=99 Participants
|
49 participants
n=107 Participants
|
94 participants
n=206 Participants
|
|
Tired of hearing about HIV prevention information
Do not Somewhat/strongly agree
|
138 participants
n=99 Participants
|
134 participants
n=107 Participants
|
272 participants
n=206 Participants
|
|
Above average change of getting HIV
Yes
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Above average change of getting HIV
No
|
171 participants
n=99 Participants
|
171 participants
n=107 Participants
|
342 participants
n=206 Participants
|
|
Beliefs supportive of HIV Stigma
|
1.1 units on a scale
STANDARD_DEVIATION .9 • n=99 Participants
|
1.2 units on a scale
STANDARD_DEVIATION 1.1 • n=107 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 1.0 • n=206 Participants
|
|
Ever had a boyfriend/girlfriend
Yes
|
141 participants
n=99 Participants
|
137 participants
n=107 Participants
|
278 participants
n=206 Participants
|
|
Ever had a boyfriend/girlfriend
No
|
42 participants
n=99 Participants
|
46 participants
n=107 Participants
|
88 participants
n=206 Participants
|
|
Ever been a victim of teen dating violence
Yes
|
35 participants
n=99 Participants
|
43 participants
n=107 Participants
|
78 participants
n=206 Participants
|
|
Ever been a victim of teen dating violence
No
|
148 participants
n=99 Participants
|
140 participants
n=107 Participants
|
288 participants
n=206 Participants
|
|
Ever been a perpetrator of teen dating violence
Yes
|
28 participants
n=99 Participants
|
37 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Ever been a perpetrator of teen dating violence
No
|
155 participants
n=99 Participants
|
146 participants
n=107 Participants
|
301 participants
n=206 Participants
|
|
Beliefs consistent with female empowerment in relationships
|
8.2 units on a scale
STANDARD_DEVIATION 2.8 • n=99 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 2.8 • n=107 Participants
|
8.1 units on a scale
STANDARD_DEVIATION 2.8 • n=206 Participants
|
|
Fair or poor health
Yes
|
35 participants
n=99 Participants
|
24 participants
n=107 Participants
|
59 participants
n=206 Participants
|
|
Fair or poor health
No
|
148 participants
n=99 Participants
|
159 participants
n=107 Participants
|
307 participants
n=206 Participants
|
|
Bright future somewhat/very unlikely
Yes
|
20 participants
n=99 Participants
|
15 participants
n=107 Participants
|
35 participants
n=206 Participants
|
|
Bright future somewhat/very unlikely
No
|
163 participants
n=99 Participants
|
168 participants
n=107 Participants
|
331 participants
n=206 Participants
|
|
Wish to have more self-respect
Yes
|
149 participants
n=99 Participants
|
144 participants
n=107 Participants
|
293 participants
n=206 Participants
|
|
Wish to have more self-respect
No
|
34 participants
n=99 Participants
|
39 participants
n=107 Participants
|
73 participants
n=206 Participants
|
|
The Multidimensional Scale of Perceived Social Support : Social support from "special person"
|
16.7 units on a scale
STANDARD_DEVIATION 2.8 • n=99 Participants
|
16.2 units on a scale
STANDARD_DEVIATION 4.1 • n=107 Participants
|
16.5 units on a scale
STANDARD_DEVIATION 4.0 • n=206 Participants
|
|
The Multidimensional Scale of Perceived Social Support: Social support from family
|
17.1 units on a scale
STANDARD_DEVIATION 3.1 • n=99 Participants
|
17.7 units on a scale
STANDARD_DEVIATION 3.0 • n=107 Participants
|
17.4 units on a scale
STANDARD_DEVIATION 3.1 • n=206 Participants
|
|
Information
Yes
|
86 participants
n=99 Participants
|
97 participants
n=107 Participants
|
183 participants
n=206 Participants
|
|
Information
No
|
97 participants
n=99 Participants
|
86 participants
n=107 Participants
|
183 participants
n=206 Participants
|
|
Motivation: Attitudes towards HIV preventive acts
|
3.6 units on a scale
STANDARD_DEVIATION .9 • n=99 Participants
|
3.5 units on a scale
STANDARD_DEVIATION .9 • n=107 Participants
|
3.6 units on a scale
STANDARD_DEVIATION .9 • n=206 Participants
|
|
Motivation: Subjective norms regarding HIV preventive acts
|
3.6 units on a scale
STANDARD_DEVIATION .9 • n=99 Participants
|
3.5 units on a scale
STANDARD_DEVIATION .9 • n=107 Participants
|
3.6 units on a scale
STANDARD_DEVIATION .9 • n=206 Participants
|
|
Motivation: Behavioral intentions for HIV prevention
|
3.5 units on a scale
STANDARD_DEVIATION .9 • n=99 Participants
|
3.5 units on a scale
STANDARD_DEVIATION .9 • n=107 Participants
|
3.5 units on a scale
STANDARD_DEVIATION .9 • n=206 Participants
|
|
Behavioral Skills
|
2.9 units on a scale
STANDARD_DEVIATION .7 • n=99 Participants
|
2.9 units on a scale
STANDARD_DEVIATION .7 • n=107 Participants
|
2.9 units on a scale
STANDARD_DEVIATION .7 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6-months post-interventionPopulation: ITT - Intention to Treat
Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months
Outcome measures
| Measure |
HIV Prevention
n=183 Participants
6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program
|
Control
n=183 Participants
"treatment as usual" - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program
|
|---|---|---|
|
Sex Without a Condom as Assessed by Self-report
|
26 participants
|
24 participants
|
PRIMARY outcome
Timeframe: 6-months post-interventionPopulation: ITT - Intention to Treat
Not having had vaginal or anal sex in the past three months
Outcome measures
| Measure |
HIV Prevention
n=183 Participants
6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program
|
Control
n=183 Participants
"treatment as usual" - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program
|
|---|---|---|
|
Sexual Abstinence
|
138 participants
|
137 participants
|
SECONDARY outcome
Timeframe: 3 months post-interventionPopulation: ITT--Intention to Treat
Sexual abstinence (i.e., not having vaginal or anal sex) in the past 90 days
Outcome measures
| Measure |
HIV Prevention
n=183 Participants
6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program
|
Control
n=183 Participants
"treatment as usual" - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program
|
|---|---|---|
|
Abstinence at Three-month Follow-up
|
135 participants
|
149 participants
|
SECONDARY outcome
Timeframe: 3 months post-interventionPopulation: ITT--Intention to Treat
Ever had vaginal or anal sex without a condom in the past 90 days
Outcome measures
| Measure |
HIV Prevention
n=183 Participants
6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program
|
Control
n=183 Participants
"treatment as usual" - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program
|
|---|---|---|
|
Unprotected Sex at Three-month Follow-up
|
21 participants
|
28 participants
|
Adverse Events
HIV Prevention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michele Ybarra
Center for Innovative Public Health Reserch
Phone: 877-302-6858
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place