Condom Use, Sexual Abstinence
Conditions
Keywords
HIV prevention, technology, adolescent, developing countries
Brief summary
The investigators propose to design and test an Internet-based HIV prevention program for adolescents in Uganda.
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.
Interventions
BEHAVIORALCyberSenga
Internet-based HIV prevention program
Sponsors
Mbarara University of Science and Technology
Harvard University
University of Colorado, Denver
Internet Solutions for Kids Uganda, Limited
National Institute of Mental Health (NIMH)
Center for Innovative Public Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Uganda
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%).
Participants by arm
| Arm | Count |
|---|---|
| HIV Prevention 6-module HIV prevention program tailored for adolescents in Uganda
CybereSenga: Internet-based HIV prevention program | 183 |
| Control treatment as usual - the sexual health education adolescents currently receive in secondary school
CybereSenga: Internet-based HIV prevention program | 183 |
| Total | 366 |
Baseline characteristics
| Characteristic | HIV Prevention | Control | Total |
|---|---|---|---|
| Above average change of getting HIV No | 171 participants | 171 participants | 342 participants |
| Above average change of getting HIV Yes | 12 participants | 12 participants | 24 participants |
| Age, Continuous | 16.0 years STANDARD_DEVIATION 1.4 | 16.2 years STANDARD_DEVIATION 1.5 | 16.1 years STANDARD_DEVIATION 1.4 |
| Behavioral Skills | 2.9 units on a scale STANDARD_DEVIATION 0.7 | 2.9 units on a scale STANDARD_DEVIATION 0.7 | 2.9 units on a scale STANDARD_DEVIATION 0.7 |
| Beliefs consistent with female empowerment in relationships | 8.2 units on a scale STANDARD_DEVIATION 2.8 | 8.0 units on a scale STANDARD_DEVIATION 2.8 | 8.1 units on a scale STANDARD_DEVIATION 2.8 |
| Beliefs supportive of HIV Stigma | 1.1 units on a scale STANDARD_DEVIATION 0.9 | 1.2 units on a scale STANDARD_DEVIATION 1.1 | 1.1 units on a scale STANDARD_DEVIATION 1 |
| Bright future somewhat/very unlikely No | 163 participants | 168 participants | 331 participants |
| Bright future somewhat/very unlikely Yes | 20 participants | 15 participants | 35 participants |
| Ever been a perpetrator of teen dating violence No | 155 participants | 146 participants | 301 participants |
| Ever been a perpetrator of teen dating violence Yes | 28 participants | 37 participants | 65 participants |
| Ever been a victim of teen dating violence No | 148 participants | 140 participants | 288 participants |
| Ever been a victim of teen dating violence Yes | 35 participants | 43 participants | 78 participants |
| Ever Been Tested for HIV No | 108 participants | 119 participants | 227 participants |
| Ever Been Tested for HIV Yes | 75 participants | 64 participants | 139 participants |
| Ever had a boyfriend/girlfriend No | 42 participants | 46 participants | 88 participants |
| Ever had a boyfriend/girlfriend Yes | 141 participants | 137 participants | 278 participants |
| Ever Had Anal Sex No | 179 participants | 178 participants | 357 participants |
| Ever Had Anal Sex Yes | 4 participants | 5 participants | 9 participants |
| Ever Had Oral Sex No | 164 participants | 166 participants | 330 participants |
| Ever Had Oral Sex Yes | 19 participants | 17 participants | 36 participants |
| Ever Had Vaginal Sex No | 125 participants | 128 participants | 253 participants |
| Ever Had Vaginal Sex Yes | 58 participants | 55 participants | 113 participants |
| Ever known someone who died from AIDS No | 116 participants | 112 participants | 228 participants |
| Ever known someone who died from AIDS Yes | 67 participants | 71 participants | 138 participants |
| Fair or poor health No | 148 participants | 159 participants | 307 participants |
| Fair or poor health Yes | 35 participants | 24 participants | 59 participants |
| Grade Secondary 2 | 47 participants | 50 participants | 97 participants |
| Grade Secondary 3 | 73 participants | 58 participants | 131 participants |
| Grade Secondary 4 | 63 participants | 75 participants | 138 participants |
| Information No | 97 participants | 86 participants | 183 participants |
| Information Yes | 86 participants | 97 participants | 183 participants |
| Internet Use Frequent | 82 participants | 81 participants | 163 participants |
| Internet Use Infrequent | 101 participants | 102 participants | 203 participants |
| Maternal Education More Than Primary School | 123 participants | 120 participants | 243 participants |
| Maternal Education Primary School or Less/Don't Know | 60 participants | 63 participants | 123 participants |
| Motivation: Attitudes towards HIV preventive acts | 3.6 units on a scale STANDARD_DEVIATION 0.9 | 3.5 units on a scale STANDARD_DEVIATION 0.9 | 3.6 units on a scale STANDARD_DEVIATION 0.9 |
| Motivation: Behavioral intentions for HIV prevention | 3.5 units on a scale STANDARD_DEVIATION 0.9 | 3.5 units on a scale STANDARD_DEVIATION 0.9 | 3.5 units on a scale STANDARD_DEVIATION 0.9 |
| Motivation: Subjective norms regarding HIV preventive acts | 3.6 units on a scale STANDARD_DEVIATION 0.9 | 3.5 units on a scale STANDARD_DEVIATION 0.9 | 3.6 units on a scale STANDARD_DEVIATION 0.9 |
| Paternal Education More Than Primary School | 135 participants | 133 participants | 268 participants |
| Paternal Education Primary School or Less/Don't Know | 48 participants | 50 participants | 98 participants |
| Sex: Female, Male Female | 31 Participants | 28 Participants | 59 Participants |
| Sex: Female, Male Male | 152 Participants | 155 Participants | 307 Participants |
| The Multidimensional Scale of Perceived Social Support: Social support from family | 17.1 units on a scale STANDARD_DEVIATION 3.1 | 17.7 units on a scale STANDARD_DEVIATION 3 | 17.4 units on a scale STANDARD_DEVIATION 3.1 |
| The Multidimensional Scale of Perceived Social Support : Social support from special person | 16.7 units on a scale STANDARD_DEVIATION 2.8 | 16.2 units on a scale STANDARD_DEVIATION 4.1 | 16.5 units on a scale STANDARD_DEVIATION 4 |
| Tired of hearing about HIV prevention information Do not Somewhat/strongly agree | 138 participants | 134 participants | 272 participants |
| Tired of hearing about HIV prevention information Somewhat/strongly agree | 45 participants | 49 participants | 94 participants |
| Wish to have more self-respect No | 34 participants | 39 participants | 73 participants |
| Wish to have more self-respect Yes | 149 participants | 144 participants | 293 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 183 | 0 / 183 |
| serious Total, serious adverse events | 0 / 183 | 0 / 183 |
Outcome results
Primary
Sexual Abstinence
Not having had vaginal or anal sex in the past three months
Time frame: 6-months post-intervention
Population: ITT - Intention to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV Prevention | Sexual Abstinence | 138 participants |
| Control | Sexual Abstinence | 137 participants |
95% CI: [0.62, 1.65]
Primary
Sex Without a Condom as Assessed by Self-report
Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months
Time frame: 6-months post-intervention
Population: ITT - Intention to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV Prevention | Sex Without a Condom as Assessed by Self-report | 26 participants |
| Control | Sex Without a Condom as Assessed by Self-report | 24 participants |
95% CI: [0.57, 1.94]
Secondary
Abstinence at Three-month Follow-up
Sexual abstinence (i.e., not having vaginal or anal sex) in the past 90 days
Time frame: 3 months post-intervention
Population: ITT--Intention to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV Prevention | Abstinence at Three-month Follow-up | 135 participants |
| Control | Abstinence at Three-month Follow-up | 149 participants |
95% CI: [0.93, 2.62]
Secondary
Unprotected Sex at Three-month Follow-up
Ever had vaginal or anal sex without a condom in the past 90 days
Time frame: 3 months post-intervention
Population: ITT--Intention to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV Prevention | Unprotected Sex at Three-month Follow-up | 21 participants |
| Control | Unprotected Sex at Three-month Follow-up | 28 participants |
95% CI: [0.37, 1.3]