HIV Infections, Sexually Transmitted Diseases
Conditions
Keywords
HIV Prevention, Internet Intervention, STDs
Brief summary
This study will evaluate the effectiveness of a tailored interactive online risk reduction program versus a standard online risk reduction program in reducing the risk of Sexually Transmitted Diseases (STD) infection in young adults.
Detailed description
Adolescents and young adults are at the greatest risk for acquiring an STD. Approximately 3 million people between the ages of 18 and 24 become infected each year. Education about the risks and consequences of unprotected sex is a powerful tool that can be used to prevent or reduce the risk of infection. The program in this study will deliver messages to educate participants about condom use and the risk of STD infection. This study will evaluate the effectiveness of a tailored interactive online risk reduction program versus a standard online risk reduction program in reducing the risk of STD infection in young adults. Participants in this 1-year open-label study will be recruited exclusively via the internet. Participants will be randomly assigned to receive internet-based messages from either the Youthnet program or the control program. Messages from the Youthnet program will be interactive and tailored specifically to Human Immunodeficiency Virus/Sexually Transmitted Diseases (HIV/STD) risk reduction. The control program will deliver standard STD/HIV prevention messages. Participants will be assessed at baseline and a follow-up session 4 months after enrollment. Frequency of condom use and attitudes toward condom use will be assessed using behavioral scales.
Interventions
BEHAVIORALYouthnet Internet-based program
Messages from the Youthnet program will be interactive and tailored specifically to HIV/STD risk reduction. Participants will be exposed to five flash computer vignettes of 30 seconds each, concerning condom attitudes, norms self-efficacy, and risk awareness.
BEHAVIORALControl Internet based program
The control program will deliver standard STD/HIV prevention messages.
Sponsors
National Institute of Mental Health (NIMH)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Has access to the internet * Has an e-mail address
Exclusion criteria
* Colorado resident
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of Internet-based Program for Increasing Condom Use With Non-main Sex Partners | Month 2 post baseline |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Internet-based Program for Increasing Condom Use Attitudes, Norms, and Intentions With Non-main Sex Partners | Month 2 post baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants will receive internet-based messages from the Youthnet program
Youthnet Internet-based program: Messages from the Youthnet program will be interactive and tailored specifically to HIV/STD risk reduction. Participants will be exposed to five flash computer vignettes of 30 seconds each, concerning condom attitudes, norms self-efficacy, and risk awareness. | 514 |
| Control Participants will receive internet-based messages from the control program
Control Internet based program: The control program will deliver standard STD/HIV prevention messages. | 477 |
| Total | 991 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 797 | 834 |
Baseline characteristics
| Characteristic | Control | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 21.8 years STANDARD_DEVIATION 1.8 | 21.7 years STANDARD_DEVIATION 1.8 | 21.7 years STANDARD_DEVIATION 1.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 22 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 470 Participants | 969 Participants | 499 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 86 Participants | 189 Participants | 103 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 22 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 31 Participants | 62 Participants | 31 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 33 Participants | 67 Participants | 34 Participants |
| Race (NIH/OMB) White | 316 Participants | 651 Participants | 335 Participants |
| Sex: Female, Male Female | 234 Participants | 464 Participants | 230 Participants |
| Sex: Female, Male Male | 243 Participants | 527 Participants | 284 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,311 | 0 / 1,311 |
| serious Total, serious adverse events | 0 / 1,311 | 0 / 1,311 |
Outcome results
Primary
Efficacy of Internet-based Program for Increasing Condom Use With Non-main Sex Partners
Time frame: Month 2 post baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm--exposure to Facebook | Efficacy of Internet-based Program for Increasing Condom Use With Non-main Sex Partners | .68 percentage of sex acts protected by cond | Standard Deviation 1.96 |
| Control Arm--exposure to Control Content on Facebook | Efficacy of Internet-based Program for Increasing Condom Use With Non-main Sex Partners | .56 percentage of sex acts protected by cond | Standard Deviation 1.96 |
Secondary
Efficacy of Internet-based Program for Increasing Condom Use Attitudes, Norms, and Intentions With Non-main Sex Partners
Time frame: Month 2 post baseline