Trial Outcomes & Findings for Effectiveness of an Online Prevention Program in Reducing the Risk of STD Infection in Young Adults (NCT NCT00255944)

NCT ID: NCT00255944

Last Updated: 2020-10-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2622 participants
• Primary outcome timeframe: Month 2 post baseline
• Results posted on: 2020-10-05

Participant Flow

Participant milestones

Measure	Intervention Arm--exposure to Intervention on Facebook 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.	Control Arm--exposure to Control Content on Facebook Participants will receive internet-based messages from the control program Control Internet based program: The control program will deliver standard STD/HIV prevention messages.
Overall Study STARTED	1311	1311
Overall Study COMPLETED	514	477
Overall Study NOT COMPLETED	797	834

Reasons for withdrawal

Measure	Intervention Arm--exposure to Intervention on Facebook 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.	Control Arm--exposure to Control Content on Facebook Participants will receive internet-based messages from the control program Control Internet based program: The control program will deliver standard STD/HIV prevention messages.
Overall Study Lost to Follow-up	797	834

Baseline Characteristics

Effectiveness of an Online Prevention Program in Reducing the Risk of STD Infection in Young Adults

Baseline characteristics by cohort

Measure	Intervention n=514 Participants 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.	Control n=477 Participants Participants will receive internet-based messages from the control program Control Internet based program: The control program will deliver standard STD/HIV prevention messages.	Total n=991 Participants Total of all reporting groups
Age, Continuous	21.7 years STANDARD_DEVIATION 1.8 • n=5 Participants	21.8 years STANDARD_DEVIATION 1.8 • n=7 Participants	21.7 years STANDARD_DEVIATION 1.8 • n=5 Participants
Sex: Female, Male Female	230 Participants n=5 Participants	234 Participants n=7 Participants	464 Participants n=5 Participants
Sex: Female, Male Male	284 Participants n=5 Participants	243 Participants n=7 Participants	527 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants	7 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	499 Participants n=5 Participants	470 Participants n=7 Participants	969 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	103 Participants n=5 Participants	86 Participants n=7 Participants	189 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) White	335 Participants n=5 Participants	316 Participants n=7 Participants	651 Participants n=5 Participants
Race (NIH/OMB) More than one race	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 2 post baseline

Outcome measures

Measure	Intervention Arm--exposure to Facebook n=514 Participants 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.	Control Arm--exposure to Control Content on Facebook n=447 Participants Participants will receive internet-based messages from the control program Control Internet based program: The control program will deliver standard STD/HIV prevention messages.
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	.56 percentage of sex acts protected by cond Standard Deviation 1.96

SECONDARY outcome

Timeframe: Month 2 post baseline

Outcome measures

Outcome data not reported

Adverse Events

Intervention Arm--exposure to Intervention on Facebook

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm--exposure to Control Content on Facebook

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. Sheana Bull

University of Colorado

Phone: 3037241238

Email: sheana.bull@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place