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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT00255944
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 2,622
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 69

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; Sexually Transmitted Diseases	Behavioral: Youthnet Internet-based program; Behavioral: Control Internet based program	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2622 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Internet-based Efficacy Trial of an HIV Prevention Program
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Youthnet messages on Facebook Participants will receive internet-based messages from the Youthnet program	Behavioral: 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.
Active Comparator: Messages on Facebook about current events Participants will receive internet-based messages from the control program	Behavioral: Control Internet based program; The control program will deliver standard STD/HIV prevention messages.

Outcome Measures

Primary Outcome Measures

1. Efficacy of Internet-based Program for Increasing Condom Use With Non-main Sex Partners [Month 2 post baseline]

Secondary Outcome Measures

1. Efficacy of Internet-based Program for Increasing Condom Use Attitudes, Norms, and Intentions With Non-main Sex Partners [Month 2 post baseline]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Has access to the internet

• Has an e-mail address

Exclusion Criteria:

• Colorado resident

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Internet-Based, accessible from anywhere	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• University of Colorado, Denver
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Sheana Bull, PhD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00255944
• Other Study ID Numbers: 02-0764b; R01MH063690; DAHBR 9A-ASI
• First Posted: Nov 21, 2005
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Colorado, Denver: HIV Prevention; Internet Intervention; STDs
• Additional relevant MeSH terms: Infections; Sexually Transmitted Diseases

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	514	477	991
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.7 (1.8)	21.8 (1.8)	21.7 (1.8)
Sex: Female, Male (Count of Participants)
Female	230 44.7%	234 49.1%	464 46.8%
Male	284 55.3%	243 50.9%	527 53.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 2.9%	7 1.5%	22 2.2%
Not Hispanic or Latino	499 97.1%	470 98.5%	969 97.8%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	103 20%	86 18%	189 19.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	11 2.1%	11 2.3%	22 2.2%
White	335 65.2%	316 66.2%	651 65.7%
More than one race	31 6%	31 6.5%	62 6.3%
Unknown or Not Reported	34 6.6%	33 6.9%	67 6.8%

Outcome Measures

1. Primary Outcome

Title	Efficacy of Internet-based Program for Increasing Condom Use With Non-main Sex Partners
Time Frame	Month 2 post baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm--exposure to Facebook	Control Arm--exposure to Control Content on Facebook
Arm/Group Description	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.	Participants will receive internet-based messages from the control program Control Internet based program: The control program will deliver standard STD/HIV prevention messages.
Measure Participants	514	447
Mean (Standard Deviation) [percentage of sex acts protected by cond]	.68 (1.96)	.56 (1.96)

2. Secondary Outcome

Title	Efficacy of Internet-based Program for Increasing Condom Use Attitudes, Norms, and Intentions With Non-main Sex Partners
Time Frame	Month 2 post baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Intervention Arm--exposure to Intervention on Facebook		Control Arm--exposure to Control Content on Facebook
Arm/Group Description	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.		Participants will receive internet-based messages from the control program Control Internet based program: The control program will deliver standard STD/HIV prevention messages.
All Cause Mortality
	Intervention Arm--exposure to Intervention on Facebook		Control Arm--exposure to Control Content on Facebook
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Intervention Arm--exposure to Intervention on Facebook		Control Arm--exposure to Control Content on Facebook
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1311 (0%)		0/1311 (0%)
Other (Not Including Serious) Adverse Events
	Intervention Arm--exposure to Intervention on Facebook		Control Arm--exposure to Control Content on Facebook
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1311 (0%)		0/1311 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.