HIV InfectionsYouthnetsNCT00255944
Effectiveness of an Online Prevention Program in Reducing the Risk of STD Infection in Young Adults
A study testing Youthnet Internet-based program in people with HIV Infections and Sexually Transmitted Diseases, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Youthnet Internet-based program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,622 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has access to the internet
- Has an e-mail address
Who cannot join
- Colorado resident
Trial locations and contacts
1 site in 1 country.
United States1 site
Internet-Based, accessible from anywhere
Bethesda, Maryland, 20892
About this study
Official title: Internet-based Efficacy Trial of an HIV Prevention Program
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.
Read the 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.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Youthnet Internet-based program, Control Internet based program
- Keywords
- HIV Prevention, Internet Intervention, STDs
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youthnet Internet-based programBehavioural
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 Internet based programBehavioural
The control program will deliver standard STD/HIV prevention messages.
| Study group | Role | What they receive |
|---|---|---|
| Youthnet messages on Facebook | Experimental | Participants will receive internet-based messages from the Youthnet program Receives: Behavioral: Youthnet Internet-based program |
| Messages on Facebook about current events | Active comparator | Participants will receive internet-based messages from the control program Receives: Behavioral: Control Internet based program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Internet-based Program for Increasing Condom Use With Non-main Sex Partners
Measured: Month 2 post baseline
Secondary outcomes (1)
Efficacy of Internet-based Program for Increasing Condom Use Attitudes, Norms, and Intentions With Non-main Sex Partners
Measured: Month 2 post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startOct 2005
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,622 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sheana Bull, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255944
- Sponsor's protocol ID
- 02-0764b
- Other IDs
- R01MH063690, DAHBR 9A-ASI
- Acronym
- Youthnets
- Status last verified
- Sep 2020
- First submitted
- 16 Nov 2005
- Last updated
- 5 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Efficacy Trial of an HIV Prevention Program
- ClinicalTrials.gov ID
- NCT00255944
- Acronym / sponsor ID
- Youthnets / 02-0764b
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- HIV Prevention, Internet Intervention, STDs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,622 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Posted 5 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Youthnet messages on Facebook | Experimental | Behavioral: Youthnet Internet-based programParticipants will receive internet-based messages from the Youthnet program |
| Messages on Facebook about current events | Active comparator | Behavioral: Control Internet based programParticipants will receive internet-based messages from the control program |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Has access to the internet
- Has an e-mail address
Key exclusion criteria (1 listed)
- Colorado resident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Youthnet Internet-based programMessages 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. | Behavioural | Youthnet messages on Facebook |
| Control Internet based programThe control program will deliver standard STD/HIV prevention messages. | Behavioural | Messages on Facebook about current events |
Primary outcome
Efficacy of Internet-based Program for Increasing Condom Use With Non-main Sex Partners
Time frame: Month 2 post baseline
1 secondary outcome
Efficacy of Internet-based Program for Increasing Condom Use Attitudes, Norms, and Intentions With Non-main Sex Partners
Time frame: Month 2 post baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheana Bull, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youthnet Internet-based program in people with HIV Infections and Sexually Transmitted Diseases, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Internet-based Program for Increasing Condom Use With Non-main Sex Partners (time frame: Month 2 post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.