HIV InfectionsPhase 2YouthnetNCT00183638
A Tailored Interactive Website for Promoting Condom Use Among Young Adults
A Phase 2 study testing Internet-based tailored prevention messages and Non-tailored messages 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 develop and evaluate the effectiveness of tailored web-based messages in promoting condom use among 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?
- Internet-based tailored prevention messages and Non-tailored messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,870 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Client of Denver Metropolitan Health Clinic or Planned Parenthood
- English-speaking
- Access to a computer and an existing e-mail account
- Will be in Denver for at least 4 months
Who cannot join
- Not a resident of the Denver metropolitan area
- No existing e-mail address
- No access to a computer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Health Sciences Center
Aurora, Colorado, 80045-0508
About this study
Official title: Randomized Controlled Trial to Establish Efficacy of a Website to Promote Condom Use for Adults Aged 18-25
This study will develop and evaluate the effectiveness of tailored web-based messages in promoting condom use among young adults.
Read the detailed description
Adolescents and young adults are at the greatest risk for acquiring a sexually transmitted disease (STD). Approximately 3 million people between the ages of 18 and 24 become infected with an STD 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. The 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 open-label study will be recruited from one of two clinics in the Denver, Colorado area: Denver Metropolitan Health Clinic or Planned Parenthood of the Rocky Mountains. Participants will be randomly assigned to receive internet-based messages from either the Youthnet program or the control program while filling out a risk assessment survey. Participants in the Youthnet program will be asked their gender and ethnicity so they may be assigned to a role model of the same gender and ethnicity via a computer program. This role model will appear online 5 times during the survey to deliver interactive messages that will be tailored to HIV/STD risk reduction and will specifically address attitudes about condom usage. The control program will deliver 5 general, non-tailored messages containing information on reproductive health not specific to condoms or STDs. Participants will be assessed at baseline and a follow-up session 3 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
- Internet-based tailored prevention messages, Non-tailored messages
- Keywords
- Internet, Interactive Computer Program, HIV Prevention
- 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.
Internet-based tailored prevention messagesBehavioural
Also called Youthnet
Participants will receive five 30-second flash clips promoting condom norms, positive attitudes, self-efficacy, and risk awareness. Participants in the Youthnet program will be asked their gender and ethnicity so they may be assigned to a role model of the same gender and ethnicity via a computer program. This role model will appear online 5 times during the survey to deliver interactive messages that will be tailored to HIV/STD risk reduction and will specifically address attitudes about condom usage.
Non-tailored messagesBehavioural
The control program will deliver five general, non-tailored messages containing information on reproductive health not specific to condoms or STDs.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive Internet-based tailored prevention messages Receives: Behavioral: Internet-based tailored prevention messages |
| 2 | Active comparator | Participants will receive non-tailored messages containing information on reproductive health Receives: Behavioral: Non-tailored messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Condom use with non main partners
Measured: Measured at Month 3
Secondary outcomes (2)
Self-efficacy for condom use and condom negotiation
Measured: Measured at Month 3
Attitudes and norms towards condom use
Measured: Measured at Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,870 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 S. Bull, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183638
- Sponsor's protocol ID
- 02-0764a
- Other IDs
- R01MH063690, DAHBR 9A-ASI
- Acronym
- Youthnet
- Status last verified
- Nov 2013
- First submitted
- 13 Sep 2005
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Establish Efficacy of a Website to Promote Condom Use for Adults Aged 18-25
- ClinicalTrials.gov ID
- NCT00183638
- Acronym / sponsor ID
- Youthnet / 02-0764a
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- Internet, Interactive Computer Program, HIV Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,870 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
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 develop and evaluate the effectiveness of tailored web-based messages in promoting condom use among young adults.
Detailed description
Adolescents and young adults are at the greatest risk for acquiring a sexually transmitted disease (STD). Approximately 3 million people between the ages of 18 and 24 become infected with an STD 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. The 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 open-label study will be recruited from one of two clinics in the Denver, Colorado area: Denver Metropolitan Health Clinic or Planned Parenthood of the Rocky Mountains. Participants will be randomly assigned to receive internet-based messages from either the Youthnet program or the control program while filling out a risk assessment survey. Participants in the Youthnet program will be asked their gender and ethnicity so they may be assigned to a role model of the same gender and ethnicity via a computer program. This role model will appear online 5 times during the survey to deliver interactive messages that will be tailored to HIV/STD risk reduction and will specifically address attitudes about condom usage. The control program will deliver 5 general, non-tailored messages containing information on reproductive health not specific to condoms or STDs. Participants will be assessed at baseline and a follow-up session 3 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 |
|---|---|---|
| 1 | Experimental | Behavioral: Internet-based tailored prevention messagesParticipants will receive Internet-based tailored prevention messages |
| 2 | Active comparator | Behavioral: Non-tailored messagesParticipants will receive non-tailored messages containing information on reproductive health |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Client of Denver Metropolitan Health Clinic or Planned Parenthood
- English-speaking
- Access to a computer and an existing e-mail account
- Will be in Denver for at least 4 months
Key exclusion criteria (3 listed)
- Not a resident of the Denver metropolitan area
- No existing e-mail address
- No access to a computer
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 |
|---|---|---|
| Internet-based tailored prevention messagesAlso: YouthnetParticipants will receive five 30-second flash clips promoting condom norms, positive attitudes, self-efficacy, and risk awareness. Participants in the Youthnet program will be asked their gender and ethnicity so they may be assigned to a role model of the same gender and ethnicity via a computer program. This role model will appear online 5 times during the survey to deliver interactive messages that will be tailored to HIV/STD risk reduction and will specifically address attitudes about condom usage. | Behavioural | 1 |
| Non-tailored messagesThe control program will deliver five general, non-tailored messages containing information on reproductive health not specific to condoms or STDs. | Behavioural | 2 |
Primary outcome
Condom use with non main partners
Time frame: Measured at Month 3
2 secondary outcomes
Self-efficacy for condom use and condom negotiation
Time frame: Measured at Month 3
Attitudes and norms towards condom use
Time frame: Measured at Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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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 S. 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 Phase 2 study testing Internet-based tailored prevention messages and Non-tailored messages 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 4 inclusion and 3 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 27 Nov 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Condom use with non main partners (time frame: Measured at Month 3). 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 27 Nov 2013.