HIVKIUNCT00968188
Internet-based HIV/STI Prevention for Young MSM Receiving HIV Testing
A study testing Keep It Up! and Information only in people with HIV and HIV Infections, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The purpose of this study is to develop an empirically validated, scientifically-based HIV and STI prevention program that can be delivered online to young men who have sex with men (YMSM) who were recently tested for HIV. Read more about this study
- Who is it for?
- Ages 18 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- Keep It Up! and Information only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Sep 2010
- Phase
- Interventional
- 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 24 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 24 years of age
- Self-identify as a biological male
- Understand and read English
- Have tested HIV negative at an approved clinic within 6 weeks
- Report at least one (male) sex partners in the past three months, and unprotected anal sex with at least one male sex partner in the past three months.
Who cannot join
- Have been diagnosed with HIV within the past three months
- Participation in another HIV prevention program
- No access to the Internet or an email address
Trial locations and contacts
1 site in 1 country.
United States1 site
Howard Brown Health Center
Chicago, Illinois, 60613-2010
About this study
Official title: A Randomized Control Trial of an Internet-based HIV/STI Prevention for Young MSM Receiving HIV Testing.
The purpose of this study is to develop an empirically validated, scientifically-based HIV and STI prevention program that can be delivered online to young men who have sex with men (YMSM) who were recently tested for HIV.
Read the detailed description
Presently, there are a limited number of proven HIV interventions culturally tailored to young men who have sex with men (YMSM). This is alarming because Men who have sex with men comprise 68% of HIV/AIDS diagnoses in men, despite representing a much smaller proportion of the population. In addition, MSM are reporting more sexual risk behavior than in previous years and there is significant concern that HIV infection rates may once again be on the rise after more than a decade of remaining relatively stable.
The Internet is a viable intervention avenue because of it's high percentage of accessibility and usage, especially among young adults. Moreover, it might hold a strong appeal for YMSM, since its anonymity confers a sense of perceived safety against stigma surrounding HIV prevention information.
The purpose of this study is to compare two different versions of an online HIV/STI intervention for YMSM. This study is part of an overall program of research designed to understand and prevent HIV infection among high-risk youth. Participation in this study will help us to determine the usefulness of an tailored and interactive HIV Internet-assisted intervention.
- Conditions
- HIV, HIV Infections
- Being tested
- Keep It Up!, Information only
- Keywords
- HIV Risk, Internet Intervention, Homosexuality, Male, HIV Seronegativity
- Medical subject headings
- HIV Infections, Homosexuality, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keep It Up!Behavioural
Online HIV Intervention Prevention Website tailored to Young Men that Have Sex with Men. Website is tailored to be more engaging, includes videos and games.
Information onlyBehavioural
Medically fact based HIV information delivered online.
| Study group | Role | What they receive |
|---|---|---|
| Active intervention | Experimental | Highly interactive, motivational, culturally tailored, online HIV prevention. Receives: Behavioral: Keep It Up! |
| Information only | Active comparator | Medically fact based online intervention. Receives: Behavioral: Information only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Risk Behavior
Measured: 3 months
Secondary outcomes (1)
HIV knowledge, Decisional Balance, condom errors, safer sex self-efficacy, intentions
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Brian Mustanski, University of Illinois Chicago
- Investigators
- Brian S Mustanski, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968188
- Sponsor's protocol ID
- 2007-0182
- Other IDs
- 1R34MH079714-01A1
- Acronym
- KIU
- Status last verified
- Sep 2019
- First submitted
- 27 Aug 2009
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of an Internet-based HIV/STI Prevention for Young MSM Receiving HIV Testing.
- ClinicalTrials.gov ID
- NCT00968188
- Acronym / sponsor ID
- KIU / 2007-0182
- Conditions
- HIV, HIV Infections
- Keywords
- HIV Risk, Internet Intervention, Homosexuality, Male, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2009 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 28 Aug 2009 (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.
The purpose of this study is to develop an empirically validated, scientifically-based HIV and STI prevention program that can be delivered online to young men who have sex with men (YMSM) who were recently tested for HIV.
Detailed description
Presently, there are a limited number of proven HIV interventions culturally tailored to young men who have sex with men (YMSM). This is alarming because Men who have sex with men comprise 68% of HIV/AIDS diagnoses in men, despite representing a much smaller proportion of the population. In addition, MSM are reporting more sexual risk behavior than in previous years and there is significant concern that HIV infection rates may once again be on the rise after more than a decade of remaining relatively stable.
The Internet is a viable intervention avenue because of it's high percentage of accessibility and usage, especially among young adults. Moreover, it might hold a strong appeal for YMSM, since its anonymity confers a sense of perceived safety against stigma surrounding HIV prevention information.
The purpose of this study is to compare two different versions of an online HIV/STI intervention for YMSM. This study is part of an overall program of research designed to understand and prevent HIV infection among high-risk youth. Participation in this study will help us to determine the usefulness of an tailored and interactive HIV Internet-assisted intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active intervention | Experimental | Behavioral: Keep It Up!Highly interactive, motivational, culturally tailored, online HIV prevention. |
| Information only | Active comparator | Behavioral: Information onlyMedically fact based online intervention. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between 18 and 24 years of age
- Self-identify as a biological male
- Understand and read English
- Have tested HIV negative at an approved clinic within 6 weeks
- Report at least one (male) sex partners in the past three months, and unprotected anal sex with at least one male sex partner in the past three months.
Key exclusion criteria (3 listed)
- Have been diagnosed with HIV within the past three months
- Participation in another HIV prevention program
- No access to the Internet or an email address
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 |
|---|---|---|
| Keep It Up!Online HIV Intervention Prevention Website tailored to Young Men that Have Sex with Men. Website is tailored to be more engaging, includes videos and games. | Behavioural | Active intervention |
| Information onlyMedically fact based HIV information delivered online. | Behavioural | Information only |
Primary outcome
Sexual Risk Behavior
Time frame: 3 months
1 secondary outcome
HIV knowledge, Decisional Balance, condom errors, safer sex self-efficacy, intentions
Time frame: 3 months
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 2 Oct 2019.
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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.
Brian S Mustanski, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keep It Up! and Information only in people with HIV and HIV Infections, run by University of Illinois Chicago 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 5 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 2 Oct 2019. 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?
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?
Sexual Risk Behavior (time frame: 3 months). 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 2 Oct 2019.