HIV InfectionsNCT00249327
Online HIV Prevention Vignette Evaluation
A study testing education in people with HIV Infections, run by Public Health Solutions at 1 site in United States.
Trial summary
This is an evaluation of the effect that an online live action, dramatic vignette about four gay men, two HIV positive and two HIV negative, struggling with the responsibility for safer sex has on the sexual behavior and HIV testing intentions of the gay/bisexual men who watch the vignette and participate in the… Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Feb 2006
- 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 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Gay/bisexual men
- Age > 18
Who cannot join
- Women
- Men under 18
- Men who do not have sex with other men
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical and Health Research Association of New York City, Inc.
New York, New York, 10013
About this study
This is an evaluation of the effect that an online live action, dramatic vignette about four gay men, two HIV positive and two HIV negative, struggling with the responsibility for safer sex has on the sexual behavior and HIV testing intentions of the gay/bisexual men who watch the vignette and participate in the evaluation study. The primary hypothesis is that men will be more likely to: 1)express the intent to have an HIV test and 2) to express the intent to inform their sex partners of their HIV status after watching the vignette. The secondary hypothesis is that men will be more likely to follow through on these intentions in the three months following the intervention than they were in the three months before viewing the vignette. This is a one group pre-posttest intervention in which each man serves as his own control.
Read the detailed description
- Men over 18 years of age will be recruited for the study through a banner posted on the exit page of manhunt.net an internet gay hook-up site. Those clicking on the banner will go to the evaluation website (www.hivbigdeal.org)
- asked to read the consent and click agreement.
- asked to complete a relatively brief questionnaire about their sexual behavior, HIV testing and HIV disclosure in the preceding three months
- watch the 8 minute dramatic vignette
- complete a brief questionnaire that elicits their response to the video and their HIV testing and disclosure intentions.
- if they agree to provide the study with their e-mail address, participants will be re-contacted in three months and asked to complete a second behavioral survey online that asks about sexual behavior, HIV testing and HIV disclosure in the three months since watching the vignette.Behavior before and after watching the vignette will be compared.
- The entire study will be conducted online.
- Conditions
- HIV Infections
- Being tested
- education
- Keywords
- HIV testing, HIV disclosure, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in HIV testing
Increase in disclosure of HIV status to sex partner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startOct 2005
- Study completionFeb 2006
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.
- 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
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Public Health Solutions
- Sponsor type
- University, hospital or other
- Collaborators
- Van Ameringen Foundation Inc, The New York Community Trust
- Investigators
- Mary Ann Chiasson, DrPH, Principal investigator, Medical and Health Research Association of New York City Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249327
- Sponsor's protocol ID
- 063005
- Status last verified
- Apr 2007
- First submitted
- 4 Nov 2005
- Last updated
- 19 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online HIV Prevention Vignette Evaluation
- ClinicalTrials.gov ID
- NCT00249327
- Acronym / sponsor ID
- 063005
- Conditions
- HIV Infections
- Keywords
- HIV testing, HIV disclosure, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- Public Health SolutionsUniversity, hospital or other
- Collaborators
- Van Ameringen Foundation Inc, The New York Community Trust
- Study start
- Oct 2005
- Study completion
- Feb 2006 (actual)
- First posted
- 7 Nov 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 is an evaluation of the effect that an online live action, dramatic vignette about four gay men, two HIV positive and two HIV negative, struggling with the responsibility for safer sex has on the sexual behavior and HIV testing intentions of the gay/bisexual men who watch the vignette and participate in the evaluation study. The primary hypothesis is that men will be more likely to: 1)express the intent to have an HIV test and 2) to express the intent to inform their sex partners of their HIV status after watching the vignette. The secondary hypothesis is that men will be more likely to follow through on these intentions in the three months following the intervention than they were in the three months before viewing the vignette. This is a one group pre-posttest intervention in which each man serves as his own control.
Detailed description
- Men over 18 years of age will be recruited for the study through a banner posted on the exit page of manhunt.net an internet gay hook-up site. Those clicking on the banner will go to the evaluation website (www.hivbigdeal.org)
- asked to read the consent and click agreement.
- asked to complete a relatively brief questionnaire about their sexual behavior, HIV testing and HIV disclosure in the preceding three months
- watch the 8 minute dramatic vignette
- complete a brief questionnaire that elicits their response to the video and their HIV testing and disclosure intentions.
- if they agree to provide the study with their e-mail address, participants will be re-contacted in three months and asked to complete a second behavioral survey online that asks about sexual behavior, HIV testing and HIV disclosure in the three months since watching the vignette.Behavior before and after watching the vignette will be compared.
- The entire study will be conducted online.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking
- Gay/bisexual men
- Age > 18
Key exclusion criteria (3 listed)
- Women
- Men under 18
- Men who do not have sex with other men
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 |
|---|---|---|
| education | Behavioural | – |
Primary outcome
Increase in HIV testing
Increase in disclosure of HIV status to sex partner
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 19 Apr 2007.
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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.
Mary Ann Chiasson, DrPH principal investigator
Medical and Health Research Association of New York City Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with HIV Infections, run by Public Health Solutions 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 3 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 19 Apr 2007. 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?
Increase in HIV testing. The study lists 2 primary outcomes in all. 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 19 Apr 2007.