HIV InfectionsPhase 15PartNCT00649701
Novel Internet-Based Interventions to Reduce Sexual Risk Among Men Who Have Sex With Men
A Phase 1 study testing Standard Text-Based Prevention Web Page, The Morning After and Talking About HIV in people with HIV Infections, run by Public Health Solutions at 1 site in United States.
Trial summary
The purpose of this study is to develop and test the efficacy of online HIV risk reduction interventions among men who have sex with men. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Standard Text-Based Prevention Web Page, The Morning After and Talking About HIV
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,097 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Dec 2008
- Phase
- Phase 1
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male;
- Age 18 and over;
- Ability to read and respond in English;
- Reside within the United States;
- Report oral or anal sex with any male (new partner or not) in the past 60 days AND report oral, anal or vaginal sex for the first time with any partner (male or female) in the past 60 days;
- Complete baseline survey
- Provide an email address;
Who cannot join
- Women and transgender persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Online Intervention to Reduce Sexual Risk Among Men Who Have Sex With Men
The purpose of this study is to develop and test the efficacy of online HIV risk reduction interventions among men who have sex with men.
Read the detailed description
This is an Internet-based, five-branch randomized controlled intervention, enrolling 3,000 adult MSM. The five branches include 1) a control condition receiving no intervention content, 2) a standard text-based prevention webpage, 3) an 8 minute dramatic video addressing sexual risk reduction within the context of alcohol use, 4) a 5 minute documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use, and 5) both videos. After completing the baseline survey, eligible participants who consent to participate in the intervention will be randomly assigned to the control condition or one of the four intervention conditions. The control condition will not include the delivery of any intervention content. All participants (branches 1-5) will be asked to complete a brief post-intervention survey (to measure intentions). All intervention participants will be invited to complete a final 60-day follow-up survey.
- Conditions
- HIV Infections
- Being tested
- Standard Text-Based Prevention Web Page, The Morning After, Talking About HIV, Both Videos
- Keywords
- HIV, Internet, MSM, Condom Use, Disclosure
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Text-Based Prevention Web PageBehavioural
A link to the CDC.gov web page which describes HIV prevention among men who have sex with men.
The Morning AfterBehavioural
A dramatic video about 4 gay men addressing sexual risk reduction within the context of alcohol use.
Talking About HIVBehavioural
A documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use.
Both VideosBehavioural
Morning After and Talking About HIV videos
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | Text-based webpage Receives: Behavioral: Standard Text-Based Prevention Web Page |
| 3 | Experimental | Talking about HIV video Receives: Behavioral: Talking About HIV |
| 4 | Experimental | The Morning After video Receives: Behavioral: The Morning After |
| 5 | Experimental | Both videos Receives: Behavioral: Both Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV disclosure, HIV testing, and condom use
Measured: 60 days
Secondary outcomes (1)
drug and/or alcohol use before sex, and depressive and/or anxiety symptomatology (past 2 weeks)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,097 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Solutions
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Sabina Hirshfield, PhD, Principal investigator, Public Health Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649701
- Sponsor's protocol ID
- CDC-URS PS000415
- Acronym
- 5Part
- Status last verified
- Jun 2008
- First submitted
- 27 Mar 2008
- Last updated
- 20 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hirshfield S, Chiasson MA, Joseph H, Scheinmann R, Johnson WD, Remien RH, Shaw FS, Emmons R, Yu G, Margolis AD. An online randomized controlled trial evaluating HIV prevention digital media interventions for men who have sex with men. PLoS One. 2012;7(10):e46252. doi: 10.1371/journal.pone.0046252. Epub 2012 Oct 2.
PubMed 23071551
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Online Intervention to Reduce Sexual Risk Among Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT00649701
- Acronym / sponsor ID
- 5Part / CDC-URS PS000415
- Conditions
- HIV Infections
- Keywords
- HIV, Internet, MSM, Condom Use, Disclosure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,097 participants (actual)
- Lead sponsor
- Public Health SolutionsUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 1 Apr 2008 (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 and test the efficacy of online HIV risk reduction interventions among men who have sex with men.
Detailed description
This is an Internet-based, five-branch randomized controlled intervention, enrolling 3,000 adult MSM. The five branches include 1) a control condition receiving no intervention content, 2) a standard text-based prevention webpage, 3) an 8 minute dramatic video addressing sexual risk reduction within the context of alcohol use, 4) a 5 minute documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use, and 5) both videos. After completing the baseline survey, eligible participants who consent to participate in the intervention will be randomly assigned to the control condition or one of the four intervention conditions. The control condition will not include the delivery of any intervention content. All participants (branches 1-5) will be asked to complete a brief post-intervention survey (to measure intentions). All intervention participants will be invited to complete a final 60-day follow-up survey.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Behavioral: Standard Text-Based Prevention Web PageText-based webpage |
| 3 | Experimental | Behavioral: Talking About HIVTalking about HIV video |
| 4 | Experimental | Behavioral: The Morning AfterThe Morning After video |
| 5 | Experimental | Behavioral: Both VideosBoth videos |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male;
- Age 18 and over;
- Ability to read and respond in English;
- Reside within the United States;
- Report oral or anal sex with any male (new partner or not) in the past 60 days AND report oral, anal or vaginal sex for the first time with any partner (male or female) in the past 60 days;
Key exclusion criteria (1 listed)
- Women and transgender persons
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 |
|---|---|---|
| Standard Text-Based Prevention Web PageA link to the CDC.gov web page which describes HIV prevention among men who have sex with men. | Behavioural | 2 |
| The Morning AfterA dramatic video about 4 gay men addressing sexual risk reduction within the context of alcohol use. | Behavioural | 4 |
| Talking About HIVA documentary video addressing HIV disclosure, HIV testing, and condom use with the sub-context of drug use. | Behavioural | 3 |
| Both VideosMorning After and Talking About HIV videos | Behavioural | 5 |
Primary outcome
HIV disclosure, HIV testing, and condom use
Time frame: 60 days
1 secondary outcome
drug and/or alcohol use before sex, and depressive and/or anxiety symptomatology (past 2 weeks)
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
- Derived from this study: PubMed 23071551Hirshfield S, Chiasson MA, Joseph H, Scheinmann R, Johnson WD, Remien RH, Shaw FS, Emmons R, Yu G, Margolis AD. An online randomized controlled trial evaluating HIV prevention digital media interventions for men who have sex with men. PLoS One. 2012;7(10):e46252. doi: 10.1371/journal.pone.0046252. Epub 2012 Oct 2.
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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.
Sabina Hirshfield, PhD principal investigator
Public Health Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Standard Text-Based Prevention Web Page, The Morning After and Talking About HIV 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 7 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: status not confirmed, as of the sponsor's last update on 20 Jun 2008. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
HIV disclosure, HIV testing, and condom use (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00649701, which also lists 1 linked publication.
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 20 Jun 2008.