HIVNCT00725959
Online Social Networking for HIV Prevention
A study testing Online social networking HIV prevention in people with HIV, run by Colorado School of Public Health.
Trial summary
In this randomized controlled trial, we will identify social networks on Facebook, an randomly assign each network to control or intervention status. We will then intervene at the level of the network with dynamic, interactive HIV prevention messages (intervention) or static messages about HIV prevention (control). Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Online social networking HIV prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,578 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Dec 2011
- 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 16 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Facebook user with an existing Facebook page
- at least 16
- no older than 24
- English speaker
Who cannot join
- older than 24 or younger than 16
- non English speaker
- does not have a Facebook page
About this study
In this randomized controlled trial, we will identify social networks on Facebook, an randomly assign each network to control or intervention status. We will then intervene at the level of the network with dynamic, interactive HIV prevention messages (intervention) or static messages about HIV prevention (control). We will develop the intervention content with input from our target audience (Facebook users) and will measure baseline, and 3 and 6 month assessments of condom use and abstinence among all participants
- Conditions
- HIV
- Being tested
- Online social networking HIV prevention
- Keywords
- HIV Prevention, Social Networking, Technology Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online social networking HIV preventionBehavioural
messages about HIV posted in online social networking sites
| Study group | Role | What they receive |
|---|---|---|
| Facebook Arm | Experimental | Participants in this arm will have exposure to innovative, dynamic and regularly updated HIV Prevention messages on Facebook Receives: Behavioral: Online social networking HIV prevention |
| Control arm | Active comparator | Participants in this arm will have exposure to static information on HIV prevention currently available online Receives: Behavioral: Online social networking HIV prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Condom Usage
number of times condom used divided by number of times person had sex in past 60 days
Measured: two months
Secondary outcomes (1)
Condom and Abstinence Norms, Attitudes, Self-efficacy and Intentions
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2010
- Study completionDec 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Internet Sexuality Information Services (ISIS), Columbia University, Rutgers University
- Responsible party
- Principal investigator, Sheana Bull, Colorado School of Public Health
- Investigators
- Sheana Bull, Ph.D., Principal investigator, University of Colorado at Denver and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725959
- Sponsor's protocol ID
- COMIRB 07-0459
- Other IDs
- R01NR010492, 1R01NR01492-01
- Status last verified
- Oct 2017
- First submitted
- 29 Jul 2008
- Last updated
- 7 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bull SS, Levine DK, Black SR, Schmiege SJ, Santelli J. Social media-delivered sexual health intervention: a cluster randomized controlled trial. Am J Prev Med. 2012 Nov;43(5):467-74. doi: 10.1016/j.amepre.2012.07.022.
PubMed 23079168
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Social Networking for HIV Prevention
- ClinicalTrials.gov ID
- NCT00725959
- Acronym / sponsor ID
- COMIRB 07-0459
- Conditions
- HIV
- Keywords
- HIV Prevention, Social Networking, Technology Based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,578 participants (actual)
- Lead sponsor
- Colorado School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Internet Sexuality Information Services (ISIS), Columbia University, Rutgers University
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Posted 7 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized controlled trial, we will identify social networks on Facebook, an randomly assign each network to control or intervention status. We will then intervene at the level of the network with dynamic, interactive HIV prevention messages (intervention) or static messages about HIV prevention (control). We will develop the intervention content with input from our target audience (Facebook users) and will measure baseline, and 3 and 6 month assessments of condom use and abstinence among all participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facebook Arm | Experimental | Behavioral: Online social networking HIV preventionParticipants in this arm will have exposure to innovative, dynamic and regularly updated HIV Prevention messages on Facebook |
| Control arm | Active comparator | Behavioral: Online social networking HIV preventionParticipants in this arm will have exposure to static information on HIV prevention currently available online |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Facebook user with an existing Facebook page
- at least 16
- no older than 24
- English speaker
Key exclusion criteria (3 listed)
- older than 24 or younger than 16
- non English speaker
- does not have a Facebook page
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 |
|---|---|---|
| Online social networking HIV preventionmessages about HIV posted in online social networking sites | Behavioural | Control arm, Facebook Arm |
Primary outcome
Proportion of Condom Usage
Time frame: two months
number of times condom used divided by number of times person had sex in past 60 days
1 secondary outcome
Condom and Abstinence Norms, Attitudes, Self-efficacy and Intentions
Time frame: two months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23079168Bull SS, Levine DK, Black SR, Schmiege SJ, Santelli J. Social media-delivered sexual health intervention: a cluster randomized controlled trial. Am J Prev Med. 2012 Nov;43(5):467-74. doi: 10.1016/j.amepre.2012.07.022.
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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, Ph.D. principal investigator
University of Colorado at Denver and Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Online social networking HIV prevention in people with HIV, run by Colorado School of Public Health.
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 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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 7 Nov 2017). 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?
Proportion of Condom Usage (time frame: two months). 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 NCT00725959, 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 7 Nov 2017.