HIVControlNCT00851539
Evaluating Post-test HIV Counseling Videos for Teens
A study testing Video in people with HIV and HIV Infections, run by North Bronx Healthcare Network at 1 site in United States.
Trial summary
The design of this randomized controlled trial (RCT) is to test the effectiveness of a post-test behavioral video in educating adolescents about HIV transmission and affecting their intentions to engage in risk-reduction behavior. Read more about this study
- Who is it for?
- Ages 15 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Apr 2011
- 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 15 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Youth who have had vaginal, anal or oral sex
- 15-21 years of age
- English speaking
Who cannot join
- Clinically unstable secondary to pain or unstable vitals signs
- Unable to understand the consent process for the study
- Known HIV status or recent HIV test
- Language other than English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Educational Effectiveness of an HIV Pretest Video for Adolescents: A Randomized Controlled Trial
The design of this randomized controlled trial (RCT) is to test the effectiveness of a post-test behavioral video in educating adolescents about HIV transmission and affecting their intentions to engage in risk-reduction behavior.
Read the detailed description
Adolescents are at risk for HIV because of their engagement in high risk sexual activity. This study seeks to determine effective ways to educate teens about HIV and how to protect themselves by use of multimedia. All eligible participants who agree to enroll in this trial will be randomized into two arms: the behavioral intervention video (intervention group) or meeting with an in-person counselor (control group) as they wait for their rapid HIV results. The goals of the RCT involve establishing the feasibility of using touch-screen technology for teenagers in the ED; establishing the receptivity of teens to HIV rapid testing in the ED; providing data on rates, and obtaining preliminary data on the effectiveness of the video in changing condom efficacy, condom outcome expectancies and condom use intention. Consenting to rapid HIV testing is a secondary outcome.
- Conditions
- HIV, HIV Infections
- Being tested
- Video
- Keywords
- HIV, Teenagers, Adolescent, HIV Testing, 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.
VideoBehavioural
Behavioral Intervention Video
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants received counseling from a live counselor. |
| Video | Experimental | Behavioral Intervention Video Receives: Behavioral: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intention to use condoms
Participants are asked about their intention to use condoms during sexual activity over the next 5 months
Measured: 5 months
Secondary outcomes (1)
Consent to rapid HIV testing
All participants are offered an HIV test but do not have to get tested to participate. We will evaluate whether the videos or counselors convince more participants to get tested for HIV.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionApr 2011
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 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Bronx Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Yvette Calderon,MD, MS, North Bronx Healthcare Network
- Investigators
- Yvette Calderon, MD MS, Principal investigator, Jacobi Medical Center/ Albert Einstein Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851539
- Sponsor's protocol ID
- 2006-443
- Other IDs
- 5K23HD054315
- Acronym
- Control
- Status last verified
- Dec 2014
- First submitted
- 25 Feb 2009
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Calderon Y, Cowan E, Leu CS, Brusalis C, Rhee JY, Nickerson J, Leider J, Bauman LJ. A human immunodeficiency virus posttest video to increase condom use among adolescent emergency department patients. J Adolesc Health. 2013 Jul;53(1):79-84. doi: 10.1016/j.jadohealth.2013.01.028. Epub 2013 Apr 9.
PubMed 23582525
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Effectiveness of an HIV Pretest Video for Adolescents: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00851539
- Acronym / sponsor ID
- Control / 2006-443
- Conditions
- HIV, HIV Infections
- Keywords
- HIV, Teenagers, Adolescent, HIV Testing, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- North Bronx Healthcare NetworkUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 26 Feb 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 design of this randomized controlled trial (RCT) is to test the effectiveness of a post-test behavioral video in educating adolescents about HIV transmission and affecting their intentions to engage in risk-reduction behavior.
Detailed description
Adolescents are at risk for HIV because of their engagement in high risk sexual activity. This study seeks to determine effective ways to educate teens about HIV and how to protect themselves by use of multimedia. All eligible participants who agree to enroll in this trial will be randomized into two arms: the behavioral intervention video (intervention group) or meeting with an in-person counselor (control group) as they wait for their rapid HIV results. The goals of the RCT involve establishing the feasibility of using touch-screen technology for teenagers in the ED; establishing the receptivity of teens to HIV rapid testing in the ED; providing data on rates, and obtaining preliminary data on the effectiveness of the video in changing condom efficacy, condom outcome expectancies and condom use intention. Consenting to rapid HIV testing is a secondary outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants received counseling from a live counselor. |
| Video | Experimental | Behavioral: VideoBehavioral Intervention Video |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Youth who have had vaginal, anal or oral sex
- 15-21 years of age
- English speaking
Key exclusion criteria (4 listed)
- Clinically unstable secondary to pain or unstable vitals signs
- Unable to understand the consent process for the study
- Known HIV status or recent HIV test
- Language other than English
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 |
|---|---|---|
| VideoBehavioral Intervention Video | Behavioural | Video |
Primary outcome
Intention to use condoms
Time frame: 5 months
Participants are asked about their intention to use condoms during sexual activity over the next 5 months
1 secondary outcome
Consent to rapid HIV testing
Time frame: Immediate
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 10 Dec 2014.
- Derived from this study: PubMed 23582525Calderon Y, Cowan E, Leu CS, Brusalis C, Rhee JY, Nickerson J, Leider J, Bauman LJ. A human immunodeficiency virus posttest video to increase condom use among adolescent emergency department patients. J Adolesc Health. 2013 Jul;53(1):79-84. doi: 10.1016/j.jadohealth.2013.01.028. Epub 2013 Apr 9.
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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.
Yvette Calderon, MD MS principal investigator
Jacobi Medical Center/ Albert Einstein Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video in people with HIV and HIV Infections, run by North Bronx Healthcare Network 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 4 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 10 Dec 2014. 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?
Intention to use condoms (time frame: 5 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 NCT00851539, 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 10 Dec 2014.