HIVPhase 3NCT01452555
Video-Based Delivery of HIV Test Information for Spanish-Speaking Latinos
A Phase 3 study testing Video or In-Person Presentation in people with HIV and AIDS, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The purpose of the study is to determine if a Spanish-language HIV and HIV test information video is as effective in delivering basic information regarding HIV and HIV tests to primarily Spanish-speaking HIV test recipients as an in-person presentation with an HIV test counselor. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- What is being tested?
- Video or In-Person Presentation
- 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
- Aug 2011to not given
- Phase
- Phase 3
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-64 years of age
- Self-identify as Latino
- Able to give informed consent
- Spanish speaking
Who cannot join
- Intoxicated
- Being treated for acute psychiatric illness
- Mental incapacitation
- Significant visual or hearing impairment
- Prisoner or under home confinement
- Participating in HIV vaccine trial
- Critically ill
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Ayanaris Reyes, BS, 401-444-9085, areyes@lifespan.org
Dr. Roland Merchant, MD, MPH, ScD
About this study
The purpose of the study is to determine if a Spanish-language HIV and HIV test information video is as effective in delivering basic information regarding HIV and HIV tests to primarily Spanish-speaking HIV test recipients as an in-person presentation with an HIV test counselor.
- Being tested
- Video or In-Person Presentation
- Keywords
- HIV, HIV Prevention, HIV testing, HIV Rapid Test
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video or In-Person PresentationBehavioural
Participants will be randomly assigned to an in person counseling session or will watch a HIV and HIV testing video
| Study group | Role | What they receive |
|---|---|---|
| In Person Counseling | Active comparator | Participants will receive an in person HIV and HIV testing counseling session Receives: Behavioral: Video or In-Person Presentation |
| Video Presentation | Experimental | Participants will watch an HIV and HIV testing video Receives: Behavioral: Video or In-Person Presentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of an educational video regarding HIV and HIV testing for Spanish speaking Latinos
Participants in both arms will complete an HIV knowledge questionnaire after recieving an in-person presentation or watching the video to compare the effectiveness of an HIV educational video for Spanish speaking Latinos regarding HIV and HIV tests.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startAug 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Roland Merchant, MD, MPH, ScD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452555
- Sponsor's protocol ID
- 1R21NR011997
- Status last verified
- Aug 2011
- First submitted
- 6 Oct 2011
- Last updated
- 17 Oct 2011
- Results posted
- No
Publications
Merchant RC, Clark MA, Santelices CA, Liu T, Cortes DE. Efficacy of an HIV/AIDS and HIV testing video for Spanish-speaking Latinos in healthcare and non-healthcare settings. AIDS Behav. 2015 Mar;19(3):523-35. doi: 10.1007/s10461-014-0889-6.
PubMed 25179540
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-Based Delivery of HIV Test Information for Spanish-Speaking Latinos
- ClinicalTrials.gov ID
- NCT01452555
- Acronym / sponsor ID
- 1R21NR011997
- Keywords
- HIV, HIV Prevention, HIV testing, HIV Rapid Test
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Aug 2011
- First posted
- 17 Oct 2011 (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 the study is to determine if a Spanish-language HIV and HIV test information video is as effective in delivering basic information regarding HIV and HIV tests to primarily Spanish-speaking HIV test recipients as an in-person presentation with an HIV test counselor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In Person Counseling | Active comparator | Behavioral: Video or In-Person PresentationParticipants will receive an in person HIV and HIV testing counseling session |
| Video Presentation | Experimental | Behavioral: Video or In-Person PresentationParticipants will watch an HIV and HIV testing video |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-64 years of age
- Self-identify as Latino
- Able to give informed consent
- Spanish speaking
Key exclusion criteria (7 listed)
- Intoxicated
- Being treated for acute psychiatric illness
- Mental incapacitation
- Significant visual or hearing impairment
- Prisoner or under home confinement
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 |
|---|---|---|
| Video or In-Person PresentationParticipants will be randomly assigned to an in person counseling session or will watch a HIV and HIV testing video | Behavioural | In Person Counseling, Video Presentation |
Primary outcome
Effectiveness of an educational video regarding HIV and HIV testing for Spanish speaking Latinos
Participants in both arms will complete an HIV knowledge questionnaire after recieving an in-person presentation or watching the video to compare the effectiveness of an HIV educational video for Spanish speaking Latinos regarding HIV and HIV tests.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
- Derived from this study: PubMed 25179540Merchant RC, Clark MA, Santelices CA, Liu T, Cortes DE. Efficacy of an HIV/AIDS and HIV testing video for Spanish-speaking Latinos in healthcare and non-healthcare settings. AIDS Behav. 2015 Mar;19(3):523-35. doi: 10.1007/s10461-014-0889-6.
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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.
Dr. Roland Merchant, MD, MPH, ScD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Video or In-Person Presentation in people with HIV and AIDS, run by Rhode Island Hospital 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 4 inclusion and 7 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 17 Oct 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Ayanaris Reyes, BS (401-444-9085, areyes@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of an educational video regarding HIV and HIV testing for Spanish speaking Latinos. 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 NCT01452555, 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 17 Oct 2011.