HIV TestingTuNexoNCT01760057
Evaluating the Effect of a Novel Web-based Intervention to Increase HIV Testing in Men Who Have Sex With Men
A study testing Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging and Standard online message with an invitation for free HIV testing similar in content to other Peruvian websites in people with HIV Testing, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
Trial summary
The proposed study is designed to develop and test the effectiveness of a novel web-based HIV intervention to motivate HIV testing among men who have sex with men (MSM). The intervention arm includes the delivery of videos tailored to the reasons MSM have for not getting tested for HIV, as well as HIV testing… 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 Testing
- What is being tested?
- Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging and Standard online message with an invitation for free HIV testing similar in content to other Peruvian websites
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 sitePeru
- Study dates
- Jan 2013to Mar 2015
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be 18 years of age or older,
- be a man and report having had sex with a man within the last 12 months,
- be a resident of metropolitan Lima, Peru,
- have not been tested for HIV within the last 12 months,
- have a valid e-mail address,
- do not report being HIV positive.
Who cannot join
- Do not meet the inclusion criteria specified above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Evaluate the Effect of a Novel Web-based Intervention to Increase HIV Testing in Men Who Have Sex With Men in Lima-Peru
The proposed study is designed to develop and test the effectiveness of a novel web-based HIV intervention to motivate HIV testing among men who have sex with men (MSM). The intervention arm includes the delivery of videos tailored to the reasons MSM have for not getting tested for HIV, as well as HIV testing motivational messages sent via mobile-phone text messaging, e-mail or instant messaging. The intervention and assessments will be guided by the Information-Motivation-Behavioral skills model, the Health Belief Model and the Stages of Change theory. The control intervention will be a health promotion message (similar in content to other Peruvian websites) with an invitation for free HIV testing. Testing will be offered at the Via Libre and Epicentro clinic, and at a mobile unit whose location will be determined based on participants' demand. The outcomes evaluated will be intention to get tested and actual HIV testing among MSM of each of the trial arms.
- Conditions
- HIV Testing
- Being tested
- Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging, Standard online message with an invitation for free HIV testing similar in content to other Peruvian websites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messagingBehavioural
Standard online message with an invitation for free HIV testing similar in content to other Peruvian websitesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Health promotion message | Placebo comparator | Standard online message with an invitation for free HIV testing similar in content to other Peruvian websites Receives: Behavioral: Standard online message with an invitation for free HIV testing similar in content to other Peruvian websites |
| Combined Web-based HIV intervention | Experimental | Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging Receives: Behavioral: Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV testing
Measured: 6 months after been exposed to the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV TestingStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Peruana Cayetano Heredia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), NGO Via Libre
- Responsible party
- Principal investigator, Magaly Blas, Universidad Peruana Cayetano Heredia
- Investigators
- Magaly M Blas, MD, PhD, Principal investigator, Universidad Peruana Cayetano Heredia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760057
- Sponsor's protocol ID
- R01TW008398
- Acronym
- TuNexo
- Status last verified
- May 2015
- First submitted
- 28 Dec 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Blas MM, Alva IE, Cabello R, Carcamo C, Kurth AE. Risk behaviors and reasons for not getting tested for HIV among men who have sex with men: an online survey in Peru. PLoS One. 2011;6(11):e27334. doi: 10.1371/journal.pone.0027334. Epub 2011 Nov 9.
PubMed 22096551Blas MM, Alva IE, Carcamo CP, Cabello R, Goodreau SM, Kimball AM, Kurth AE. Effect of an online video-based intervention to increase HIV testing in men who have sex with men in Peru. PLoS One. 2010 May 3;5(5):e10448. doi: 10.1371/journal.pone.0010448.
PubMed 20454667Blas MM, Alva IE, Cabello R, Garcia PJ, Carcamo C, Redmon M, Kimball AM, Ryan R, Kurth AE. Internet as a tool to access high-risk men who have sex with men from a resource-constrained setting: a study from Peru. Sex Transm Infect. 2007 Dec;83(7):567-70. doi: 10.1136/sti.2007.027276. Epub 2007 Oct 11.
PubMed 17932128Curioso WH, Blas MM, Nodell B, Alva IE, Kurth AE. Opportunities for providing web-based interventions to prevent sexually transmitted infections in Peru. PLoS Med. 2007 Feb;4(2):e11. doi: 10.1371/journal.pmed.0040011.
PubMed 17326701Blas MM, Menacho LA, Alva IE, Cabello R, Orellana ER. Motivating men who have sex with men to get tested for HIV through the internet and mobile phones: a qualitative study. PLoS One. 2013;8(1):e54012. doi: 10.1371/journal.pone.0054012. Epub 2013 Jan 8.
PubMed 23320116
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Effect of a Novel Web-based Intervention to Increase HIV Testing in Men Who Have Sex With Men in Lima-Peru
- ClinicalTrials.gov ID
- NCT01760057
- Acronym / sponsor ID
- TuNexo / R01TW008398
- Conditions
- HIV Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Universidad Peruana Cayetano HerediaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), NGO Via Libre
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Jan 2013 (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 proposed study is designed to develop and test the effectiveness of a novel web-based HIV intervention to motivate HIV testing among men who have sex with men (MSM). The intervention arm includes the delivery of videos tailored to the reasons MSM have for not getting tested for HIV, as well as HIV testing motivational messages sent via mobile-phone text messaging, e-mail or instant messaging. The intervention and assessments will be guided by the Information-Motivation-Behavioral skills model, the Health Belief Model and the Stages of Change theory. The control intervention will be a health promotion message (similar in content to other Peruvian websites) with an invitation for free HIV testing. Testing will be offered at the Via Libre and Epicentro clinic, and at a mobile unit whose location will be determined based on participants' demand. The outcomes evaluated will be intention to get tested and actual HIV testing among MSM of each of the trial arms.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health promotion message | Placebo comparator | Behavioral: Standard online message with an invitation for free HIV testing similar in content to other Peruvian websitesStandard online message with an invitation for free HIV testing similar in content to other Peruvian websites |
| Combined Web-based HIV intervention | Experimental | Behavioral: Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messagingOnline HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be 18 years of age or older,
- be a man and report having had sex with a man within the last 12 months,
- be a resident of metropolitan Lima, Peru,
- have not been tested for HIV within the last 12 months,
- have a valid e-mail address,
Key exclusion criteria (1 listed)
- Do not meet the inclusion criteria specified above
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 HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging | Behavioural | Combined Web-based HIV intervention |
| Standard online message with an invitation for free HIV testing similar in content to other Peruvian websites | Behavioural | Health promotion message |
Primary outcome
HIV testing
Time frame: 6 months after been exposed to the intervention
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 28 May 2015.
- Background: PubMed 22096551Blas MM, Alva IE, Cabello R, Carcamo C, Kurth AE. Risk behaviors and reasons for not getting tested for HIV among men who have sex with men: an online survey in Peru. PLoS One. 2011;6(11):e27334. doi: 10.1371/journal.pone.0027334. Epub 2011 Nov 9.
- Background: PubMed 20454667Blas MM, Alva IE, Carcamo CP, Cabello R, Goodreau SM, Kimball AM, Kurth AE. Effect of an online video-based intervention to increase HIV testing in men who have sex with men in Peru. PLoS One. 2010 May 3;5(5):e10448. doi: 10.1371/journal.pone.0010448.
- Background: PubMed 17932128Blas MM, Alva IE, Cabello R, Garcia PJ, Carcamo C, Redmon M, Kimball AM, Ryan R, Kurth AE. Internet as a tool to access high-risk men who have sex with men from a resource-constrained setting: a study from Peru. Sex Transm Infect. 2007 Dec;83(7):567-70. doi: 10.1136/sti.2007.027276. Epub 2007 Oct 11.
- Background: PubMed 17326701Curioso WH, Blas MM, Nodell B, Alva IE, Kurth AE. Opportunities for providing web-based interventions to prevent sexually transmitted infections in Peru. PLoS Med. 2007 Feb;4(2):e11. doi: 10.1371/journal.pmed.0040011.
- Results publication: PubMed 23320116Blas MM, Menacho LA, Alva IE, Cabello R, Orellana ER. Motivating men who have sex with men to get tested for HIV through the internet and mobile phones: a qualitative study. PLoS One. 2013;8(1):e54012. doi: 10.1371/journal.pone.0054012. Epub 2013 Jan 8.
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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.
Magaly M Blas, MD, PhD principal investigator
Universidad Peruana Cayetano Heredia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging and Standard online message with an invitation for free HIV testing similar in content to other Peruvian websites in people with HIV Testing, run by Universidad Peruana Cayetano Heredia at 1 site in Peru.
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 6 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: finished, as of the sponsor's last update on 28 May 2015. 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 Peru. 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. Some participants in this study may receive a placebo. 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?
HIV testing (time frame: 6 months after been exposed to the intervention). 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 NCT01760057, which also lists 5 linked publications.
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 28 May 2015.