Evaluating the Effect of a Novel Web-based Intervention to Increase HIV Testing in Men Who Have Sex With Men (TuNexo)
This study is currently recruiting participants.
Verified January 2013 by Universidad Peruana Cayetano Heredia
Sponsor:
Universidad Peruana Cayetano Heredia
Collaborators:
NGO Via Libre
Information provided by (Responsible Party):
Magaly Blas, Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier:
NCT01760057
First received: December 28, 2012
Last updated: January 18, 2013
Last verified: January 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 28, 2012 | ||||||||
| Last Updated Date | January 18, 2013 | ||||||||
| Start Date ICMJE | January 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
HIV testing [ Time Frame: 6 months after been exposed to the intervention ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01760057 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluating the Effect of a Novel Web-based Intervention to Increase HIV Testing in Men Who Have Sex With Men | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
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| Condition ICMJE | HIV Testing | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Peru | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01760057 | ||||||||
| Other Study ID Numbers ICMJE | R01TW008398 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Magaly Blas, Universidad Peruana Cayetano Heredia | ||||||||
| Study Sponsor ICMJE | Universidad Peruana Cayetano Heredia | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Universidad Peruana Cayetano Heredia | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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