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Evaluating the Effect of a Novel Web-based Intervention to Increase HIV Testing in Men Who Have Sex With Men (TuNexo)

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ClinicalTrials.gov Identifier: NCT01760057
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : May 28, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
NGO Via Libre
Information provided by (Responsible Party):
Magaly Blas, Universidad Peruana Cayetano Heredia

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Testing Behavioral: Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging Behavioral: Standard online message with an invitation for free HIV testing similar in content to other Peruvian websites Not Applicable

Study Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Study Start Date : January 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Health promotion message
Standard online message with an invitation for free HIV testing similar in content to other Peruvian websites
 Behavioral: Standard online message with an invitation for free HIV testing similar in content to other Peruvian websites
Experimental: Combined Web-based HIV intervention
Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging
 Behavioral: Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HIV testing [ Time Frame: 6 months after been exposed to the intervention ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Do not meet the inclusion criteria specified above
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760057


Locations
Peru
Universidad Peruana Cayetano Heredia
Lima, Peru
Sponsors and Collaborators
Universidad Peruana Cayetano Heredia
National Institutes of Health (NIH)
NGO Via Libre
Investigators
Principal Investigator: Magaly M Blas, MD, PhD Universidad Peruana Cayetano Heredia
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Responsible Party: Magaly Blas, Research professor, Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT01760057     History of Changes
Other Study ID Numbers: R01TW008398 ( U.S. NIH Grant/Contract )
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015