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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)

This study is currently recruiting participants.
Verified January 2013 by Universidad Peruana Cayetano Heredia
Sponsor:
Collaborators:
National Institutes of Health (NIH)
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
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Universidad Peruana Cayetano Heredia:

Primary Outcome Measures:
  • HIV testing [ Time Frame: 6 months after been exposed to the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760057

Contacts
Contact: Magaly M Blas, MD, PhD 51-995386711 magaly.blas@upch.pe
Contact: Luis Menacho, MD, MPH luchomenacho@gmail.com

Locations
Peru
Universidad Peruana Cayetano Heredia Recruiting
Lima, Peru
Contact: Magaly M Blas, MD, MPH, PhD     51-995386711     magaly.blas@upch.pe    
Contact: Luis Menacho, MD, PhD         luchomenacho@gmail.com    
Principal Investigator: Magaly M Blas, MD, MPH, PhD            
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

Publications:

Responsible Party: Magaly Blas, Research professor, Universidad Peruana Cayetano Heredia
ClinicalTrials.gov Identifier: NCT01760057     History of Changes
Other Study ID Numbers: R01TW008398
Study First Received: December 28, 2012
Last Updated: January 18, 2013
Health Authority: Peru: Institutional Review Board of the Universidad Peruana Cayetano Heredia
Peru: Institutional Review Board of the Non-governmental Organization Via Libre

Additional relevant MeSH terms:
HIV Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013