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

This study has been completed.

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: May 27, 2015

Last verified: May 2015

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 ]


Enrollment:	400
Study Start Date:	January 2013
Study Completion Date:	March 2015
Primary Completion Date:	February 2014 (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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:

Blas 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.

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.

Blas 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.

Blas 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. Epub 2007 Oct 11.

Curioso 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.


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:	May 27, 2015
Health Authority:	Peru: Institutional Review Board of the Universidad Peruana Cayetano Heredia Peru: Institutional Review Board of the Non-governmental Organization Via Libre

ClinicalTrials.gov processed this record on September 23, 2016

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