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

May 27, 2015 updated by: Magaly Blas, Universidad Peruana Cayetano Heredia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Peru
      • Lima, Peru
        • Universidad Peruana Cayetano Heredia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIV testing
Time Frame: 6 months after been exposed to the intervention
6 months after been exposed to the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Peruana Cayetano Heredia

Collaborators

National Institutes of Health (NIH)
NGO Via Libre

Investigators

  • Principal Investigator: Magaly M Blas, MD, PhD, Universidad Peruana Cayetano Heredia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 28, 2012

First Submitted That Met QC Criteria

December 28, 2012

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • R01TW008398 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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