Abstract
BackgroundIn the recent years, the Internet has been used as a medium to find sexual partners and engage in risky sexual behavior. This has changed the way in which men having have sex with men (MSM) seek sexual partners and has increased the number of high-risk sexual encounters. Therefore, developers of human immunodeficiency virus (HIV)-prevention interventions have also started using the Internet as a viable medium to promote safe sexual behaviors. However, much of the efforts thus far have been aimed at HIV-negative rather than HIV-positive MSM. HIV-positive individuals continue to engage in risky sexual behaviors and thus constitute an important group in which HIV prevention strategies need to be addressed. Therefore, HIV prevention in HIV-positive MSM is a critical issue.ObjectiveCondom-Him, an Internet-based intervention tailored to increase condom use among HIV-positive MSM, was developed with the aim of improving condom use, self-efficacy, and intentions to use condoms among these individuals. The acceptability and feasibility of this Internet-based intervention will be examined in a pilot study.MethodsWe will perform a randomized controlled parallel-group superiority trial. HIV-positive MSM who currently engage in unprotected anal sex will be recruited for the study. Participants will be randomly assigned using a one-to-one allocation ratio generated by the computer program. The researchers will be blinded to participant’s group assignment. Participants will be assigned either to use the Condom-Him intervention (experimental arm) or to view a list of websites containing HIV/AIDS related information (control arm). Self-administered questionnaires will be provided online before randomization (baseline) and two weeks after intervention (post-test).ResultsThe study will include a total of 60 participants with 30 in each group. The results from this pilot study will provide further evidence for a larger study to examine the effectiveness of this intervention and will provide a cost-effective and widely accessible approach to HIV prevention for HIV-positive MSM.ConclusionsInternet-based interventions for HIV-positive MSM, a population that has been under-represented in the efforts for positive prevention of HIV within Canada, have the potential to provide a cost-effective strategy, which influences the way in which information is accessed and provided to high-risk individuals. The advantages of an Internet-based intervention include the potential to provide consistency in the delivery of an intervention and the ability to disseminate the intervention to a wider population. Internet-based interventions are perceived as vital tools in combating HIV infection within the realm of social media. Therefore, it is important to determine the feasibility and acceptability of these interventions before implementing them.Trial RegistrationClinicaltrials.gov: NCT01726153; http://clinicaltrials.gov/ct2/show/NCT01726153 (Archived by WebCite at http://www.webcitation.org/6Jljzip8B).
Highlights
A randomized control trial of an internet-based intervention to increase condom use among HIV-positive men who are having sex with men: protocol for the Condom-HIM intervention
TITLE 1a-i) Identify the mode of delivery in the title "An internet-based intervention" 1a-ii) Non-web-based components or important co-interventions in title The paper does not mention non-web-based components such as email which is used in the intervention as the emphasis is not on the e-mail component of the intervention. 1a-iii) Primary condition or target group in the title "Positive men who have sex with men" ABSTRACT 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT "Participants will be assigned either to use the Condom-HIM intervention condition or to view a list of websites containing HIV/AIDS related information". 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
"A total of 60 participants, 30 per experimental and 30 per control group will participate in the study". 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials Due to this manuscript being a study protocol, the results are not yet available and conclusions based on the results of the study cannot be discussed at this moment in time
Summary
A randomized control trial of an internet-based intervention to increase condom use among HIV-positive men who are having sex with men: protocol for the Condom-HIM intervention. 12a) CONSORT: Statistical methods used to compare groups for primary and secondary outcomes Independent t-tests will be used to examine the differences between the control and experimental groups in terms of participants’ self-efficacy, intention to use condoms, and actual condom use prior to the intervention and 2 weeks post intervention.
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