An Internet-Based Intervention (Condom-Him) to Increase Condom Use Among HIV-Positive Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial

Background In 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. Objective Condom-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. Methods We 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). Results The 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. Conclusions Internet-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 Registration Clinicaltrials.gov: NCT01726153; http://clinicaltrials.gov/ct2/show/NCT01726153 (Archived by WebCite at http://www.webcitation.org/6Jljzip8B).

INTRODUCTION 2a-i) Problem and the type of system/solution "Many individuals who engage in risky sexual behaviors use the Internet to meet their sexual partners, and the Internet itself may facilitate such risktaking behaviors [5,6]. To adhere to current trends, those working in the field of HIV prevention need to incorporate the same medium individuals use in order to reduce risky sexual behaviors. Thus developing technological innovations such as Internet-based interventions is critical". 2a-ii) Scientific background, rationale: What is known about the (type of) system "Many individuals who engage in risky sexual behaviors use the Internet to meet their sexual partners, and the Internet itself may facilitate such risktaking behaviors [5,6]." METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio "The primary objective of this study is to examine the overall feasibility and acceptability of the Internet-based intervention 2 weeks post intervention as well as examining participants' utilization of the Internet-based intervention". 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons The study is currently being piloted to identify any required changes to the study design. 3b-i) Bug fixes, Downtimes, Content Changes The study is currently being piloted to identify any required changes to the study design. 4a) CONSORT: Eligibility criteria for participants "Individuals will be selected to participate in the study if they meet the following preset inclusion criteria: (1) 18 years of age or older, (2) HIV-positive, (3) are men who are having sex with men, (4) engage in unprotected anal intercourse with a partner who is HIV-negative or of unknown status, (5) read English, and (6) have access to a computer and the Internet". 4a-i) Computer / Internet literacy The study details that participants must have access to a computer and internet. It does not specifically indicate that participants must have computer/internet literacy skills. 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: "A two-pronged approach will be used to recruit participants. The first method of recruitment will use internet-based methods (i.e. advertisement in chatrooms, online classified ads, social media such as facebook and twitter, links to the intervention website will be posted on within various HIV/AIDS community center websites). The second method of recruitment will use offline strategies (i.e. flyers and brochures will be posted in various community sexual health clinics). Advertisement in local newspapers will also be used to aid in participant recruitment". 4a-iii) Information giving during recruitment "Participants interested in the study will be directed to the study website where further information regarding the study will be provided via a video. Participants interested in the study, will be asked to complete an on-line consent form. The consent form will provide information relating to the study in addition to research staff telephone and e-mail contacts for further questions prior to consenting to participate". 4b) CONSORT: Settings and locations where the data were collected "The data that is collected online will be stored on a secured server located at the Research Chair -Centre Hospitalier de l'Université de Montreal (CR-CHUM)". 4b-i) Report if outcomes were (self-)assessed through online questionnaires "All measurements are self-administered online". 4b-ii) Report how institutional affiliations are displayed This information is not addressed within the study protocol, but is in fact identified within the study website. Each of the academic and research institutions are identified in the study website. 5) CONSORT: Describe the interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners This information is not identified within the study protocol. The information of the developers is addressed within the actual study website. 5-ii) Describe the history/development process Information describing the history/development of the intervention is not addressed within this study protocol as the emphasis is on the pilot study itself. A future manuscript will be produced based on the development of the internet-based intervention.

5-iii) Revisions and updating
The study protocol is the first version as it is being pilot tested, there are no revisions to date. 5-iv) Quality assurance methods This information is not identified within the study protocol. The aim of the study is to determine its feasibility and acceptability. Results from this pilot study will help the research team determine whether or not the current quality measures implemented in the study will need to be revised/addressed. 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used As the study is currently a pilot study to determine its feasibility, the algorithm has not yet been made available.

5-vi) Digital preservation
The study protocol is being implemented at the moment and therefore this information has not yet been made available as it may be revised based ont he study results.

5-vii) Access
The study protocol is being implemented at the moment and therefore this information is unavailable. 5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework "The single session is divided into three segments to increase condom use, self-efficacy in condom use and intention to use condoms: 1. Planning condom use when having anal intercourse; 2. Negotiating the use of a condom with a partner; and 3. Choosing not to have sexual intercourse without a condom. Within each of the three segments of the intervention, participants are given tailored messages pertaining to the focus of the segment. The Intervention Mapping method was used to develop the intervention. This process consists of six consecutive steps to systematically develop health promotion programs using theory, empirical evidence from the literature, and additional evidence from research [12]. The theory-informed methods and practical strategies chosen to increase condom use practices of the target population were supported by Social Cognitive Theory and the Theory of Planned Behavior." 5-ix) Describe use parameters The study protocol is being implemented at the moment and therefore this information is currently being tested in the pilot study.

5-x) Clarify the level of human involvement
The study protocol is being implemented at the moment and therefore this information is currently being tested in the pilot study. 5-xi) Report any prompts/reminders used "Participants will be sent an e-mail two-weeks post intervention reminding them to revisit the study website to complete the post-test questionnaires". 5-xii) Describe any co-interventions (incl. training/support) This information is not relevant as there are no additional co-interventions. 6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed "The outcomes of the study will be collected at two points in time: pre-intervention (T0) two-weeks post intervention (T1)".
"The primary outcome measure is condom use. Secondary outcome measures include self-efficacy in condom use, intention to increase condom use, and the acceptability, feasibility, and utilization of Condom-HIM. All measurements are self-administered online". 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed The information relating to online questionnaire development is not addressed within the study protocol as the study is currently being pilot tested. 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored "The utilization of the Internet-based intervention will be measured by the length of time participant spent in completing the single session". 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained "participants' qualitative responses to open questions in regards to the acceptability of Condom-HIM will be content analyzed to identify any problems with the intervention". 6b) CONSORT: Any changes to trial outcomes after the trial commenced, with reasons This information is not relevant at this point in time as the study is currently being tested. 7a) CONSORT: How sample size was determined 7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size "The sample size calculation is based on the rule of 10 cases per independent variable included in the analysis". 7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines This information is not relevant at this point in time as the study is currently being tested. 8a) CONSORT: Method used to generate the random allocation sequence "The participant assignment protocol will be based on a ratio of 1:1, which will be performed by a computer program". 8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) This information is not relevant to the study as the randomization allocation sequence is a 1:1 ratio. 9) CONSORT: Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned "The computer program will automatically allocate participants at random to either the experimental or control condition". 10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions "Due to the automatic nature of the allocation process, there are no direct exposure to the treatment allocation process by any members of the research team". 11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who wasn't The researcher will be blinded to the participant's treatment assignment. Only the research assistant, who will be downloading the data, will be the only individual aware of the participant's assignment. The research assistant will not have any participation in the random assignment of participants as this process has been removed from any individuals and is completely being conducted by the computer system programming.
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator"