Feasibility and Preliminary Effectiveness of the Homework Intervention Strategy (eHIS) Program to Enhance Male Condom Use: Research Protocol

Abstract

BackgroundAlthough condoms are effective in reducing the risk of sexually transmitted infections (STIs) and unintended pregnancy, they are still often not used consistently and correctly. Negative impact on sensation and pleasure, ruining the mood, causing problems with maintaining erection, and condom slippage or breakage are some of the reasons given by men explaining why they do not want to use condoms. Although many interventions promoting condom use exist, some of them delivered online are complex and time- and resource-intensive. The Homework Intervention Strategy (eHIS) program, adapted from the existing face-to-face Kinsey Institute Homework Intervention Strategy (KIHIS) program, aims to address these issues by encouraging men to focus on sensation and pleasure when trying different types of condoms and lubricants in a low-pressure situation (on their own, without a partner present).ObjectiveThe objectives of this study are to assess the feasibility, acceptability, and users’ engagement with the eHIS program, its preliminary effectiveness in increasing condom use frequency and consistency, as well as the feasibility of the program's evaluation approach, including choice of measures and participant recruitment and retaining strategies (primary outcomes). Secondary outcomes include condom use experience, condom use attitudes, condom use self-efficacy, condom use errors and problems, and condom fit-and-feel. All of these will be analyzed in the context of participants’ demographics, sexual history, and previous condom use.MethodsThe study has a pre-post-test, within-subjects design. Men aged 18 to 69 and living in the United Kingdom are recruited through posters, leaflets, social media, and emails. Study participants are asked to complete T1 (baseline) measures before entering the eHIS website. After completing the T1 measures, they can order a free condoms and lubricants kit and have access to the eHIS website for 4 weeks. During that time they are asked to practice using different types of condoms and lubricants on their own in a no-pressure situation. Following T1, participants are asked to complete the T2 and T3 measures at 4 and 10 weeks, respectively.ResultsData collection for the study is completed. Data analysis is in progress and is expected to be completed by February 2018.ConclusionsThis brief, home-based, self-guided program may lead to increased consistent and correct condom use. Online delivery can make the program an easily accessible and low-cost health promotion intervention, which has the potential to reach a wide and diverse audience. If results of the current study show the program’s feasibility and preliminary effectiveness in changing condom use related outcomes, a larger scale randomized controlled trial (RCT) will be conducted.Trial RegistrationResearch Registry: researchregistry2325; http://www.researchregistry.com/browse-the-registry.html# home/registrationdetails/58da6cad1d7ab0314337d076/ (Archived by WebCite at http://www.webcitation.org/6vXs6S9XW)

Reducing New Chlamydia Infection Among Young Men by Promoting Correct and Consistent Condom Use: Protocol for a Randomized Controlled Trial

“…The trial is delivered using Lifeguide , an interactive web-based intervention software platform and secure validated data management system designed to collect participant information and deliver digital interventions to support health behavior change [ 23 , 26 ]. The Lifeguide platform can be accessed via any internet-enabled device, and recruitment sites are provided with handheld tablet computers for recruitment purposes.…”

“…Our trial is powered to detect a 45% reduction in chlamydia test positivity among our intervention arms—from 11% to 6% at 6 months after randomization. Previous piloting suggests that the intervention is likely to be equally effective across all stratification subgroups (deprivation, ethnicity, sexual orientation, and age) [ 22 , 23 ].…”

“…Two development and feasibility studies were conducted to inform the adapted design of the HIS-UK intervention, research methodology, and data collection tools [22][23][24]. The following 2 delivery models of the education and training component of HIS-UK were designed: (1) face-to-face delivery by a trained health professional (ProHIS) and (2) a digital intervention using an interactive website (e-HIS) and without the need for specialist provider contact.…”

Evaluating the Home-based Intervention Strategy (HIS-UK) to reduce new chlamydia infection among young men aged 16-25 years by promoting correct and consistent condom use: Findings from a randomised controlled trial

“…The trial was designed to detect a reduction in positivity rates from 11% (observed among men aged 15-24 years in national screening [33]) to 6% at six months post randomisation. Based on pilot data suggesting equal intervention effectiveness across subgroups (deprivation, ethnicity, sexual orientation, age) and aiming for 85% power and assuming 36% attrition (observed in feasibility testing), the trial targeted 2231 participants across all arms (G*Power 3.1.9.2) [24,25,34]. Progression criteria were established for recruitment, uptake of STI screening and follow-up attrition [27].…”

“…Development of the HIS-UK intervention was guided by the Information-Motivation-Behavioural Skills (IMBS) theoretical model of behaviour change which has been shown to be effective with young people [21,22]. In HIS-UK the impetus for change comes from the promotion of solitary experimentation with different condom and lubricant types and a focus on pleasure [23][24][25][26].…”