Individuals and test size reason
An overall total of 400 topics should be recruited for the RCT. Predicated on an impact measurements of 0.3 (as reported in meta-analysis ), it’s been determined that the test size for every single group should really be 175 (for example. 350 as a whole) to accomplish 80% power in detecting a between-group distinction using a separate t-test at a 0.05 importance degree. Presuming a believed 12.4% attrition price (as reported in a RCT in a comparable environment ), a complete of 400 subjects (for example. 200 subjects in each team) is important.
To qualify for addition into the RCT, people must certanly be i that is( MSM, (ii) cis male, (iii) aged 18 or above, (iv) present dating application users, (v) -negative, (vi) intimately active, and (vii) able to see and comprehend Chinese.
Numerous resources of recruitment shall be used. First, neighborhood non-governmental organisations that target the MSM population will make it possible to recruit individuals. Second, because of the high prevalence of dating use that is app college students based in the previous research , mass college email messages and on-campus posters will likely be utilized to recruit possible individuals. Third, marketing materials is going to be published on social media and online discussion boards focusing on MSM. 4th, direct recruitment via dating apps will need destination. Finally, snowballing is supposed to be utilized, with enrolled individuals asked to invite possibly interested buddies to get in on the research.
On the web consent and enrolment
Individuals will enrol when you look at the test through the intervention site. an assessment questionnaire shall be administered to make sure participant eligibility. Qualified individuals will likely then be expected to signal a consent that is electronic and supply email address. After these initial actions, individuals will likely be required to accomplish a web-based standard questionnaire.
Randomisation and allocation concealment
After conclusion associated with the standard questionnaire, individuals is going to be arbitrarily assigned to either the intervention control or team group via computer-generated block randomisation (with blocks of size 4) on a 1:1 randomisation ratio; no stratification is likely to be used. Individuals will likely be immediately directed to your content connected with their allocation.
A participatory design approach is employed to build up the intervention. a qualitative research has been carried out to understand dating app usersвЂ™ experience of using dating apps and participating in dangerous intimate behaviours and exploring what elements of sexual health training will tend to be appealing and engaging to the populace. The findings associated with qualitative research will notify the intervention development.
The theoretical framework associated with the intervention are on the basis of the TPB. The aims for the intervention are to: (i) encourage a confident mindset towards constant condom usage and /STI testing, and bad attitude towards chemsex and team sex; (ii) place condom use and regular /STI testing as normative; and (iii) improve observed self-efficacy concerning condom usage and settlement and /STI testing. The intervention is likely to feature: (i) interactive elements, and (ii) other academic materials.
The control team will be involved in a web-based intervention without any intimate wellness information.
Individuals both in teams will soon be afforded access that is unlimited their allocated content within the 6-month research duration, but that content are going to be available simply to individuals who sign in with a subscribed current email address and password. The content accessed by the intervention group will be made available to the control group subjects as well after the study period.
The analysis results will likely to be calculated both in teams at baseline (T0) as well as a couple of months (T1) and six months (T2) after standard. The outcome that is primary end up being the regularity of condomless anal intercourse in past times a couple of months, on the basis of the suggestion of the systematic report on 56 studies . The additional results will function as regularity of team intercourse and chemsex, self-efficacy and attitudes toward condom usage, and regularity of as well as other STI evaluating.
Data on these results is gathered and examined the following.
Regularity of condomless anal intercourse in yesteryear a few months is calculated by way of a self-reported product at standard, 3-month follow-up and 6-month followup.
Frequency of team intercourse in past times a few months is calculated by a self-reported product at standard, 3-month follow-up and 6-month followup.
Frequency of chemsex in past times a few months is calculated by a self-reported item at standard, 3-month follow-up and follow-up that is 6-month.
Self-efficacy in condom usage is calculated by the validated conventional Chinese form of the Condom Self-Efficacy Scale at standard, 3-month follow-up and 6-month that is follow-up.
Attitudes towards condom usage is calculated because of the UCLA Multidimensional Condom Attitudes Scale at standard, 3-month follow-up and 6-month follow-up .
Regularity of evaluating in the past a couple of months is calculated with a self-reported item at baseline, 3-month follow-up and 6-month followup.
Frequency of STI screening in past times a few months is measured by a self-reported item at standard, 3-month follow-up and follow-up that is 6-month.
Finally, individualsвЂ™ sociodemographic traits ( ag e.g. age and training degree), intimate records ( e.g. chronilogical age of intimate initiation), reported utilization of pre-exposure prophylaxis and their habits of dating usage that is app be gathered.
At 6-month follow-up (T2), individuals are going to be expected if they discover the web-based information helpful consequently they are pleased with the information that is web-based.
dining dining Table 1 shows the SPIRIT diagram for the schedule of enrolment, interventions, and assessments.
Dining Table 1
SPIRIT diagram for the routine of enrolment, interventions, and assessments