Reproductive health Urological and Genital Diseases
Conditions
Interventions
Feasibility study:
Baseline
Participants will be recruited from a STI self-sampling website, freetest.me. After requesting a self-sampling kit, users of the website will be shown one of six brief mes
demographics information, STI diagnosis, sexual wellbeing, condom use, motivation, intentions and attitude, health economics and adverse effects. One reminder will be sent if the baseline survey is in
Sponsors
University of Hertfordshire
Eligibility
Sex/Gender
All
Age
16 Years to 24 Years
Inclusion criteria
Inclusion criteria: Feasibility trial: 1. Young people aged 16-24 years 2. Living in one of the Local Authority locations involved in the study Nested qualitative study: 3. A participant of the trial 4. Sexual partner of someone participating in the trial
Exclusion criteria
Exclusion criteria: Feasibility trial: 1. No internet access 2. Having sexual preferences which mean that they are unlikely to have penetrative sex (penis in either vagina or anus) over the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 23/06/2025: 1. The proportion of participants recruited to the feasibility RCT per day (assessed as the number of participants randomised) out of those in the sampling pool 2. The percentage of randomised participants with valid primary outcome measure (chlamydia positivity measured using biological samples) at 12 months Previous primary outcome measures: 1. The proportion of participants recruited to the feasibility RCT per day (assessed as the number of participants randomised) out of those using freetest.me in the four areas 2. The percentage of randomised participants with valid primary outcome measure (cumulative incidence of chlamydia measured using biological samples) at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 23/06/2025: 1. Percentage of participants with outcome data required to measure the cumulative incidence of chlamydia (measured using M3 and M12 chlamydia self-sample, and the relevant item within M3, M6 and M12 surveys) 2. Distribution of IMD quintile among those in the sampling pool compared to that of the final sample (deprivation assessed using IMD based on participants’ postcodes) 3. Percentage of randomised participants with valid primary outcome measure at 12 months by group (gender, ethnicity, sexual identity, deprivation, randomised groups, chlamydia diagnosis at baseline) 4. Percentage of participants with a positive chlamydia test result at 12 months in the intervention and control groups 5. Attrition curves comparing the percentage of valid participants in the trial at randomisation, M3, M6 and M12 plotted for the intervention and control arms (drop-out attrition) 6. The percentage of valid participants in the two arms that don’t achieve pre-determined intervention ‘goals’, and the bounce rate for home and content pages (assessed using web analytics data at 12M) 7. Completeness of data from outcome measures that would be needed in a definitive trial (including self-report of chlamydia result at baseline, results from biological samples [3M and 12M], demographic information [baseline survey], self-report of condom use [all surveys], and data needed for cost-effectiveness and cost utility analyses [all surveys]) 8. The number of participants randomised as a direct result of each of the different recruitment messages employed (assessed using web analytics data at end of recruitment) 9. Completeness of data on costs and resource use that would be needed for the economic evaluation in a definitive trial (all surveys) 10. Proportion of participants in the control group who report (at 12M survey) any exposure to Wrapped 11. Proportion of participants who report (at M12 survey) having experienced an adverse event during t | — |
Countries
England, United Kingdom
Outcome results
None listed