“Test n Treat”: a feasibility trial of rapid STI testing and treatment
| ISRCTN | ISRCTN58038795 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58038795 |
| Secondary identifying numbers | 20672 |
- Submission date
- 05/04/2016
- Registration date
- 31/08/2016
- Last edited
- 16/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Chlamydia and gonorrhoea are sexually transmitted infections affecting 150,000 young people in England and costing over £100 million each year. Despite this, very few young people seek testing (<30% annually), which is too low to reduce infection rates, and there are often delays in the time between diagnosis and treatment. Bringing new rapid 90 minute chlamydia/gonorrhoea tests and on-site treatment (“TnT=Test n Treat”) to the community might get more people treated faster. This could reduce infection rates and serious complications like infertility, and save NHS costs. The aim of this study is to see if it is feasible to conduct a trial to see if offering rapid testing for chlamydia/gonorrhoea and on the spot treatment can reduce infection rates in young people.
Who can participate?
Students aged between 16 and 24 who have had penetrative sexual intercourse at least once.
What does the study involve?
Six further education colleges are taking part in this study, with 80 students being recruited from each. Participating colleges are randomly allocated to one of two groups. One month after this, colleges in the first group are visited on two consecutive days by the TnT team. The participating students from these colleges are then sent a text message inviting them to come for on-site rapid chlamydia/gonorrhoea testing. At the testing, students provide self-taken urine or vaginal samples which are immediately tested. Negative results will be sent to participants by text or WhatsApp or whatever preferred method they prefer. Students with positive results are telephoned and invited to come to the college nurse’s room for treatment, partner notification, advice and follow up by a visiting nurse health adviser. After four months, this process is repeated. Participants attending colleges in the second group continue as normal, and receive text messages at one and four months, thanking them for taking part in the study. At the start of the study and then seven months later, participants provide samples which are all tested at seven months for chlamydia/gonorrhoea. At the same times, participants complete a questionnaire about their sexual health. The time it takes for 80 participants to be recruited at each college is recorded at the start of the study and at the end. The number of participants who gave samples and sought treatment is also recorded.
What are the possible benefits and risks of participating?
Students who provide samples for rapid Test and Treat in college will be checked for chlamydia and gonorrhea and treated if necessary. This might prevent infection spreading to the testicles or womb and causing long-term complications. All students who take part in the TnT study will be given £5 and a lollipop at recruitment and £10 and a lollipop at seven months follow up. Those who take part in interviews will receive £10 for their time. There are no notable risks involved with participating in the study.
Where is the study run from?
The study is run by St George's, University of London and takes place in six further education colleges in London (UK)
When is the study starting and how long is it expected to run for?
September 2014 to December 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Professor Pippa Oakeshott (scientific)
2. Ms Sarah Kerry (scientific)
Contact information
Scientific
Population Health Research Institute
St George's, University of London
London
SW17ORE
United Kingdom
Scientific
Population Health Research Institute
St George's, University of London
London
SW17ORE
United Kingdom
 ORCID ID |
0000-0002-3794-8335 |
|---|
Study information
| Study design | Cluster randomised feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Screening |
| Participant information sheet | ISRCTN58038795_PIS_01Jun2016_V5.doc |
| Scientific title | “Test n Treat (TnT)”: a cluster randomised feasibility trial of frequent, rapid testing and same day on-site treatment to reduce rates of chlamydia and gonorrhoea in high risk Further Education college students |
| Study acronym | Test n Treat (TnT) |
| Study objectives | The aim of this study is to assess the feasibility of conducting a trial of "Test n Treat" (TnT) in further education (FE) colleges, and obtain estimates of key values to inform sample size estimates and timescales. |
| Ethics approval(s) | Bromley NRES Committee London, 21/12/2015: ref: 15/LO/1929 |
| Health condition(s) or problem(s) studied | Chlamydia trachomatis and Neisseria gonorrhoeae infection |
| Intervention | Participating colleges are randomised to one of two groups using block randomisation to ensure three colleges are allocated to each group. Intervention group: One month after recruitment each intervention college will be visited on two consecutive days by the “TnT” team. The 80 participating students in each college will be texted and invited to come for on-site rapid chlamydia/gonorrhoea TnT. They will be invited to provide a sample, but this time the sample will be tested immediately using the Cepheid GeneXpert system which takes 90 minutes. Negative results will be sent to participants by text or WhatsApp or whatever preferred method they indicated on the consent form. Participants with positive results will be telephoned and invited to come to the college nurse’s room for treatment, partner notification, advice and follow up by a visiting nurse health adviser. (Students positive for gonorrhoea will have a confirmatory test and GUM referral). At four months participants in intervention colleges will again be invited to provide samples for TnT. Control group: Participants from the three control colleges continue as normal for the duration of the study. They will receive texts one and four months after recruitment thanking them for being in the study. At baseline and 7 months, participants in both groups complete questionnaires on their sexual health and provide genitourinary samples for chlamydia/gonorrhoea testing. |
| Intervention type | Other |
| Primary outcome measure | 1. Recruitment rate is measured as the time taken to recruit 80 participants at each site at recruitment end (1 month) 2. Testing and Treatment uptake rates at three intervention sites are measured by the proportion of the 80 participants at each site who take part in Test and Treat for chlamydia/gonorrhoea at 1 and 3 months after recruitment end 3. Follow up rate is measured at 7 months by: 3.1. Calculating the percentage of participants who provide samples at all sites 3.2. Calculating the percentage who complete the final questionnaires 3.3. Recording the time to treatment for participants who test positive 4. Prevalence of chlamydia/gonorrhoea is measured using PCR of genitourinary samples taken at baseline and 7 months |
| Secondary outcome measures | 1. Acceptability of TnT in FE colleges is measured through qualitative interviews at 1-9 months after recruitment 2. Cost of implementing TnT in FE colleges compared with usual care (no TnT) is measured by estimating: 2.1. The cost per person screened and treated of implementing TnT in FE colleges compared with usual care (no TnT) 2.2. The incremental cost per chlamydia and gonorrhoea infection averted Costs will be classified as solely research; capital set-up costs; or on-going running costs. Data will be collected in months 1-9, and the analysis conducted in months 10 to 20. |
| Overall study start date | 01/09/2014 |
| Completion date | 20/12/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 80 students in each of 6 clusters - total 480 |
| Key inclusion criteria | 1. Sexually experienced Further Education College student 2. Aged 16-24 |
| Key exclusion criteria | 1. Students who have never had penetrative sexual intercourse 2. Students with severe learning disability |
| Date of first enrolment | 20/09/2016 |
| Date of final enrolment | 20/12/2016 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
London
SW18 ORE
United Kingdom
Sponsor information
University/education
Cranmer Terrace
London
SW17 0RE
England
United Kingdom
"ROR" |
https://ror.org/040f08y74 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high impact peer reviewed journal. |
| IPD sharing plan | The dataset will not be made available as it is sensitive data on sexual health and lifestyles. It will be held at St George’s and may be available to researchers with ethically approved projects. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V5 | 01/06/2016 | 31/08/2016 | No | Yes |
| Protocol article | protocol | 05/06/2018 | Yes | No | |
| Statistical Analysis Plan | statistical analysis plan | 05/06/2018 | No | No | |
| Results article | results | 01/07/2019 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN58038795_PIS_01Jun2016_V5.doc
- Uploaded 31/08/2016
Editorial Notes
16/03/2020: Internal review.
16/01/2019: IPD sharing statement added.
14/01/2019: Publication reference added.
02/07/2018: Publication reference added.
07/06/2018: Publication reference added.
