Plain English Summary
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)
Trial website
Contact information
Type
Scientific
Primary contact
Prof Pippa Oakeshott
ORCID ID
Contact details
Population Health Research Institute
St George's
University of London
London
SW17ORE
United Kingdom
Type
Scientific
Additional contact
Ms Sarah Kerry
ORCID ID
http://orcid.org/0000-0002-3794-8335
Contact details
Population Health Research Institute
St George's
University of London
London
SW17ORE
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
20672
Study information
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
Acronym
Test n Treat (TnT)
Study hypothesis
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
Bromley NRES Committee London, 21/12/2015: ref: 15/LO/1929
Study design
Cluster randomised feasibility study
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Screening
Patient information sheet
See additional files
Condition
1. Chlamydia trachomatis
2. Neisseria gonotthoea
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
Phase
Drug names
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 trial start date
01/09/2014
Overall trial end date
20/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Sexually experienced Further Education College student
2. Aged 16-24
Participant type
Healthy volunteer
Age group
Mixed
Gender
Both
Target number of participants
80 students in each of 6 clusters-total 480
Participant exclusion criteria
1. Students who have never had penetrative sexual intercourse
2. Students with severe learning disability
Recruitment start date
20/09/2016
Recruitment end date
20/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St George's, University of London
Cranmer Terrace
London
SW18 ORE
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high impact peer reviewed journal.
Intention to publish date
31/12/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2018 statistical analysis plan in: https://www.ncbi.nlm.nih.gov/pubmed/29871668
Publication citations
Additional files
- ISRCTN58038795_PIS_01Jun2016_V5.doc Uploaded 31/08/2016