Condition category
Urological and Genital Diseases
Date applied
05/04/2016
Date assigned
31/08/2016
Last edited
02/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

Eligibility

Participant inclusion criteria

1. Sexually experienced Further Education College student
2. Aged 16-24

Participant type

Healthy volunteer

Age group

Other

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

Sponsor information

Organisation

St George's, University of London

Sponsor details

Cranmer Terrace
London
SW17 0RE
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes