Condition category
Pregnancy and Childbirth
Date applied
17/03/2017
Date assigned
20/03/2017
Last edited
19/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Emergency contraception (EC) is a tablet that can prevent pregnancy following unprotected sex. Most women in the UK go to a pharmacy for EC. It is important to start a regular method of contraception after EC, but most pharmacies cannot provide this without a prescription. This means that women must then go to a GP or a family planning clinic and some fall pregnant during this time. the aim of this study is to find out whether pharmacists should give a supply of the progestogen only pill (POP) along with EC to women as temporary contraception until they can get to a clinic. The POP is very safe with no serious risks. A smaller similar study showed that women who received the POP were likely to use it and more likely to be using contraception 6 weeks later than those who just got EC.

Who can participate?
Women aged 16 and over who attend a participating pharmacy for EC

What does the study involve?
Participating pharmacies are randomly allocated to give EC as usual, or to give the POP with the offer of rapid access to the local family planning clinic. Participating women are surveyed at 4 months about contraceptive use, and about any pregnancies they may have had. Women who received the POP are asked if they used it and/or attended the family planning clinic. In order to find out whether providing the POP prevents unintended pregnancies, with the participating women’s permission, existing NHS databases are checked to see how many women in the study had an abortion within one year. Women, pharmacists and family planning clinic staff are also interviewed about how providing the POP/rapid access might work in everyday practice.

What are the possible benefits and risks of participating?
The information from this study will help to determine whether providing women with a temporary supply of POP along with help to get a quick appointment at a local sexual health clinic prevents more unintended pregnancies than just using EC alone. The POP is a very safe method of contraception and the POP used in the study is widely used, so no risks are expected.

Where is the study run from?
1. Community pharmacies in NHS Lothian & Chalmers Sexual Health Centre (UK)
2. Margaret Pyke Centre & participating community pharmacies (UK)
3. Kings College London Sexual Health Service & participating community pharmacies (UK)
4. Community pharmacies in NHS Tayside & Tayside Sexual Health Service (UK)

When is the study starting and how long is it expected to run for?
April 2017 to March 2020

Who is funding the study?
Health Technology Assessment Programme (UK)

Who is the main contact?
Professor Sharon Cameron
Sharon.Cameron@ed.ac.uk or Bridge-IT@ed.ac.uk

Trial website

https://w3.abdn.ac.uk/hsru/BRIDGE-IT/Public/Public/index.cshtml

Contact information

Type

Public

Primary contact

Prof Sharon Cameron

ORCID ID

http://orcid.org/0000-0002-1168-2276

Contact details

Chalmers Centre
Edinburgh
EH3 9ES
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 15/113/01

Study information

Scientific title

A randomised controlled trial to determine the effectiveness of bridging from emergency to regular contraception: the Bridge–it study

Acronym

Study hypothesis

Provision of a ‘bridging' supply of the progestogen only pill plus an invitation for a rapid appointment at a local sexual health and reproductive health service to women at the time they present for emergency contraception (EC) at a community pharmacy, will be associated with higher uptake of effective contraception and fewer unintended pregnancies (and reduced abortion rates) compared to standard care alone (provision of EC and advice on commencing effective contraception after EC).

Ethics approval

South East Scotland REC 01, 27/06/2017, ref: 17/SS/0080

Study design

Cluster randomised controlled cross over trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Reproductive health

Intervention

Current intervention as of 31/01/2019:
Community pharmacies will be cluster randomised to provide the intervention followed by a control phase (on a new group of women) or vice versa.

The planned intervention is a composite intervention consisting of 3 months of a progestogen only pill (POP) containing 75 mcg desogestrel and the offer to attend a local participating sexual and reproductive health (SRH) service to discuss and provide ongoing effective contraception.


Previous intervention:
Community pharmacies will be cluster randomised to provide the intervention followed by a control phase (on a new group of women) or vice versa. Computer generated cluster randomisation: a confidential list is generated made up of a random mix of permuted blocks of size 2, 4 and 6 (100 units) and then assigned the order by looking it up on the confidential list as new pharmacies join.

The planned intervention is a composite intervention consisting of 3 months of a progestogen only pill (POP) containing 75 mcg desogestrel and the offer to attend a local participating sexual and reproductive health (SRH) service to discuss and provide ongoing effective contraception.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Current primary outcome measure as of 31/01/2019:
Effective contraception use (hormonal and intrauterine) determined by telephone contact (or survey) at 4 months.

Previous primary outcome measure:
1. Effective contraception use (hormonal and intrauterine) determined by telephone contact (or survey) at 4 months
2. Long acting reversible conraception (LARC) use, self reported at 4 months
3. Proportion of participants having undergone an abortion using record linkage from participants to national registries at 12 months

Secondary outcome measures

Current secondary outcome measures as of 31/01/2019:
1. Proportion having undergone an abortion at 12 months (Data linkage from Information Services Division (ISD Scotland) and Department of Health (DOH England) will provide the number of abortions occurring during the 12 month follow up period.)
2. To determine whether the intervention is cost effective to the NHS. (An economic evaluation will be undertaken comparing the intervention and control arms in a cost effectiveness analysis.) This will depend on the results of the study.


Previous secondary outcome measures:
1. Effective contraception use, determined by telephone contact (or survey) at 12 months
2. LARC use in both groups at 12 months
3. Proportion of participants with unintended pregnancy, self-reported using validated tool the London measure of Unintended Pregnancy, at 12 months
4. Process evaluation of the intervention; implementation, fidelity and reach (to understand why/why not the intervention works and to inform future roll out/implementation), measured from quantitative and qualitative interviews of women, and qualitative interviews of pharmacists and focus group discussions with staff from sexual ad reproductive health service at varying time points throughout the study
5. Cost effectiveness: incremental cost-effectiveness ratio at 12 months: every £100 spent on the intervention resulted in X fewer abortions for a savings of £Y (costs will include the pharmacist training to provide POP, direct and indirect costs of health service use, and the provision and dispensing of POP, abortion costs)

Overall trial start date

01/04/2017

Overall trial end date

31/03/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 31/01/2019:
1. Intake of oral emergency contraception (1.5 mg or 3 mg Levonorgestrel)
2. Capacity to give informed consent to participate in the trial which includes adherence to trial requirements
3. Willing to give contact details and be contacted at 4 months by phone or text or e-mail or post
4. Willing to give identifying data sufficient to allow data linkage with NHS registries
5. Female aged 16 years or over

Previous inclusion criteria:
1. Intake of oral emergency contraception (1.5 mg Levonorgestrel)
2. Willing to participate in the trial
3. Willing to give contact details and be contacted at 4 and 12 months by phone or text or e-mail or post
4. Willing to give identifying data sufficient to allow data linkage with NHS registries
5. Female 16 years or older

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

626-737 participants total; 31 clusters, average cluster size of 12-13 in each phase

Total final enrolment

636

Participant exclusion criteria

Current exclusion criteria as of 31/01/2019:
1 Contraindications to the POP (there are very few)
2 On medication that interacts adversely with POP
3. Already using a hormonal method of contraception
4. Require interpreting services
5. If pharmacist has concerns about non-consensual sex

Previous exclusion criteria:
1. Not willing to provide contact details or personal data sufficient to allow identification/linkage with NHS registries
2. Contraindications to the POP (there are very few)
3. On medication that interacts adversely with POP
4. Age under 16
5. Already using a hormonal method of contraception
6. Require interpreting services

Recruitment start date

16/12/2017

Recruitment end date

30/06/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Community pharmacies in NHS Lothian & Chalmers Sexual Health Centre
Chalmers Centre 2a Chlamers street
Edinburgh
EH3 9ES
United Kingdom

Trial participating centre

Margaret Pyke Centre & participating community pharmacies
Mortimer Market
London
wc1E6JP
United Kingdom

Trial participating centre

Kings College London Sexual Health Service & participating community pharmacies
Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

Community pharmacies in NHS Tayside & Tayside Sexual Health Service
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Edinburgh

Sponsor details

Old College
South Bridge
Edinburgh
EH8
United Kingdom

Sponsor type

University/education

Website

www.accord.scot

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

1. The clinical study report for NIHR/HTA will be used for publication and presentation at scientific meetings. Investigators will publish the results of the study in peer reviewed journals
2. Summaries of results will also be made available to all participants at the end of the study

IPD sharing plan
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

30/04/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/07/2019: The total final enrolment was added. 31/01/2019: The following changes were made: 1. The intervention has been changed. 2. The primary outcome measure has been changed. 3. The overall trial end date has been changed from 30/09/2019 to 31/03/2020. 4. The inclusion criteria have been changed. 5. The target number of participants has been changed from "2080 participants total; 26 clusters, 80 per cluster" to "626-737 participants total; 31 clusters, average cluster size of 12-13 in each phase". 6. The exclusion criteria have been changed. 7. The recruitment end date has been changed from 30/04/2019 to 30/06/2019. 8. The intention to publish date has been changed from 30/09/2020 to 30/04/2020. 9. The plain English summary has been updated to reflect the above changes. 10. The secondary outcome measures have been changed. 14/08/2018: The recruitment end date has been changed from 08/06/2018 to 30/04/2019 05/03/2018: Recruitment start date has been updated from 01/10/2017 to 16/12/2017. Recruitment end date has been updated from 28/02/2018 to 08/06/2018. 26/10/2017: Trial website was added 01/09/2017: Ethics approval information has been added. Recruitment start date has been updated from 01/06/2017 to 01/10/2017. Recruitment end date has been updated from 01/09/2017 to 28/02/2018. Added contact details Sharon.Cameron@ed.ac.uk or Bridge-IT@ed.ac.uk.