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Initiating Contraception After Emergency Contraception From Pharmacy

Primary Purpose

Contraceptive Use After Emergency Contraception

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
rapid access
one month progestogen only pill
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Contraceptive Use After Emergency Contraception focused on measuring emergency contraception, community pharmacy

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age >= 16 yrs
  • requesting emergency contraception
  • eligible for emergency contraception
  • written , informed consent

Exclusion Criteria:

  • age < 16 yrs
  • not able to give written , informed consent

Sites / Locations

  • Chalmers sexual and reproductive health service

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

control (standard care)

rapid access

progestogen only pill

Arm Description

standard verbal and written advice on contraception from pharmacy

rapid access to family planning service

one month progestogen only pill

Outcomes

Primary Outcome Measures

Self-reported Uptake of Effective Ongoing Contraception (Not Condoms)
Outcome measure identified when participants conducted for agreed telephone interview 6-8 weeks following recruitment to study. Participants asked via telephone what method of contraception, if any, there were currently using.

Secondary Outcome Measures

Pharmacy Recruitment Rates
Proportion of participants that pharmacists were successful in recruiting during the specified 8 month recruitment time period. Initial target set to recruit 60 participants to each arm/group.
Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc)
Proportion of Women Who Agree to Participate Who Can be Successfully Contacted

Full Information

First Posted
November 28, 2012
Last Updated
August 1, 2014
Sponsor
University of Edinburgh
Collaborators
NHS Lothian, London School of Hygiene and Tropical Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01738971
Brief Title
Initiating Contraception After Emergency Contraception From Pharmacy
Official Title
Pharmacy Based Interventions for Initiating Effective Contraception Following the Use of Emergency Contraception : a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian, London School of Hygiene and Tropical Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Pharmacists do not provide immediate contraception to women after emergency contraception (EC); they can only give advice on local contraceptive services. The investigators wish to establish the following 2 pharmacy- based interventions in NHS Lothian, designed to increase uptake of effective contraception as soon as possible, after EC Pharmacists would provide one packet of progestogen-only pills, giving women one month to arrange an appointment with contraceptive services. Rapid access to a family planning clinic upon presentation of the empty EC packet. Women would be seen as a 'walk-in' and contraception provided. If feasible, these interventions could reduce unintended pregnancies. Participating pharmacies will be randomised to provide one of the interventions, or standard care (verbal/written advice on local contraceptive services). Women requesting EC from study pharmacies will be recruited by the research nurse/doctor to participate in the study that will involve them consenting to contact by telephone 6-8 weeks after EC by the researcher, to evaluate the interventions in terms of : (i) determine women's experiences/ views of the interventions and control. (ii) determine if women have commenced effective contraception and if not , reasons why. A subset of 12 women will also be invited for in-depth interview to collect more detailed qualitative data on their EC experience. The investigators also wish to (iii) explore pharmacists views on the interventions Data from this pilot will enable the investigators to determine whether a larger multisite study is feasible. The aims of a larger study being to determine if either of the two interventions being tested result in an increased proportion of women using effective ongoing contraception compared to the control.
Detailed Description
The investigators propose to test 2 pharmacy based interventions to increase uptake of effective contraception after EC: Pharmacists would provide one packet of progestogen-only pills to women, so that they would have 28 days to arrange an appointment with contraceptive services to get a supply of ongoing contraception. Rapid access to a family planning clinic upon presentation of their empty(used) packet of EC. Women would be seen as a 'walk-in' (without appointment) and ongoing contraception discussed and provided. These interventions would be compared with the status quo, i.e. pharmacists give verbal advice and written information on local contraceptive services where ongoing contraception can be accessed. The interventions that we are testing are low cost i.e one packet of progestogen-only pills (£3 for most costly brand) plus additional consultation time with the pharmacist (estimated 20 mins@ £1 per minute), versus the staff consultation time in a family planning clinic. In the family planning clinic, women would be seen as a 'walk-in' and so this may not add costs, since staff are already present.These interventions could, if shown to be effective, offer huge costs savings to the NHS, by reducing the costs of unintended pregnancies (abortion, miscarriage, birth).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraceptive Use After Emergency Contraception
Keywords
emergency contraception, community pharmacy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control (standard care)
Arm Type
No Intervention
Arm Description
standard verbal and written advice on contraception from pharmacy
Arm Title
rapid access
Arm Type
Experimental
Arm Description
rapid access to family planning service
Arm Title
progestogen only pill
Arm Type
Experimental
Arm Description
one month progestogen only pill
Intervention Type
Other
Intervention Name(s)
rapid access
Intervention Description
Provision of box which the participant can take to local family planning clinic (contraceptive service) allowing rapid access (i.e. will be seen by a health professional for a consultation regarding contraception there and then).
Intervention Type
Other
Intervention Name(s)
one month progestogen only pill
Other Intervention Name(s)
Norgeston (Bayer, UK)
Intervention Description
Provision of 1 month supply of a progestogen only pill (levonorgestrel 35mcg - Norgeston, Bayer, UK)
Primary Outcome Measure Information:
Title
Self-reported Uptake of Effective Ongoing Contraception (Not Condoms)
Description
Outcome measure identified when participants conducted for agreed telephone interview 6-8 weeks following recruitment to study. Participants asked via telephone what method of contraception, if any, there were currently using.
Time Frame
6-8 weeks after EC
Secondary Outcome Measure Information:
Title
Pharmacy Recruitment Rates
Description
Proportion of participants that pharmacists were successful in recruiting during the specified 8 month recruitment time period. Initial target set to recruit 60 participants to each arm/group.
Time Frame
8 months
Title
Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc)
Time Frame
8 months
Title
Proportion of Women Who Agree to Participate Who Can be Successfully Contacted
Time Frame
8 months
Other Pre-specified Outcome Measures:
Title
Qualitative Outcomes : Women's Views on Different Measures to Determine Validity of Self-reported Data on Contraceptive Use , Determined by in Depth Interviews.
Time Frame
8 months
Title
Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age >= 16 yrs requesting emergency contraception eligible for emergency contraception written , informed consent Exclusion Criteria: age < 16 yrs not able to give written , informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon T Cameron, MBChB
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chalmers sexual and reproductive health service
City
Edinburgh
State/Province
Lothian
ZIP/Postal Code
EH39ES
Country
United Kingdom

12. IPD Sharing Statement

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Initiating Contraception After Emergency Contraception From Pharmacy

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