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Initiating Contraception After Emergency Contraception From Pharmacy

This study has been completed.
Sponsor:
Collaborators:
NHS Lothian
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01738971
First received: November 28, 2012
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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

  1. Pharmacists would provide one packet of progestogen-only pills, giving women one month to arrange an appointment with contraceptive services.
  2. 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.


Condition Intervention
Contraceptive Use After Emergency Contraception
Other: rapid access
Other: one month progestogen only pill

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pharmacy Based Interventions for Initiating Effective Contraception Following the Use of Emergency Contraception : a Feasibility Study

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Self-reported Uptake of Effective Ongoing Contraception (Not Condoms) [ Time Frame: 6-8 weeks after EC ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Proportion of Women Who Agree to Participate Who Can be Successfully Contacted [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control (standard care)
standard verbal and written advice on contraception from pharmacy
Experimental: rapid access
rapid access to family planning service
Other: rapid access
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).
Experimental: progestogen only pill
one month progestogen only pill
Other: one month progestogen only pill
Provision of 1 month supply of a progestogen only pill (levonorgestrel 35mcg - Norgeston, Bayer, UK)
Other Name: Norgeston (Bayer, UK)

Detailed Description:

The investigators propose to test 2 pharmacy based interventions to increase uptake of effective contraception after EC:

  1. 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.
  2. 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).

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738971

Locations
United Kingdom
Chalmers sexual and reproductive health service
Edinburgh, Lothian, United Kingdom, EH39ES
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
London School of Hygiene and Tropical Medicine
Investigators
Principal Investigator: Sharon T Cameron, MBChB University of Edinburgh
  More Information

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01738971     History of Changes
Other Study ID Numbers: Protocol ECfe03, 182.
Study First Received: November 28, 2012
Results First Received: June 23, 2014
Last Updated: August 1, 2014
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
emergency contraception
community pharmacy

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014