Clinical trial NCT01738971: 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
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Use After Emergency Contraception
Keywords: emergency contraception
community pharmacy
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: London School of Hygiene and Tropical Medicine
First posted: 2012-11-30
Enrollment: 168
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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.

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 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

Primary outcomes:
measure: Self-reported Uptake of Effective Ongoing Contraception (Not Condoms)
timeFrame: 6-8 weeks after EC
Secondary outcomes:
measure: Pharmacy Recruitment Rates
timeFrame: 8 months
measure: Completeness (Quality) of Data Recorded by Pharmacists (Numbers of Women Attending for EC,Demographics of All Attendees- Age, Ethnicity Etc)
timeFrame: 8 months
measure: Proportion of Women Who Agree to Participate Who Can be Successfully Contacted
timeFrame: 8 months
Other outcomes:
measure: Qualitative Outcomes : Women's Views on Different Measures to Determine Validity of Self-reported Data on Contraceptive Use , Determined by in Depth Interviews.
timeFrame: 8 months
measure: Qualitative Outcomes : Pharmacist's Views on Interventions and Any Study Difficulties
timeFrame: 12 months
Locations:
city: Edinburgh
country: United Kingdom
facility: Chalmers sexual and reproductive health service
state: Lothian
Study officials:
affiliation: University of Edinburgh
name: Sharon T Cameron, MBChB
role: PRINCIPAL_INVESTIGATOR
References: