Reproductive health Pregnancy and Childbirth
Conditions
Interventions
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 in
Sponsors
University of Edinburgh
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactSharon Cameron
Outcome results
None listed