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Quality family planning services and referrals in community pharmacy: Expanding pharmacists’ scope of practice (The ALLIANCE Trial)

The ALLIANCE Trial: testing the effect of expanding pharmacists’ current scope of practice on uptake of effective contraception among women seeking an emergency contraception pill or early medical abortion medicines using a stepped-wedge pragmatic cluster randomised controlled trial in community pharmacy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001024730
Acronym
ALLIANCE
Enrollment
1554
Registered
2022-07-22
Start date
2023-03-20
Completion date
2024-05-20
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Community pharmacies are accessible health services where the public can access the ECP over-the-counter and have their MS-2 Step prescriptions for EMA filled. All women should receive information about and be offered effective contraception as part of their care when seeking ECP and EMA: this is because delayed contraceptive provision is associated with higher odds of repeat unintended pregnancy. The study's primary aim is to compare the subsequent uptake of effective contraception (hormonal or intrauterine) in women seeking EC or MS-2Step medicines, who receive the ALLIANCE community pharmacy-based intervention with those who do not receive the intervention. We will utilise a pragmatic stepped-wedge cluster randomised trial across three Australian states. In the intervention phase, women purchasing EC or medical abortion medicines will be offered contraceptive counselling and referral to contraceptive providers when appropriate. Pharmacists will be supported through: online education, academic detailing (co-designed with consumers and pharmacy stakeholders), assistance identifying referral pathways, peer-support through AusCAPPS online community of practice and remuneration. It is anticipated that this trial will equip community-based pharmacists with the resources, networks, knowledge and skills to expand their scope of practice to include the delivery of high-quality, patient-centred, effectiveness-based contraceptive counselling. This will result in improved access to and more effective use of contraception by Australian women, and reduce their risk of subsequent unintended pregnancy after ECP or EMA.

Interventions

The ALLIANCE trial provides an opportunity to use the pharmacy setting to increase contraceptive knowledge, access, and use among women presenting to pharmacies for an emergency contraceptive pill (ECP) or MS-2 Step (mifepristone + misoprostol) early medical abortion (EMA) medicines. The intervention consists of the following: 1) High-quality, person-centred, effectiveness-based contraceptive counselling, delivered by a community pharmacist to a woman in a private consultation room, as part of

The ALLIANCE trial provides an opportunity to use the pharmacy setting to increase contraceptive knowledge, access, and use among women presenting to pharmacies for an emergency contraceptive pill (ECP) or MS-2 Step (mifepristone + misoprostol) early medical abortion (EMA) medicines. The intervention consists of the following: 1) High-quality, person-centred, effectiveness-based contraceptive counselling, delivered by a community pharmacist to a woman in a private consultation room, as part of a billed consultation. This will be delivered individually in a single 20-30minute session. The pharmacist will go over the woman's contraceptive options from most to least effective and discuss what will be the most appropriate to meet her needs. 2) Referral to a contraception provider will be provided to the woman after the contraceptive counseling session, if the woman has decided on a method and would like a referral. Fidelity checking, a component of the process evaluation of the trial, will be carried out at the end of the study through interviews with pharmacists and women.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Healthy volunteers
Yes

Inclusion criteria

PHARMACISTS Those working in community pharmacies, located in either metropolitan, regional or rural areas of NSW, VIC and the NT, that have: A) Quality Care Pharmacy Program (QCPP) accreditation; B) A private consultation room; C) At least one pharmacist who works at least 30 hours per week (0.8 FTE) willing to commit to participation, D) participating pharmacist is accredited to dispense MS 2-Step (medical abortion medicines) and; E) consent from the pharmacy owner for the pharmacy to participate. CONSUMERS Any woman** attending the pharmacy for the purpose of purchasing the ECP or to fill a prescription for MS-2 Step, who: 1) Gives informed consent to participate in and adhere to trial requirements, and; 2) Is willing to give contact details and be contacted by phone/SMS/e-mail to complete a survey at baseline, and at 4 months and 12 months after receiving ECP or MS-2 Step (i.e. after entering the study). **Consistent with current emergency contraception guidelines, there will be no age restriction (minimum or maximum age) on participants. Consumers seeking emergency contraception or MS-2 Step would be of reproductive age.

Exclusion criteria

Women requiring interpreting services

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 8, 2026