Using telemedicine to improve early medical abortion at home (UTAH): a randomised controlled trial to compare telemedicine with in-person consultation for early medical abortion.

OBJECTIVES: To compare telephone consultations with in-person consultations for the provision of medical abortion (using mifepristone 200 mg and misoprostol 800 µg). We hypothesised that telemedicine consultations would be non-inferior to in-person consultations with a non-inferiority limit of 3%. DESIGN: Randomised controlled trial with 1:1 allocation. SETTING: Community abortion service housed within an integrated sexual and reproductive health service in Edinburgh, UK. PARTICIPANTS: The trial began on 13 January 2020, but was stopped early due to COVID-19; recruitment was suspended on 31 March 2020, and was formally closed on 31 August 2021. A total of 125 participants were randomised, approximately 10% of the total planned, with 63 assigned to telemedicine and 62 to in-person consultation. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome: efficacy of medical abortion, defined as complete abortion without surgical intervention. SECONDARY OUTCOMES: satisfaction with consultation type, preparedness, unscheduled contact with care, complication rate, time spent in clinical contact and uptake of long-acting contraception. RESULTS: Primary outcome was available for 115 participants (lost-to-follow-up telemedicine=2, in-person=8), secondary outcomes were available for 110 participants (n=5 and n=10 in telemedicine and in-person groups did not complete questionnaires). There were no significant differences between groups in treatment efficacy (telemedicine 57/63 (90.5%), in-person 48/62 (77.4%)). However, non-inferiority was not demonstrated (+3.3% in favour of telemedicine, CI -6.6% to +13.3%, lower than non-inferiority margin). There were no significant differences in most secondary outcomes, however, there was more unscheduled contact with care in the telemedicine group (12 (19%) vs 3 (5%), p=0.01). The overall time spent in clinical contact was statistically significantly lower in the telemedicine group (mean 94 (SD 24) vs 111 (24) min, p=0.0005). CONCLUSIONS: Telemedicine for medical abortion appeared to be effective, safe and acceptable to women, with less time spent in the clinic. However, due to the small sample size resulting from early cessation, the study was underpowered to confirm this conclusion. These findings warrant further investigation in larger scale studies. TRIAL REGISTRATION NUMBER: NCT04139382.

Expanding community pharmacists' scope of practice in relation to contraceptive counselling and referral: a protocol for a pragmatic, stepped-wedge, cluster randomised trial (ALLIANCE).

INTRODUCTION: Improving access to effective contraception has the potential to reduce unintended pregnancy and abortion rates. Community pharmacists could play an expanded role in contraceptive counselling and referral to contraceptive prescribers particularly when women are already attending community pharmacy to obtain emergency contraceptive pills (ECPs) or to have medical abortion (MA) medicines dispensed. The ALLIANCE trial aims to compare the subsequent uptake of effective contraception (hormonal or intrauterine) in women seeking ECP or MA medicines, who receive the ALLIANCE community pharmacy-based intervention with those who do not receive the intervention. METHODS AND ANALYSIS: ALLIANCE is a stepped-wedge pragmatic cluster randomised trial in Australian community pharmacies. The ALLIANCE intervention involves community pharmacists delivering structured, patient-centred, effectiveness-based contraceptive counselling (and a referral to a contraceptive prescriber where appropriate) to women seeking either ECPs or to have MA medicines dispensed. Women participants will be recruited by participating pharmacists. A total of 37 pharmacies and 1554 participants will be recruited. Pharmacies commence in the control phase and are randomised to transition to the intervention phase at different time points (steps). The primary outcome is the self-reported use of effective contraception at 4 months; secondary outcomes include use of effective contraception and the rate of pregnancies or induced abortions at 12 months. A process and economic evaluation of the trial will also be undertaken. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Monash University Human Research Ethics Committee (#34563). An explanatory statement will be provided and written consent will be obtained from all participants (pharmacy owner, pharmacist and women) before their commencement in the trial. Dissemination will occur through a knowledge exchange workshop, peer-reviewed journal publications, presentations, social media and conferences. TRIAL REGISTRATION NUMBER: ACTRN12622001024730.

Improving effective contraception uptake through provision of bridging contraception within community pharmacies: findings from the Bridge-it Study process evaluation.

OBJECTIVE: To present process evaluation results from the Bridge-it Study, a pragmatic cluster randomised cross-over trial to improve effective contraception uptake through provision of the progestogen only pill (POP) plus sexual and reproductive health (SRH) clinic rapid-access to women presenting to community pharmacies for emergency contraception (EC). RESEARCH DESIGN AND METHODS: A multimethod process evaluation was conducted to assess intervention implementation, mechanisms of change and contextual factors. Data were gathered from screening logs (n=599), observations of pharmacist training, analysis of data from 4-month follow-up questionnaires (n=406), monitoring of contemporaneous events and qualitative interviews with 22 pharmacists, 5 SRH clinical staff and 36 study participants in three participating UK sites in Lothian, Tayside and London. RESULTS: The intervention was largely delivered as intended and was acceptable. Pharmacists', SRH clinical staff and participants' accounts highlighted that providing a supply of POP with EC from the pharmacy as routine practice may have positive impacts on contraceptive practices in the short term, and potentially longer term. Key mechanisms of change included ease of access, increased awareness of contraception and services, and greater motivation and perceptions of self-efficacy. Few participants took up the offer to attend an SRH service (rapid-access component), and existing barriers within the SRH context were apparent (eg, lack of staff). Participant accounts highlight persistent barriers to accessing and using routine effective contraception remain. CONCLUSIONS: Implementation appeared to be acceptable and feasible, highlighting the potential for provision of POP within EC consultations as routine practice in community pharmacies. However, lack of engagement with the rapid access component of the intervention and existing barriers within the SRH context suggest that signposting to SRH services may be sufficient. Wider implementation should consider ways to address key implementation challenges to increase effectiveness and sustainability, and to overcome persistent barriers to accessing and using effective contraception. TRIAL REGISTRATION NUMBER: ISRCTN70616901.

UTAH: Using Telemedicine to improve early medical Abortion at Home: a protocol for a randomised controlled trial comparing face-to-face with telephone consultations for women seeking early medical abortion.

INTRODUCTION: Early medical abortion (EMA) is a two-stage process of terminating pregnancy using oral mifepristone (a progesterone-receptor antagonist) followed usually 1-2 days later by sublingual, vaginal or buccal misoprostol (a prostaglandin analogue). There are no published randomised controlled trials (RCTs) on the use of telemedicine for EMA. Our proposed research will determine if telephone consultations for EMA (the most common method of abortion in the UK) is non-inferior to standard face-to-face consultations with regard to the efficacy of EMA. METHODS AND ANALYSIS: This study will be conducted as an RCT. The recruitment target is 1222 participants.The primary outcome is success of EMA (complete abortion rate). This will be determined based on a negative low-sensitivity urine pregnancy test result (2 weeks after misoprostol use) and absence of surgical intervention or diagnosis of ongoing pregnancy (within 6 weeks of misoprostol).Secondary outcomes include total time spent at a clinic appointment to receive EMA, self-reported preparedness for EMA, level of satisfaction with consultation and effective contraception uptake compared with when women attend for a face-to-face consultation.The main analysis will be a modified intention-to-treat analysis. This will include all randomised women (with a viable pregnancy) using EMA and follow-up for the main outcome. The study initiated on 13 January 2020 and is anticipated to finish in late 2021. ETHICS AND DISSEMINATION: Ethical approval was given by the South East Scotland NHS Research Ethics Committee, reference: 19/SS/0111. Results will be published in peer-reviewed journals, presented at clinical and academic meetings, and shared with participants via the clinic website. TRIAL REGISTRATION NUMBER: NCT04139382.

Pragmatic cluster randomised cohort cross-over trial to determine the effectiveness of bridging from emergency to regular contraception: the Bridge-It study protocol.

INTRODUCTION: Oral emergency contraception (EC) can prevent unintended pregnancy but it is important to start a regular method of contraception. Women in the UK usually access EC from a pharmacy but then need a subsequent appointment with a general practitioner or a sexual and reproductive health (SRH) service to access regular contraception. Unintended pregnancies can occur during this time. METHODS AND ANALYSIS: Bridge-It is a pragmatic cluster randomised cohort cross-over trial designed to determine whether pharmacist provision of a bridging supply of a progestogen-only pill (POP) plus rapid access to a local SRH clinic, results in increased uptake of effective contraception and prevents more unintended pregnancies than provision of EC alone. Bridge-It involves 31 pharmacies in three UK regions (London, Lothian and Tayside) aiming to recruit 626-737 women. Pharmacies will give EC (levonorgestrel) according to normal practice and recruit women to both intervention and the control phases of the study. In the intervention phase, pharmacists will provide the POP (desogestrel) and offer rapid access to an SRH clinic. In the control phase, pharmacists will advise women to attend a contraceptive provider for contraception (standard care).Women will be asked 4 months later about contraceptive use. Data linkage to abortion registries will provide abortion rates over 12 months. The sample size is calculated on the primary outcome of effective contraception use at 4 months (yes/no) with 90% power and a 5% level of significance. Abortion rates will be an exploratory secondary analysis. Process evaluation includes interviews with pharmacists, SRH clinicians and women. Cost-effectiveness analysis will use a healthcare system perspective and be expressed as incremental cost-effectiveness ratio. ETHICS AND DISSEMINATION: Ethical approval was received from South East Scotland REC June 2017. Results will be published in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN70616901.

Comparison of two low-sensitivity urine pregnancy tests for confirming the success of early medical abortion.

BACKGROUND: We introduced a single-window low-sensitivity urine pregnancy test (LSPT) to replace a double-window LSPT (both 1000 IU hCG) for self-assessment of the outcome of early medical abortion (EMA) (≤63 days gestation) 2 weeks later. We wished to compare assessment of outcomes of EMA with each LSPT. METHODS: A retrospective review of the outcomes of EMA during 10 months' use of the double-window LSPT and the subsequent 10 months' use of the single-window LSPT to compare (i) detection of ongoing pregnancies and (ii) false-positive and invalid results with each LSPT. RESULTS: 492 and 555 women self-assessed the outcome of their EMA with the double- and single-window LSPTs, respectively. Ongoing pregnancies were uncommon and occurred in 4/1047 women (0.4%). Two of these four women did not conduct a LSPT as they presented before the LSPT was due with scant bleeding or continuing pregnancy symptoms. False-positive LSPT results occurred in 6 (1.2%) and 19 (3.4%) double- and single-window LSPT tests, respectively (P=0.0244). Invalid results were reported in 18 (3.6%) and 6 (1.1%) of double- and single-window LSPT groups, respectively (P=0.01). CONCLUSION: The introduction of the single-window LSPT has not impacted on the detection of ongoing pregnancy or on contact with the service due to a positive or invalid LSPT. Services could consider use of either LSPT but should also place emphasis on informing women about the clinical signs and symptoms that suggest failed abortion.