Women's satisfaction with and ongoing use of hormonal long-acting methods compared to the oral contraceptive pill: Findings from an Australian general practice cluster randomised trial (ACCORd).

BACKGROUND: The Australian Contraceptive ChOice pRoject (ACCORd) aimed to assess the impact of a complex general practice intervention on the uptake of long-acting reversible contraceptives (LARC). AIMS: Using survey data from enrolled women, we aimed to compare the ongoing use and satisfaction of women who chose one of the hormonal LARC methods including the levonorgestrel intrauterine system (LNG-IUS) or levonorgestrel implant compared to the oral contraceptive pill (OCP). MATERIALS AND METHODS: We used the data from participants' baseline, six and 12-month surveys to identify new users of implants, LNG-IUS or OCP. We included demographic information, ongoing use of the contraceptive method, reasons for dissatisfaction and discontinuation and experience of side-effects. Proportions were compared using χ2 tests. RESULTS: Of the 740 women enrolled in ACCORd, 176 started using a hormonal LARC or OCP in the study's first six months with 76 using the IUS (43%), 60 the implant (34%) and 40 (23%) the OCP. Twelve-month continuation rates for the LNG-IUS, implant and OCP were 93, 83 and 65% respectively (P < 0.001). Satisfaction was highest among the LNG-IUS users; 86% were very/somewhat satisfied compared to 75% of implant users and 61% of OCP users (P < 0.001). Main reasons for method dissatisfaction were irregular bleeding and mood changes which were similar for all methods. CONCLUSIONS: This study provides further evidence that hormonal LARC methods have higher continuation and satisfaction rates compared to the OCP with similar side-effects. Since hormonal LARC methods have the highest contraceptive efficacy, these should be offered first-line to women.

Increasing long-acting reversible contraceptives: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomized trial.

BACKGROUND: Long-active reversible contraceptives reduce unintended pregnancy and abortions, but uptake is low. Interventions to increase uptake in family medicine settings are untested. OBJECTIVE: The Australian Contraceptive ChOice pRoject, which was adapted from the successful US Contraceptive CHOICE study, aimed to evaluate whether a complex intervention in family medicine practices resulted in increased long-active reversible contraceptive uptake. STUDY DESIGN: This cluster randomized controlled trial was set in family practices in metropolitan Melbourne, Australia. From April 2016 to January 2017, we recruited 57 family physicians by mail invitation. Each family physician aimed to recruit at least 14 female patients. Eligible family physicians worked ≥3 sessions per week in computerized practices. Eligible women were English-speaking, sexually active, not pregnant, not planning a pregnancy in the next year, 16-45 years old, and interested in discussing contraception or in starting a new, reversible method. With the use of a randomization sequence with permuted blocks that were stratified by whether the family physician performed long-active reversible contraceptive insertion or not, family physicians were assigned randomly to a complex intervention that involved training to provide structured effectiveness-based contraceptive counselling and access to rapid referral to long-active reversible contraceptive insertion clinics. The 6-hour, online educational intervention was based on the US Contraceptive CHOICE Project and adapted for the Australian context. The control family physicians received neither the educational intervention nor access to the long-active reversible contraceptive rapid referral clinics and conducted their usual contraception counselling. We used the chi-square test, which was adjusted for clustering and stratification by whether the family physician inserted long-active reversible contraceptives, and binary regression models with generalized estimating equations and robust standard errors to compare, between the intervention and control groups, the proportions of women who had a long-active reversible contraceptive inserted. The primary outcome was the proportion of women with long-active reversible contraceptives that were inserted at 4 weeks. Secondary outcomes included women's choice of contraceptive method, quality of life, and long-active reversible contraceptive use at 6 and 12 months. Analyses were performed according to intention-to-treat. RESULTS: A total of 25 intervention and 32 control family physicians recruited 307 and 433 women, respectively (N=740). Within 4 weeks, 19.3% of women in the intervention group and 12.9% of women in the control group had long-active reversible contraceptive inserted (relative risk, 2.0; 95% confidence interval, 1.1-3.9; P=.033). By 6 months, this number had risen to 44.4% and 29.3%, respectively (relative risk, 1.6; 95% confidence interval, 1.2-2.17; P=.001); by 12 months, it had risen to 46.6% and 32.8%, respectively (relative risk, 1.5; 95% confidence interval, 1.2-2.0; P=.0015). The levonorgestrel intrauterine system was the most commonly chosen long-active reversible contraceptive by women in the intervention group at all time points. Differences between intervention and control groups in mean quality-of-life scores across all domains at 6 and 12 months were small. CONCLUSION: A complex intervention combination of family physician training on contraceptive effectiveness counselling and rapid access to long-active reversible contraceptive insertion clinics resulted in greater long-active reversible contraceptive uptake and has the potential to reduce unintended pregnancies.

Pathways to IUD and implant insertion in general practice: a secondary analysis of the ACCORd study.

BACKGROUND: Despite recommendations, long-acting reversible contraceptives (LARC) are not always offered as first-line contraceptives in general practice. This study aimed to describe pathways used by women for insertion of LARC. METHODS: This is a secondary analysis of data from the Australian Contraceptives ChOice pRoject (ACCORd), a cluster randomised controlled trial set in 57 general practices in Melbourne, Australia. We investigated whether an educational intervention for general practitioners (GPs) and a rapid LARC insertion clinic increased LARC uptake. The main outcome measures were the type of health service, location/provider of intrauterine device (IUD) insertion; time to insertion; and distance travelled for IUD insertion. RESULTS: During ACCORd, 149 women had LARC insertion. IUD training was reported by 37% of GPs, but only 12% inserted them. In contrast, 70% of GPs inserted implants and 95% of women accessed implant insertion through their own general practice. LARC rapid referral clinics were used by 52% (13/25) of intervention GPs, where 71% (41/56) of IUD insertions occurred in these clinics (but no implants). There was no difference in the mean time from referral to IUD insertion between women attending intervention and control GPs (mean days 37.6vs 32.7; P =0.61). GPs (including IUD inserters) used a variety of referral pathways for IUD insertion, including public and private clinics, and other GPs. Women travelled up to 90km for IUD insertion. CONCLUSIONS: Although implant insertion has been integrated into general practice, few GPs insert IUDs. Where the option exists for GPs to refer to a LARC rapid referral clinic, the majority of IUD insertions will take place there. Establishing a network of such clinics Australia wide may both increase IUD uptake and address the extensive need for GP training in IUD insertion.

Candida causes recurrent vulvovaginal candidiasis by forming morphologically disparate biofilms on the human vaginal epithelium.

Background: Recurrent vulvovaginal candidiasis (RVVC) is a recalcitrant medical condition that affects many women of reproductive age. The importance of biofilm formation by Candida in RVVC has been recently questioned. This study aimed to elucidate the fundamental growth modes of Candida in the vagina of patients with RVVC or sporadic vulvovaginal candidiasis (VVC) and to assess their roles in the persistence of RVVC. Methods: Vaginal tissues were sampled from twelve patients clinically and microbiologically diagnosed as RVVC or VVC at a post-antifungal-treatment and asymptomatic period. High-resolution scanning electron microscopy, fluorescence in situ hybridization in combination with Candida-specific 18S rRNA probes and viable fungal burden were used to qualitatively and quantitatively evaluate Candida growth in the human vagina. The presence of Candida biofilm extracellular polymeric substances was examined using confocal laser scanning microscopy and biopsy sections pre-stained with Concanavalin A. Histopathological analysis was carried out on infected vaginal tissues stained with hematoxylin and eosin. Lastly, the susceptibility of epithelium-associated Candida biofilms to fluconazole at the peak serum concentration was evaluated. Results: Candida species grew on the vaginal epithelium of RVVC patients as morphologically disparate biofilms including monolayers, microcolonies, and macro-colonies, in addition to sporadic adherent cells. Candida biofilm growth on the vaginal epithelium was associated with mild lymphocytic infiltration of the vaginal mucosa. These epithelium-based Candida biofilms presented an important characteristic contributing to the persistence of RVVC that is the high tolerance to fluconazole. Conclusions: In summary, our study provides direct evidence to support the presence of Candida biofilms in RVVC and an important role of biofilm formation in disease persistence.

Sustainable and effective methods to increase long-acting reversible contraception uptake from the ACCORd general practice trial.

OBJECTIVE: Most Australian women access contraception through general practitioners (GPs) but choose oral methods rather than long-acting reversible contraceptives (LARCS). The Australian Contraceptive ChOice pRoject (ACCORd) successfully tested a complex intervention for LARC uptake. We aimed to explore the critical elements of this intervention to increase LARC uptake. DESIGN: ACCORd was a cluster randomised control trial conducted in 57 GP clinics in Melbourne, Australia. To explore intervention impact, fidelity checks (n=21 GPs) and interviews with 37 GPs and 40 patients were undertaken 12 months after initial consultations. Data were inductively coded, thematically analysed and mapped to Normalization Process Theory constructs. RESULTS: Doctors understood the importance of effectiveness-based contraceptive counselling (EBCC). GPs demonstrated cognitive engagement in the promotion of LARC and some appreciated the rapid referral pathways. GPs and women valued the effectiveness approach. GPs held varying views about having a rapid referral pathway, with many already having established pathways in place. Some GPs viewed intrauterine device insertion costs or insertion training as barriers to ongoing practice. Most GPs and women saw the ACCORD model as effective and sustainable. CONCLUSIONS: GP training in EBCC and the use of rapid referral pathways were critical features of an effective sustainable model for successful uptake of LARCs in primary care. IMPLICATIONS FOR PUBLIC HEALTH: Improving Australian women's access to and use of LARCs is sustainable with EBCC training and support for general practitioners.

Best Practice During Teleconsultations With Adolescents: A Scoping Review.

PURPOSE: Teleconsultations are increasingly used to deliver health care, yet guidance on how to maximize health outcomes and ensure the quality and rights-based principles of adolescent health care during teleconsultations is lacking. This scoping review synthesized the literature on teleconsultations with adolescents, with the objective of informing a practical guidance for healthcare professionals. METHODS: Eight databases were searched to identify articles published between 2010 and 2020 in English, French, or Spanish that provided evidence or guidance on synchronous teleconsultations with 10- to 19-year-olds. Web sites in six high-income countries and six low- to middle-income countries were also searched and a Google search was conducted. Data were analyzed using narrative synthesis. RESULTS: Of 59 total references, 51 were from high-income countries. References included primary research (n = 21), reviews (n = 13), clinical guidance (n = 9), case reports (n = 9), commentaries (n = 6), and a website (n = 1). Just under half (46%) were descriptive, qualitative, or expert opinion. The main focus was mental health and behavioral disorders. DISCUSSION: Good evidence on the complexities of conducting teleconsultations with adolescents is lacking. Questions remain regarding the scope and acuity of health issues for which teleconsultations are appropriate, their role in overcoming or contributing to inequalities, and the practicalities of conducting consultations.

Influences on condom use: A secondary analysis of women's perceptions from the Australian Contraceptive ChOice pRoject (ACCORd) trial.

BACKGROUND AND OBJECTIVES: Women's ability to negotiate condom use helps prevent sexually transmissible infections (STIs) and unintended pregnancies. The aim of this study was to assess the relationship between substance use, risk perception and the certainty of using condoms in several hypothetical situations. METHOD: This is a secondary analysis from the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial. Descriptive statistics and logistic regression were used for the analysis. RESULTS: At baseline, contraceptive questions were answered by 698 women attending 57 general practices in Melbourne, Australia. Condom use was reported by 47%. Of those using condoms as the sole form of contraception (n = 137), 20% used them inconsistently. Dual protection was used by 58% of women (188/325). Condoms and the pill were more frequently used than condoms and longer-acting contraceptives. Women were less likely to be confident negotiating condom use when using substances. DISCUSSION: Substance use and the concurrent use of other forms of contraception impact use of condoms. Even when condoms are the sole form of contraception with willing partners, use is inconsistent, leaving women at risk of pregnancy and STI.

Current contraceptive use in women with a history of unintended pregnancies: Insights from the Australian Contraceptive ChOice pRoject (ACCORd) trial.

BACKGROUND AND OBJECTIVES: Clinical guidelines advocate using long-acting reversible contraceptives (LARC) to reduce unintended pregnancy, but LARC use in Australia is poor. Additionally, little is known about contraceptive practices of women with a history of unintended pregnancy. The aim of this study was to describe current contraception use according to a history of unintended pregnancy. METHOD: Data were analysed from women recruited into The Australian Contraceptive ChOice pRoject (ACCORd) trial. RESULTS: Approximately 47% (128/275) of women aged 16-45 years reported unintended pregnancies, and 30% had an abortion (83/275). Contraceptive data available from 117 women showed that condoms (24%, n = 28/117) and the oral contraceptive pill (22%, n = 26/117) were most commonly used among women reporting one unintended pregnancy or more. DISCUSSION: These findings support implementing interventions to increase the uptake of effective contraception, as successfully demonstrated in the ACCORd trial, in general practice.

Cost-effectiveness of a complex intervention in general practice to increase uptake of long-acting reversible contraceptives in Australia.

Objective The aim of this study was to evaluate the cost-effectiveness of the Australian Contraceptive ChOice pRoject (ACCORd) intervention. Methods An economic evaluation compared the costs and outcomes of the ACCORd intervention with usual care (UC). Data from the ACCORd trial were used to estimate costs and efficacy in terms of contraceptive uptake and quality of life. Rates of contraceptive failure and pregnancy were sourced from the literature. Using a Markov model, within-trial results were extrapolated over 10 years and subjected to univariate sensitivity analyses. Model outputs were expressed as the cost per quality-adjusted life years (QALY) gained and cost per unintended pregnancy resulting in birth (UPB) avoided. Results Over 10 years, compared with UC, initiating contraception through the ACCORd intervention resulted in 0.02 fewer UPB and higher total costs (A$2505 vs A$1179) per woman. The incremental cost-effectiveness of the ACCORd intervention versus UC was A$1172 per QALY gained and A$7385 per UPB averted. If the start-up cost of the ACCORd intervention was removed, the incremental cost-effectiveness ratio was A$81 per QALY gained and A$511 per UPB averted. The results were most sensitive to the probability of contraceptive failure, the probability of pregnancy-related healthcare service utilisation or the inclusion of the costs of implementing the ACCORd intervention. Conclusions From a health system perspective, if implemented appropriately in terms of uptake and reach, and assuming an implicit willingness to pay threshold of A$50 000 the ACCORd intervention is cost-effective. What is known about the topic? The uptake of long-active reversible contraceptives (LARC) in Australia is low. The ACCORd trial assessed the efficacy of providing structured training to general practitioners (GPs) on LARC counselling, together with access to rapid referral to insertion clinics. What does this paper add? This study is the first to assess the cost-effectiveness of a complex intervention in the general practice setting aimed at increasing the uptake of LARC in Australia. What are the implications for practitioners? The results show that implementing a complex intervention in general practice involving GP education and the availability of rapid referral to LARC insertion clinics is a cost-effective approach to increase LARC use and its attending efficacy. If the majority of Australian GPs were able to deliver effectiveness-based contraceptive counselling and either insert LARC or use a rapid referral process to a LARC insertion clinic, the additional cost associated with the purchase of LARC products and their insertion would be offset by reductions to health system costs as a result of fewer UPB and abortions. Moreover, the benefits to women's physical and psychological health of avoiding such events is substantial.

Increasing the uptake of long-acting reversible contraception in general practice: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomised controlled trial longitudinal follow-up protocol.

INTRODUCTION: Through addressing main barriers to the uptake of long-acting reversible contraceptives (LARCs) among Australian women, the Australian Contraceptive ChOice pRoject (ACCORd) trialled an educational intervention targeting general practitioners (GPs) and provided those in the intervention group with a rapid referral service for quick insertion. The cluster randomised controlled trial resulted in greater uptake of LARC in the intervention group. This protocol paper describes a longitudinal follow-up to the ACCORd Study to assess the long-term efficacy and cost-effectiveness of the intervention. METHODS AND ANALYSIS: Women participants (patients of ACCORd GPs) completed a baseline, 6-month and 12-month survey. These participants will be invited to complete an additional follow-up survey 3 years post completion of their baseline interview. Based on the original ACCORd Study tools, the online survey will address long-term outcomes including contraceptive continuation rates and reproductive history, any unintended pregnancies, satisfaction and concerns with their current contraceptive method, and an assessment of quality of life. We will analyse data using binary regression models with generalised estimating equations and robust standard errors to account for clustering. DISCUSSION: Demonstration of sustained use, effectiveness at reducing unwanted pregnancies and cost-effectiveness of this strategy among this cohort of Australian primary care patients, will strengthen the policy and programme urgency of addressing wider dissemination of these strategies and replicating the study elsewhere. ETHICS AND DISSEMINATION: The ACCORd Study received approval from the Monash University Human Research Ethics Committee: CF16/188-201000080. Additionally, an amendment to conduct this 3-year longitudinal follow-up survey has been approved. The trial follow-up outcomes will be disseminated through formal academic pathways, including journal articles, national and international conferences and reports as well as using more 'mainstream' strategies such as seminars, workshops and media engagement. Additionally, outcomes will be communicated through policy briefs to Australian state and federal governments. TRAIL REGISTRATION NUMBER: This trial is registered with the Australian and New Zealand Trials Registry ACTRN12615001346561. Recruitment and data collection have been completed for the baseline, 6-month and 12-month surveys. Data collection for the 3-year survey commenced in August 2019.

Associations with asymptomatic colonization with Candida in women reporting past vaginal candidiasis: an observational study.

OBJECTIVE: Asymptomatic vaginal colonization with Candida species is a known risk factor for vulvovaginal candidiasis (VVC). Taking known risk factors for symptomatic VVC, the authors sought to identify factors associated with asymptomatic colonization. STUDY DESIGN: As part of a randomized controlled trial which compared vaginal candidal colony counts in women taking garlic tablets or placebo, 192 asymptomatic women collected a baseline screening swab for Candida species. Eligibility for this study included at least one self-reported episode of VVC in the previous 12 months and age 18-50 years. Known risk factors for VVC were compared in women colonized with candida and those without colonization. RESULTS: 37% of asymptomatic women who self-reported VVC in the previous 12 months were colonized with vaginal Candida species. Using multivariate analysis, two factors were associated with asymptomatic colonization: a current sexual partner (P=0.02) and being born outside of Australia (P=0.05). Use of oral contraceptives was not statistically significant (P=0.27). CONCLUSIONS: Clinical relevance of asymptomatic colonization with vaginal yeast and its link to episodes of VVC warrants further investigation.

Premenstrual vaginal colonization of Candida and symptoms of vaginitis.

Although premenstrual exacerbation of vulvovaginal symptoms attributed to Candida spp. is well documented, the causation of these symptoms is not well understood. This study describes the daily vaginal colonization of Candida in three women. A single pilot study was designed to test the methodology of the proposed randomized controlled trial, Garlic and Candida. This study reports the colonization of Candida spp. in three women. Ten women aged 18-50 who reported at least one episode of vulvovaginal candidiasis were recruited by the University of Melbourne. Each participant took daily vaginal swabs for 2 weeks during the luteal phase of their menstrual cycle, which were analysed for quantitative colony counts of Candida spp. Of these, three women were colonized with Candida spp. For the first time, to our knowledge, daily colonization of Candida during the luteal phase of the menstrual cycle is described in three women, demonstrating an increase in the colony count preceding symptom development. This small study demonstrated the colonization of Candida spp. during the luteal phase of the menstrual cycle in three women. Candida colonization is poorly understood, yet investigating the relevance of the link between symptom exacerbation and the menstrual cycle in those women who experience recurrent episodes of vulvovaginal candidiasis may influence the management of this condition.