Prescription contraception use: a cross-sectional population study of psychosocial determinants

Objective: Many forms of contraception are available on prescription only for example, the oral contraceptive pill (OCP) and long-acting reversible contraceptives (LARCs). In this analysis we aim to identify key determinants of prescription contraceptive use.

Design: Cross-sectional population survey. Data on sociodemographic indices, concerns about the OCP and perceived barriers to access were collected.

Setting: Data set constructed from a representative population-based telephone survey of community dwelling adults in the Republic of Ireland (RoI)

Participants: 1515 women aged between 18 and 45 years

Main outcome measure: Self-reported user of the OCP or LARCs (intrauterine contraception, contraceptive injections or subdermal contraceptive implants) in the previous 12 months.

Results: For at least some of the previous year, 35% had used the OCP and 14% had used LARCs, while 3% had used two or more of these methods. OCP users were significantly younger, more likely to be unmarried and had higher income than non-users. Overall, 68% agreed with the statement ‘that taking a break from long-term use of the contraceptive pill is a good idea’ and 37% agreed with the statement that ‘the OCP has dangerous side effects’ and this was the strongest predictor variable of non-use of the OCP. Intrauterine contraception users were significantly older, more likely to be married and had lower income than non-users. Injections or subdermal contraceptive implant users were significantly younger, less likely to be married, had lower income and were less likely to agree that taking a break from long-term use of the pill is a good idea than non-users.

Conclusions: Prescription contraceptive use is sociodemographically patterned, with LARCs in particular being associated with lower incomes in the RoI. Concerns about the safety of the OCP remain prevalent and are important and modifiable determinants of contraceptive-related behaviour.

The first time: young people and sex in Northern Ireland.

The sexual health of people, particularly young people, in Northern Ireland is currently poor. Yet there has been little research conducted on sexual attitudes and lifestyles. This paper is based on data from the first ever major research project in this field in Northern Ireland. Using quantitative and qualitative methods, it targeted young people aged 14-25. A combination of a self-administered survey questionnaire, focus group discussions and one-to-one interviews was found to be most suitable for the collection of sensitive data on sexuality in a country where the social and moral climate had previously prevented studies of this nature. Information was collected on sexual attitudes and behaviour generally. This paper focuses on one crucial issue: the age of first sexual encounter. It explores the attitudes of young people to that experience and the use of contraception. Many of the findings match those of similar large-scale surveys in England and Wales, including the modal age of first sexual encounter and the influence of peer pressure on decision-making about first sex. There were significant gender differences in both behaviour and attitudes. It is hoped that the research results will influence future education and health policy, which has all too often been based on ignorance.

Sexual behaviour of young people in Northern Ireland: First sexual experience

Two National Surveys of Sexual Attitudes and Lifestyles in Britain (Natsal) were conducted, one in 1990 and one in 2000. Northern Ireland was excluded from both studies. Now, for the first time, comparable data about sexual attitudes and lifestyles of young people (14- to 25-year-olds) in Northern Ireland are available. Data were collected through self-administered questionnaires, one-to-one interviews and focus-group discussions. As in Natsal 1990 and 2000, young people were asked about their sexual attitudes towards sex, experiences of sex education, knowledge of sexually transmitted infections (STIs) and, if sexually active, about the circumstances in which sexual intercourse occurred. A total of 1013 young people in the target age group completed the self-administered questionnaire. Young people in Northern Ireland do not differ significantly from their counterparts in Britain in terms of sexual lifestyles and attitudes. Some 53.3% of all respondents reported that they had had sexual intercourse. Condom use at first sex was reported by 64% of sexually active respondents; 27.4% said they used no contraception; 26.7% of all respondents said they had sex before age 16. Respondents who first had sex when they were 15 or 16 years were more likely than other respondents to say that 'being drunk' was the main reason why intercourse occurred. Peer pressure to engage in sex was more prevalent among males than females. Young people in Northern Ireland regard friends as their most important source of sex education. School is the second most important source but most respondents wanted more sex education in school. It is important that it is needs focused and includes potentially sensitive and contentious information.

Advances in microbicide vaginal rings

Vaginal ring devices capable of providing sustained/controlled release of incorporated actives are already marketed for steroidal contraception and estrogen replacement therapy. In recent years, there has been considerable interest in developing similar ring devices for the administration of microbicidal compounds to prevent vaginal HIV transmission. Intended to be worn continuously, such coitally independent micro- bicide rings are being developed to maintain effective vaginal microbicide concentrations over many weeks or months, thereby overcoming issues around timing of product application, user compliance and acceptability associated with more conventional semi-solid formulations. In this article, an overview of vaginal ring technologies is presented, followed by a review of recent advances and issues pertaining to their application for the delivery of HIV microbicides. This article forms part of a special supplement on presentations covering intravaginal rings, based on the symposium “Trends in Microbicide Formulations”, held on 25 and 26 January 2010, Arlington, VA.

Evaluation of a DVD for women with diabetes: impact on knowledge and attitudes to preconception care

Aims: To determine if an educational DVD increases knowledge and changes attitudes of women with diabetes towards preconception care.

Methods: Ninety-seven women with diabetes (Type 1, n = 89; Type 2, n = 8), aged 18–40 years, completed a pre-DVD and post-DVD intervention study by postal questionnaire. Beliefs and attitudes associated with preventing an unplanned pregnancy and seeking preconception care were assessed using a validated questionnaire; scales included benefits, barriers, personal attitudes and self-efficacy. Knowledge of pregnancy planning and pregnancy-related risks were assessed by a 22-item questionnaire.

Results: After viewing the DVD there was significant positive change in women’s perceived benefits of, and their personal attitudes to, receiving preconception care and using contraception: change in score post-DVD viewing 0.7 (95% confidence interval 0.3, 1.2), P = 0.003, and 0.8 (0.3, 1.2), P = 0.001, respectively. The DVD significantly improved self-efficacy, that is, self-confidence to use contraception for prevention of an unplanned pregnancy and to access preconception care [3.3 (1.9, 4.7), P < 0.001], and significantly reduced perceived barriers to preconception care [-0.7 (-1.2, -0.2), P = 0.01]. Knowledge of pregnancy planning and pregnancy-related risks increased significantly after viewing the DVD: mean increase was 37.6 ± 20.0%, P < 0.001, and 16.9 ± 21.2%, P < 0.001, respectively.

Conclusions: This study demonstrates the effectiveness of a DVD in increasing knowledge and enhancing attitudes of women with diabetes to preconception care. This DVD could be used as a prepregnancy counselling resource to prepare women with diabetes for pregnancy.

Vaginal rings for delivery of HIV microbicides

Following the successful development of long-acting steroid-releasing vaginal ring devices for treatment of menopausal symptoms and contraception, there is now considerable interest in applying similar devices to the controlled release of microbicides against HIV. In this review article, the vaginal ring concept is first considered within the wider context of the early advances in controlled release technology, before describing the various types of ring device available today. The remainder of the article highlights the key developments in HIV microbicide-releasing vaginal rings, with a particular focus on the dapivirine ring that is presently in late-stage clinical testing. © 2012 Malcolm et al, publisher and licensee Dove Medical Press Ltd.

A modified SILCS contraceptive diaphragm for long-term controlled release of the HIV microbicide dapivirine

Background: There is considerable interest in developing new multipurpose prevention technologies to address women's reproductive health needs. This study describes an innovative barrier contraceptive device--based on the SILCS diaphragm--that also provides long-term controlled release of the lead candidate anti-HIV microbicide dapivirine.

Study design: Diaphragm devices comprising various dapivirine-loaded polymer spring cores overmolded with a nonmedicated silicone elastomer sheath were fabricated by injection molding processes. In vitro release testing, thermal analysis and mechanical characterization were performed on the devices.

Results: A diaphragm device containing a polyoxymethylene spring core loaded with 10% w/w dapivirine provided continuous and controlled release of dapivirine over a 6-month period, with a mean in vitro daily release rate of 174 mcg/day. The mechanical properties of the new diaphragm were closely matched to the SILCS diaphragm.

Conclusions: The study demonstrates proof of concept for a dapivirine-releasing diaphragm with daily release quantities potentially capable of preventing HIV transmission. In discontinuous clinical use, release of dapivirine may be readily extended over 1 or more years. © 2013 Elsevier Inc. All rights reserved.

The systematic development of an innovative DVD to raise awareness of preconception care

The purpose of this article is to describe the design, development and process evaluation of a preconception counselling resource (a DVD) for women with pre-gestational diabetes. DVD design and development centred on two key stakeholders ('DVD user group' and 'professional advisory group') working alongside a professional multimedia company. The DVD user group provided feedback on preferred DVD style, and informed modifications and improvements. The professional advisory group prepared the script, and ensured content and face validity. Evaluation of the DVD's acceptability and usefulness was assessed among women with diabetes via a postal questionnaire. Development phase: the resulting DVD is a 45-minute programme with three parts, featuring eight women with diabetes sharing their views and experiences, alongside an evidence-based commentary. The programme focuses on the importance of preventing an unplanned pregnancy (highlighting contraception) and on essential planning advice. Evaluation phase: 97 women (89 with type 1 and 8 with type 2 diabetes) evaluated the DVD using a rating scale of 0-10. Mean (SD) scores were: 9.1 (1.3) for quality; 9.0 (1.4) for content; 8.8 (1.5) for interest; 8.7 (1.8) for usefulness; 7.8 (2.2) for knowledge acquisition; and 8.0 (2.1) for knowledge confirmation. This combined user and multi-professional advisory group approach has produced an innovative and highly acceptable preconception counselling resource for women with diabetes. The development process and outcome evaluation are an important point of reference for future educational programmes. Future research will evaluate the impact of this preconception counselling resource on pregnancy planning indicators and pregnancy outcome.

Beyond HIV microbicides: multipurpose prevention technology (MPT) products

Multi-purpose prevention technologies (MPTs) that aim to simultaneously prevent unintended pregnancy, human immunodeficiency virus type 1 (HIV-1) infection and other sexually transmitted infections (STIs) are among the most innovative and complex products currently in development within women’s sexual and reproductive healthcare. In this review article, MPTs are placed within the wider context of combination products, combination drug products and multi-indication products. The current MPT product landscape is mapped and assessed with reference to existing products for the corresponding single indications, before identifying the gaps in the current MPT product pipeline and highlighting priority products and challenges moving forward.

Wanted and Unwanted Fertility in Bolivia:Does Ethnicity Matter?

CONTEXT: In Bolivia, the total fertility rate (TFR) among indigenous populations is higher than that among the nonindigenous population. It is important to investigate whether this difference is attributable to ethnic differences in wanted or unwanted fertility.
METHODS: Data from the 2003 Bolivian Demographic and Health Survey were used to estimate women's wanted and unwanted TFRs. Logistic regression analyses were conducted to examine whether women's, men's and couples' characteristics were associated with use of any contraceptive method and modern methods.
RESULTS: The TFRs for indigenous and nonindigenous women were 1.5 and 1.7, [corrected] respectively. The wanted fertility rate for indigenous women was nearly the same as that for nonindigenous women (2.8 and 1.4, [corrected] respectively); virtually all of the ethnic difference in the TFRs was attributable to the ethnic difference in unwanted fertility. The proportion of women in need of contraception was greater among indigenous women than among nonindigenous women (26% vs. 19%). In logistic regression analyses, male fertility preferences explained only a small part of the ethnic difference in contraceptive use.
CONCLUSION: Women's, men's and couples' preferences contribute only marginally to unwanted fertility, suggesting that structural factors act as obstacles to preventing unwanted fertility.

Development of a Temperature-Recording Vaginal Ring for Monitoring User Adherence

Background: Vaginal ring devices are being actively developed for controlled delivery of HIV microbicides and as multi-purpose prevention technology (MPT) products combining hormonal contraception with prevention of HIV and other sexually transmitted diseases. Presently, there is no reliable method for monitoring user adherence in HIV vaginal ring trials; previous acceptability studies have included some type of participant self-reporting mechanism, which have often been unreliable. More objective, quantitative and accurate methods for assessing adherence are needed.
Methods: A silicone elastomer vaginal ring containing an encapsulated miniature temperature recording device has been developed that can capture and store real-time temperature data during the period of designated use. Devices were tested in both simulated vaginal environments and following vaginal placement in cynomolgus macaques. Various use protocols and data sampling rates were tested to simulate typical patient usage scenarios. Results: The temperature logging devices accurately recorded vaginal temperature in macaques, clearly showing the regular diurnal temperature cycle. When environmental temperature and vaginal temperature was significantly different, the device was able to accurately pinpoint the insertion and removal times. Based on the data collected it was possible to infer removal periods as short as 5 min when the external environmental temperature was 25 °C. Accuracy increased with data sampling rate. Conclusions: This work provides proof-of-concept for monitoring adherence using a vaginal ring device containing an encapsulated temperature logger. The addition of one or more active agents into the ring body is not anticipated to affect the temperature monitoring function. A clinical study to compare self- reported user adherence data with that obtained by the device would be highly informative.

Evaluation of the Factors Contributing to Levonorgestrel Binding in Addition Cure Silicone Elastomer Vaginal Rings

Background: Following progress of the dapivirine (DPV)-releasing silicone elastomer (SE) vaginal ring (VR) into Phase III clinical studies, there is now interest in developing next-generation rings that additionally provide contraception. Levonorgestrel (LNG) is a safe and effective progestin that is being widely considered for use as a hormonal contraceptive agent in future multipurpose prevention technology (MPT) products. Although LNG has previously been incorporated into various controlled release SE devices, minimal attention has focused on its propensity to irreversibly react with addition cure SE systems. Here, for the first time, we investigate this LNG binding phenomenon and outline strategies for overcoming it.
Methods: VRs containing various loadings of DPV and LNG were manufactured and in vitro release assessed. Different LNG-only SE samples were also prepared to assess the following parameters: (i) addition cure vs. condensation cure SEs; (ii) different types of addition cure SEs; (iii) mixing time, (iv) cure temperature, (v) cure time; and (vi) LNG particle size. After manufacture, the LNG-only samples were assayed for total drug content using a solvent extraction method. The SE curing reaction and the LNG binding reaction was probed using nuclear magnetic resonance (NMR) spectroscopy. Results:
Under certain drug/formulation/processing conditions, LNG was not recoverable from VRs. Further studies using non-ring samples showed that: (a) the phenomenon was only observed with addition cure SEs (and not condensation cure SEs); (b) the extent of binding was dependent upon the type of addition cure SE; (c) micronised LNG showed significantly greater binding than non-micronised LNG; (d) the extent of binding correlated with increased mixing time, cure time and cure temperature.
Conclusions: Careful control of the API characteristics, the SE composition, and the manufacturing conditions will be necessary to establish a practical VR formulation for controlled release of LNG.

Development of a continuing professional development website to raise awareness of preconception counselling and pre-pregnancy care for Women with Diabetes

Aims: Pre-pregnancy care reduces the risk of adverse pregnancy outcomes in women with diabetes, yet the majority of women receive suboptimal care due to poor preconception counselling rates and a lack of awareness about the importance of specialised pre-pregnancy care. The primary aim was to develop a continuing professional development (CPD) resource for healthcare professionals (HCPs) who work with women with diabetes to facilitate preconception counselling with this group.

Methods: The website was developed under the direction of a multidisciplinary team, adhering to NICE guidelines. The tone, key messages and format are informed by the “Women with Diabetes” preconception counselling website, www.womenwithdiabetes.net, an existing resource which is effective in helping women to be better prepared for pregnancy.Results: This e-learning resource will give HCPs the necessary knowledge and tools to prepare women with diabetes to plan for pregnancy. The website features women with diabetes sharing their views and experiences, alongside an evidence-based commentary and key messages from research papers and clinical guidelines. It comprises two modules: “Planning for Pregnancy”, focusing on contraception, risks and planning; and “Diabetes and Pregnancy”, focusing on support during pregnancy with an overview of each trimester of pregnancy.

Conclusion: This website will be a useful CPD resource for all HCPs working with women with diabetes, providing a certificate on completion. This resource will empower HCPs to engage in preconception counselling with women with diabetes by providing the HCP with a greater understanding of the specific needs of women with diabetes both preconception and during pregnancy.

Microbicide Vaginal Rings: Technological Challenges and Clinical Development

Vaginal rings (VRs) are flexible, torus-shaped, polymeric devices designed to sustain delivery of pharmaceutical drugs to the vagina for clinical benefit. Following first report in a 1970 patent application, several steroid-releasing VR products have since been marketed for use in hormone replacement therapy and contraception. Since 2002, there has been growing interest in the use of VR technology for delivery of drugs that can reduce the risk of sexual acquisition of human immunodeficiency virus type 1 (HIV-1), the causative agent of acquired immunodeficiency syndrome (AIDS). Although no vaginally-administered product has yet been approved for HIV reduction/prevention, extensive research efforts are continuing and a number of VR devices offering sustained release of so-called ‘HIV microbicide’ compounds are currently being evaluated in late-stage clinical studies. This review article provides an overview of the published scientific literature within this important field of research, focusing primarily on articles published within peer-reviewed journal publications. Many important aspects of microbicide-releasing VR technology are discussed, with a particular emphasis on the technological, manufacturing and clinical challenges that have emerged in recent years.