Nataliya Brima

Determinants of long-acting reversible contraceptive (LARC) use by adolescent girls and young women.

Abstract Objectives To identify factors relevant for adolescents and young women in their selection of a contraceptive method and reasons for acceptance or rejection of long-acting reversible contraceptives (LARCs). Method Questionnaire survey among 194 women attending an integrated young people service. Results Compared to the number of those who had heard about all LARCs (71%), the number of respondents who had used a LARC was low (28%). Awareness of intrauterine methods was the lowest, compared to other LARCs. High efficacy, protection against sexually transmitted infections and non interference with sex were the three most important factors when choosing a contraceptive method, whereas the possibility of altering the menstrual pattern and reversibility were not considered important. Qualities of LARCs such as reliability and long duration of action would encourage young women to accept LARCs. Knowledge of peers’ good experience with a LARC fosters, but fear of pain and needle (most obvious for intrauterine methods) restrains use of these methods. Conclusions Despite reliability and long-term use being important advantages, fear of pain and needles make LARCs less appealing to young people. Current LARCs meet some, but not all expectations of adolescents and young women.

Randomized trial of the effect of tailored versus standard use of the combined oral contraceptive pill on continuation rates at 1 year

BACKGROUND There is growing interest from women and clinicians in extended or tailored use of the combined oral contraceptive (COC) pill. Potential advantages include less bleeding, greater contraceptive efficacy and user satisfaction. We examined the effect of a tailored pill regimen, compared with the standard regimen, on continuation and satisfaction rates at 1 year and associated bleeding patterns. STUDY DESIGN This was a randomized controlled trial with 503 women aged 18-45 years. Women were randomized to either the standard regimen (21 daily pills followed by a 7-day pill-free interval) or tailored regimen (daily pills until three consecutive days bleeding triggers a 3-day pill-free interval) of Microgynon 30® (ethinyl oestradiol 30 mcg, levonorgestrel 150 mcg). Primary outcome was COC continuation at 12 months; secondary outcomes included satisfaction with pill regimen regarding contraception and bleeding pattern. Daily electronic diaries were used to record womens pill use, switching to other contraceptive methods, menstrual bleeding patterns and satisfaction levels. RESULTS Eighty-three percent of women were already taking the COC at recruitment, 13% were restarting the COC and 4% were first time COC users. Seventy-one percent of all women were followed up at 12 months. Continuation rates at 1 year were 82% in the tailored arm versus 80% in the standard arm [odds ratio (OR)=1.13; 95% confidence interval (CI)=0.67-1.91]. Satisfaction with contraceptive regimen was 86% (tailored) versus 94% (standard) (OR=0.37; 95% CI=0.17-0.79), and satisfaction with bleeding pattern was 79% versus 87%, respectively (OR=0.53; 95% CI=0.30-0.93). Median number of bleeding days per month was 2.4 (tailored) and 4.9 (standard). Incidence, duration and intensity of bleeding episodes were significantly lower in the tailored arm. CONCLUSIONS In women familiar with standard use of the COC, switching to tailored COC use or continuing with standard use were both associated with high COC continuation rates and high satisfaction with contraceptive regimen and bleeding pattern. While significant differences tended to favor the standard group, tailored COC use was associated with significantly less bleeding, suited some women very well and can provide a suitable alternative to standard use.

Stopping and switching contraceptive methods: findings from Contessa, a prospective longitudinal study of women of reproductive age in England

BACKGROUND Discontinuation of, and change in, use of contraceptive methods contributes to high unplanned pregnancy rates. The aims of the Contessa study were to estimate the prevalence of and reasons for discontinuation and change and to assess the implications for preventive intervention. METHODS Prospective cohort study of 1091 potentially fertile women aged 18-49, carried out during 2008, using a sample drawn from the Health Survey for England 2006, a random probability survey of health. We carried out a baseline survey followed by three further waves, exploring patterns of contraceptive use, characteristics of women experiencing each, and reasons for discontinuation and change. FINDINGS A percentage of 3.7 of women were at risk of unplanned pregnancy and discontinued and/or changed a contraceptive method in a year, compared with 4.7% who were at risk of unplanned pregnancy and used no method. Compared with continuous users, stoppers and switchers were younger, better educated and more likely to be single. Women discontinued or changed their contraceptive method for reasons of ease of use, reliability, side effects or concerns over health effects. Barely a quarter of such decisions were influenced by medical staff. INTERPRETATION Effective strategies to aid contraceptive adherence have proved elusive but, if found, could reduce unplanned pregnancy rates appreciably. Understanding of the factors contributing to successful contraceptive practice is essential to prevention of unintended pregnancy.

Patients' experiences and providers' observations on pain during intrauterine device insertion

Abstract Objective To determine womens (patients’) experiences of intrauterine device (IUD) insertion under our current practice and the extent to which these agreed with the observations of the health professionals (providers) who had performed the IUD insertion procedures. Method Questionnaires were used to collect information on womens experiences of the IUD insertion procedure from both patients and providers in a sexual and reproductive health service. Results Overall response rates were high (77%, 284 responses in total). Seventy-three percent of patients were nulliparous and over half nulligravid. The providers predominantly used local anaesthesia for IUD insertions (93%). Most patients reported being anxious before their procedure (86%). Patients mainly described the overall experience of their IUD insertion procedure as being associated with ‘minimal discomfort/nothing’ (42%) or ‘uncomfortable’ (41%). ‘Minimal discomfort/nothing’ (56%) and ‘uncomfortable’ (33%) were the main observations of providers. When responses of patients and their providers were compared, agreement was slight for reported pain levels (k = 0.167 CI [0.13–0.24]). Patients’ reported pain levels were significantly higher than those reported to have been observed by their providers (p < 0.001). Conclusion Patients’ and providers’ responses suggested that the IUD insertion procedure under our current practice appeared acceptable to most patients. However, providers were not usually accurate in their observations and tended to underestimate the degree of pain experienced by their patients during IUD insertion procedures. Chinese Abstract 摘要： 目的 了解妇女（患者）在宫内节育器放置术中的感受与术者观察评估的一致性。 方法 在一个性健康和生殖健康服务机构，对患者和术者进行问卷调查，收集妇女在宫内节育器放置过程中的感受的信息。 结果 总共284人回答，问卷回收率较高，为77%。其中73%的妇女未生育过，超过一半未妊娠过。术者放置宫内节育器时主要采用局麻方式，占（93%）。大部分患者（86%）报告说在术前感到紧张。患者描述在宫内节育器放置过程中总的反应主要为极少的不适/没有不适（42%）或感觉不舒服（41%）。极少的不适/没有不适（56%）和感觉不舒服（33%）是术者的主要的观察意见。关于疼痛水平，患者的感受和术者的观察评估比较一致性较差( k= 0.167 CI [0.13 -0.24])。患者报告的疼痛程度明显高于她们的术者报告的观察到的疼痛程度。 结论 患者和术者的反应提示：按照我们目前的操作，宫内节育器放置过程可被大多数患者接受。然而，术者的观察评估往往不准确，并且往往会低估患者在宫内节育器放置术中感受到的疼痛的程度。

The "3 in 1" Study: Pooling Self-Taken Pharyngeal, Urethral, and Rectal Samples into a Single Sample for Analysis for Detection of Neisseria gonorrhoeae and Chlamydia trachomatis in Men Who Have Sex with Men.

ABSTRACT Triple-site testing (using pharyngeal, rectal, and urethral/first-void urine samples) for Neisseria gonorrhoeae and Chlamydia trachomatis using nucleic acid amplification tests detects greater numbers of infections among men who have sex with men (MSM). However, triple-site testing represents a cost pressure for services. MSM over 18 years of age were eligible if they requested testing for sexually transmitted infections (STIs), reported recent sexual contact with either C. trachomatis or N. gonorrhoeae, or had symptoms of an STI. Each patient underwent standard-of-care (SOC) triple-site testing, and swabs were taken to form a pooled sample (PS) (pharyngeal, rectal, and urine specimens). The PS was created using two methods during different periods at one clinic, but we analyzed the data in combination because the sensitivity of the two methods did not differ significantly for C. trachomatis (P = 0.774) or N. gonorrhoeae (P = 0.163). The sensitivity of PS testing (92%) was slightly lower than that of SOC testing (96%) for detecting C. trachomatis (P = 0.167). For N. gonorrhoeae, the sensitivity of PS testing (90%) was significantly lower than that of SOC testing (99%) (P < 0.001). When pharynx-only infections were excluded, the sensitivity of PS testing to detect N. gonorrhoeae infections increased to 94%. Our findings show that pooling of self-taken samples could be an effective and cost-saving method, with high negative predictive values. (Interim results of this study were presented at the BASHH 2013 summer meeting.)

Factors Associated with HIV Prevalence and HIV Testing in Sierra Leone: Findings from the 2008 Demographic Health Survey

Background The Sierra Leone Demographic Health Survey 2008 found an HIV prevalence of 1.5%. This study investigates associations with HIV infection and HIV testing. Methods Households were selected using stratified multi-stage sampling. In all selected households women aged 15–49 were eligible. In every second household men aged 15–59 were also eligible. Participants were asked to consent for anonymous HIV testing. All participants interviewed and tested were analysed. Multiple logistic regression identified associations with HIV infection, undiagnosed infection and with ever having a voluntary HIV test among sexually active participants. Results Of 7495 invited 86% (6,475) agreed to an interview and HIV test. Among 96 HIV positive participants, 78% had never taken a voluntary HIV test so were unaware of their serostatus, and 86% were sexually active in the last 12 months among whom 96% did not use a condom at last intercourse. 11% of all participants had previously voluntarily tested. Among women who had tested, 60% did so in antenatal care. We found that those living in an urban area, and those previously married, were more likely to be HIV infected. Voluntary HIV testing was more common in those aged 25–44, living in an urban area, females, having secondary or higher education, having first sexual intercourse at age 17 years or older, and using condoms at last sex. Although 82% of men and 69% of women had heard of HIV, only 35% and 29% respectively had heard of antiretroviral therapy. Conclusions The HIV prevalence in Sierra Leone has been stable. HIV testing, however, is uncommon and most infected individuals are unaware of their serostatus. This could allow the epidemic to escalate as individuals with undiagnosed infection are unlikely to change their behaviour or access treatment. Improving knowledge and increasing testing need to remain central to HIV prevention interventions in Sierra Leone.

Outcomes from treating tuberculosis with rifampicin or rifabutin in HIV-infected persons also receiving antiretroviral therapy.

To the Editors: Treatment of tuberculosis (TB) and HIV co-infection poses a number of important challenges for clinicians, including drug–drug interactions between components of antiretroviral therapy (ART) and anti-TB treatment. This is especially important between ritonavirboosted protease inhibitor (PI) therapy and rifampicin, a key component of quadruple short-course TB treatment. The current United Kingdom and United States guidelines recommend that HIV–TB co-infected patients should be treated for both TB and HIV contemporaneously, to achieve optimal outcomes. Where the use of first-line ART with a non-nucleoside reverse transcriptase inhibitor (NNRTI) is contraindicated, for example, acquired or transmitted resistance, intolerance, or toxicity of NNRTI, a ritonavir-boosted PI ART regimen is recommended. However, there are significant interactions between ritonavir-boosted PIs and rifampicin. Rifampicin is a potent inducer of several cytochrome P450 isoenzymes, including CYP3A4, as well as P-glycoprotein, and phase-2 enzyme activity, which have important actions on the metabolism of PIs and NNRTI. These effects may lead to subtherapeutic PI levels even when PI pharmacokinetics are boosted by ritonavir and, as a result ritonavir-boosted PI regimes are contraindicated in coadministration with rifampicin. Rifabutin, a rifamycin family member, is effective in treatment of TB in HIV-negative subjects. Based on pharmacokinetic studies, rifabutin has less of an effect than rifampicin on inducing hepatic enzymes and can be used in combination with PI-based ART regimens. Several studies have reported good outcomes from rifabutinbased regimens for treatment of TB in HIV-infected individuals, but there is a paucity of data describing outcomes in HIV-infected patients with TB treated with rifabutin, while also receiving ART. We undertook a retrospective observational study of outcomes among HIV/TB co-infected patients, who received either rifampicin or rifabutin for the treatment of TB and ART, to identify if outcomes differed according to the type of rifamycin used. Adult HIV-infected individuals treated for TB with either rifampicin or rifabutin, and who received ART (containing either a ritonavir-boosted PI or an NNRTI) at 2 inner city HIV treatment centers (Chelsea and Westminster Hospital and University College London Hospitals, London, United Kingdom), between April 1999 and August 2011 were identified. Data were extracted from case note and electronic patient records, including patient demographics (age, gender, ethnicity, risk factor for HIV acquisition), previous history of TB, site of TB (pulmonary, lymph node, or disseminated), interval between diagnosis of TB and HIV, details of anti-TB and ART regimens, occurrence of adverse drug reactions (ADRs) (grade 3/4) requiring TB treatment interruption, occurrence of immune reconstitution inflammatory syndrome (IRIS), and outcomes (completed treatment, died). End of treatment plasma HIV viral load, and change in CD4 count between the start and end of TB treatment were noted. Each patient was followed up for 24 months: outcomes during follow-up, including death or recurrence, were recorded. Patients with known rifamycin and/or isoniazid resistance were excluded. Patients were categorized as having either definite or presumptive TB, as previously described. ART was defined as the use of at least 3 antiretroviral drugs including either a ritonavirboosted PI (lopinavir or darunavir) or an NNRTI. Prescription of anti-TB medication and ART was based on the British HIV Association Guidelines, and was at the discretion of individual physicians: treatment was self-administered in the majority of patients. All patients started standard 4-drug TB therapy with isoniazid, pyrazinamide, ethambutol, and either rifabutin or rifampicin, except for 2 rifabutin-treated patients who started a quinolone in place of pyrazinamide (both had indeterminate pyrazinamide sensitivities and were fully sensitive to the other first-line medications). Rifampicin dosing was weight-based (450 or 600 mg once daily) and was given with a gvfNNRTI. Rifabutin 450 mg once daily was used with efavirenz, 300 mg once daily with nevirapine, and 150 mg 3 times weekly was given with a ritonavir-boosted PI. All other anti-TB drugs were taken daily. Data were analyzed using STATA SE12 (Statacorp LP, College Station, TX). The x2, Mann–Whitney U test, and Fisher exact tests were used to compare rifabutinand rifampicintreated groups. A P , 0.05 was considered significant. Ethics committee approval was not required because this R.F.M. has received honoraria from Gilead, Janssen, Merck, and ViiV, for giving nonpromotional lectures on clinical aspects of HIV and tuberculosis, is a member of the British HIV Association TB/HIV Guidelines Committee, and is a panel member for Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-infected Adults and Adolescents. A.L.P. has received honoraria from AbbVie, BMS, Gilead, Janssen, Merck, Tobira, and ViiV, for giving nonpromotional lectures on clinical aspects of HIV and tuberculosis, has received payment from Janssen for expert testimony relating to an HIV drug submission to the European Medicines Agency, is Chair of the British HIV Association TB/HIV Guidelines Committee and a member of the British HIV Association, European Aids Clinical Society, and WHO HIV Treatment Guidelines Committees. The remaining authors have no conflicts of interest to disclose. T.M.R. and R.F.M. acquired data, analyzed, and interpreted the data, wrote the first and final drafts of the article. A.L.P. was responsible for the study concept and design, analyzed and interpreted the data, critically reviewed drafts of the article for important intellectual content. N.B.,S.M., and A.J.C. analyzed and interpreted the data, critically reviewed drafts of the article for important intellectual content. F.A.,A.J.,S.B., and L.K. acquired data, analyzed and interpreted the data, critically reviewed drafts of the article for important intellectual content.

Offering extended use of the combined contraceptive pill: a survey of specialist family planning services

Background The purpose of this study was to determine attitudes to, and provision of, extended regimens for taking the combined oral contraceptive pill (COC) by specialist contraception practitioners from three contrasting specialist contraception services in London. Methods An online cross-sectional survey was administered to all doctors and nurses, who counsel, provide, or prescribe the oral contraceptive pill at each clinic. Results A total of 105 clinicians received the questionnaire and 67 (64%) responded. Only one of three clinics initiated and maintained guidelines for extended COC use. In that service, 60% of staff prescribing COC advised more than 50% of patients regarding alternative COC regimens. In the other two services, this was discussed with 20% and 6% of patients, respectively (P < 0.001). The reasons for prescribing extended use included cyclic headaches, menorrhagia, patient request, menstrual-related cramps, and endometriosis, and did not differ between the three different settings. The most common extended regimens were 63 pills or continuous use until bleeding occurs, followed by a hormone-free interval. Concerns highlighted by providers and patients were “unhealthy not to have a monthly bleed”, “future fertility”, and “breakthrough bleeding”. Such comments highlight the need for further information for providers and patients. Conclusion There is growing evidence, backed by national guidance, about extended COC use, but routine provision of this information is patchy and varies ten-fold, even within specialist family planning services. Targeted training, use of service guidelines, and implementation research will be needed to extend patient choice of different COC regimens and change clinical practice.

Counselling to include tailored use of combined oral contraception in clinical practice: an evaluation.

Background Combined oral contraception (COC, ‘the pill’) remains the most prescribed method of contraception in the UK. Although a variety of regimens for taking monophasic COC are held to be clinically safe, women are not routinely counselled about these choices and there is a lack of evidence on how to provide this information to women. Aim To assess the usefulness and feasibility of including tailored use of monophasic COC within routine COC counselling in a sexual and reproductive health (SRH) service using a structured format. Method Using a structured format, healthcare professionals (HCPs) counselled new and established COC users attending an SRH service about standard and tailored ways of taking the pill. Questionnaires were used to survey both the HCPs and patients immediately after the initial consultation, and then the patients again 8 weeks later. Results Nearly all patients (98%, n=95) felt it was helpful to be informed of the different ways of using monophasic COC by the HCP, without giving too much information at one time (96%, n=108). The HCPs were confident of their COC counselling (99%, n=110) and did not think the consultations took significantly longer (88%, n=98). Conclusion This study demonstrates that information on different pill taking regimens is useful and acceptable to patients, and can improve contraceptive pill user choice. It is also feasible for HCPs to perform COC counselling to include tailored pill use during routine consultations in a clinical setting.

Prospective observational study to evaluate the performance of the BioSure HIV Self-Test in the hands of lay users

Objectives In order to assess whether the BioSure HIV Self-Test could be reliably performed by users at home and to determine whether they were able to perform and correctly interpret the test, we carried out an evaluation study among attendees at a sexual health service. Methods A prospective observational study of clinic attendees to determine their ability to follow the instructions, complete the test on themselves and correctly interpret the results. The evaluation included interpretation of three dummy (contrived) devices, chosen at random from a sample of 12 devices, to ensure that a sufficient number of all possible test outcomes were included. Results Two hundred participants were recruited. 97.0% (95% CI 93.5 to 98.9) conducted the test so as to achieve a valid result. 99.5% correctly identified the test result. Participants correctly interpreted the result of 94.0% (95% CI 91.4 to 95.9) of 586 contrived devices. Conclusions The majority of participants were able to follow the instructions and perform the test in order to get a valid result. Interpretation of the test results was good and the majority of participants were able to correctly read the result of their own and contrived tests. The availability of HIV self-tests will provide another option to increase access to testing particularly for those who may not wish or are unable to access clinical services.