SARS-CoV-2 infection in the first trimester and the risk of early miscarriage: a UK population-based prospective cohort study of 3041 pregnancies conceived during the pandemic.

STUDY QUESTION: Does maternal infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the first trimester affect the risk of miscarriage before 13 week's gestation? SUMMARY ANSWER: Pregnant women with self-reported diagnosis of SARS-CoV-2 in the first trimester had a higher risk of early miscarriage. WHAT IS KNOWN ALREADY: Viral infections during pregnancy have a broad spectrum of placental and neonatal pathology. Data on the effects of the SARS-CoV-2 infection in pregnancy are still emerging. Two systematic reviews and meta-analyses reported an increased risk of preterm birth, caesarean delivery, maternal morbidity and stillbirth. Data on the impact of first trimester infection on early pregnancy outcomes are scarce. This is the first study, to our knowledge, to investigate the rates of early pregnancy loss during the SARS-CoV-2 outbreak among women with self-reported infection. STUDY DESIGN, SIZE, DURATION: This was a nationwide prospective cohort study of pregnant women in the community recruited using social media between 21 May and 31 December 2020. We recruited 3545 women who conceived during the SARS-CoV-2 pandemic who were <13 week's gestation at the time of recruitment. PARTICIPANTS/MATERIALS, SETTING, METHODS: The COVID-19 Contraception and Pregnancy Study (CAP-COVID) was an on-line survey study collecting longitudinal data from pregnant women in the UK aged 18 years or older. Women who were pregnant during the pandemic were asked to complete on-line surveys at the end of each trimester. We collected data on current and past pregnancy complications, their medical history and whether they or anyone in their household had symptoms or been diagnosed with SARS-CoV-2 infection during each trimester of their pregnancy. RT-PCR-based SARS-CoV-2 RNA detection from respiratory samples (e.g. nasopharynx) is the standard practice for diagnosis of SARS-CoV-2 in the UK. We compared rate of self-reported miscarriage in three groups: 'presumed infected', i.e. those who reported a diagnosis with SARS-CoV-2 infection in the first trimester; 'uncertain', i.e. those who did not report a diagnosis but had symptoms/household contacts with symptoms/diagnosis; and 'presumed uninfected', i.e. those who did not report any symptoms/diagnosis and had no household contacts with symptoms/diagnosis of SARS-CoV-2. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 3545 women registered for the CAP-COVID study at <13 weeks gestation and were eligible for this analysis. Data for the primary outcome were available from 3041 women (86%). In the overall sample, the rate of self-reported miscarriage was 7.8% (238/3041 [95% CI, 7-9]). The median gestational age (GA) at miscarriage was 9 weeks (interquartile range 8-11). Seventy-seven women were in the 'presumed infected' group (77/3041, 2.5% [95% CI 2-3]), 295/3041 were in the uncertain group (9.7% [95% CI 9-11]) and the rest in the 'presumed uninfected' (87.8%, 2669/3041 [95% CI 87-89]). The rate of early miscarriage was 14% in the 'presumed infected' group, 5% in the 'uncertain' and 8% in the 'presumed uninfected' (11/77 [95% CI 6-22] versus 15/295 [95% CI 3-8] versus 212/2669 [95% CI 7-9], P = 0.02). After adjusting for age, BMI, ethnicity, smoking status, GA at registration and the number of previous miscarriages, the risk of early miscarriage appears to be higher in the 'presumed infected' group (relative rate 1.7, 95% CI 1.0-3.0, P = 0.06). LIMITATIONS, REASONS FOR CAUTION: We relied on self-reported data on early pregnancy loss and SARS-CoV-2 infection without any means of checking validity. Some women in the 'presumed uninfected' and 'uncertain' groups may have had asymptomatic infections. The number of 'presumed infected' in our study was low and therefore the study was relatively underpowered. WIDER IMPLICATIONS OF THE FINDINGS: This was a national study from the UK, where infection rates were one of the highest in the world. Based on the evidence presented here, women who are infected with SARS-CoV-2 in their first trimester may be at an increased risk of a miscarriage. However, the overall rate of miscarriage in our study population was 8%. This is reassuring and suggests that if there is an effect of SARS-CoV-2 on the risk of miscarriage, this may be limited to those with symptoms substantial enough to lead to a diagnostic test. Further studies are warranted to evaluate a causal association between SARS-CoV-2 infection in early pregnancy and miscarriage risk. Although we did not see an overall increase in the risk of miscarriage, the observed comparative increase in the presumed infected group reinforces the message that pregnant women should continue to exercise social distancing measures and good hygiene throughout their pregnancy to limit their risk of infection. STUDY FUNDING/COMPETING INTEREST(S): This study was supported by a grant from the Elizabeth Garrett Anderson Hospital Charity (G13-559194). The funders of the study had no role in study design, data collection, data analysis, data interpretation or writing of the report. J.A.H. is supported by an NIHR Advanced Fellowship. A.L.D. is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre. All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: support to J.A.H. and A.L.D. as above; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work. TRIAL REGISTRATION NUMBER: N/A.

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

OBJECTIVE: To determine women's (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 women's 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.

Desire to Avoid Pregnancy scale: clinical considerations and comparison with other questions about pregnancy preferences.

BACKGROUND: Clinicians and women of reproductive age would benefit from a reliable way to identify who is likely to become pregnant in the next year, in order to direct health advice. The 14-item Desire to Avoid Pregnancy (DAP) scale is predictive of pregnancy; this paper compares it with other ways of assessing pregnancy preferences to shortlist options for clinical implementation. METHODS: A cohort of 994 UK women of reproductive age completed the DAP and other questions about pregnancy preferences, including the Attitude towards Potential Pregnancy Scale (APPS), at baseline and reported on pregnancies quarterly for a year. For each question, DAP item and combinations of DAP items, we examined the predictive ability, sensitivity, specificity, area under the receiver operating curve (AUROC), and positive and negative predictive values. RESULTS: The AUROCs and predictive ability of the APPS and DAP single items were weaker than the full DAP, though all except one had acceptable AUROCs (>0.7). The most predictive individual DAP item was 'It would be a good thing for me if I became pregnant in the next 3 months', where women who strongly agreed had a 66.7% chance of pregnancy within 12 months and the AUROC was acceptable (0.77). CONCLUSION: We recommend exploring the acceptability to women and healthcare professionals of asking a single DAP item ('It would be a good thing for me if I became pregnant in the next 3 months'), possibly in combination with additional DAP items. This will help to guide service provision to support reproductive preferences.

Chlamydia control activities in Europe: cross-sectional survey.

BACKGROUND: Chlamydia is the most commonly reported bacterial sexually transmitted infection in Europe. The objective of the Screening for Chlamydia in Europe (SCREen) project was to describe current and planned chlamydia control activities in Europe. METHODS: The authors sent a questionnaire asking about different aspects of chlamydia epidemiology and control to public health and clinical experts in each country in 2007. The principles of sexually transmitted infection control were used to develop a typology comprising five categories of chlamydia control activities. Each country was assigned to a category, based on responses to the questionnaire. RESULTS: Experts in 29 of 33 (88%) invited countries responded. Thirteen of 29 countries (45%) had no current chlamydia control activities. Six countries in this group stated that there were plans to introduce chlamydia screening programmes. There were five countries (17%) with case management guidelines only. Three countries (10%) also recommended case finding amongst partners of diagnosed chlamydia cases or people with another sexually transmitted infection. Six countries (21%) further specified groups of asymptomatic people eligible for opportunistic chlamydia testing. Two countries (7%) reported a chlamydia screening programme. There was no consistent association between the per capita gross domestic product of a country and the intensity of chlamydia control activities (P = 0.816). CONCLUSION: A newly developed classification system allowed the breadth of ongoing national chlamydia control activities to be described and categorized. Chlamydia control strategies should ensure that clinical guidelines to optimize chlamydia diagnosis and case management have been implemented before considering the appropriateness of screening programmes.

Impact of the SARS-CoV-2 pandemic on access to contraception and pregnancy intentions: a national prospective cohort study of the UK population.

OBJECTIVE: Evaluate the impact of the COVID-19 pandemic on access to contraception and pregnancy intentions. DESIGN: Nationwide prospective cohort study. SETTING: United Kingdom. PARTICIPANTS: Women in the UK who were pregnant between 24 May and 31 December 2020. MAIN OUTCOME MEASURES: Access to contraception and level of pregnancy intentions, using the London Measure of Unplanned Pregnancy (LMUP) in women whose last menstrual period was before or after 1 April 2020. While the official date of the first UK lockdown was 23 March, we used 1 April to ensure that those in the post-lockdown group would have faced restrictions in the month that they conceived. RESULTS: A total of 9784 women enrolled in the cohort: 4114 (42.0%) conceived pre-lockdown and 5670 (58.0%) conceived post-lockdown. The proportion of women reporting difficulties accessing contraception was higher in those who conceived after lockdown (n=366, 6.5% vs n=25, 0.6%, p<0.001) and continued to rise from March to September 2020. After adjusting for confounders, women were nine times more likely to report difficulty accessing contraception after lockdown (adjusted odds ratio (aOR) 8.96, 95% CI 5.89 to 13.63, p<0.001). There is a significant difference in the levels of pregnancy planning, with higher proportions of unplanned (n=119, 2.1% vs n=55, 1.3%) and ambivalent pregnancies (n=1163, 20.5% vs n=663, 16.1%) and lower proportions of planned pregnancies (n=4388, 77.4% vs n=3396, 82.5%) in the post-lockdown group (p<0.001). After adjusting for confounders, women who conceived after lockdown were still significantly less likely to have a planned pregnancy (aOR 0.88, 95% CI 0.79 to 0.98, p=0.025). CONCLUSIONS: Access to contraception in the UK has become harder during the COVID-19 pandemic and the proportion of unplanned pregnancies has almost doubled.

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.

What influences young women to choose between the emergency contraceptive pill and an intrauterine device? A qualitative study.

OBJECTIVE: To explore key factors influencing young women when choosing between two methods of emergency contraception (EC). METHODS: We interviewed 26 young women who accessed community sexual and reproductive health services for emergency contraception after they had chosen an EC. RESULTS: Most women had an unrealistically high expectation about efficacy of the emergency contraceptive pill (ECP) and lacked knowledge of the intrauterine device (IUD) as an alternative method of EC. Previous use, easy accessibility, ease of use, and advice from peers, influenced women to choose the ECP, whereas past experience of abortion, firm motivation to avoid pregnancy, presentation after 72 hours, and considering that an IUD may provide long-term contraception as well, inclined women to choose the IUD. When participants were shown the IUD, many found it to be smaller and less frightening than they had imagined. CONCLUSIONS: Women need better information and education about the IUD as a highly effective method of EC. Health professionals must provide such information at every opportunity. Showing the IUD during counselling might help correct misconceptions and would improve acceptability. Wider availability of expertise concerning EC-IUDs is essential to assist more women in making informed decisions when choosing a method for EC.

Emergency contraception from the pharmacy 20 years on: a mystery shopper study.

BACKGROUND: Emergency contraception (EC) was approved in the UK as a pharmacy medicine for purchase without prescription in 2001. Twenty years later we conducted a study to characterise routine practice pharmacy provision of EC. STUDY DESIGN: Mystery shopper study of 30 pharmacies in Edinburgh, Dundee and London participating in a clinical trial of contraception after EC. METHODS: Mystery shoppers, aged ≥16 years, followed a standard scenario requesting EC. After the pharmacy visit, they completed a proforma recording the duration of the consultation, where it took place, and whether advice was given to them about the importance of ongoing contraception after EC. RESULTS: Fifty-five mystery shopper visits were conducted. The median reported duration of the consultation with the pharmacist was 6 (range 1-18) min. Consultations took place in a private room in 34 cases (62%) and at the shop counter in the remainder. In 27 cases (49%) women received advice about ongoing contraception. Eleven women (20%) left the pharmacy without EC due to lack of supplies or of a trained pharmacist. Most women were generally positive about the consultation. CONCLUSIONS: While availability of EC from UK pharmacies has undoubtedly improved access, the necessity to have a consultation, however helpful, with a pharmacist introduces delays and around one in five of our mystery shoppers left without getting EC. Consultations in private are not always possible and little advice is given about ongoing contraception. It is time to make EC available without a pharmacy consultation.

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.

The Regai Dzive Shiri Project: a cluster randomised controlled trial to determine the effectiveness of a multi-component community-based HIV prevention intervention for rural youth in Zimbabwe--study design and baseline results.

OBJECTIVE: To assess the effectiveness of a community-based HIV prevention intervention for adolescents in terms of its impact on (1) HIV and Herpes simplex virus type 2 (HSV-2) incidence and on rates of unintended pregnancy and (2) reported sexual behaviour, knowledge and attitudes. METHODS: Cluster randomised trial of a multi-component HIV prevention intervention for adolescents based in rural Zimbabwe. Thirty communities were selected and randomised in 2003 to early or deferred intervention implementation. A baseline bio-behavioural survey was conducted among 6791 secondary school pupils (86% of eligibles) prior to intervention implementation. RESULTS: Baseline prevalences were 0.8% (95% CI: 0.6-1.0) for HIV and 0.2% (95% CI: 0.1-0.3%) for HSV-2. Four girls (0.12%) were pregnant. There was excellent balance between study arms. Orphans who made up 35% of the cohort were at increased risk of HIV [age-sex adjusted odds ratio 3.4 (95% CI: 1.7-6.5)]. 11.9% of young men and 2.9% of young women reported that they were sexually active (P < 0.001); however, there were inconsistencies in the sexual behaviour data. Girls were less likely to know about reproductive health issues than boys (P < 0.001) and were less likely to have used and to be able to access condoms (P < 0.001). CONCLUSION: This is one of the first rigorous evaluations of a community-based HIV prevention intervention for young people in southern Africa. The low rates of HIV suggest that the intervention was started before this population became sexually active. Inconsistency and under-reporting of sexual behaviour re-emphasise the importance of using externally validated measures of sexual risk reduction in behavioural intervention studies.

School based HIV prevention in Zimbabwe: feasibility and acceptability of evaluation trials using biological outcomes.

OBJECTIVE: To determine the feasibility and acceptability of conducting a community randomized trial (CRT) of an adolescent reproductive health intervention (ARHI) using biological measures of effectiveness. SETTING: Four secondary schools and surrounding communities in rural Zimbabwe. METHODS: Discussions were held with pupils, parents, teachers and community leaders to determine acceptability. A questionnaire and urine sampling survey was undertaken among Form 1 and 2 pupils. Studies were undertaken to inform likely participation and follow up in a future CRT. A community survey of 16-19-year-olds was conducted to determine levels of secondary school attendance and likely HIV prevalence at final follow up in the event of a trial. RESULTS: Form 1 and 2 pupils aged 12-18 years (n = 723; median age, 15 years) participated in the research. Prevalences of HIV, Chlamydia and gonorrhoea were 3.6% [95% confidence interval (CI), 2.3-5.3%], 0.4% (95% CI, 0.1-1.3%) and 1.9% (95% CI, 1.0-3.3%) respectively. There was poor correlation between biological evidence of sexual experience and questionnaire responses, due to concerns about confidentiality. Only 13% (95% CI, 4-27%) of those infected with HIV and/or a sexually transmitted disease admitted to having had sex. In the community survey of 573 adolescents aged 16-19 years, 6.6% (95% CI, 3.9-10.3%) of females and 5.1% (95% CI, 2.9-8.2%) of males were HIV positive. High participation and retention rates are achievable within a trial in this setting. CONCLUSIONS: It is acceptable and feasible to conduct randomized trials to establish the effectiveness of ARHIs. However, self-reported behavioural outcomes will probably be biased, emphasizing the importance of using externally validated biological outcome measures to determine effectiveness.

A novel approach for evaluating the performance of real time quantitative loop-mediated isothermal amplification-based methods.

Molecular diagnostic measurements are currently underpinned by the polymerase chain reaction (PCR). There are also a number of alternative nucleic acid amplification technologies, which unlike PCR, work at a single temperature. These 'isothermal' methods, reportedly offer potential advantages over PCR such as simplicity, speed and resistance to inhibitors and could also be used for quantitative molecular analysis. However there are currently limited mechanisms to evaluate their quantitative performance, which would assist assay development and study comparisons. This study uses a sexually transmitted infection diagnostic model in combination with an adapted metric termed isothermal doubling time (IDT), akin to PCR efficiency, to compare quantitative PCR and quantitative loop-mediated isothermal amplification (qLAMP) assays, and to quantify the impact of matrix interference. The performance metric described here facilitates the comparison of qLAMP assays that could assist assay development and validation activities.

The use of local anaesthesia for intrauterine device insertion by health professionals in the UK.

BACKGROUND: Pain associated with the insertion of an intrauterine device (IUD) is a known barrier to intrauterine contraception use in the UK. It is good practice for health professionals to discuss pain relief and use with women prior to the insertion of an IUD. OBJECTIVES: This study aimed to determine the prevalence of and reasons for and against the use of local anaesthesia (LA) for IUD insertion. METHODS: A survey was undertaken using paper questionnaires to determine LA use for IUD insertion by UK health professionals. RESULTS: Overall, approximately one quarter (n=129) of all respondents use LA routinely, one quarter hardly ever or never use LA, while the remaining half use it sometimes. Use of LA was more prevalent among health professionals who worked in integrated sexual and reproductive health and contraception-only services, compared to general practice. UK health professionals who hardly ever or never used LA for the insertion of IUDs were more likely to be working in general practice. CONCLUSIONS: The results of this survey suggest that more UK health professionals need to routinely discuss pain relief and offer this to their patients prior to IUD insertion as part of the care pathway for patients who choose to use intrauterine contraception.

HIV and STI prevalence and determinants among male migrant workers in India.

BACKGROUND: Our objective was to estimate for the first time the prevalence and determinants of human immunodeficiency virus type 1 (HIV-1) and sexually transmitted infections (STIs) among male migrants in India. METHODOLOGY/PRINCIPAL FINDINGS: We conducted a multi-stage stratified probability sample survey of migrant (defined as not born in Surat city) men aged 18 to 49 years working in the diamond and textile industries in Surat city. Behavioural and biological data were collected. Biological data included laboratory diagnosed herpes simplex virus type 2 (HSV-2), syphilis, chlamydia, gonorrhoea, Trichomonas vaginalis (together defined as 'any STI') and HIV-1. Likely recently acquired STIs included chlamydia, gonorrhoea, T. vaginalis and syphilis with rapid plasma reagin ≥1:8. The response rate was 77% (845/1099). Among 841 participants, HIV-1 prevalence was 1.0%, 'any STI' prevalence was 9.5% and 38.9% of these STIs were likely to have been recently acquired. Being a diamond worker, Surat resident for 10+ years and recent antibiotic use were each associated with higher odds of 'any STI' (aORs 1.83 (95% CI 1.09-3.09), 1.98 (95% CI 1.22-3.22) and 2.57 (95% CI 1 .17-5.64), respectively) after adjusting for the other two factors and age. The main study limitation was social desirability bias for self-reported sexual behaviour; STIs were diagnosed in some self-reported virgins. CONCLUSIONS/SIGNIFICANCE: HIV and STI prevalence were lower than expected, but prevention interventions remain necessary in Surat since almost 40% of STIs among participants were probably recently acquired and sentinel surveillance HIV prevalence remains high. The participants had a similar HIV prevalence to Surat antenatal clinic attendees, a proxy for the general population. This suggests migrants are not always at higher risk of HIV compared to the general population in their migration destination. Our findings highlight the need to contextualise research findings from a specific setting with other local information to guide HIV/STI prevention interventions.

The Regai Dzive Shiri project: results of a randomized trial of an HIV prevention intervention for youth.

BACKGROUND: HIV prevention among young people in southern Africa is a public health priority. There is little rigorous evidence of the effectiveness of different intervention approaches. We describe findings of a cluster randomized trial of a community-based, multicomponent HIV, and reproductive health intervention aimed at changing social norms for adolescents in rural Zimbabwe. METHODS: Thirty rural communities were randomized to early or deferred implementation of the intervention in 2003. Impact was assessed in a representative survey of 18-22-year-olds after 4 years. Participants self-completed a questionnaire and gave a dried blood spot sample for HIV and herpes simplex virus-2 (HSV-2) antibody testing. Young women had a urinary pregnancy test. Analyses were by intention-to-treat and were adjusted for clustering. FINDINGS: Four thousand six hundred and eighty-four, 18-22-year-olds participated in the survey (97.1% of eligible candidates, 55.5% women). Just over 40% had been exposed to at least 10 intervention sessions. There were modest improvements in knowledge and attitudes among young men and women in intervention communities, but no impact on self-reported sexual behavior. There was no impact of the intervention on prevalence of HIV or HSV-2 or current pregnancy. Women in intervention communities were less likely to report ever having been pregnant. INTERPRETATION: Despite an impact on knowledge, some attitudes, and reported pregnancy, there was no impact of this intervention on HIV or HSV-2 prevalence, further evidence that behavioral interventions alone are unlikely to be sufficient to reverse the HIV epidemic. The challenge remains to find effective HIV prevention approaches for young people in the face of continued and unacceptably high HIV incidence, particularly among young women.

Effectiveness of chlamydia screening: systematic review.

BACKGROUND: Screening programmes are promoted to control transmission of and prevent female reproductive tract morbidity caused by genital chlamydia. The objective of this study was to examine the effectiveness of register-based and opportunistic chlamydia screening interventions. METHODS: We searched seven electronic databases (Cinahl, Cochrane Controlled Trials Register, DARE, Embase, Medline, PsycINFO and SIGLE) without language restrictions from January 1990 to October 2007 and reference lists of retrieved articles to identify studies published before 1990. We included studies examining primary outcomes (pelvic inflammatory disease, ectopic pregnancy, infertility, adverse pregnancy outcomes, neonatal infection, chlamydia prevalence) and harms of chlamydia screening in men and non-pregnant and pregnant women. We extracted data in duplicate and synthesized the data narratively or used random effects meta-analysis, where appropriate. RESULTS: We included six systematic reviews, five randomized trials, one non-randomized comparative study and one time trend study. Five reviews recommended screening of women at high risk of chlamydia. Two randomized trials found that register-based screening of women at high risk of chlamydia and of female and male high school students reduced the incidence of pelvic inflammatory disease in women at 1 year. Methodological inadequacies could have overestimated the observed benefits. One randomized trial showed that opportunistic screening in women undergoing surgical termination of pregnancy reduced post-abortal rates of pelvic inflammatory disease compared with no screening. We found no randomized trials showing a benefit of opportunistic screening in other populations, no trial examining the effects of more than one screening round and no trials examining the harms of chlamydia screening. CONCLUSION: There is an absence of evidence supporting opportunistic chlamydia screening in the general population younger than 25 years, the most commonly recommended approach. Equipoise remains, so high-quality randomized trials of multiple rounds of screening with biological outcome measures are still needed to determine the balance of benefits and harms of chlamydia screening.