Does the evidence support global promotion of the calendar-based Standard Days Method® of contraception?

OBJECTIVES: To scrutinise claims about the effectiveness of the Standard Days Method® (SDM). The SDM is a calendar method with similarities to the rhythm method that has now been reclassified and is marketed as a modern contraceptive method. As promoted, it requires users to avoid unprotected intercourse on days 8-19 of the menstrual cycle. It is used in at least 100 countries. SDM has been researched, developed, and is marketed by the Institute of Reproductive Health (IRH) at Georgetown University, USA, and a for-profit company Cycle Technologies. SDM proponents say it is a major advance on traditional periodic abstinence, claiming that it is 95% effective when used correctly - rivalling pills and condoms. The effectiveness claim is repeated in recent documents from the World Health Organization. STUDY DESIGN: Evaluation of evidence obtained via literature review of published and unpublished reports. RESULTS: Claims made for SDM effectiveness appear to rely on a single efficacy study where "correct use" of SDM was defined as total abstinence from intercourse in cycle days 8-19. It may therefore be misleading to apply a 95% effectiveness figure from the study to SDM as promoted, where abstinence is not required. Moreover, "typical use" effectiveness figures, cited as 88%, are based on an unrepresentative sample of women using SDM in ways likely to vary from how SDM is used in practice. CONCLUSION: Existing evidence does not support claims that the effectiveness of SDM as promoted is comparable to the best short-acting modern contraceptive methods. SDM is promoted in ways that may mislead users, by quoting overestimates of effectiveness and providing efficacy comparisons only with selected methods of contraception. Users should be provided with full and accurate information to make contraceptive choices. IMPLICATIONS: Use, delivery and promotion of SDM should be reevaluated. Meanwhile, SDM should only be offered to family planning clients as an adaptation of traditional periodic abstinence methods, requiring total abstinence in fertile days - reflecting "correct use" in the efficacy study - to achieve high effectiveness. Delivery of any form of SDM should include presentation of the full range of other contraceptive methods, including the most effective options

Increased adhesion of Plasmodium falciparum infected erythrocytes to ICAM-1 in children with acute intestinal injury

Background Children with severe malaria are at increased risk of invasive bacterial disease particularly infection with enteric gram-negative organisms. These organisms are likely to originate from the gut, however, how and why they breach the intestinal interface in the context of malaria infection remains unclear. One explanation is that accumulation of infected red blood cells (iRBCs) in the intestinal microvasculature contributes to tissue damage and subsequent microbial translocation which can be addressed through investigation of the impact of cytoadhesion in patients with malaria and intestinal damage. Methods Using a static adhesion assay, cytoadhesion of iRBCs was quantified in 48 children with malaria to recombinant proteins constitutively expressed on endothelial cell surfaces. Cytoadhesive phenotypes between children with and without biochemical evidence of intestinal damage [defined as endotoxemia or elevated plasma intestinal fatty acid binding protein (I-FABP)] was compared. Results The majority of parasites demonstrated binding to the endothelial receptors CD36 and to a lesser extent to ICAM-1. Reduced adhesion to CD36 but not adhesion to ICAM-1 or rosetting was associated with malarial anaemia (p = 0.004). Increased adhesion of iRBCs to ICAM-1 in children who had evidence of elevated I-FABP (p = 0.022), a marker of intestinal ischaemia was observed. There was no correlation between the presence of endotoxemia and increased adhesion to any of the recombinant proteins. Conclusion Increased parasite adhesion to ICAM-1 in children with evidence of intestinal ischaemia lends further evidence to a link between the cytoadherence of iRBCs in gut microvasculature and intestinal damage

Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial.

BACKGROUND: Adoption of modern contraceptive methods after menstrual regulation (MR) is thought to reduce subsequent unwanted pregnancy and abortion. Long-acting reversible contraceptives (LARCs) are highly effective at reducing unintended pregnancy, but uptake in Bangladesh is low. Providing information on the most effective methods of contraception increases uptake of more effective methods. This protocol describes a randomised controlled trial of an intervention delivered by mobile phone designed to support post-MR contraceptive use in Bangladesh. METHODS: This is a multi-site single blind individual randomised controlled trial. At least 960 women undergoing MR procedures at selected facilities will be recruited after their procedure by female research assistants. Women will be randomised into the control or intervention group with a 1:1 ratio. All participants will receive usual clinic care, including contraceptive counselling and the telephone number of a non-toll-free call centre which provides counselling on MR and contraception. During the 4 months after their MR procedure, intervention participants will be sent 11 recorded interactive voice messages to their mobile phone about contraception with a focus on their chosen method and LARCs. Each message allows the participant to connect directly to the call centre. The intervention is free to the user. The control group will receive no messages delivered by mobile phone. All participants will be asked to complete an in-person questionnaire at recruitment and follow-up questionnaires by telephone at 2 weeks, 4 months and 12 months after their MR. The primary outcome for the trial will be self-reported LARC use 4 months post-MR. Secondary outcomes include LARC use at 2 weeks and 12 months post-MR, use of any effective modern contraceptive method at 2 weeks, 4 months and 12 months post-MR, and contraceptive discontinuation, contraceptive method switching, pregnancy, subsequent MR and experience of violence during the 12 month study period. DISCUSSION: Mobile phones offer a low-cost mechanism for providing individualised support to women with contraception outside of the clinic setting. This study will provide information on the effects of such an intervention among MR clients in Bangladesh. TRIAL REGISTRATION: Trial registered with clinicaltrials.gov Registration number: NCT02579785 Date of registration: 16th October 2015

Delaying first birth: an analysis of household survey data from rural Southern Tanzania.

BACKGROUND: Currently, family planning metrics derived from nationally-representative household surveys such as the Demographic and Health Surveys (DHS) categorise women into those desiring to space or limit (permanently stop) births, or according to their age in the case of young women. This conceptualisation potentially ignores a large and growing group of young women who desire to delay a first birth. This study uses household survey data to investigate the characteristics and needs for family planning of women who want to delay their first birth. METHODS: The research was conducted in two rural districts in southern Tanzania (Tandahimba and Newala), and nested within the Expanded Quality Management Using Information Power (EQUIP) study. Data were collected as part of a repeated cross sectional household survey conducted between September 2013 and April 2014. The socio-demographic characteristics, including parity, contraceptive practices and fertility intentions of 2128 women aged 13-49 were analysed. The association between women's life stages of reproduction (delayers of first birth, spacers of subsequent pregnancies and limiters of future birth) and selected contraceptive outcomes (current use, unmet need and demand for modern contraceptives) was assessed using the point estimates and 95% confidence intervals for each indicator, adjusted for the survey design. RESULTS: Overall, four percent of women surveyed were categorised as 'delayers of first birth', i.e. sexually active but not started childbearing. Among this group, the majority were younger than 20 years old (82%) and unmarried (88%). Fifty-nine percent were currently using a modern method of contraception and injectables dominated their contraceptive use. Unmet need for contraception was higher among delayers (41%; 95% CI 32-51) and limiters (41%; 95% CI 35-47) compared to spacers (19%; 95% CI 17-22). CONCLUSIONS: Delayers of first birth have very high unmet needs for modern contraceptives and they should be routinely and separately categorised and measured within nationally-representative surveys such as Demographic and Health Survey and Multiple Indicator Cluster surveys. Acknowledging their unique needs could help catalyse a programmatic response

Treading the thin line: pharmacy workers’ perspectives on medication abortion provision in Lusaka, Zambia

Context: Despite liberal abortion laws, safe abortion access in Zambia is impeded by limited legal awareness, lack of services, and restrictive clinical policies. As in many countries with restricted abortion access, women frequently seek abortions informally from pharmacies. Methods: We conducted 16 in-depth interviews in 2019 to understand the experiences and motivations of pharmacy workers who sell medication abortion (MA) drugs in Lusaka. Results: We found that pharmacy staff reluctantly assume a gatekeeper role for MA due to competing pressures from clients and from regulatory constraints. Pharmacy staff often decide to provide MA, motivated by their duty of care and desire to help clients, as well as financial interests. However, pharmacy workers’ motivation to protect themselves from legal and business risk perpetuates inequalities in abortion access, as pharmacy workers improvise additional eligibility criteria based on personal risk and values such as age, partner approval, reason for abortion and level of desperation. Conclusion: These findings highlight how pharmacy staff informally determine women’s abortion access when laws and policies prevent comprehensive access to safe abortion. Reform of clinical guidelines, public education, strengthened public sector availability, task-sharing, and improved access to prescription services are needed to ensure women can legally access safe abortion