Study protocol for a randomised controlled trial of a virtual antenatal intervention for improved diet and iron intake in Kapilvastu district, Nepal: VALID.

INTRODUCTION: Despite evidence that iron and folic acid (IFA) supplements can improve anaemia in pregnant women, uptake in Nepal is suboptimal. We hypothesised that providing virtual counselling twice in mid-pregnancy, would increase compliance to IFA tablets during the COVID-19 pandemic compared with antenatal care (ANC alone. METHODS AND ANALYSIS: This non-blinded individually randomised controlled trial in the plains of Nepal has two study arms: (1) control: routine ANC; and (2) 'Virtual' antenatal counselling plus routine ANC. Pregnant women are eligible to enrol if they are married, aged 13-49 years, able to respond to questions, 12-28 weeks' gestation, and plan to reside in Nepal for the next 5 weeks. The intervention comprises two virtual counselling sessions facilitated by auxiliary nurse midwives at least 2 weeks apart in mid-pregnancy. Virtual counselling uses a dialogical problem-solving approach with pregnant women and their families. We randomised 150 pregnant women to each arm, stratifying by primigravida/multigravida and IFA consumption at baseline, providing 80% power to detect a 15% absolute difference in primary outcome assuming 67% prevalence in control arm and 10% loss-to-follow-up. Outcomes are measured 49-70 days after enrolment, or up to delivery otherwise. PRIMARY OUTCOME: consumption of IFA on at least 80% of the previous 14 days. SECONDARY OUTCOMES: dietary diversity, consumption of intervention-promoted foods, practicing ways to enhance bioavailability and knowledge of iron-rich foods. Our mixed-methods process evaluation explores acceptability, fidelity, feasibility, coverage (equity and reach), sustainability and pathways to impact. We estimate costs and cost-effectiveness of the intervention from a provider perspective. Primary analysis is by intention-to-treat, using logistic regression. ETHICS AND DISSEMINATION: We obtained ethical approval from Nepal Health Research Council (570/2021) and UCL ethics committee (14301/001). We will disseminate findings in peer-reviewed journal articles and by engaging policymakers in Nepal. TRIAL REGISTRATION NUMBER: ISRCTN17842200.

Comprehensive Anaemia Programme and Personalized Therapies (CAPPT): protocol for a cluster-randomised controlled trial testing the effect women's groups, home counselling and iron supplementation on haemoglobin in pregnancy in southern Nepal.

BACKGROUND: Anaemia in pregnancy remains prevalent in Nepal and causes severe adverse health outcomes. METHODS: This non-blinded cluster-randomised controlled trial in the plains of Nepal has two study arms: (1) Control: routine antenatal care (ANC); (2) Home visiting, iron supplementation, Participatory Learning and Action (PLA) groups, plus routine ANC. Participants, including women in 54 non-contiguous clusters (mean 2582; range 1299-4865 population) in Southern Kapilbastu district, are eligible if they consent to menstrual monitoring, are resident, married, aged 13-49 years and able to respond to questions. After 1-2 missed menses and a positive pregnancy test, consenting women < 20 weeks' gestation, who plan to reside locally for most of the pregnancy, enrol into trial follow-up. Interventions comprise two home-counselling visits (at 12-21 and 22-26 weeks' gestation) with iron folic acid (IFA) supplement dosage tailored to women's haemoglobin concentration, plus monthly PLA women's group meetings using a dialogical problem-solving approach to engage pregnant women and their families. Home visits and PLA meetings will be facilitated by auxiliary nurse midwives. The hypothesis is as follows: Haemoglobin of women at 30 ± 2 weeks' gestation is ≥ 0.4 g/dL higher in the intervention arm than in the control. A sample of 842 women (421 per arm, average 15.6 per cluster) will provide 88% power, assuming SD 1.2, ICC 0.09 and CV of cluster size 0.27. Outcomes are captured at 30 ± 2 weeks gestation. Primary outcome is haemoglobin concentration (g/dL). Secondary outcomes are as follows: anaemia prevalence (%), mid-upper arm circumference (cm), mean probability of micronutrient adequacy (MPA) and number of ANC visits at a health facility. Indicators to assess pathways to impact include number of IFA tablets consumed during pregnancy, intake of energy (kcal/day) and dietary iron (mg/day), a score of bioavailability-enhancing behaviours and recall of one nutrition knowledge indicator. Costs and cost-effectiveness of the intervention will be estimated from a provider perspective. Using constrained randomisation, we allocated clusters to study arms, ensuring similarity with respect to cluster size, ethnicity, religion and distance to a health facility. Analysis is by intention-to-treat at the individual level, using mixed-effects regression. DISCUSSION: Findings will inform Nepal government policy on approaches to increase adherence to IFA, improve diets and reduce anaemia in pregnancy. TRIAL REGISTRATION: ISRCTN 12272130 .

Participatory Women's Groups with Cash Transfers Can Increase Dietary Diversity and Micronutrient Adequacy during Pregnancy, whereas Women's Groups with Food Transfers Can Increase Equity in Intrahousehold Energy Allocation.

Background: There is scarce evidence on the impacts of food transfers, cash transfers, or women's groups on food sharing, dietary intakes, or nutrition during pregnancy, when nutritional needs are elevated. Objective: This study measured the effects of 3 pregnancy-focused nutrition interventions on intrahousehold food allocation, dietary adequacy, and maternal nutritional status in Nepal. Methods: Interventions tested in a cluster-randomized controlled trial (ISRCTN 75964374) were "Participatory Learning and Action" (PLA) monthly women's groups, PLA with transfers of 10 kg fortified flour ("Super Cereal"), and PLA plus transfers of 750 Nepalese rupees (∼US$7.5) to pregnant women. Control clusters received usual government services. Primary outcomes were Relative Dietary Energy Adequacy Ratios (RDEARs) between pregnant women and male household heads and pregnant women and their mothers-in-law. Diets were measured by repeated 24-h dietary recalls. Results: Relative to control, RDEARs between pregnant women and their mothers-in-law were 12% higher in the PLA plus food arm (log-RDEAR coefficient = 0.12; 95% CI: 0.02, 0.21; P = 0.014), but 10% lower in the PLA-only arm between pregnant women and male household heads (-0.11; 95% CI: -0.19, -0.02; P = 0.020). In all interventions, pregnant women's energy intakes did not improve, but odds of pregnant women consuming iron-folate supplements were 2.5-4.6 times higher, odds of pregnant women consuming more animal-source foods than the household head were 1.7-2.4 times higher, and midupper arm circumference was higher relative to control. Dietary diversity was 0.4 food groups higher in the PLA plus cash arm than in the control arm. Conclusions: All interventions improved maternal diets and nutritional status in pregnancy. PLA women's groups with food transfers increased equity in energy allocation, whereas PLA with cash improved dietary diversity. PLA alone improved diets, but effects were mixed. Scale-up of these interventions in marginalized populations is a policy option, but researchers should find ways to increase adherence to interventions. This trial was registered at www.controlled-trials.com as ISRCTN 75964374.

Ethnic variations in sexual behaviours and sexual health markers: findings from the third British National Survey of Sexual Attitudes and Lifestyles (Natsal-3).

BACKGROUND: Sexual health entails the absence of disease and the ability to lead a pleasurable and safe sex life. In Britain, ethnic inequalities in diagnoses of sexually transmitted infections (STI) persist; however, the reasons for these inequalities, and ethnic variations in other markers of sexual health, remain poorly understood. We investigated ethnic differences in hypothesised explanatory factors such as socioeconomic factors, substance use, depression, and sexual behaviours, and whether they explained ethnic variations in sexual health markers (reported STI diagnoses, attendance at sexual health clinics, use of emergency contraception, and sexual function). METHODS: We analysed probability survey data from Britain's third National Survey of Sexual Attitudes and Lifestyles (Natsal-3; n=15 162, conducted in 2010-12). Reflecting Britain's current ethnic composition, we included in our analysis participants who identified in 2011 as belonging to one of the following seven largest ethnic groups: white British, black Caribbean, black African, Indian, Pakistani, white other, and mixed ethnicity. We calculated age-standardised estimates and age-adjusted odds ratios for all explanatory factors and sexual health markers for all these ethnic groups with white British as the reference category. We used multivariable regression to examine the extent to which adjusting for explanatory factors explained ethnic variations in sexual health markers. FINDINGS: We included 14 563 (96·0%) of the 15 162 participants surveyed in Natsal-3. Greater proportions of black Caribbean, black African, and Pakistani people lived in deprived areas than those of other ethnic groups (36·9-55·3% vs 16·4-29·4%). Recreational drug use was highest among white other and mixed ethnicity groups (25·6-27·7% in men and 10·3-12·9% in women in the white other and mixed ethnicity groups vs 4·1-15·6% in men and 1·0-11·2% in women of other ethnicities). Compared with white British men, the proportions of black Caribbean and black African men reporting being sexually competent at sexual debut were lower (32·9% for black Caribbean and 21·9% for black African vs 47·4% for white British) and the number of partners in the past 5 years was greater (median 2 [IQR 1-4] for black Caribbean and 2 [1-5] for black African vs 1 [1-2] for white British), and although black Caribbean and black African men reported greater proportions of concurrent partnerships (26·5% for black Caribbean and 38·9% for black African vs 14·8% for white British), these differences were not significant after adjusting for age. Compared with white British women, the proportions of black African and mixed ethnicity women reporting being sexually competent were lower (18·0% for black African and 35·3% for mixed ethnicity vs 47·9% for white British), and mixed ethnicity women reported larger numbers of partners in the past 5 years (median 1 [IQR 1-4] vs 1 [1-2]) and greater concurrency (14·3% vs 8·0%). Reporting STI diagnoses was higher in black Caribbean men (8·7%) and mixed ethnicity women (6·7%) than white British participants (3·6% in men and 3·2% in women). Use of emergency contraception was most commonly reported among black Caribbean women (30·7%). Low sexual function was most common among women of white other ethnicity (30·1%). Adjustment for explanatory factors only partly explained inequalities among some ethnic groups relative to white British ethnicity but did not eliminate ethnic differences in these markers. INTERPRETATION: Ethnic inequalities in sexual health markers exist, and they were not fully explained by differences in their broader determinants. Holistic interventions addressing modifiable risk factors and targeting ethnic groups at risk of poor sexual health are needed. FUNDING: Medical Research Council, the Wellcome Trust, the Economic and Social Research Council, UK Department of Health, and The National Institute for Health Research.

Using Observational Data to Estimate the Effect of Hand Washing and Clean Delivery Kit Use by Birth Attendants on Maternal Deaths after Home Deliveries in Rural Bangladesh, India and Nepal.

BACKGROUND: Globally, puerperal sepsis accounts for an estimated 8-12% of maternal deaths, but evidence is lacking on the extent to which clean delivery practices could improve maternal survival. We used data from the control arms of four cluster-randomised controlled trials conducted in rural India, Bangladesh and Nepal, to examine associations between clean delivery kit use and hand washing by the birth attendant with maternal mortality among home deliveries. METHODS: We tested associations between clean delivery practices and maternal deaths, using a pooled dataset for 40,602 home births across sites in the three countries. Cross-sectional data were analysed by fitting logistic regression models with and without multiple imputation, and confounders were selected a priori using causal directed acyclic graphs. The robustness of estimates was investigated through sensitivity analyses. RESULTS: Hand washing was associated with a 49% reduction in the odds of maternal mortality after adjusting for confounding factors (adjusted odds ratio (AOR) 0.51, 95% CI 0.28-0.93). The sensitivity analysis testing the missing at random assumption for the multiple imputation, as well as the sensitivity analysis accounting for possible misclassification bias in the use of clean delivery practices, indicated that the association between hand washing and maternal death had been over estimated. Clean delivery kit use was not associated with a maternal death (AOR 1.26, 95% CI 0.62-2.56). CONCLUSIONS: Our evidence suggests that hand washing in delivery is critical for maternal survival among home deliveries in rural South Asia, although the exact magnitude of this effect is uncertain due to inherent biases associated with observational data from low resource settings. Our findings indicating kit use does not improve maternal survival, suggests that the soap is not being used in all instances that kit use is being reported.

Associations between health and sexual lifestyles in Britain: findings from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3).

BACKGROUND: Physical and mental health could greatly affect sexual activity and fulfilment, but the nature of associations at a population level is poorly understood. We used data from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3) to explore associations between health and sexual lifestyles in Britain (England, Scotland, and Wales). METHODS: Men and women aged 16-74 years who were resident in households in Britain were interviewed between Sept 6, 2010, and Aug 31, 2012. Participants completed the survey in their own homes through computer-assisted face-to-face interviews and self-interview. We analysed data for self-reported health status, chronic conditions, and sexual lifestyles, weighted to account for unequal selection probabilities and non-response to correct for differences in sex, age group, and region according to 2011 Census figures. FINDINGS: Interviews were done with 15,162 participants (6293 men, 8869 women). The proportion reporting recent sexual activity (one or more occasion of vaginal, oral, or anal sex with a partner of the opposite sex, or oral or anal sex or genital contact with a partner of the same sex in the past 4 weeks) decreased with age after the age of 45 years in men and after the age of 35 years in women, while the proportion in poorer health categories increased with age. Recent sexual activity was less common in participants reporting bad or very bad health than in those reporting very good health (men: 35·7% [95% CI 28·6-43·5] vs 74·8% [72·7-76·7]; women: 34·0% [28·6-39·9] vs 67·4% [65·4-69·3]), and this association remained after adjusting for age and relationship status (men: adjusted odds ratio [AOR] 0·29 [95% CI 0·19-0·44]; women: 0·43 [0·31-0·61]). Sexual satisfaction generally decreased with age, and was significantly lower in those reporting bad or very bad health than in those reporting very good health (men: 45·4% [38·4-52·7] vs 69·5% [67·3-71·6], AOR 0·51 [0·36-0·72]; women: 48·6% [42·9-54·3] vs 65·6% [63·6-67·4], AOR 0·69 [0·53-0·91]). In both sexes, reduced sexual activity and reduced satisfaction were associated with limiting disability and depressive symptoms, and reduced sexual activity was associated with chronic airways disease and difficulty walking up the stairs because of a health problem. 16·6% (95% CI 15·4-17·7) of men and 17·2% (16·3-18·2) of women reported that their health had affected their sex life in the past year, increasing to about 60% in those reporting bad or very bad health. 23·5% (20·3-26·9) of men and 18·4% (16·0-20·9) of women who reported that their health affected their sex life reported that they had sought clinical help (>80% from general practitioners; <10% from specialist services). INTERPRETATION: Poor health is independently associated with decreased sexual activity and satisfaction at all ages in Britain. Many people in poor health report an effect on their sex life, but few seek clinical help. Sexual lifestyle advice should be a component of holistic health care for patients with chronic ill health. FUNDING: Grants from the UK Medical Research Council and the Wellcome Trust, with support from the Economic and Social Research Council and Department of Health.