Marie E. Thoma

Effectiveness of an integrated intimate partner violence and HIV prevention intervention in Rakai, Uganda: analysis of an intervention in an existing cluster randomised cohort.

BACKGROUND Intimate partner violence (IPV) is associated with HIV infection. We aimed to assess whether provision of a combination of IPV prevention and HIV services would reduce IPV and HIV incidence in individuals enrolled in the Rakai Community Cohort Study (RCCS), Rakai, Uganda. METHODS We used pre-existing clusters of communities randomised as part of a previous family planning trial in this cohort. Four intervention group clusters from the previous trial were provided standard of care HIV services plus a community-level mobilisation intervention to change attitudes, social norms, and behaviours related to IPV, and a screening and brief intervention to promote safe HIV disclosure and risk reduction in women seeking HIV counselling and testing services (the Safe Homes and Respect for Everyone [SHARE] Project). Seven control group clusters (including two intervention groups from the original trial) received only standard of care HIV services. Investigators for the RCCS did a baseline survey between February, 2005, and June, 2006, and two follow-up surveys between August, 2006, and April, 2008, and June, 2008, and December, 2009. Our primary endpoints were self-reported experience and perpetration of past year IPV (emotional, physical, and sexual) and laboratory-based diagnosis of HIV incidence in the study population. We used Poisson multivariable regression to estimate adjusted prevalence risk ratios (aPRR) of IPV, and adjusted incidence rate ratios (aIRR) of HIV acquisition. This study was registered with ClinicalTrials.gov, number NCT02050763. FINDINGS Between Feb 15, 2005, and June 30, 2006, we enrolled 11 448 individuals aged 15-49 years. 5337 individuals (in four intervention clusters) were allocated into the SHARE plus HIV services group and 6111 individuals (in seven control clusters) were allocated into the HIV services only group. Compared with control groups, individuals in the SHARE intervention groups had fewer self-reports of past-year physical IPV (346 [16%] of 2127 responders in control groups vs 217 [12%] of 1812 responders in intervention groups; aPRR 0·79, 95% CI 0·67-0·92) and sexual IPV (261 [13%] of 2038 vs 167 [10%] of 1737; 0·80, 0·67-0·97). Incidence of emotional IPV did not differ (409 [20%] of 2039 vs 311 [18%] of 1737; 0·91, 0·79-1·04). SHARE had no effect on male-reported IPV perpetration. At follow-up 2 (after about 35 months) the intervention was associated with a reduction in HIV incidence (1·15 cases per 100 person-years in control vs 0·87 cases per 100 person-years in intervention group; aIRR 0·67, 95% CI 0·46-0·97, p=0·0362). INTERPRETATION SHARE could reduce some forms of IPV towards women and overall HIV incidence, possibly through a reduction in forced sex and increased disclosure of HIV results. Findings from this study should inform future work toward HIV prevention, treatment, and care, and SHAREs ecological approach could be adopted, at least partly, as a standard of care for other HIV programmes in sub-Saharan Africa. FUNDING Bill & Melinda Gates Foundation, US National Institutes of Health, WHO, Presidents Emergency Plan for AIDS Relief, Fogarty International Center.

Methodology for establishing a population-based birth cohort focusing on couple fertility and children's development, the Upstate KIDS Study.

BACKGROUND Critical data gaps remain regarding infertility treatment and child development. We assessed the utility of a birth certificate registry for developing a population cohort aimed at answering such questions. METHODS We utilised the Upstate New York livebirth registry (n = 201,063) to select births conceived with (n = 4024) infertility treatment or exposed infants, who were then frequency-matched by residence to a random sample of infants conceived without (n = 14,455) treatment or unexposed infants, 2008-10. Mothers were recruited at 2-4 months postpartum and queried about their reproductive histories, including infertility treatment for comparison with birth certificate data. Overall, 1297 (32%) mothers of exposed and 3692 of unexposed (26%) infants enrolled. RESULTS Twins represented 22% of each infant group. The percentage of infants conceived with/without infertility treatment was similar whether derived from the birth registry or maternal report: 71% none, 16% drugs or intrauterine insemination, and 14% assisted reproductive technologies (ART). Concordant reporting between the two data sources was 93% for no treatment, 88% for ART, and 83% for fertility drugs, but differed by plurality. Exposed infants had slightly (P < 0.01) earlier gestations than unexposed infants (38.3 ± 2.8 and 38.7 ± 2.7 weeks, respectively) based upon birth certificates but not maternal report (38.7 ± 2.7 and 38.7 ± 2.9, respectively). Conversely, mean birthweight was comparable using birth certificates (3157 ± 704 and 3194 ± 679 g, respectively), but differed using maternal report (3167 ± 692 and 3224 ± 661, respectively P < 0.05). CONCLUSIONS The birth certificate registry is a suitable sampling framework as measured by concordance with maternally reported infertility treatment. Future efforts should address the impact of factors associated with discordant reporting on research findings.

The short-term variability of bacterial vaginosis diagnosed by Nugent Gram stain criteria among sexually active women in Rakai, Uganda.

Background: Studies evaluating clinical and behavioral factors related to short-term fluctuations in vaginal microbiota are limited. We sought to describe changes in vaginal microbiota evaluated by Gram stain and assess factors associated with progression to and resolution of bacterial vaginosis (BV) at weekly intervals. Methods: A cohort of 255 sexually experienced, postmenarcheal women provided self-collected vaginal swabs to assess vaginal microbiota by Nugent score criteria at weekly visits for up to 2 years contributing 16,757 sequential observations. Absolute differences in Nugent scores (0–10) and transition probabilities of vaginal microbiota states classified by Nugent score into normal (0–3), intermediate (4–6), and BV (7–10) between visits were estimated. Allowing each woman to serve as her own control, weekly time-varying factors associated with progression from normal microbiota to BV and resolution of BV to normal microbiota were estimated using conditional logistic regression. Results: The distribution of absolute difference in Nugent scores was fairly symmetric with a mode of 0 (no change) and a standard deviation of 2.64. Transition probabilities showed weekly persistence, was highest for normal (76.1%) and BV (73.6%) states; whereas, intermediate states had similar probabilities of progression (36.6%), resolution (36.0%), and persistence (27.4%). Weekly fluctuation between normal and BV states was associated with menstrual cycle phase, recency of sex, treatment for vaginal symptoms, pregnancy, and prior Nugent score. Conclusions: Weekly changes in vaginal microbiota were common in this population. Clinical and behavioral characteristics were associated with vaginal microbiota transitioning, which may be used to inform future studies and clinical management of BV.

Longitudinal changes in vaginal microbiota composition assessed by gram stain among never sexually active pre- and postmenarcheal adolescents in Rakai, Uganda.

STUDY OBJECTIVE To describe changes in vaginal microbiota and pH over time among never sexually active adolescents at different menarcheal stages. DESIGN A cohort of 49 sexually inexperienced Ugandan adolescents provided weekly self-collected vaginal swabs and behavioral/health information for up to two years. Menarcheal stage was classified as: not experiencing menarche during follow-up (premenarcheal, n = 9), achieving menarche during follow-up (perimenarcheal, n = 20), and being postmenarcheal (n = 20) at enrollment. Vaginal microbiota were characterized as morphotypes of large gram-positive rods, small gram-negative or variable rods, and curved gram-negative rods based on Nugent Gram-stain criteria. Baseline measures were compared using nonparametric tests. Mean changes (β) in morphotypes and pH over time were estimated using longitudinal mixed-effects models. RESULTS The baseline median (IQR: interquartile range) Nugent score was 8 (7-8) in premenarcheal, 4.5 (1-8) in perimenarcheal, and 1 (0-3) in postmenarcheal girls (P = 0.001). For each respective menarcheal stage, the median (IQR) counts of gram-positive rods were 0 (0-0), 10 (0-30), and 30 (18-30) (P = 0.002) and gram-negative or variable rods were 30 (30-30), 16 (0.5-30), and 0.5 (0-2.5) (P = 0.002) at enrollment. Counts of gram-positive rods increased (β = 0.259, 95% CI: 0.156, 0.362) and gram-negative or variable rods decreased (β = -0.201, 95% CI:-0.298,-0.103) significantly over time in premenarcheal girls, but not in other groups. Vaginal pH declined significantly in peri- and postmenarcheal girls only. CONCLUSION Vaginal microbiota composition varied by menarcheal stage at enrollment. Over time, significant changes in vaginal morphotypes occurred in premenarcheal girls, suggesting this may be an important period of transition.

The natural history of bacterial vaginosis diagnosed by gram stain among women in Rakai, Uganda.

Background: Large datasets for investigating vaginal flora change at frequent, repeated intervals are limited and graphical methods for exploring such data are inadequate. We report 2-year weekly vaginal flora changes based on Gram stain using lasagna plots. Methods: Weekly vaginal flora patterns were evaluated among 211 sexually experienced women with ≥18 months of follow-up in Rakai, Uganda. Vaginal flora swabs were self-collected weekly and categorized by Nugent Gram stain criteria (0–3, normal; 4–6, intermediate; 7–10, bacterial vaginosis [BV]). Vaginal flora patterns were analyzed as the percentage of weekly observations with BV (longitudinal prevalence) and illustrated by lasagna plots. Characteristics of women were compared across tertiles of longitudinal prevalence of BV. Results: Ninety-five percent of women had at least 1 episode of BV over 2 years, with one-third of women spending more than half (52%–100%) of their time with BV. Vaginal pH >4.5 increased with increasing tertiles of longitudinal prevalence of BV (P < 0.001). Weekly fluctuation in vaginal flora states, as measured by a change in flora states from the before current visit, was highest in the middle (41.9%) compared with the lower (30.1%) and upper tertiles (27.8%, P < 0.001). HIV status and reported vaginal symptoms did not differ significantly across BV tertiles. Conclusions: Women exhibited different patterns of vaginal flora changes over time, which could not be described by baseline behaviors. Lasagna plots aided in describing the natural history of BV within and across women and may be applied to future BV natural history studies.

Comparing apples and pears: women's perceptions of their body size and shape.

BACKGROUND Obesity is a growing public health problem among reproductive-aged women, with consequences for chronic disease risk and reproductive and obstetric morbidities. Evidence also suggests that body shape (i.e., regional fat distribution) may be independently associated with risk, yet it is not known if women adequately perceive their shape. This study aimed to assess the validity of self-reported body size and shape figure drawings when compared to anthropometric measures among reproductive-aged women. METHODS Self-reported body size was ascertained using the Stunkard nine-level figures and self-reported body shape using stylized pear, hourglass, rectangle, and apple figures. Anthropometry was performed by trained researchers. Body size and body mass index (BMI) were compared using Spearmans correlation coefficient. Fat distribution indicators were compared across body shapes for nonobese and obese women using analysis of variance (ANOVA) and Fishers exact test. Percent agreement and kappa statistics were computed for apple and pear body shapes. RESULTS The 131 women studied were primarily Caucasian (81%), aged 32 years, with a mean BMI of 27.1 kg/m(2) (range 16.6-52.8 kg/m(2)). The correlation between body size and BMI was 0.85 (p<0.001). Among nonobese women, waist-to-hip ratios (WHR) were 0.75, 0.75, 0.80, and 0.82 for pear, hourglass, rectangle, and apple, respectively (p<0.001). Comparing apples and pears, the percent agreement (kappa) for WHR≥0.80 was 83% (0.55). CONCLUSIONS Self-reported size and shape were consistent with anthropometric measures commonly used to assess obesity and fat distribution, respectively. Self-reported body shape may be a useful proxy measure in addition to body size in large-scale surveys.

Bacterial Vaginosis Is Associated with Variation in Dietary Indices

Bacterial vaginosis (BV) is a common condition of unknown etiology and has been linked to adverse reproductive and obstetric health outcomes. Prior dietary research on BV has focused on specific macro- and micronutrients, but not dietary indices. We assessed the relationship between BV and selected dietary indicators among a cohort of 1735 nonpregnant women ages 15-44 y from Birmingham, Alabama. Annual intake was assessed with the Block98 FFQ, and the glycemic index, glycemic load (GL), and Healthy Eating Index were calculated by the Block Dietary Data System. The Naturally Nutrient Rich (NNR) score was also calculated. Vaginal flora was evaluated using Nugent Gram-stain criteria. Crude OR and adjusted OR were determined by multinomial and logistic regression in cross-sectional and prospective analyses, respectively. Participants were predominantly African American (85.5%) aged 25.3 ± 6.8 y (mean ± SD). Per 10-unit increase, GL was positively (adjusted OR = 1.01, 95% CI = 1.00-1.03) and NNR was negatively (adjusted OR = 0.93, 95% CI = 0.88-0.99) associated with BV compared to normal vaginal flora. In prospective analyses, only GL was associated with BV progression (adjusted OR = 1.03, 95% CI = 1.00-1.05) and persistence (adjusted OR = 1.02, 95% CI = 1.01-1.04) after adjustment. Both GL and NNR were associated with greater BV prevalence and GL was associated with an increase in BV persistence and acquisition. These results suggest that diet composition may contribute to vaginal flora imbalances and be important for elucidating the etiology of BV.

Trends in Maternal Mortality by Sociodemographic Characteristics and Cause of Death in 27 States and the District of Columbia

OBJECTIVE To analyze recent trends in maternal mortality by sociodemographic characteristics and cause of death and to evaluate data quality. METHODS This observational study compared data from 2008-2009 with 2013-2014 for 27 states and the District of Columbia that had comparable reporting of maternal mortality throughout the period. Maternal mortality rates were computed per 100,000 live births. Statistical significance of trends and differentials was evaluated using a two-proportion z-test. RESULTS The study population included 1,687 maternal deaths and 7,369,966 live births. The maternal mortality rate increased by 23% from 20.6 maternal deaths per 100,000 live births in 2008-2009 to 25.4 in 2013-2014. However, most of the increase was among women aged 40 years or older and for nonspecific causes of death. From 2008-2009 to 2013-2014, maternal mortality rates increased by 90% for women 40 years of age or older but did not increase significantly for women younger than 40 years. The maternal mortality rate for nonspecific causes of death increased by 48%; however, the rate for specific causes of death did not increase significantly between 2008-2009 (13.5) and 2013-2014 (15.0). CONCLUSION Despite the United Nations Millennium Development Goal and a 44% decline in maternal mortality worldwide from 1990 to 2015, maternal mortality has not improved in the United States and appears to be increasing. Maternal mortality rates for women 40 years or older and for nonspecific causes of death were implausibly high and increased rapidly, suggesting possible overreporting of maternal deaths, which may be increasing over time. Efforts to improve reporting for the pregnancy checkbox and to modify coding procedures to place less reliance on the checkbox are essential to improving vital statistics maternal mortality data, the official data source for maternal mortality statistics used to monitor trends, identify at-risk populations, and evaluate the success of prevention efforts.

Unintended pregnancy and interpregnancy interval by maternal age, National Survey of Family Growth

BACKGROUND The relationship between unintended pregnancy and interpregnancy interval (IPI) across maternal age is not clear. METHODS Using data from the National Survey of Family Growth, we estimated the percentages of pregnancies that were unintended among IPI groups (<6, 6-11, 12-17, 18-23, 24+ months) by maternal age at last live birth (15-19, 20-24, 25-29, 30-44 years). RESULTS Approximately 40% of pregnancies were unintended and 36% followed an IPI<18 months. Within each maternal age group, the percentage of pregnancies that were unintended decreased as IPI increased. CONCLUSION Unintended pregnancies are associated with shorter IPI across the reproductive age spectrum.

Estimating infertility prevalence in low-to-middle-income countries: an application of a current duration approach to Demographic and Health Survey data

Abstract STUDY QUESTION Can infertility prevalence be estimated using a current duration (CD) approach when applied to nationally representative Demographic and Health Survey (DHS) data collected routinely in low- or middle-income countries? SUMMARY ANSWER Our analysis suggests that a CD approach applied to DHS data from Nigeria provides infertility prevalence estimates comparable to other smaller studies in the same region. WHAT IS KNOWN ALREADY Despite associations with serious negative health, social and economic outcomes, infertility in developing countries is a marginalized issue in sexual and reproductive health. Obtaining reliable, nationally representative prevalence estimates is critical to address the issue, but methodological and resource challenges have impeded this goal. STUDY DESIGN, SIZE, DURATION This cross-sectional study was based on standard information available in the DHS core questionnaire and data sets, which are collected routinely among participating low-to-middle-income countries. Our research question was examined among women participating in the 2013 Nigeria DHS (n = 38 948). Among women eligible for the study, 98% were interviewed. PARTICIPANTS/MATERIALS, SETTING, METHODS We applied a CD approach (i.e. current length of time-at-risk of pregnancy) to estimate time-to-pregnancy (TTP) and 12-month infertility prevalence among women ‘at risk’ of pregnancy at the time of interview (n = 7063). Women who were 18–44 years old, married or cohabitating, sexually active within the past 4 weeks and not currently using contraception (and had not been sterilized) were included in the analysis. Estimates were based on parametric survival methods using bootstrap methods (500 bootstrap replicates) to obtain 95% CIs. MAIN RESULTS AND THE ROLE OF CHANCE The estimated median TTP among couples at risk of pregnancy was 5.1 months (95% CI: 4.2–6.3). The estimated percentage of infertile couples was 31.1% (95% CI: 27.9–34.7%)—consistent with other smaller studies from Nigeria. Primary infertility (17.4%, 95% CI: 12.9–23.8%) was substantially lower than secondary infertility (34.1%, 95% CI: 30.3–39.3%) in this population. Overall estimates for TTP >24 or >36 months dropped to 17.7% (95% CI: 15.7–20%) and 11.5% (95% CI: 10.2–13%), respectively. Subgroup analyses showed that estimates varied by age, coital frequency and fertility intentions, while being in a polygynous relationship showed minimal impact. LIMITATIONS, REASONS FOR CAUTION The CD approach may be limited by assumptions on when exposure to risk of pregnancy began and methodologic assumptions required for estimation, which may be less accurate for particular subgroups or populations. Unrecognized pregnancies may have also biased our findings; however, we attempted to address this in our exclusion criteria. Limiting to married/cohabiting couples may have excluded women who are no longer in a relationship after being blamed for infertility. Although probably rare in this setting, we lack information on couples undergoing infertility treatment. Like other TTP measurement approaches, pregnancies resulting from contraceptive failure are not included, which may bias estimates. WIDER IMPLICATIONS OF THE FINDINGS Nationally representative estimates of TTP and infertility based on a clinical definition of 12 months have been limited within developing countries. This approach represents a pragmatic advance in our ability to measure and monitor infertility in the developing world, with potentially far-reaching implications for policies and programs intended to address reproductive health. STUDY FUNDING/COMPETING INTERESTS There are no competing interests and no financial support was provided for this study. Financial support for Open Access publication was provided by the World Health Organization.