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Consensus recommendations for measuring the impact of contraception on the menstrual cycle in contraceptive clinical trials
No full textObjective: We sought to develop consensus recommendations for measurement and analysis of data on contraceptive-induced menstrual changes (CIMCs) in contraceptive clinical trials. We built upon previous standardization efforts over the last 50 years and prioritized input from a variety of global experts and current regulatory authority guidance on patient-reported outcomes. Study Design: We completed a formal consensus-building process with an interdisciplinary group of 57 experts from 30 organizations and 14 countries in five global regions who work across academia, nonprofit research organizations, the pharmaceutical industry, and funding agencies. Smaller topical working groups drafted and revised recommendations. Results: We developed 44 consensus recommendations, including research approaches to establish the evidence for future improvement in the measurement and analysis of CIMC data and guidance for investigators to implement presently. Priority recommendations call for simplification of terminology to make measurement accessible and patient-centered, accounting for intrinsic and extrinsic factors that may impact outcomes during study design and recruitment, standardized data collection of primary CIMC and acceptability outcomes, and harmonized approaches for analysis of these data, including addressing missing data. Conclusion: By virtually convening a large group of global experts working across disciplines and sectors via a formal methodology, we developed consensus recommendations that will improve the current and future measurement and analysis of CIMC data in contraceptive clinical trials. Using these standardized approaches will permit valid and reliable contraceptive product labeling on CIMC outcomes that matter to users and greater comparability across trials that can inform clinical guidance and contraceptive counseling
Bridging the gaps: Mental health support for out of school adolescents in urban slums in Kenya
No full textThis data is from a longitudinal study that evaluated the feasibility and accessibility of integrating a mental-health component into a safe spaces program. The study included 400 adolescents: 260 girls and 140 boys aged 15–18 who are out of school, split across two areas of Kenya—Rhonda in Nakuru and Kariobangi in Nairobi
A comparison of acceptability of contraceptive vaginal rings, pills, and injectables among cisgender women in Kenya and Zimbabwe: Protocol for a mixed-methods study
No full textExpanding contraceptive options could better meet users’ diverse needs and preferences. Annovera ® is a contraceptive vaginal ring that provides a year of pregnancy prevention while remaining under user control and allowing for regular menstrual cycles. This method may also help to reduce burdens on some health care and supply chain systems. However, knowledge gaps exist regarding initial and ongoing acceptability of contraceptive vaginal rings in African settings.
We will undertake an open-label, non-randomized, two-arm, parallel clinical acceptability study with an embedded qualitative component, based in clinics providing contraceptive services in Kenya and Zimbabwe. Women aged 18-45 interested in newly initiating or switching contraception will choose from among all available contraceptive options, including Annovera. We aim to enroll 200 participants selecting Annovera and 200 participants selecting either contraceptive injectables or pills. We will compare method uptake, continuation, and satisfaction over one year. Participants will complete questionnaires administered by study staff during two in-person visits (a screening/enrollment visit, and an end of study visit after 52 weeks of method use or at discontinuation) and four phone appointments (at 4, 12, 24, and 36 weeks of use). We will evaluate used rings for discoloration and residual drug levels. The qualitative component involve in-depth interviews with women in the clinical study, their sexual partners, and their service providers, to further examine drivers of and barriers to interest in and use of contraceptive vaginal rings.
This study will explore acceptability of contraceptive vaginal rings in ‘real-world’ contraceptive service settings in two African countries. Findings will be based on actual ring use and contextualized via comparison to two other commonly available methods. As vaginal rings are being considered for multiple reproductive health indications, this work can fill key knowledge gaps and empower decision-makers with information needed to inform future investments in reproductive health
Intergenerational (im)mobility in a developing economy context: Is the social elevator broken?
No full textThere is an extensive literature available on intergenerational social and educational mobility in developed countries, but the evidence is still scant in developing countries. In the existing literature, household background has been predicted as a significant determinant of individuals’ current and future social status because it influences almost every aspect of their lives. We examine various channels through which socioeconomic background and other household and individual characteristics affect individuals’ educational and social opportunities in a developing economy, Pakistan. To accomplish the objectives, we have used a rich dataset: the Pakistan Standards of Living Measurement (PSLM) survey 2019-20, which contains information on individuals and their real parents. The empirical analysis highlights that the level of parents’ education is more relevant than the level of parents’ occupational skills in individuals’ social and educational opportunities
Penile human papillomavirus prevalence in circumcised sexual minority men living with and without HIV
No full textObjective: Understanding the burden of penile human papillomavirus (HPV) among high-risk groups is essential to inform tailored prevention strategies to reduce HPV-related morbidity. We estimated the prevalence of penile HPV and its association with HIV among circumcised sexual minority men (SMM). Design: A cross-sectional study from a community-based cohort of SMM with and without HIV in Nigeria. Methods: Penile swabs were genotyped with a next-generation sequencing assay for any and high-risk HPV (HPV16/18/31/33/35/39/45/51/52/56/58/59/68). HIV status was ascertained using rapid diagnostic tests. Multivariable logistic regression models estimated the adjusted odds ratios (aORs) and 95% confidence intervals (CIs) for the association between HIV and any and high-risk penile HPV. Results: Among 498 participants, median age was 24 (interquartile range: 22-28) years and 70.5% (n=351) were living with HIV. The prevalence of any (n=362) and high-risk (n=239) penile HPV was 72.7% [95% confidence interval (95% CI): 68.6-76.4] and 48.0% (95% CI: 43.6-52.4), respectively. The most common high-risk HPV types were 16, 51, 45, and 18, while the most common low-risk types were 6 and 11. HIV was significantly associated with increased odds of any penile HPV (aOR 1.93, 95% CI: 1.20-3.12). Similar to any HPV, the association of HIV with high-risk penile HPV trended in the positive direction (aOR 1.45, 95% CI: 0.96-2.27), but it was not statistically significant. Conclusion: Penile HPV and HIV were highly prevalent among circumcised SMM in Nigeria. The most prevalent strains were vaccine-preventable, highlighting the need to prioritize HPV vaccination for boys as an additional strategy to prevent HPV-related morbidities
Effects of preconception nutrition interventions on pregnancy and birth outcomes in South Asia: A systematic review
No full textUndernutrition amongst reproductive age women, low birth weight, small for gestational age and preterm birth present significant health burdens in South Asia which interventions in pregnancy alone have not resolved. Effectiveness of preconception nutrition interventions is not well-documented. This systematic review summarises evidence on the effect of preconception nutrition interventions on pregnancy and birth outcomes in South Asia. We found highly heterogeneous evidence across four micronutrient supplementation, two food supplementation, and three complex interventions trials. Preconception micronutrient supplementation alone did not affect birth size, but food supplementation was effective with and without multiple micronutrients, especially when initiated at least 90 days before conception. Combined health, nutrition, psychosocial care, and WaSH interventions addressing determinants at multiple levels were most effective. However intensive delivery by project employees poses problems for scale-up. More robust South Asian preconception intervention trials to identify scalable interventions that are effective in real-world delivery settings are needed
Community-based approaches to promote uptake of Sulfadoxine-Pyrimethamine for intermittent preventive treatment of malaria in pregnancy: Midline findings from Kisumu and Migori Counties—Evidence brief
Full text linkEthiopia Humanitarian Violence Against Children and Youth Survey, 2024: Data-to-Action workshop report
Full text linkThe Government of Ethiopia’s Refugees and Returnees Service (RRS) officials, various government ministry delegates, representatives from International and national Non-Governmental Organisations, UN bodies, and various delivery partners, came together for a Data to Action (D2A) workshop in Addis Ababa from November 19th to 21st, 2024. During this workshop, participants prioritized violence prevention and response activities, directly informed by the HVACS data. This was achieved by translating the Ethiopia HVACS findings into key indicators that were then mapped into actionable next steps by linking this data to the INSPIRE: Seven Strategies for Ending Violence Against Children technical package and the Child Protection Minimal Standards (CPMS). The outcome of this D2A workshop, contextualized to activities conducted in the country, was data-driven, evidence-based recommendations for Ethiopia, with the aim of preventing and responding to violence against children in humanitarian settings. These priorities complemented existing implementation plans, drawing on recent and robust evidence specifically from refugee populations
Climate change and migration
Full text linkAs rural-urban migration is increasing, by and large, research to inform climate adaptation strategies on many scales can help governments make informed social policy decisions that take into account changing demographics, human rights considerations, and political pressures. This brief provides and overview of the Population Council\u27s PERCC initiative\u27s research on climate and migration intersections
Development and validation of a multidimensional intravaginal ring acceptability scale among US women and their male partners
No full textObjective: Intravaginal rings (IVRs) are marketed or in development for contraception and other indications. We sought to develop and validate the IVR Acceptability Scale (IVR-AS) as a multidimensional, standardized tool for assessing IVR acceptability among end-users in the United States. Methods: Scale items reflect specific aspects of IVR acceptability for women and male partners. Response options range from 1 (not-at-all acceptable) to 5 (highly acceptable). We evaluated the IVR-AS within a randomized, crossover clinical trial of three nonmedicated silicone IVRs of differing external diameters (46, 56, 66 mm) in heterosexual couples who used each for ~30 days, then completed a self-administered survey. We conducted exploratory factor analysis and multivariable regression to assess convergent validity. Follow-up in-depth interviews with all participants explored scale salience. Results: Twenty-four couples participated (mean age 27). The final 19-item women\u27s scale (Cronbach\u27s alpha = 0.93) included six subdimensions: ease of use; experience and sensation; effect on sexual desire/engagement, and effect on vaginal sex (all alphas \u3e 0.78). The final eight-item men\u27s scale comprised two subdimensions: effect on sexual desire/engagement and effect on vaginal sex (all alphas \u3e 0.89). For both sexes, higher overall/subdimension scores were consistently associated with favorable assessments of the ring, for example, ease of insertion/removal; adherence (most p \u3c 0.001). The 46/56 mm IVRs had higher overall and subdimension scores than the 66 mm IVR (most p \u3c 0.001). Qualitative reports reinforced the salience of scale subdimensions and item content. Conclusion: The IVR-AS captures multiple dimensions of IVR acceptability among women and their partners. The scales demonstrated excellent reliability and convergent validity. Further validation is warranted in future studies