Frontiers in reproductive health最新文献

{"title":"Longitudinal trends and correlation between autism spectrum disorder prevalence and sperm quality parameters (2000-2024): a comprehensive statistical analysis.","authors":"Adil Abdul-Rehman Siddiq Al-Salihy","doi":"10.3389/frph.2024.1438049","DOIUrl":"10.3389/frph.2024.1438049","url":null,"abstract":"<p><strong>Introduction: </strong>Over the past few decades, there has been growing concern about the concurrent trends of increasing Autism Spectrum Disorder (ASD) prevalence and declining sperm quality. These trends represent significant public health challenges that warrant thorough investigation of their underlying causes and implications.</p><p><strong>Objectives: </strong>The primary objectives of this study are to analyze trends in ASD prevalence and sperm quality parameters from 2000 to 2024, assess the statistical significance and effect size of these trends, explore potential correlations between ASD prevalence and sperm quality parameters, and identify significant predictors among sperm quality parameters that influence ASD prevalence.</p><p><strong>Methods: </strong>This study employed a longitudinal approach using multiple regression, time series analysis, ANOVA, Principal Component Analysis (PCA), hierarchical clustering, logistic regression, and cross-correlation analysis. Data on ASD prevalence were sourced from the CDC Autism and Developmental Disabilities Monitoring Network, while sperm quality data were collected from various published studies.</p><p><strong>Results: </strong>The findings reveal significant negative associations between ASD prevalence and sperm quality parameters such as sperm concentration and motility, suggesting that better sperm quality is linked to lower ASD rates. Conversely, parameters like sperm DNA fragmentation (SDF), volume of ejaculate, pH level, and semen viscosity show positive associations with ASD prevalence, indicating higher values in these parameters correlate with higher ASD rates.</p><p><strong>Conclusion: </strong>The study highlights the importance of maintaining reproductive health to potentially mitigate ASD risk and calls for further research to elucidate the underlying mechanisms driving these trends. These findings support the hypothesis that reproductive health factors play a crucial role in ASD etiology and suggest potential biological markers for assessing ASD risk.</p>","PeriodicalId":73103,"journal":{"name":"Frontiers in reproductive health","volume":"6 ","pages":"1438049"},"PeriodicalIF":2.3,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11374721/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142141918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Editorial: Sexual and reproductive health among transgender and non-binary adolescents and young adults.","authors":"Nadia Dowshen, Diane Chen","doi":"10.3389/frph.2024.1437349","DOIUrl":"10.3389/frph.2024.1437349","url":null,"abstract":"","PeriodicalId":73103,"journal":{"name":"Frontiers in reproductive health","volume":"6 ","pages":"1437349"},"PeriodicalIF":2.3,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11345259/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142074674","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Individual and relational dynamics perceived to influence the sexual behaviour of adolescents in Ethiopia: a qualitative study.","authors":"Semere Gebremariam Baraki, Gloria Thupayagale-Tshweneagae","doi":"10.3389/frph.2024.1348953","DOIUrl":"10.3389/frph.2024.1348953","url":null,"abstract":"<p><strong>Background: </strong>There are 1.2 billion adolescents in the world today, more than ever before, making up 16% of the world's population and nearly one-fourth of the total population in Sub-Saharan Africa. Adolescents are facing life-threatening health challenges attributed to sexual and reproductive health issues such as unwanted pregnancies, unsafe abortions, and sexually transmitted infections, including the human immunodeficiency virus, and acquired immunodeficiency syndrome. The aim of this research is to explore the individual and relational levels of factors that drive adolescents to engage in risky sexual behaviour.</p><p><strong>Methods: </strong>A qualitative phenomenological study design was used from February to June 2020. Adolescents and health professionals were selected purposefully. A total of 12 individual in-depth interviews, five focus group discussions with adolescents, and eight key informant interviews with health professionals were conducted using a semi-structured guide. Data analysis was performed using thematic analysis with ATLAS Ti version 7 software. Credibility, dependability, transferability, and confirmability were used to ensure the trustworthiness of the data.</p><p><strong>Results: </strong>In this study, two themes were identified; individual level factors such as sexual desire and emotion driven sex, limited knowledge of sexual and reproductive health, and a permissive attitude towards sexual activities drive adolescents to engage in risky sexual behaviour; and relational level factors such as, limited family support and involvement, negative peer pressure and influence, male partner dominance during the partnership, and pressuring females to engage in sexual intercourse were perceived factors influencing adolescents to engage in risky sexual behaviour.</p><p><strong>Conclusion: </strong>Various individual-level and relational-level factors are influencing adolescents to engage in risky sexual behaviour. Socially and culturally acceptable, comprehensive sexual education should be provided for in-school and out-school adolescents to enhance their knowledge, attitude, and skill about sexual and reproductive health. Interventions at the peer and partner level should be considered to enhance the life skills that enable them to resist pressure from peers and their partners. Child-parent communication on sexual and reproductive health matters should be promoted.</p>","PeriodicalId":73103,"journal":{"name":"Frontiers in reproductive health","volume":"6 ","pages":"1348953"},"PeriodicalIF":2.3,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11333451/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142010032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drinking water quality impacts oocyte viability and embryo development.","authors":"Yasmyn E Winstanley, Macarena B Gonzalez, Eryk Andreas, Haley Connaughton, Jean Bergen, Miranda Ween, Darryl L Russell, Cameron J Shearer, Sarah A Robertson, Rebecca L Robker","doi":"10.3389/frph.2024.1394099","DOIUrl":"10.3389/frph.2024.1394099","url":null,"abstract":"<p><p>Normal reproductive function and fertility is considered a \"sixth vital sign\" because disruptions to this sensitive physiological system can forewarn other health issues, including exposure to environmental toxicants. We found that female mice exhibited profound loss of embryos during pre-implantation and fetal development coincident with a change to the source of their drinking water. When female mice were provided with tap water from the building in which they were housed (Water 2), instead of tap water from a neighboring building which was their previous supply (Water 1), ovulated oocytes were degenerated or had impaired meiotic maturation, and failed to form embryos. The harmful effects of Water 2 exposure were not reversible even following a recovery period; however, carbon-filtration of Water 2 removed the toxic contaminant. Water composition analysis to identify the responsible toxicant(s) found that trace elements were present at expected levels and phthalates were undetectable. Per- and Poly-fluoroalkyl Substances (PFAS), a family of persistent organic pollutants were detected at ∼4 ng/L. To investigate further, female mice were given drinking water categorized by level of PFAS contamination (0.6 ng/L, 2.8 ng/L, or 4.4 ng/L) for 9 weeks. Compared to mice consuming purified MilliQ water, mice consuming PFAS-contaminated water had decreased oocyte quality, impaired embryogenesis and reduced cell numbers in blastocysts. PFAS concentration in the drinking water was negatively correlated with oocyte viability. Importantly, the levels of PFAS detected in the tap water are within current \"safe level\" guidelines, and further research is needed to determine whether PFAS are responsible for the observed reproductive toxicity. However, this research demonstrating that water deemed suitable for human consumption has detrimental effects on mammalian embryo development has important implications for public health and water quality policies.</p>","PeriodicalId":73103,"journal":{"name":"Frontiers in reproductive health","volume":"6 ","pages":"1394099"},"PeriodicalIF":2.3,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11333305/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142010031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding inequalities in the coverage of adolescent sexual and reproductive health services: a qualitative case study of the selected regions of Zambia.","authors":"Margarate Nzala Munakampe, Alice Ngoma-Hazemba, Mutale Sampa, Choolwe N Jacobs","doi":"10.3389/frph.2024.1399289","DOIUrl":"10.3389/frph.2024.1399289","url":null,"abstract":"<p><strong>Introduction: </strong>Despite substantial investment in improving healthcare among adolescents in low- and middle-income countries, barriers to access and utilization of services persist, especially to sexual and reproductive health (SRH) services. In response to adolescents' health service needs due to their vulnerability, interventions aimed at improving access and utilization of sexual and reproductive health services have been implemented in specific regions of Zambia. To highlight progress in the access and the overall delivery of services in Zambia, in the wake of a system-level funding mechanism, this paper aims to understand the accessibility, availability, acceptability and quality (AAAQ) of health services provided to young people.</p><p><strong>Materials and methods: </strong>In a qualitative case study, 48 discussions- 32 individual interviews with stakeholders and 16 focus group discussions, consisting of 128 male and female adolescents were conducted in six districts from Eastern, Southern and Muchinga provinces of Zambia. Interviews were audio-recorded, recordings transcribed verbatim, and transcripts were analysed using deductive thematic analysis, using the AAAQ framework and Atun's framework on integration, as a guide to reporting the findings.</p><p><strong>Results: </strong>We found that adolescents knew of and had access to common commodities and services- male condoms, health education and HIV counselling and testing. However, availability was affected by access-related barriers such as frequent stock-outs and insufficiently trained healthcare providers. In addition, accessibility was more restricted during the COVID-19 pandemic lockdown and compounded by the low acceptability of SRH service among adolescents across all contexts. This led to the use of alternatives such as herbal medicine and maintained common myths and misconceptions. The overall quality was marred by the lack of dedicated spaces for adolescent health services and the lack of information, education and communication (IEC) materials in some spaces.</p><p><strong>Conclusion: </strong>While it was noted that some services were available for adolescents in all the study sites, numerous barriers inhibited access to these services and had an impact on the quality-of-service provision. With the added restriction to SRH service asses for young people, due to the low acceptability of adolescent SRH service use, the overall integration of adolescent SRH interventions into routine service provision was low and can be improved by targeting contextual barriers and maintaining best practices.</p>","PeriodicalId":73103,"journal":{"name":"Frontiers in reproductive health","volume":"6 ","pages":"1399289"},"PeriodicalIF":2.3,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11333446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142010033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Examining modification of the associations between air pollution and birth outcomes by neighborhood deprivation in a North Carolina birth cohort, 2011-2015.","authors":"Kristen N Cowan, Alison K Krajewski, Monica P Jimenez, Thomas J Luben, Lynne C Messer, Kristen M Rappazzo","doi":"10.3389/frph.2024.1304749","DOIUrl":"10.3389/frph.2024.1304749","url":null,"abstract":"<p><strong>Background: </strong>Evidence from studies of air pollutants and birth outcomes suggests an association, but uncertainties around geographical variability and modifying factors still remain. As neighborhood-level social characteristics are associated with birth outcomes, we assess whether neighborhood deprivation level is an effect measure modifier on the association between air pollution and birth outcomes in a North Carolina birth cohort.</p><p><strong>Methods: </strong>Using birth certificate data, all North Carolina residential singleton live births from 1 January 2011 to 31 December 2015 with gestational ages of 20-44 weeks (<i>n</i> = 566,799) were examined for birth defect diagnoses and preterm birth. Exposures were daily average fine particulate matter (PM_2.5), daily 8-h maximum nitrogen dioxide (NO₂), and daily 8-h maximum ozone (O₃) modeled concentrations, and the modifier of interest was the neighborhood deprivation index (NDI). Linear binomial models were used to estimate the prevalence differences and 95% confidence intervals (CI) for the association between ambient air pollution and birth defect diagnoses. Modified Poisson regression models were used to estimate risk differences (RDs) and 95% CIs for air pollution and preterm birth. Models were stratified by the neighborhood deprivation index group (low, medium, or high) to assess potential modification by NDI.</p><p><strong>Results: </strong>Approximately 3.1% of the study population had at least one birth defect and 8.18% were born preterm. For preterm birth, associations with PM_2.5 and O₃ did not follow a conclusive pattern and there was no evidence of modification by NDI. The associations between NO₂ and preterm birth were generally negative across exposure windows except for a positive association with NO₂ and preterm birth for high NDI [RD: 34.70 (95% CI 4.84-64.56)] for entire pregnancy exposure. There was no evidence of associations between pollutants examined and birth defects.</p><p><strong>Conclusions: </strong>There may be differences in the association between NO₂ exposure and preterm birth by NDI but we did not observe any evidence of associations for birth defects. Our results support the public health protection afforded by reductions in air pollution, even in areas of neighborhood deprivation, but future research conducted in areas with higher levels of air pollution and evaluating the potential for modification by neighborhood deprivation level would be informative.</p>","PeriodicalId":73103,"journal":{"name":"Frontiers in reproductive health","volume":"6 ","pages":"1304749"},"PeriodicalIF":2.3,"publicationDate":"2024-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11269152/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141763063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adolescent utilization of sexual and reproductive health services in Gamo Zone, Southern Ethiopia. Insights from multilevel and latent class analysis.","authors":"Negussie Boti Sidamo, Amene Abebe Kerbo, Kassa Daka Gidebo, Yohannes Dibaba Wado","doi":"10.3389/frph.2024.1356969","DOIUrl":"10.3389/frph.2024.1356969","url":null,"abstract":"<p><strong>Introduction: </strong>Adolescents face unique challenges related to their sexual and reproductive health (SRH), with access to timely services being critical for positive outcomes. However, SRH service utilization among adolescents remains low. This study aimed to identify factors influencing SRH service use among adolescents in Gamo Zone, Ethiopia.</p><p><strong>Methods: </strong>A community-based cross-sectional study involved 1172 adolescents selected through stratified sampling. Structured face-to-face interviews were employed for data collection. Multilevel mixed logistic regression was fitted to identify factors and latent class analysis was conducted to understand population heterogeneity.</p><p><strong>Results: </strong>The findings of this study reveal that 198 (16.89%) adolescents (95% CI: 14.8%-19.2%) utilized SRH services within the past 12 months. Factors significantly associated with SRH service utilization included good knowledge about SRH rights (AOR = 4.65; 95% CI: 2.68, 8.07), belonging to one-parent families (AOR = 4.13; 95% CI: 2.39, 7.12), engaging in parental discussions regarding SRH issues (AOR = 3.17; 95% CI: 1.89, 5.29), high family support (AOR = 1.96; 95% CI: 1.09, 3.51), and enrolling in school (AOR = 0.19; 95% CI: 0.11, 0.33). Additionally, access to social media was associated with increased SRH service utilization among adolescents (AOR = 1.98; 95% CI: 1.25, 3.15). Latent class analysis identified four groups: rural school-enrolled adolescents living with parents, urban school-enrolled adolescents with both parents, urban disadvantaged female adolescents, and early adolescents with limited social media access.</p><p><strong>Conclusions: </strong>In conclusion, our study sheds light on the utilization of SRH services among adolescents, revealing that 16.89% of the participants accessed these services within the past year. Significant factors associated with SRH service utilization included good knowledge about SRH rights, belonging to one-parent families, engaging in parental discussions regarding SRH issues, high family support, and enrollment in school. Interestingly, access to social media was also linked to increased utilization of SRH services among adolescents. Furthermore, our latent class analysis identified four distinct classes of adolescents based on socio-demographic indicators, highlighting the heterogeneity within this population. These findings underscore the importance of tailored interventions and targeted approaches to address the diverse needs of adolescents in accessing and utilizing SRH services.</p>","PeriodicalId":73103,"journal":{"name":"Frontiers in reproductive health","volume":"6 ","pages":"1356969"},"PeriodicalIF":2.3,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11251959/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141636055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A qualitative exploration of how a community engagement approach influences community and health worker perceptions related to family planning service delivery in Togo.","authors":"Leanne Dougherty, Sethson Kassegne, Robert Nagbe, Joseph Babogou, Paula Peace, Farida Moussa, Karen Kirk, Hilaire Tokplo, Djibril Ouro-Gnao, Serge Prince Agbodjan, Dana Loll, Timothy R Werwie, Martha Silva","doi":"10.3389/frph.2024.1389716","DOIUrl":"10.3389/frph.2024.1389716","url":null,"abstract":"<p><strong>Background: </strong>There is a growing body of evidence that asserts community engagement approaches can improve the quality of reproductive health services. Family planning (FP) programs in Togo are implementing such approaches, which aim to mobilize both health workers and communities to improve FP service quality and FP uptake. However, there is not enough known about the enabling factors and challenges associated with implementation, or the extent to which the programs improve outcomes leading to contraceptive uptake.</p><p><strong>Methods: </strong>We qualitatively explored how a community engagement approach influenced health worker and community perceptions related to FP service delivery in and around the city of Lomé, Togo, within the context of the broader integration of social and behavior change and service delivery. We conducted 18 in-depth interviews with health workers and 9 focus group discussions with community members.</p><p><strong>Results: </strong>We found the approach, which included community dialogues, site walkthrough visits and the development of community action plans, worked synergistically together to support collaborative action between communities and health workers to increase mutual understanding of their collective needs related to FP services. Community members cited improved reception at the health facilities by health workers and indicated that the site walkthrough visits created a greater sense of empathy towards the providers and the challenges faced in their work environment. Health workers acknowledged a greater understanding of barriers at the community level following community dialogues, particularly among community members that are not routinely encountered at the health facility for reproductive health services such as men and youth. We found limited implementation of health facility improvements included in community action plans because they were dependent on commitment from community leadership and the need to mobilize additional support or financial resources.</p><p><strong>Conclusion: </strong>Community engagement approaches are a promising mechanism to support collaboration and enhance mutual understanding between health workers and communities to achieve improved FP service quality. Future programs should consider incorporating additional mechanisms to monitor community action plans and provide support to address structural challenges at the facility level particularly those that require financial resources.</p>","PeriodicalId":73103,"journal":{"name":"Frontiers in reproductive health","volume":"6 ","pages":"1389716"},"PeriodicalIF":2.3,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11251956/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141636054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevention method preferences and factors influencing hypothetical choice among women in South Africa: a survey exploring opportunities for a multipurpose prevention technology implant.","authors":"Catherine E Martin, Alison Kutywayo, Paballo Mataboge, Glory Chidumwa, Nqaba Mthimkhulu, Rutendo Bothma, Saiqa Mullick","doi":"10.3389/frph.2024.1368889","DOIUrl":"10.3389/frph.2024.1368889","url":null,"abstract":"<p><strong>Introduction: </strong>South African women bear an intersecting burden of HIV, sexually transmitted infections (STIs) and unintended pregnancy. Multipurpose prevention technologies (MPTs) are a class of products that address multiple needs and have the potential to improve uptake and use of prevention products.</p><p><strong>Methods: </strong>Analysing survey data from 703 HIV-negative women 18-40 years in three provinces in South Africa, collected between July and November 2022, this study explores their preferences for prevention methods and factors influencing choice of hypothetical prevention methods, including MPTs. Descriptive statistics and multinomial regression analyses were conducted to determine prevention method preferences and factors associated with choosing a pill, injectable or MPT-implant type prevention method.</p><p><strong>Results: </strong>Most women wanted to prevent HIV, STIs and pregnancy. The most important factors when choosing a prevention product were whether it provided dual and long-term protection and if side effects were manageable. If choosing only one method, half of women would choose any MPT-implant and a quarter each would choose a pill or an injectable method, with method choices differing by population group.</p><p><strong>Discussion: </strong>Prevention method choices were influenced by sexual-behavioural factors and current and prior contraceptive method use. Providing a choice of prevention methods and a population specific approach to new method development and introduction with access to accurate information could enhance their ability to fill a gap in prevention needs.</p>","PeriodicalId":73103,"journal":{"name":"Frontiers in reproductive health","volume":"6 ","pages":"1368889"},"PeriodicalIF":2.3,"publicationDate":"2024-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11231390/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141565328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishing adherence-concentration-efficacy thresholds of TDF-FTC pre-exposure prophylaxis for HIV prevention in African women: a protocol for the Women TDF-FTC Benchmark Study.","authors":"Linxuan Wu, Matilda Saina, Clare Brown, David Chege, Deborah Donnell, David V Glidden, Kenneth Ngure, Nelly R Mugo, Nina Akelo, Torin Schaafsma, Peter L Anderson, Kenneth K Mugwanya","doi":"10.3389/frph.2024.1325257","DOIUrl":"10.3389/frph.2024.1325257","url":null,"abstract":"<p><strong>Background: </strong>Oral pre-exposure prophylaxis (PrEP) using co-formulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) is a potent HIV prevention method for men and women, with its efficacy highly dependent on adherence. A pivotal HIV efficacy study combined with a directly observed pharmacological study defined the thresholds for HIV protection in men who have sex with men (MSM), which are the keys to PrEP promotion and development of new PrEP agents. For African women at risk for HIV and belonging to a priority group considered due to disproportionately high incident HIV infections, the variable adherence in PrEP clinical trials and the limited pharmacologic data have resulted in a lack of clarity about the PrEP adherence required for HIV protection. We propose a study to quantify the adherence-concentration-efficacy thresholds of TDF/FTC PrEP among African cisgender women to inform decisions about optimal PrEP dosing and adherence for HIV protection.</p><p><strong>Methods: </strong>We randomized 45 low-risk HIV-uninfected African women, aged 18-30 years old, to directly observe the TDF/FTC PrEP of two, four, or seven doses per week for 8 weeks. A complementary age-matched pregnant women cohort at high risk of HIV, who will receive seven doses per week, was recruited (<i>N</i> = 15) with the primary aim of establishing benchmark concentrations in dried blood spots and peripheral blood mononuclear cells. Plasma, whole blood (WB), urine, hair, vaginal fluid, and vaginal tissue (non-pregnant women only) were archived for future testing. Drug concentrations were measured using methods validated for each biological matrix. Pharmacokinetic models were fitted to drug concentrations to quantify concentration-adherence thresholds. To define the drug concentrations associated with HIV protection, we applied the newly defined thresholds from the primary pharmacologic trial to the subset of women randomized to TDF/FTC or TDF in the Partners PrEP Study with the drug concentration assessed in plasma and WB samples. Multiple imputation was used to construct a data set with drug concentrations at each visit when an HIV test was performed for the entire cohort, replicating the work for MSM.</p><p><strong>Discussion: </strong>The proposed study generated the first African women-specific TDF-PrEP adherence-concentration-efficacy thresholds essential for guiding the accurate interpretation of TDF/FTC PrEP programs and clinical trials of novel HIV prevention products using TDF/FTC as an active control.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov, identifier (NCT05057858).</p>","PeriodicalId":73103,"journal":{"name":"Frontiers in reproductive health","volume":"6 ","pages":"1325257"},"PeriodicalIF":0.0,"publicationDate":"2024-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11163076/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141302272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}