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Background: Women living with HIV (WLWH) face unique reproductive health (RH) barriers which increase their risks of unmet need for contraception, contraceptive failure, unintended pregnancy, and pregnancy-related morbidity and mortality and may prevent them from achieving their reproductive goals. Patient-centered counseling interventions that support health care workers (HCWs) in providing high-quality RH counseling, tailored to the needs of WLWH, may improve reproductive health outcomes. Methods and design: We are conducting a non-blinded cluster randomized controlled trial (cRCT) of a digital health intervention for WLWH (clinicaltrials.gov #NCT05285670). We will enroll 3,300 WLWH seeking care in 10 HIV care and treatment centers in Nairobi and Western Kenya. WLWH at intervention sites receive the Mobile WACh Empower intervention, a tablet-based RH decision-support counseling tool administered at baseline and SMS support during two years of follow-up. WLWH at control sites receive the standard of care FP counseling. The decision-support tool is a logic-based tool for family planning (FP) counseling that uses branching logic to guide RH questions based on participants' reproductive life plans, tailoring counseling based on the responses. Follow-up SMSs are based in the Information-Motivation-Behavioral (IMB) Skills model of behavioral change and are tailored to participant characteristics and reproductive needs through separate SMS "tracks". Follow-up visits are scheduled quarterly for 2 years to assess plans for pregnancy, pregnancy prevention, and contraceptive use. The primary outcome, FP discontinuation, will be compared using an intent-to-treat analysis. We will also assess the unmet need for FP, dual method use, viral load suppression at conception and unintended pregnancy. Discussion: The Mobile WACh Empower intervention is innovative as it combines a patient-centered counseling tool to support initial reproductive life decisions with longitudinal SMS for continued RH support and may help provide RH care within the context of provision of HIV care. [ABSTRACT FROM AUTHOR]

Infant antibody responses to viral infection can differ from those in adults. However, data on the specificity and function of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in infants, and direct comparisons between infants and adults are limited. Here, we characterize antibody binding and functionality against Wuhan-Hu-1 (B lineage) strain SARS-CoV-2 in convalescent plasma from 36 postpartum women and 14 of their infants infected with SARS-CoV-2 from a vaccine-naïve prospective cohort in Nairobi, Kenya. We find significantly higher antibody titers against SARS-CoV-2 Spike, receptor binding domain and N-terminal domain, and Spike-expressing cell-surface staining levels in infants versus mothers. Plasma antibodies from mothers and infants bind to similar regions of the Spike S2 subunit, including the fusion peptide (FP) and stem helix-heptad repeat 2. However, infants display higher antibody levels and more consistent antibody escape pathways in the FP region compared to mothers. Finally, infants have significantly higher levels of antibody-dependent cellular cytotoxicity (ADCC), though, surprisingly, Spike pseudovirus neutralization titers between infants and mothers are similar. These results suggest infants develop distinct SARS-CoV-2 binding and functional antibody activities and reveal age-related differences in humoral immunity to SARS-CoV-2 infection that could be relevant to protection and COVID-19 disease outcomes. Data on antibody response to SARS-CoV-2 in infants directly compared with their mothers is limited. Stoddard et al. find distinct antibody profiles in infants, including elevated levels of antibody binding to Spike, elevated ADCC, and convergent antibody binding escape profiles in the Spike fusion peptide. [ABSTRACT FROM AUTHOR]

Background: HIV may increase SARS-CoV-2 infection risk and COVID-19 severity generally, but data are limited about its impact on postpartum women and their infants. As such, we characterized SARS-CoV-2 infection among mother-infant pairs in Nairobi, Kenya. Methods: We conducted a nested study of 62 HIV-uninfected and 64 healthy women living with HIV, as well as their HIV-exposed uninfected (N = 61) and HIV-unexposed (N = 64) infants, participating in a prospective cohort. SARS-CoV-2 serology was performed on plasma collected between May 1, 2020-February 1, 2022 to determine the incidence, risk factors, and symptoms of infection. SARS-CoV-2 RNA PCR and sequencing was also performed on available stool samples from seropositive participants. Results: SARS-CoV-2 seropositivity was found in 66% of the 126 mothers and in 44% of the 125 infants. There was no significant association between SARS-CoV-2 infection and maternal HIV (Hazard Ratio [HR] = 0.810, 95% CI: 0.517–1.27) or infant HIV exposure (HR = 1.47, 95% CI: 0.859–2.53). Maternal SARS-CoV-2 was associated with a two-fold increased risk of infant infection (HR = 2.31, 95% CI: 1.08–4.94). Few participants (13% mothers, 33% infants) had symptoms; no participant experienced severe COVID-19 or death. Seroreversion occurred in about half of mothers and infants. SARS-CoV-2 sequences obtained from stool were related to contemporaneously circulating variants. Conclusions: These data indicate that postpartum Kenyan women and their infants were at high risk for SARS-CoV-2 infection and that antibody responses waned over an average of 8–10 months. However, most cases were asymptomatic and healthy women living with HIV did not have a substantially increased risk of infection or severe COVID-19. [ABSTRACT FROM AUTHOR]

A multitude of enzyme‐linked immunosorbent assays (ELISAs) has been developed to detect severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) antibodies since the coronavirus disease 2019 pandemic started in late 2019. Assessing the reliability of these assays in diverse global populations is critical. This study compares the use of the commercially available Platelia Total Ab Assay (Bio‐Rad) nucleocapsid ELISA to the widely used Mount Sinai spike IgG ELISA in a Kenyan population seroprevalence study. Using longitudinal plasma specimens collected from a mother–infant cohort living in Nairobi, Kenya between May 2019 and December 2020, this study demonstrates that the two assays have a high qualitative agreement (92.7%) and strong correlation of antibody levels (R2 = 0.973) in repeated measures. Within this cohort, seroprevalence detected by either ELISA closely resembled previously published seroprevalence estimates for Kenya during the sampling period and no significant difference in the incidence of SARS‐CoV‐2 antibody detection by either assay was observed. Assay comparability was not affected by HIV exposure status. These data support the use of the Platelia SARS‐CoV‐2 Total Ab ELISA as a suitable high‐throughput method for seroprevalence studies in Kenya. [ABSTRACT FROM AUTHOR]

Background: Intimate partner violence (IPV) is a major public health problem and is the most common form of violence against women. Women with HIV in serodifferent relationships may be at an increased risk of IPV compared to women without HIV, hindering their ability to adhere to antiretroviral therapy, clinic appointments, and condom use during sex. This study assessed the prevalence and correlates of IPV in the past year among women with HIV in serodifferent relationships in Nairobi, Kenya. Methods: This cross-sectional study included women with HIV in serodifferent relationships who were at least 18 years old and provided written informed consent. Their experience of physical, sexual, or emotional violence in the past year by the current partner was assessed using 13 questions adapted from the World Health Organization survey on violence against women. Standardized instruments were used to assess sociodemographic and behavioral factors. Associations between intimate partner violence and other variables were evaluated using log binomial regression models. Results: Of the 159 women enrolled, 47 (29.6%, 95% CI 22.9–37.2%) reported IPV in the past year. Of these, 32 (68.1%) reported emotional, 27 (57.4%) physical, and 27 (57.4%) sexual violence. In the multivariate model, pregnancy (adjusted prevalence ratio [aPR] 2.14, 95% CI 1.09–4.20), alcohol use (minimal drinking aPR 1.91, 95% CI 1.10–3.33; moderate/severe drinking aPR 1.17, 95% CI 0.53–2.59), male partner controlling behavior (aPR 2.09, 95% CI 1.24–3.51), and past physical violence (aPR 1.93, 95% CI 1.22–3.05) remained significantly associated with a higher prevalence of IPV in the past year. Conclusion: This study identified a high prevalence of IPV in the past year among women with HIV in serodifferent relationships. Pregnant women and women who had experienced prior violence had a higher prevalence of IPV. These data highlight the need to screen for IPV during clinic visits, and to offer evidence based interventions to support women in serodifferent relationships who have experienced IPV. [ABSTRACT FROM AUTHOR]

We conducted a population-level short message service (SMS)-based survey among individuals aged 18–34 years in six HIV high-burden counties in Western Kenya to assess pre-exposure prophylaxis (PrEP) awareness, acceptability of non-facility PrEP delivery, and willingness to pay for PrEP. In January 2019, anonymous data were collected using mSurvey Inc., Nairobi, Kenya, which sends SMS messages via mobile provider networks to a 'general audience' pool of subscribers ≥18 years. Subscribers' demographic information was matched to Kenyan census data by age, gender, and county. Of the 3825 individuals who received the survey, 2617 (68%) opened the survey and 2498/2617 (95%) completed all questions. Overall, 84% had ever heard of PrEP, of whom 59% demonstrated understanding of PrEP; understanding was greater among men than women (64% versus 55%, p < 0.001). Among participants who understood PrEP (n = 1249), 38% reported pharmacies (informal or formal) as the preferred venue to obtain PrEP. Over half (61%) were willing to pay for PrEP and 78% reported that the maximum amount they were willing to pay for a one-month supply was <5 USD. High awareness of PrEP in high HIV prevalence settings in Kenya suggests effective public health messaging. Willingness to pay and preference for pharmacy access suggest that non-facility PrEP delivery may be useful. [ABSTRACT FROM AUTHOR]

Objective: To examine the association between cultivable vaginal Lactobacillus and fecundability in Kenyan women attempting nonmedically assisted conception.Design: Prospective preconception cohort.Setting: Nairobi and Mombasa, Kenya.Patient(s): Women trying to conceive who reported ≤3 months of pre-enrollment conception attempt time.Intervention(s): Cultivable Lactobacillus (primary), Lactobacillus morphotypes on Gram stain (secondary).Main Outcome Measure(s): Participants reported the first day of their last menstrual period and recent sexual behavior, underwent pregnancy testing, and provided vaginal specimen samples for Lactobacillus culture and Gram stain at ≤6 monthly preconception visits. The outcome was fecundability-the per-menstrual cycle probability of pregnancy. Associations between cultivable Lactobacillus and Lactobacillus morphotypes on Gram stain at the visit before each pregnancy test and fecundability were estimated using proportional probabilities models to generate fecundability ratios (FRs).Result(s): A total of 458 women contributed 1,376 menstrual cycles. At enrollment, 65.3% (n = 299) of participants had cultivable Lactobacillus, 47.4% (n = 217) had cultivable hydrogen peroxide producing Lactobacillus, and 64.6% (n = 296) had Lactobacillus detected on Gram stain. In unadjusted analysis, there was no association between cultivable Lactobacillus at the prior visit and fecundability (FR, 0.92; 95% CI, 0.73-1.16); results were similar after adjustment for age, frequency of condomless sex, and study site (adjusted FR, 0.92; 95% CI, 0.72-1.18). Lactobacillus on Gram stain at the visit prior was associated with modestly higher fecundability (adjusted FR, 1.18; 95% CI, 0.92-1.51).Conclusion(s): Cultivable Lactobacillus was not associated with fecundability, although Lactobacillus morphotypes detected on Gram stain were somewhat associated with increased fecundability. The relationship between vaginal Lactobacillus and fecundity may be species-specific. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the association between metabolic syndrome (MetS) and high‐sensitivity C‐reactive protein (hsCRP), a biomarker of chronic inflammation and an independent predictor for cardiovascular disease overall and in subgroups of women with/without pre‐eclampsia and gestational hypertension (GHT). Methods: A prospective cohort study was conducted in Nairobi, Kenya. Women with pre‐eclampsia or GHT and normotensive women within 12 weeks postpartum underwent physical, anthropometric, fasting lipid profile, plasma glucose, and hsCRP measurements at 6 months postpartum. A generalized linear regression model with Poisson distribution adjusted for body mass index and age was used to estimate the association between elevated hsCRP and MetS overall and stratified by pre‐eclampsia or GHT. Results: In the 171 women included in the study, risk of elevated hsCRP (>3 mg/L) was greater among women with compared to those without MetS (adjusted relative risk [ARR] 1.70, 95% confidence interval [CI] 1.05–2.73, P=0.03) and was statistically significantly higher in the hypertensive (ARR 2.16 95% CI 1.01–4.62, P=0.04) but not in the normotensive (ARR 1.46, 95% CI 0.93–2.28) group. Conclusion: Increased risk of elevated hsCRP postpartum can guide longitudinal mechanistic and intervention studies to reduce postpartum cardiovascular morbidity in women with MetS, especially after pre‐eclampsia or GHT. At 6 months postpartum, metabolic syndrome is associated with increased high‐sensitivity C‐reactive protein, a risk factor for cardiovascular disease, especially after pre‐eclampsia and gestational hypertension. [ABSTRACT FROM AUTHOR]

Objectives: Integrating family planning (FP) into routine HIV care and treatment are recommended by WHO guidelines to improve FP access among HIV-infected individuals in sub-Saharan Africa. This study sought to assess factors that influence the delivery of integrated FP services and the impact of facility-level integration of FP on contraceptive uptake among women living with HIV (WLWH).Study Design: A national cross-sectional study was conducted among WLWH at HIV Care and Treatment centers with >1000 antiretroviral treatment (ART) clients per year. A mobile team visited 108 HIV Care and Treatment centers and administered surveys to key informants regarding facility attributes and WLWH regarding FP at these centers between June and September 2016. We classified facilities offering FP services within the same facility as 'integrated' facilities.Results: 4805 WLWH were enrolled at 108 facilities throughout Kenya. The majority (73%) of facilities offered integrated FP services. They were more likely to be offered in public than private facilities (Prevalence Ratio [PR]: 1.86, 95% Confidence Interval [CI]: 1.11-3.11; p = 0.02] and were more common in the Nyanza region than the Nairobi region (77% vs 35% respectively, p = 0.06). Any contraceptive use (89% vs 80%), use of modern contraception (88% vs 80%), dual method use (40% vs 30%), long-acting reversible contraception (LARC) (28% vs 20%), and non-barrier short-term methods (34% vs 27%) were all significantly higher in facilities with integrated FP services (p < 0.001).Conclusions: The majority of high volume facilities integrated FP services into HIV care. Integrating FP services may increase modern contraceptive use among WLWH.Implications: Integration of FP services was associated with higher modern contraceptive use, lower unmet need for modern methods and higher use of long-acting, reversible contraception (LARC), and non-barrier short-term methods among women living with HIV. Despite high prevalence of integration of FP services, organizational challenges remain at integrated clinics. [ABSTRACT FROM AUTHOR]