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OBJECTIVE: To determine whether herpes simplex virus type 2 (HSV-2) infection was associated with risk of intrapartum human immunodeficiency virus type 1 (HIV-1) transmission and to define correlates of HSV-2 infection among HIV-1-seropositive pregnant women. METHODS: We performed a nested case control study within a perinatal cohort in Nairobi, Kenya. Herpes simplex virus type 2 serostatus and the presence of genital ulcers were ascertained at 32 weeks of gestation. Maternal cervical and plasma HIV-1 RNA and cervical HSV DNA were measured at delivery. RESULTS: One hundred fifty-two (87%) of 175 HIV-1-infected mothers were HSV-2-seropositive. Among the 152 HSV-2-seropositive women, nine (6%) had genital ulcers at 32 weeks of gestation, and 13 (9%) were shedding HSV in cervical secretions. Genital ulcers were associated with increased plasma HIV-1 RNA levels (P=.02) and an increased risk of intrapartum HIV-1 transmission (16% of transmitters versus 3% of nontransmitters had ulcers; P = .003), an association which was maintained in multivariable analysis adjusting for plasma HIV-1 RNA levels (P=.04). We found a borderline association for higher plasma HIV-1 RNA among women shedding HSV (P=.07) and no association between cervical HSV shedding and either cervical HIV-1 RNA levels or intrapartum HIV-1 transmission (P=.4 and P=.5, [corrected] respectively). CONCLUSION: Herpes simplex virus type 2 is the leading cause of genital ulcers among women in sub-Saharan Africa and was highly prevalent in this cohort of pregnant women receiving prophylactic zidovudine. After adjusting for plasma HIV-1 RNA levels, genital ulcers were associated with increased risk of intrapartum HIV-1 transmission. These data suggest that management of HSV-2 during pregnancy may enhance mother-to-child HIV-1 prevention efforts. LEVEL OF EVIDENCE: II. [ABSTRACT FROM AUTHOR]

Abstract Background The breakdown of the blood-brain-barrier vascular endothelium is critical for entry of immune cells into the MS brain. Vascular co-morbidities are associated with increased risk of progression. Dyslipidemia, elevated LDL and reduced HDL may increase progression by activating inflammatory processes at the vascular endothelium. Objective To assess the associations of serum lipid profile variables (triglycerides, high and low density lipoproteins (HDL, LDL) and total cholesterol) with disability and MRI measures in multiple sclerosis (MS). Methods This study included 492 MS patients (age: 47.1 ± 10.8 years; disease duration: 12.8 ± 10.1 years) with baseline and follow-up Expanded Disability Status Score (EDSS) assessments after a mean period of 2.2 ± 1.0 years. The associations of baseline lipid profile variables with disability changes were assessed. Quantitative MRI findings at baseline were available for 210 patients. Results EDSS worsening was associated with higher baseline LDL (p = 0.006) and total cholesterol (p = 0.001, 0.008) levels, with trends for higher triglyceride (p = 0.025); HDL was not associated. A similar pattern was found for MSSS worsening. Higher HDL levels (p < 0.001) were associated with lower contrast-enhancing lesion volume. Higher total cholesterol was associated with a trend for lower brain parenchymal fraction (p = 0.033). Conclusions Serum lipid profile has modest effects on disease progression in MS. Worsening disability is associated with higher levels of LDL, total cholesterol and triglycerides. Higher HDL is associated with lower levels of acute inflammatory activity.

Abstract The study is aimed to determine the role of luteolin (3',4',5,7-tetrahydroxyflavone), alone and in combination with human interferon-beta (IFN-β), in modulating the immune response(s) of peripheral blood mononuclear cells (PBMCs) isolated from multiple sclerosis (MS) patients. PBMC proliferation in the presence or absence of these drugs was determined and the production of pro-inflammatory cytokines (IL-1β, TNF-α), and the ratio of cell migration mediator MMP-9, and its inhibitor, TIMP-1 was assessed in the culture supernatants. Luteolin reduced, in a dose-dependent manner, the proliferation of PBMCs, and modulated the levels of IL-1β and TNF-α released by PBMCs in the culture supernatants. Luteolin reduced the MMP-9/TIMP-1 ratio via lowering MMP-9 production. In the majority of cases, luteolin, when combined with IFN-β, had additive effects in modulating cell proliferation, IL-1β, TNF-α, MMP-9 and TIMP-1.

Objective: To compare preferences, uptake, and cofactors for unassisted home-based oral self-testing (HB-HIVST) versus clinic-based rapid diagnostic blood tests (CB-RDT) for maternal HIV retesting., Design: Prospective cohort., Methods: Between November 2017 and June 2019, HIV-negative pregnant Kenyan women receiving antenatal care were enrolled and given a choice to retest with HB-HIVST or CB-RDT. Women were asked to retest between 36 weeks gestation and 1-week post-delivery if the last HIV test was <24 weeks gestation or at 6 weeks postpartum if ≥24 weeks gestation, and self-report on retesting at a 14-week postpartum., Results: Overall, 994 women enrolled and 33% (n = 330) selected HB-HIVST. HB-HIVST was selected because it was private (n = 224, 68%), convenient (n = 211, 63%), and offered flexibility in the timing of retesting (n = 207, 63%), whereas CB-RDT was selected due to the trust of providers to administer the test (n = 510, 77%) and convenience of clinic testing (n = 423, 64%). Among 905 women who reported retesting at follow-up, 135 (15%) used HB-HIVST. Most (n = 595, 94%) who selected CB-RDT retested with this strategy, compared to 39% (n = 120) who selected HB-HIVST retesting with HB-HIVST. HB-HIVST retesting was more common among women with higher household income and those who may have been unable to test during pregnancy (both retested postpartum and delivered <37 weeks gestation) and less common among women who were depressed. Most women said they would retest in the future using the test selected at enrollment (99% [n = 133] HB-HIVST; 93% [n = 715] CB-RDT-RDT)., Conclusions: While most women preferred CB-RDT for maternal retesting, HB-HIVST was acceptable and feasible and could be used to expand HIV retesting options., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Drake et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Clinical risk score tools require validation in diverse settings and populations before they are widely implemented. We aimed to externally validate an HIV risk assessment tool for predicting HIV acquisition among pregnant and postpartum women. In the context of prevention of mother-to-child transmission programs, risk score tools could be used to prioritize retesting efforts and delivery of pre-exposure prophylaxis (PrEP) to pregnant and postpartum women most at risk for HIV acquisition while minimizing unnecessary perinatal exposure., Methods: Data from women enrolled in a cross-sectional study of programmatic HIV retesting and/or receiving maternal and child health care services at five facilities in Western Kenya were used to validate the predictive ability of a simplified risk score previously developed for pregnant/postpartum women. Incident HIV infections were defined as new HIV diagnoses following confirmed negative or unknown status during pregnancy. Predictive performance was assessed using the area under the receiver operating characteristic curve (AUC) and Brier score., Results: Among 1266 women with 35 incident HIV infections, we found an AUC for predicting HIV acquisition of 0.60 (95% CI, 0.51, 0.69), with a Brier score of 0.27. A risk score >6 was associated with a 2.9-fold increase in the odds of HIV acquisition (95% CI, 1.48, 5.70; p = 0.002) vs scores ≤6. Women with risk scores >6 were 27% (346/1266) of the population but accounted for 52% of HIV acquisitions. Syphilis, age at sexual debut, and unknown partner HIV status were significantly associated with increased risk of HIV in this cohort., Conclusion: The simplified risk score performed moderately at predicting risk of HIV acquisition in this population of pregnant and postpartum women and may be useful to guide PrEP use or counseling., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Chhun et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Hybrid immunity (infection plus vaccination) may increase maternally derived SARS-CoV-2 antibody responses and durability versus infection alone., Methods: Prospective cohort of pregnant participants with prior SARS-CoV-2 infection (anti-nucleocapsid IgG, RT-PCR, or antigen positive) and their infants had blood collected in pregnancy, at delivery/birth, and postpartum tested for anti-spike (anti-S) IgG and neutralizing antibodies (neutAb)., Results: Among 107 participants at enrollment, 40% were unvaccinated and 60% were vaccinated (received ≥1 dose); 102 had previous SARS-CoV-2 infection in pregnancy (median, 19 weeks' gestation); 5 were diagnosed just prior to pregnancy (median, 8 weeks). At delivery, fewer unvaccinated participants (87% anti-S IgG+, 86% neutAb) and their infants (86% anti-S IgG+, 75% neutAb) had anti-S IgG+ or neutAb compared to vaccinated participants and their infants (100%, P ≤ .01 for all). By 3-6 months postpartum, 50% of infants of unvaccinated participants were anti-S IgG+ and 14% had neutAb, versus 100% among infants of vaccinated participants (all P < .01), with lower median antibody responses (anti-S IgG log10 1.95 vs 3.84 AU/mL, P < .01; neutAb log10 1:1.34 vs 1:3.20, P = .11)., Conclusions: In pregnant people with prior SARS-CoV-2, vaccination before delivery provided more durable maternally derived antibody responses than infection alone in infants through 6 months., Competing Interests: Potential conflicts of interest. J. A. E. reports serving as a consultant for Sanofi Pasteur, AstraZeneca, Meissa Vaccines, Pfizer, and Moderna; and has received grant support from Pfizer, GlaxoSmithKline, AstraZeneca, Moderna, and Merck. A. K. reports serving as an unpaid consultant for GlaxoSmith-Kline and Pfizer; and is coinvestigator on studies funded by Pfizer and Merck. A. L. D., A. L. G., and S. L. M. all received grant support from Merck for this work. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Competing Interests: Potential conflicts of interest. J. A. E. reports serving as a consultant for Sanofi Pasteur, AstraZeneca, Meissa Vaccines, Pfizer, and Moderna and has received grant support from Pfizer, GlaxoSmithKline, AstraZeneca, Moderna and Merck. A. K. reports serving as an unpaid consultant for GlaxoSmithKline and Pfizer and is co-investigator on studies funded by Pfizer and Merck. A. L. D, A. L. G., and S.M.L. all received grant support from Merck. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

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., Competing Interests: The authors have declared that no competing interest exists., (Copyright: © 2024 Ngumbau et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Differentiated service delivery (DSD) approaches decrease frequency of clinic visits for individuals who are stable on antiretroviral therapy. It is unclear how to optimize DSD models for postpartum women living with HIV (PWLH). We evaluated longitudinal HIV viral load (VL) and cofactors, and modelled DSD eligibility with virologic failure (VF) among PWLH in prevention of mother-to-child transmission programs., Methods: This analysis used programmatic data from participants in the Mobile WAChX trial (NCT02400671). Women were assessed for DSD eligibility using the World Health Organization criteria among general people living with HIV (receiving antiretroviral therapy for ≥6 months and having at least 1 suppressed VL [<1000 copies/mL] within the past 6 months). Longitudinal VL patterns were summarized using group-based trajectory modelling. VF was defined as having a subsequent VL ≥1000 copies/mL after being assessed as DSD-eligible. Predictors of VF were determined using log-binomial models among DSD-eligible PWLH., Results: Among 761 women with 3359 VL results (median 5 VL per woman), a 3-trajectory model optimally summarized longitudinal VL, with most (80.8%) women having sustained low probability of unsuppressed VL. Among women who met DSD criteria at 6 months postpartum, most (83.8%) maintained viral suppression until 24 months. Residence in Western Kenya, depression, reported interpersonal abuse, unintended pregnancy, nevirapine-based antiretroviral therapy, low-level viremia (VL 200-1000 copies/mL), and drug resistance were associated with VF among DSD-eligible PWLH., Conclusions: Most postpartum women maintained viral suppression from early postpartum to 24 months and may be suitable for DSD referral. Women with depression, drug resistance, and detectable VL need enhanced services., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections in pregnancy contribute to adverse perinatal outcomes. We identified predictors of CT and/or NG infection among pregnant Kenyan women., Methods: Women without HIV were enrolled at 2 antenatal clinics in Western Kenya. Both CT and NG were assessed using endocervical samples for nucleic acid amplification tests. Poisson regression models were used to evaluate potential CT/NG risk factors. Classification and regression trees were generated to evaluate the joint effects of predictors., Results: Overall, 1276 women had both CT and NG assessments. Women enrolled at a median of 26 weeks' gestation (interquartile range, 22-31 weeks), median age was 22 years (interquartile range, 19-27 years), and 78% were married. In total, 98 (7.7%) tested positive for CT/NG: 70 (5.5%) for CT and 32 (2.5%) for NG, 4 of whom (0.3%) had coinfections. Two-thirds (66%) of CT/NG cases were asymptomatic and would have been missed with only syndromic management. Risk factors of CT/NG included age <22 years, crowded living conditions, being unmarried, being in partnerships for <1 year, abnormal vaginal discharge, sexually transmitted infection history, and Trichomonas vaginalis diagnosis ( P < 0.1). Classification and regression tree analyses identified unmarried women <22 years in relationships for <1 year as 6.1 times more likely to have CT/NG compared with women without these characteristics (26% vs. 6%, adjusted prevalence ratio = 6.1, 95% confidence interval = 3.55-10.39, P < 0.001)., Conclusions: Chlamydia trachomatis / Neisseria gonorrhoeae was frequently asymptomatic and common among young unmarried women in newer partnerships in this cohort. Integrating CT/NG testing into routine antenatal care may be beneficial, especially for young women in Kenya., Competing Interests: Conflict of Interest and Sources of Funding: None declared., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)

Background: HIV testing services (HTS) are the first steps in reaching the UNAIDS 95-95-95 goals to achieve and maintain low HIV incidence. Evaluating the effectiveness of different demand creation interventions to increase uptake of efficient and effective HTS is useful to prioritize limited programmatic resources. This review was undertaken to inform World Health Organization (WHO) 2019 HIV testing guidelines and assessed the research question, "Which demand creation strategies are effective for enhancing uptake of HTS?" focused on populations globally., Methods and Findings: The following electronic databases were searched through September 28, 2021: PubMed, PsycInfo, Cochrane CENTRAL, CINAHL Complete, Web of Science Core Collection, EMBASE, and Global Health Database; we searched IAS and AIDS conferences. We systematically searched for randomized controlled trials (RCTs) that compared any demand creation intervention (incentives, mobilization, counseling, tailoring, and digital interventions) to either a control or other demand creation intervention and reported HTS uptake. We pooled trials to evaluate categories of demand creation interventions using random-effects models for meta-analysis and assessed study quality with Cochrane's risk of bias 1 tool. This study was funded by the WHO and registered in Prospero with ID CRD42022296947. We screened 10,583 records and 507 conference abstracts, reviewed 952 full texts, and included 124 RCTs for data extraction. The majority of studies were from the African (N = 53) and Americas (N = 54) regions. We found that mobilization (relative risk [RR]: 2.01, 95% confidence interval [CI]: [1.30, 3.09], p < 0.05; risk difference [RD]: 0.29, 95% CI [0.16, 0.43], p < 0.05, N = 4 RCTs), couple-oriented counseling (RR: 1.98, 95% CI [1.02, 3.86], p < 0.05; RD: 0.12, 95% CI [0.03, 0.21], p < 0.05, N = 4 RCTs), peer-led interventions (RR: 1.57, 95% CI [1.15, 2.15], p < 0.05; RD: 0.18, 95% CI [0.06, 0.31], p < 0.05, N = 10 RCTs), motivation-oriented counseling (RR: 1.53, 95% CI [1.07, 2.20], p < 0.05; RD: 0.17, 95% CI [0.00, 0.34], p < 0.05, N = 4 RCTs), short message service (SMS) (RR: 1.53, 95% CI [1.09, 2.16], p < 0.05; RD: 0.11, 95% CI [0.03, 0.19], p < 0.05, N = 5 RCTs), and conditional fixed value incentives (RR: 1.52, 95% CI [1.21, 1.91], p < 0.05; RD: 0.15, 95% CI [0.07, 0.22], p < 0.05, N = 11 RCTs) all significantly and importantly (≥50% relative increase) increased HTS uptake and had medium risk of bias. Lottery-based incentives and audio-based interventions less importantly (25% to 49% increase) but not significantly increased HTS uptake (medium risk of bias). Personal invitation letters and personalized message content significantly but not importantly (<25% increase) increased HTS uptake (medium risk of bias). Reduced duration counseling had comparable performance to standard duration counseling (low risk of bias) and video-based interventions were comparable or better than in-person counseling (medium risk of bias). Heterogeneity of effect among pooled studies was high. This study was limited in that we restricted to randomized trials, which may be systematically less readily available for key populations; additionally, we compare only pooled estimates for interventions with multiple studies rather than single study estimates, and there was evidence of publication bias for several interventions., Conclusions: Mobilization, couple- and motivation-oriented counseling, peer-led interventions, conditional fixed value incentives, and SMS are high-impact demand creation interventions and should be prioritized for programmatic consideration. Reduced duration counseling and video-based interventions are an efficient and effective alternative to address staffing shortages. Investment in demand creation activities should prioritize those with undiagnosed HIV or ongoing HIV exposure. Selection of demand creation interventions must consider risks and benefits, context-specific factors, feasibility and sustainability, country ownership, and universal health coverage across disease areas., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: Prevention of mother-to-child transmission programs serve women continuing and initiating antiretroviral therapy (ART) in pregnancy, and follow-up schedules align to delivery rather than ART initiation, making conventional HIV retention measures (assessed from ART initiation) challenging to apply. We evaluated 3 measures of peripartum nonretention in Kenyan women living with HIV from pregnancy to 2 years postpartum., Methods: This longitudinal analysis used programmatic data from the Mobile WAChX trial (NCT02400671). Outcomes included loss to follow-up (LTFU) (no visit for ≥6 months), incomplete visit coverage (<80% of 3-month intervals with a visit), and late visits (>2 weeks after scheduled date). Predictors of nonretention were determined using Cox proportional hazards, log-binomial, and generalized estimating equation models., Results: Among 813 women enrolled at a median of 24 weeks gestation, incidence of LTFU was 13.6/100 person-years; cumulative incidence of LTFU by 6, 12, and 24 months postpartum was 16.7%, 20.9%, and 22.5%, respectively. Overall, 35.5% of women had incomplete visit coverage. Among 794 women with 12,437 scheduled visits, a median of 11.1% of visits per woman were late (interquartile range 4.3%-23.5%). Younger age, unsuppressed viral load, unemployment, ART initiation in pregnancy, and nondisclosure were associated with nonretention by all measures. Partner involvement was associated with better visit coverage and timely attendance. Women who became LTFU had higher frequency of previous late visits (16.7% vs. 7.7%, P < 0.0001)., Conclusions: Late visit attendance may be a sentinel indicator of LTFU. Identified cofactors of prevention of mother-to-child transmission programmatic retention may differ depending on retention measure assessed, highlighting the need for standardized measures., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Evidence on method dissatisfaction among current contraceptive users is sparse. Group-based trajectory modeling presents a novel approach to describing method dissatisfaction., Study Design: In a cohort of Kenyan women using modern contraception, we identified group-based trajectories of method dissatisfaction over 24 weeks since clinic visit., Results: Among 947 women, four trajectories were identified: consistent satisfaction (71%), increasing dissatisfaction (18%), decreasing dissatisfaction (8%), and consistent dissatisfaction (3%)., Discussion: Method dissatisfaction was common in a cohort of Kenyan women. Group-based trajectory models describe distinct and changing experiences of contraceptive use. Deeper understanding of trajectories of contraceptive experience may be useful for advancing person-centered family planning care that addresses users' changing preferences and challenges., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Antenatal care provides unique opportunities to assess severe acute respiratory syndrome coronavirus 2 seroprevalence and antibody response duration after natural infection detected during pregnancy; transplacental antibody transfer may inform peripartum and neonatal protection. We estimated seroprevalence and durability of antibodies from natural infection (anti-nucleocapsid immunoglobulin G) among pregnant people, and evaluated transplacental transfer efficiency., Objective and Design: We conducted a cross-sectional study to measure severe acute respiratory syndrome coronavirus 2 seroprevalence, and a prospective cohort study to longitudinally measure anti-nucleocapsid immunoglobulin G responses and transplacental transfer of maternally derived anti-nucleocapsid antibodies., Methods: We screened pregnant people for the seroprevalence study between 9 December 2020 and 19 June 2021 for anti-nucleocapsid immunoglobulin G in Seattle, Washington. We enrolled anti-nucleocapsid immunoglobulin G positive people from the seroprevalence study or identified through medical records with positive reverse transcription polymerase chain reaction or antigen positive results in a prospective cohort between 9 December 2020 and 9 August 2022., Results: In the cross-sectional study (N = 1284), 5% (N = 65) tested severe acute respiratory syndrome coronavirus 2 anti-nucleocapsid immunoglobulin G positive, including 39 (60%) without prior positive reverse transcription polymerase chain reaction results and 42 (65%) without symptoms. In the prospective cohort study (N = 107 total; N = 65 from the seroprevalence study), 86 (N = 80%) had anti-nucleocapsid immunoglobulin G positive results during pregnancy. Among 63 participants with delivery samples and prior anti-nucleocapsid positive results, 29 (46%) were anti-nucleocapsid immunoglobulin G negative by delivery. Of 34 remaining anti-nucleocapsid immunoglobulin G positive at delivery with paired cord blood, 19 (56%) had efficient transplacental anti-nucleocapsid immunoglobulin G antibody transfer. Median time from first anti-nucleocapsid immunoglobulin G positive to below positive antibody threshold was 19 weeks and did not differ by prior positive reverse transcription polymerase chain reaction status., Conclusions: Maternally derived severe acute respiratory syndrome coronavirus 2 antibodies to natural infection may wane before delivery. Vaccines are recommended for pregnant persons to reduce severe illness and confer protection to infants.

Importance: COVID-19 vaccine boosters or third doses are recommended for adolescents and adults who completed their initial COVID-19 vaccine course more than 5 months prior. Minimal data are available on COVID-19 vaccine booster or third dose reactogenicity among pregnant and lactating individuals., Objective: To describe the reactions to the booster or third dose of the COVID-19 vaccine and vaccine experiences among pregnant and lactating individuals., Design, Setting, and Participants: Beginning in October 2021, a follow-up Research Electronic Data Capture (REDCap) survey regarding a COVID-19 vaccine booster or third dose was sent to 17 504 participants in an ongoing online prospective cohort study on COVID-19 vaccines among pregnant and lactating individuals. A convenience sample of adults enrolled in the online prospective study who were pregnant, lactating, or neither pregnant nor lactating at the time of their booster or third dose was eligible for this follow-up survey; 17 014 (97.2%) completed the follow-up survey., Exposure: Receipt of a booster or third dose of the COVID-19 vaccine., Main Outcomes and Measures: Self-reported vaccine reactions less than 24 hours after the dose., Results: As of April 4, 2022, 17 014 eligible participants (mean [SD] age, 33.3 [3.5] years) responded to the booster or third dose survey; of these, 2009 (11.8%) were pregnant at the time of their booster or third dose, 10 279 (60.4%) were lactating, and 4726 (27.8%) were neither pregnant nor lactating. After a COVID-19 booster or third dose, most individuals (14 074 of 17 005 [82.8%]) reported a local reaction, and 11 542 of 17 005 (67.9%) reported at least 1 systemic symptom. Compared with individuals who were neither pregnant nor lactating, pregnant participants were more likely to report any local reaction to a COVID-19 booster or third dose (adjusted odds ratio [aOR], 1.2; 95% CI, 1.0-1.4; P = .01) but less likely to report any systemic reaction (aOR, 0.7; 95% CI, 0.6-0.8; P < .001). Most pregnant (1961 of 2009 [97.6%]) and lactating (9866 of 10 277 [96.0%]) individuals reported no obstetric or lactation concerns after vaccination., Conclusions and Relevance: This study suggests that COVID-19 vaccine boosters or third doses were well tolerated among pregnant and lactating individuals. Data to evaluate tolerability of boosters or additional doses among pregnant and lactating individuals will be important as they are considered for these populations.

Background: We examined longitudinal patterns and cofactors of depressive symptoms among pregnant and postpartum women living with HIV (WLWH)., Methods: This study used data from a randomized trial of a text messaging intervention. WLWH were serially assessed for depressive symptoms from pregnancy through 24 months postpartum at 6 time points (pregnancy, 6 weeks, and 6, 12, 18, and 24 months postpartum). Depressive symptoms were assessed using Patient Health Questionnaire-9 and longitudinal patterns using group-based trajectory modeling. Moderate-to-severe depressive symptoms (MSD) correlates were assessed using generalized estimating equations., Results: Among 824 enrolled women, 14.6% ever had MSD during pregnancy or postpartum; 8.6% of WLWH had MSD in pregnancy and 9.0% any postpartum MSD. MSD was associated with abuse [RR: 3.8, 95% confidence interval (CI): 2.6 to 5.4], stigma (RR: 4.4, 95% CI: 3.1 to 6.3), and food insecurity (RR: 2.7, 95% CI: 1.9 to 3.8). Unintended pregnancy (RR: 1.6, 95% CI: 1.1 to 2.3) and recent HIV diagnosis (RR: 1.8, 95% CI: 1.2 to 2.6) were associated with higher MSD risk, whereas HIV status disclosure to partner (RR: 0.3, 95% CI: 0.2 to 0.6) and social support (RR: 0.97, 95% CI: 0.96 to 0.98) were associated with lower risk. Trajectory modeling identified 4 phenotypes of peripartum depressive symptoms: persistent no/low symptoms (38.5%), mild symptoms resolving postpartum (12.6%), low symptoms increasing slightly in postpartum (47.9%), and persistent moderate-severe symptoms throughout (1.1%)., Conclusions: WLWH attending PMTCT services had varied patterns of depressive symptoms, which were associated with stressors (recent diagnosis and food insecurity) and factors reflecting low social power (abuse, stigma, and unintended pregnancy). Women experiencing concurrent abuse, stigma, and food insecurity should be prioritized for interventions to prevent persistent depression., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: Key populations, including sex workers, men who have sex with men, and people who inject drugs, have a high risk of HIV and sexually transmitted infections. We assessed the health and economic impacts of different HIV and syphilis testing strategies among three key populations in Viet Nam using a dual HIV/syphilis rapid diagnostic test (RDT)., Setting: We used the spectrum AIDS impact model to simulate the HIV epidemic in Viet Nam and evaluated five testing scenarios among key populations. We used a 15-year time horizon and a provider perspective for costs., Participants: We simulate the entire population of Viet Nam in the model., Interventions: We modelled five testing scenarios among key populations: (1) annual testing with an HIV RDT, (2) annual testing with a dual RDT, (3) biannual testing using dual RDT and HIV RDT, (4) biannual testing using HIV RDT and (5) biannual testing using dual RDT., Primary and Secondary Outcome Measures: The primary outcome is incremental cost-effectiveness ratios. Secondary outcomes include HIV and syphilis cases., Results: Annual testing using a dual HIV/syphilis RDT was cost-effective (US$10 per disability-adjusted life year (DALY)) and averted 3206 HIV cases and treated 27 727 syphilis cases compared with baseline over 15 years. Biannual testing using one dual test and one HIV RDT (US$1166 per DALY), or two dual tests (US$5672 per DALY) both averted an additional 875 HIV cases, although only the former scenario was cost-effective. Annual or biannual HIV testing using HIV RDTs and separate syphilis tests were more costly and less effective than using one or two dual RDTs., Conclusions: Annual HIV and syphilis testing using dual RDT among key populations is cost-effective in Vietnam and similar settings to reach global reduction goals for HIV and syphilis., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The aim of this study was to understand predictors of adverse pregnancy outcomes (APOs) among women on antiretroviral treatment (ART)., Design: A longitudinal cohort., Methods: Participants from the Mobile WAChX trial were evaluated for APOs, including stillbirth (fetal death at ≥20 weeks' gestation), preterm birth (PTB, livebirth at <37 weeks' gestation,) and neonatal death (NND, ≤28 days after live birth). Predictors were determined by univariable and multivariable Cox proportional hazards and log-binomial models., Results: Among 774 women included, median age was 27 years and 29.0% had unsuppressed HIV viral load (>1000 copies/ml) at enrollment. Half (55.1%) started ART prepregnancy, 89.1% on tenofovir-based regimens. Women with depression had a higher risk of stillbirth (adjusted hazard ratio [aHR] 2.93, 95% confidence interval (95% CI) 1.04-8.23), and women with lower social support score had higher risk of late stillbirth (aHR 11.74, 2.47-55.86). Among 740 livebirths, 201 (27.2%) were preterm and 22 (3.0%) experienced NND. PTB was associated with unsuppressed maternal viral load (adjusted prevalence ratio [aPR] 1.28, 95% CI 1.02-1.61), intimate partner violence (IPV) in pregnancy (aPR 1.94, 95% CI 1.28-2.94), and history of any sexually transmitted infection (STI) (aPR 1.63, 95% CI 1.06-2.51). NND was associated with PTB (aPR 2.53, 95% CI 1.10-5.78) and STI history (aPR 4.25, 95% CI 1.39-13.06). Most associations retained significance in the subgroup of women with viral suppression., Conclusion: Maternal viremia during pregnancy predicted PTB as did IPV, lower education, and STI history, while psychosocial stressors predicted stillbirth. Implementing mental health services, ART adherence, partner support, and routine STI screening and treatment could reduce APOs among women with HIV in sub-Saharan Africa settings., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To determine the contribution of specific contraceptive side effects to method switch and modern-method discontinuation among Kenyan women., Design: A prospective cohort study., Setting: Five counties in Western Kenya., Participants: Women aged ≥18 years old and emancipated female minors ≥14 years old using modern, reversible contraception were recruited while attending 10 public health facilities., Methods: Patient-reported adverse effect symptoms, method switch and discontinuation were reported through weekly text message-based surveys for 24 weeks., Main Outcome Measurements: Prevalence, hazards ratio (HR)., Results: Among 825 women, 44% were using implants, 43% injectables, 7% an intrauterine device and 6% oral contraceptive pills at enrolment. Most (61%) women were continuing a method used in the previous month. During the 24-week follow up, incidence of contraceptive switch was 61.3 per 100 person-years (95% confidence interval [CI] 52.4-71.8) and incidence of discontinuation was 38.5 per 100 person-years (95% CI 31.6-47.0). On average, one-quarter (prevalence [Pr] 0.24, 95% CI 0.22-0.26) of participants reported side effects or method problems weekly, with sexual side effects the most prevalent symptom (Pr 0.15, 95% CI 0.13-0.16). Lack of expected bleeding was associated with higher risk of method switch (adjusted hazard ratio [aHR] 2.36, 95% CI 1.22-4.57). Risk of all-modern method discontinuation was higher among women experiencing irregular bleeding (aHR 2.39, 95% CI 1.20-4.77), weight changes (aHR 2.72, 95% CI 1.47-4.68) and sexual side effects (aHR 2.42, 95% CI 1.40-4.20)., Conclusions: Addressing irregular bleeding, weight changes and sexual side effects through development of new products that minimise these specific side effects and anticipatory counseling may reduce method-related discontinuation., Tweetable Abstract: Bleeding, weight changes, sexual problems associated with discontinuation of #contraception, but many continue despite side effects., (© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Introduction: HIV retesting during pregnancy/postpartum can identify incident maternal HIV infection and prevent mother-to-child HIV transmission (MTCT). Guidelines recommend retesting HIV-negative peripartum women, but data on implementation are limited. We conducted a cross-sectional study in Kenya to measure the prevalence of maternal HIV retesting in programs and HIV incidence., Methods: Programmatic HIV retesting data was abstracted from maternal and child health booklets among women enrolled in a cross-sectional and/or seeking services during pregnancy, delivery, or 9 months postpartum in Kenya between January 2017 and July 2019. Retesting was defined as any HIV test conducted by MTCT programs after the initial antenatal care test or conducted as part of retesting policies at/after delivery for women not tested during pregnancy. Poisson generalized linear regression was used to identify correlates of programmatic retesting among women enrolled at 9 months postpartum., Results: Among 5,894 women included in the analysis, 3,124 only had data abstracted and 2,770 were enrolled in a cross-sectional study. Overall prevalence of programmatic HIV retesting was higher at 6 weeks (65%) and 9 months postpartum (72%) than in pregnancy (32%), at delivery (23%) and 6 months postpartum (28%) ( P <.001 for all comparisons). HIV incidence was 0.72/100 person-years (PY) (95% confidence interval (CI)=0.43,1.22) in pregnancy and 0.23/100 PY (95% CI=0.09, 0.62) postpartum (incidence rate ratio: 3.09; 95% CI=0.97, 12.90; P =.02)., Conclusion: Maternal retest coverage was high at 6 weeks and 9 months postpartum but low during pregnancy. Strategies to ensure high retesting coverage and detect women with incident maternal HIV infection are needed., (© Penumetsa et al.)

Depression among pregnant women living with HIV (WLWH) in sub-Saharan Africa leads to poor pregnancy and HIV outcomes. This cross-sectional analysis utilized enrollment data from a randomized trial (Mobile WAChX, NCT02400671) in six Kenyan public maternal and child health clinics. Depressive symptoms were assessed with the Patient Health Questionnaire-9 (PHQ-9), stigma with the Stigma Scale for Chronic Illness, and intimate partner violence (IPV) with the Abuse Assessment Screen. Correlates of moderate-to-severe depressive symptoms ("depression", PHQ-9 score ≥10) were assessed using generalized estimating equation models clustered by facility. Among 824 pregnant WLWH, 9% had depression; these women had more recent HIV diagnosis than those without depression (median 0.4 vs. 2.0 years since diagnosis, p  = .008). Depression was associated with HIV-related stigma (adjusted Prevalence Ratio [aPR]:2.36, p  = .025), IPV (aPR:2.93, p  = .002), and lower social support score (aPR:0.99, p  = .023). Using population-attributable risk percent to estimate contributors to maternal depression, 81% were attributable to stigma (27%), recent diagnosis (24%), and IPV (20%). Integrating depression screening and treatment in prevention of mother-to-child HIV transmission programs may be beneficial, particularly in women recently diagnosed or reporting stigma and IPV.

Objective: Cervical cancer is the leading cause of cancer-related death among Kenyan women. It is important to identify how demographics and knowledge of cervical cancer are associated with screening to determine best practices for targeted screening efforts., Methods: We conducted a sub-analysis of women who were asked about cervical cancer from a cross-sectional study of women attending large HIV care and treatment programs across Kenya between June and September 2016., Results: 1671 of 3007 (56%) women reported ever being screened, 804 (48%) of whom were screened within the last 12 months. Prevalence of screening was highest among women who were older (adjusted prevalence ratio [APR] age 35-49 vs. 18-24: 2.26, 95% CI: 1.68-3.05, P < 0.001), employed (APR: 1.55, 95% CI: 1.24-1.93, P < 0.001), married (APR: 1.27, 95% CI: 1.01-1.59, P = 0.047), had at least secondary education (APR: 1.45, 95% CI: 1.19-1.77, P < 0.001), with longer time since HIV diagnosis (APR: 1.09/year average increase, 95% CI: 1.04-1.13, P < 0.001). 36% knew cervical cancer is treatable., Conclusion: Characteristics linked to social or economic capital are correlated with cervical cancer screening. Integrating cervical cancer screening into HIV care and educating patients on the need for annual screening and potential treatment are important strategies for increasing screening uptake., (© 2021 International Federation of Gynecology and Obstetrics.)

Background: Identifying predictors of preterm birth (PTB) in high-burden regions is important as PTB is the leading cause of global child mortality., Methods: This analysis was nested in a longitudinal study of human immunodeficiency virus (HIV) incidence in Kenya. HIV-seronegative women enrolled in pregnancy had nucleic acid amplification tests (chlamydia and gonorrhea), rapid plasma reagin (syphilis), wet mount microscopy (Trichomonas and yeast), and Gram stain (bacterial vaginosis); sexually transmitted infection (STI) treatment was provided. PTB predictors were determined using log-binomial regression., Results: Among 1244 mothers of liveborn infants, median gestational age at enrollment was 26 weeks (IQR, 22-31), and at delivery was 39.1 weeks (IQR, 37.1-40.9). PTB occurred in 302 women (24.3%). Chlamydia was associated with a 1.59-fold (P = .006), gonorrhea a 1.62-fold (P = .04), and incident HIV a 2.08-fold (P = .02) increased PTB prevalence. Vaginal discharge and cervical inflammation were associated with PTB, as were age ≤21 (prevalence ratio [PR] = 1.39, P = .001) and any STI (PR = 1.47, P = .001). Associations with chlamydia and incident HIV remained in multivariable models., Conclusions: STIs and incident HIV in pregnancy predicted PTB despite treatment, suggesting the need for earlier treatment and interventions to decrease genital inflammation., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

We determined social and behavioral factors associated with virologic non-suppression among pregnant women receiving Option B+ antiretroviral treatment (ART). Baseline data was used from women in Mobile WAChX trial from 6 public maternal child health (MCH) clinics in Kenya. Virologic non-suppression was defined as HIV viral load (VL) ≥1000 copies/ml. Antiretroviral resistance testing was performed using oligonucleotide ligation (OLA) assay. ART adherence information, motivation and behavioral skills were assessed using Lifewindows IMB tool, depression using PHQ-9, and food insecurity with the Household Food Insecurity Access Scale. Correlates of virologic non-suppression were assessed using Poisson regression. Among 470 pregnant women on ART ≥4 months, 57 (12.1%) had virologic non-suppression, of whom 65% had HIV drug resistance mutations. In univariate analyses, risk of virologic non-suppression was associated with moderate-to-severe food insecurity (RR 1.80 [95% CI 1.06-3.05]), and varied significantly by clinic site (range 2%-22%, p <0.001). In contrast, disclosure (RR 0.36 [95% CI 0.17-0.78]) and having higher adherence skills (RR 0.70 [95% CI 0.58-0.85]) were associated with lower risk of virologic non-suppression. In multivariate analysis adjusting for clinic site, disclosure, depression symptoms, adherence behavior skills and food insecurity, disclosure and food insecurity remained associated with virologic non-suppression. Age, side-effects, social support, physical or emotional abuse, and distance were not associated with virologic non-suppression. Prevalence of virologic non-suppression among pregnant women on ART was appreciable and associated with food insecurity, disclosure and frequent drug resistance. HIV VL and resistance monitoring, and tailored counseling addressing food security and disclosure, may improve virologic suppression in pregnancy., Competing Interests: The authors have declared that no competing interests exist.

Objectives: Despite significant public health emphasis on unintended pregnancy prevention among adolescent girls and young women in Sub-Saharan Africa, there is a gap in understanding how adolescents' own reproductive priorities and the social influences on their decision-making align and compete. We examined the social context of contraceptive decision-making among Kenyan female adolescents., Methods: Using community-based sampling, we conducted 40 in-depth interviews and 6 focus group discussions among sexually-active or partnered adolescent girls and young women aged 15-19 in the Nyanza region of Kenya. We analyzed the data in Dedoose using an inductive, grounded theory approach, and developed a conceptual model from the data illustrating social influences on adolescent contraceptive decision-making., Results: Participants viewed adolescent pregnancy as unacceptable, and described severe social, financial, and health consequences of unintended pregnancy, including abortion under unsafe conditions. Yet, their contraceptive behaviors often did not reflect their desire to delay pregnancy. Contraceptive decision-making was influenced by multiple social factors, centering on the intersecting stigmas of adolescent female sexuality, pregnancy, and contraceptive use, as well as unequal power in sexual relationships. To prioritize pregnancy prevention, adolescents must navigate conflicting social norms and power dynamics, and put their perceived future fertility at risk., Conclusions: Contraceptive decision-making among Kenyan female adolescents is strongly influenced by opposing social norms within families, communities, and sexual relationships, which compel them to risk stigma whether they use a contraceptive method or become pregnant as adolescents. These findings put into perspective adolescents' seemingly incongruent pregnancy preferences and contraceptive behaviors. Interventions to address adolescent unintended pregnancy should focus on supporting adolescent decision-making agency, addressing fertility-related contraceptive concerns, and promoting innovative contraceptive access points rather than increasing contraceptive prevalence., Competing Interests: The authors have declared that no competing interests exist.

Objectives: To characterize contraceptive counseling experiences among women living with HIV (WLWH) receiving HIV care in Kenya., Study Design: Sexually active, WLWH aged 15 to 49 years were purposively sampled from 109 high-volume HIV Care and Treatment Centers in Kenya between June and September 2016. Cross-sectional surveys were administered to enroll women on a tablet using Open Data Kit. Poisson generalized linear regression models adjusted for facility-level clustering were used to examine cofactors for receiving family planning (FP) counseling with a provider., Results: Overall, 4805 WLWH were enrolled, 60% reported they received FP counseling during the last year, 72% of whom reported they were counseled about benefits of birth spacing and limiting. Most women who received FP counseling were married (64%) and discussed FP with their partner (78%). Use of FP in the last month (adjusted Prevalence Ratio [aPR] = 1.74, 95% confidence interval [CI]: 1.41-2.15, p < 0.001), desire for children in >2 years (aPR = 1.18, 95% CI: 1.09-1.28, p < 0.001), and concern about contraceptive side-effects (aPR = 1.13, 95% CI 1.02-1.25, p < 0.05) were significantly higher among WLWH who received FP counseling compared to those that did not., Conclusions: Over one-third of WLWH did not receiving FP counseling with an HIV care provider during the last year, and counseling was more commonly reported among women who were using FP or desired children in >2 years., Implications: There are missed opportunities for FP counseling in HIV care. FP integration in HIV care could improve FP access and birth spacing or limiting among WLWH., (Copyright © 2021. Published by Elsevier Inc.)

Introduction: Offering HIV testing services (HTS) within sexual and reproductive health (SRH) services is a priority, especially for women who have a substantial risk. To reach women with HIV who do not know their status and prevent mother-to-child HIV transmission, the World Health Organization (WHO) recommends routinely offering HTS as part of family planning (FP) service delivery in high HIV burden settings. We conducted a landscape analysis to assess HTS uptake and HIV positivity in the context of FP/SRH services. Assessment of Research and Programs: We searched records from PubMed, four gray literature databases, and 13 organization websites, and emailed 24 organizations for data on HTS in FP/SRH services. We also obtained data from International Planned Parenthood Federation (IPPF) affiliates in Eswatini, Kenya, Lesotho, Malawi, Namibia, Uganda, Zambia, and Zimbabwe. Unique programs/studies from records were included if they provided data on, or barriers/facilitators to, offering HTS in FP/SRH. Overall, 2,197 records were screened and 12 unique programs/studies were eligible, including 10 from sub-Saharan Africa. Four reported on co-delivery of SRH services (including FP), with reported HTS uptake between 17 and 94%. Six reported data on HTS in FP services: four among general FP clients; one among couples; and one among female sex workers, adolescent girls, and young women. Two of the six reported HTS uptake >50% (51%, 419/814 Kenya; 63%, 5,930/9,439 Uganda), with positivity rates of 2% and 4.1%, respectively. Uptake was low (8%, 74/969 Kenya) in the one FP program offering pre-exposure prophylaxis. In the IPPF program, seven countries reported HTS uptake in FP services and ranged from 4% in Eswatini to 90% in Lesotho; between 0.6% (Uganda) and 8% (Eswatini) of those tested were HIV positive. Implications: Data on providing HTS in FP/SRH service delivery were sparse and HTS uptake varied widely across programs. Actionable Recommendations: As countries expand HTS in FP/SRH appropriate to epidemiology, they should ensure data are reported and monitored for progress and impact., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Drake, Quinn, Kidula, Sibanda, Steyn, Barr-DiChiara, Jamil, Rodolph, Gaffield, Kiarie, Baggaley and Johnson.)

Background: Pregnant and postpartum women living with HIV (WLWH) need support for HIV and maternal child health (MCH) care, which could be provided using short message service (SMS)., Methods and Findings: We compared 2-way (interactive) and 1-way SMS messaging to no SMS in a 3-arm randomized trial in 6 MCH clinics in Kenya. Messages were developed using the Health Belief Model and Social Cognitive Theory; HIV messages were integrated into an existing MCH SMS platform. Intervention participants received visit reminders and prespecified weekly SMS on antiretroviral therapy (ART) adherence and MCH, tailored to their characteristics and timing. Two-way participants could message nurses as needed. Clinic attendance, viral load (VL), and infant HIV results were abstracted from program records. Primary outcomes were viral nonsuppression (VL ≥1,000 c/ml), on-time clinic attendance, loss to follow-up from clinical care, and infant HIV-free survival. Among 824 pregnant women randomized between November 2015 and May 2017, median age was 27 years, gestational age was 24.3 weeks, and time since initiation of ART was 1.0 year. During follow-up to 2 years postpartum, 9.8% of 3,150 VL assessments and 19.6% of women were ever nonsuppressed, with no significant difference in 1-way versus control (11.2% versus 9.6%, adjusted risk ratio (aRR) 1.02 [95% confidence interval (CI) 0.67 to 1.54], p = 0.94) or 2-way versus control (8.5% versus 9.6%, aRR 0.80 [95% CI 0.52 to 1.23], p = 0.31). Median ART adherence and incident ART resistance did not significantly differ by arm. Overall, 88.9% (95% CI 76.5 to 95.7) of visits were on time, with no significant differences between arms (88.2% in control versus 88.6% in 1-way and 88.8% in 2-way). Incidence of infant HIV or death was 3.01/100 person-years (py), with no significant difference between arms; risk of infant HIV infection was 0.94%. Time to postpartum contraception was significantly shorter in the 2-way arm than control. Study limitations include limited ability to detect improvement due to high viral suppression and visit attendance and imperfect synchronization of SMS reminders to clinic visits., Conclusions: Integrated HIV/MCH messaging did not improve HIV outcomes but was associated with improved initiation of postpartum contraception. In programs where most women are virally suppressed, targeted SMS informed by VL data may improve effectiveness. Rigorous evaluation remains important to optimize mobile health (mHealth) interventions., Trial Registration: ClinicalTrials.gov number NCT02400671., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: BR has been on a DSMB and mock FDA advisory panel for Gilead; and GJS reports financial support from NIH. All other authors declare no competing interests.

Introduction: HIV retesting during late pregnancy and breastfeeding can help detect new maternal infections and prevent mother-to-child HIV transmission (MTCT), but the optimal timing and cost-effectiveness of maternal retesting remain uncertain., Methods: We constructed deterministic models to assess the health and economic impact of maternal HIV retesting on a hypothetical population of pregnant women, following initial testing in pregnancy, on MTCT in four countries: South Africa and Kenya (high/intermediate HIV prevalence), and Colombia and Ukraine (low HIV prevalence). We evaluated six scenarios with varying retesting frequencies from late in antenatal care (ANC) through nine months postpartum. We compared strategies using incremental cost-effectiveness ratios (ICERs) over a 20-year time horizon using country-specific thresholds., Results: We found maternal retesting once in late ANC with catch-up testing through six weeks postpartum was cost-effective in Kenya (ICER = $166 per DALY averted) and South Africa (ICER=$289 per DALY averted). This strategy prevented 19% (Kenya) and 12% (South Africa) of infant HIV infections. Adding one or two additional retests postpartum provided smaller benefits (1 to 2 percentage point increase in infections averted versus one retest). Adding three retests during the postpartum period averted additional infections (1 to 3 percentage point increase in infections averted versus one retest) but ICERs ($7639 and in Kenya and $11 985 in South Africa) greatly exceeded the cost-effectiveness thresholds. In Colombia and Ukraine, all retesting strategies exceeded the cost-effectiveness threshold and prevented few infant infections (up to 31 and 5 infections, respectively)., Conclusions: In high HIV burden settings with MTCT rates similar to those seen in Kenya and South Africa, HIV retesting once in late ANC, with subsequent intervention, is the most cost-effective strategy for preventing infant HIV infections. In these settings, two HIV retests postpartum marginally reduced MTCT and were less costly than adding three retests. Retesting in low-burden settings with MTCT rates similar to Colombia and Ukraine was not cost-effective at any time point due to very low HIV prevalence and limited breastfeeding., (© 2021 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Genital cytomegalovirus (CMV) reactivation is common during the third trimester of pregnancy. We hypothesized that cervical CMV shedding may increase risk of spontaneous preterm birth (sPTB) through the release of inflammatory cytokines in the cervix. We conducted a nested case-control analysis to determine the relationship between CMV shedding and sPTB using data and samples from a prospective cohort study in western Kenya. Women who delivered between 28 + 0 and 33 + 6 weeks gestation were matched by gestational age at sample collection to controls who delivered ≥ 37 + 0 weeks. Levels of CMV DNA and interleukin (IL)-1 beta (β), IL-6, IL-8 and tumor necrosis factor (TNF)-α were measured in cervical swabs. We used conditional logistic regression to assess relationships between CMV shedding, cervical cytokine levels and sPTB. Among 86 cases and 86 matched controls, cervical CMV levels were not significantly associated with sPTB [odds ratio (OR) = 1·23, 95% confidence interval (CI) = 0·59-2·56], but were significantly associated with higher levels of cervical IL-6 (β = 0·15, 95% CI = 0·02-0·29) and TNF-α (β = 0·14, 95% CI = 0·01-0·27). In univariate analysis, higher odds of sPTB was associated with higher cervical IL-6 levels (OR = 1·54, 95% CI = 1·00-2·38), but not with other cervical cytokines. In this cohort of Kenyan women, we did not find a significant association between cervical CMV shedding and sPTB before 34 weeks., (© 2020 British Society for Immunology.)

While unmet need for contraception is commonly used to assess programmatic needs, it inadequately captures the complexity of fertility and contraceptive preferences, including women's satisfaction with their contraceptive method. In their 2019 commentary, Sarah Rominski and Rob Stephenson propose reclassifying dissatisfied current users as having an unmet need for contraception. As revising the current definition based on their proposal would require significant investment to update survey and monitoring systems, understanding the potential impact on current estimates of unmet need is critical. We estimated the impact of this approach in a Kenyan cohort of modern contraceptive users. We found the prevalence of method dissatisfaction ranges from 6.6% (95% confidence interval [CI] 5.6-7.8%) to 18.9% (95% CI 17.1-20.9%); if applied nationally, this results in a large (approximately 25-70%) increase in Kenya's current estimate of unmet need for any contraception. Our findings suggest a large impact on unmet need estimates for equivalent populations. Overall, we advocate for better measurements of method satisfaction and acceptability, with metrics developed that are robust to socioeconomic gradients and validated in low- and middle-income settings to ensure women's contraceptive needs are captured equitably., (© 2021 The Authors. Studies in Family Planning published by Wiley Periodicals LLC on behalf of Population Council.)

Background: During HIV retesting in antenatal and preexposure prophylaxis (PrEP) care, discrepant results occur, but guidelines are lacking., Methods: In a Kenyan trial implementing antenatal PrEP, if 1 test is reactive, a second is performed; if discrepant, both are repeated; if persistently discrepant, DNA polymerase chain reaction (PCR) is performed., Results: Among 4451 women, 23 265 HIV retesting sessions were performed; 14 (0.06%, 95% confidence interval, 0.03%-0.10%) had discrepant results among 10 individuals; in all 10 initial cases, PCR was negative., Conclusions: Discrepant rapid tests are an expected, rare, and important challenge for antenatal care HIV retesting, with and without PrEP., Clinical Trials Registration: NCT03070600., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: Dual HIV and syphilis testing might help to prevent mother-to-child transmission (MTCT) of HIV and syphilis through increased case detection and treatment. We aimed to model and assess the cost-effectiveness of dual testing during antenatal care in four countries with varying HIV and syphilis prevalence., Methods: In this modelling study, we developed Markov models of HIV and syphilis in pregnant women to estimate costs and infant health outcomes of maternal testing at the first antenatal care visit with individual HIV and syphilis tests (base case) and at the first antenatal care visit with a dual rapid diagnostic test (scenario one). We additionally evaluated retesting during late antenatal care and at delivery with either individual tests (scenario two) or a dual rapid diagnosis test (scenario three). We modelled four countries: South Africa, Kenya, Colombia, and Ukraine. Strategies with an incremental cost-effectiveness ratio (ICER) less than the country-specific cost-effectiveness threshold (US$500 in Kenya, $750 in South Africa, $3000 in Colombia, and $1000 in Ukraine) per disability-adjusted life-year averted were considered cost-effective., Findings: Routinely offering testing at the first antenatal care visit with a dual rapid diagnosis test was cost-saving compared with the base case in all four countries (ICER: -$26 in Kenya,-$559 in South Africa, -$844 in Colombia, and -$454 in Ukraine). Retesting during late antenatal care with a dual rapid diagnostic test (scenario three) was cost-effective compared with scenario one in all four countries (ICER: $270 in Kenya, $260 in South Africa, $2207 in Colombia, and $205 in Ukraine)., Interpretation: Incorporating dual rapid diagnostic tests in antenatal care can be cost-saving across countries with varying HIV prevalence. Countries should consider incorporating dual HIV and syphilis rapid diagnostic tests as the first test in antenatal care to support efforts to eliminate MTCT of HIV and syphilis., Funding: WHO, US Agency for International Development, and the Bill & Melinda Gates Foundation., (© 2021 This is an Open Access article published under the CC BY 3.0 IGO license which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any use of this article, there should be no suggestion that WHO endorses any specific organisation, products or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.)

Purpose of Review: Short message system (SMS) communication is widespread in low- and middle-income countries (LMICs), and may be a viable approach to address challenges with in-person data collection for HIV-related research and monitoring and evaluation. We reviewed the literature to characterize potential benefits and challenges with using SMS for remote data capture, including examples from HIV and sexual and reproductive health., Recent Findings: In our review, we found that studies that have used SMS to capture sensitive, self-reported data found this was an acceptable and feasible strategy, and may reduce social desirability bias of self-reported data; but studies are limited. Shared phones and privacy concerns have been described as challenges, but can be addressed with enhanced security features. Response rates to SMS surveys varied significantly by topic, population, and setting. SMS may improve generalizability and precision of health and behavior data for HIV in research and programs, but use in LMICs is limited. SMS systems should be carefully designed to overcome potential implementation hurdles.

Objective: We developed and validated a pragmatic risk assessment tool for identifying contraceptive discontinuation among Kenyan women who do not desire pregnancy., Study Design: Within a prospective cohort of contraceptive users, participants were randomly allocated to derivation ( n  = 558) and validation ( n  = 186) cohorts. Risk scores were developed by selecting the Cox proportional hazards model with the minimum Akaike information criterion. Predictive performance was evaluated using time-dependent receiver operating characteristic curves and area under the curve (AUC)., Results: The overall contraceptive discontinuation rate was 36.9 per 100 woman-years (95% confidence interval [CI] 30.3-44.9). The predictors of discontinuation selected for the risk score included use of a short-term method or copper intrauterine device (vs. injectable or implant), method continuation or switch (vs. initiation), < 9 years of completed education, not having a child aged < 6 months, and having no spouse or a spouse supportive of family planning (vs. having a spouse who has unsupportive or uncertain attitudes towards family planning). AUC at 24 weeks was 0.76 (95% CI 0.64-0.87) with 70.0% sensitivity and 78.6% specificity at the optimal cut point in the derivation cohort. Discontinuation was 3.8-fold higher among high- vs. low-risk women (95% CI 2.33-6.30). AUC was 0.68 (95% CI 0.47-0.90) in the validation cohort. A simplified score comprising routinely collected variables demonstrated similar performance (derivation-AUC: 0.73 [95% CI 0.60-0.85]; validation-AUC: 0.73 [95% CI 0.51-0.94]). Positive predictive value in the derivation cohort was 31.4% for the full and 28.1% for the simplified score., Conclusions: The risk scores demonstrated moderate predictive ability but identified large proportions of women as high risk. Future research is needed to improve sensitivity and specificity of a clinical tool to identify women at high risk for experiencing method-related challenges., Implications: Contraceptive discontinuation is a major driver of unmet contraceptive need globally. Few tools exist for identifying women who may benefit most from additional support in order to meet their contraceptive needs and preferences. This study developed and assessed the validity of a provider-focused risk prediction tool for contraceptive discontinuation among Kenyan women using modern contraception. High rates of early discontinuation observed in this study emphasize the necessity of investing in efforts to develop new contraceptive technologies and stronger delivery systems to better align with women's needs and preferences for voluntary family planning., (© 2020 The Authors.)

Objective: To evaluate the relationship between cervical cytokine/chemokine concentrations and HIV-1 acquisition in peripartum Kenyan women., Design: Nested case-control study., Methods: Women participating in a prospective study of peripartum HIV acquisition in Kenya (the Mama Salama Study), were tested for HIV-1 at 1-3 month intervals during pregnancy and through 9 months postpartum. Cases positive for HIV-1 RNA during follow-up (N = 14), were matched 3 : 1 with HIV-negative controls (N = 42) based on age, marital status, partner HIV-1 status, transactional sex, and timing of cervical swab collection. Concentrations of five cytokines (IL-1β, IL-6, IL-10, IFNγ, and TNFα) and four chemokines (IL-8, C-X-C motif chemokine ligand 10 (CXCL10), macrophage inflammatory protein-1 α, and macrophage inflammatory protein-1 β) were measured from cervical swabs collected at the visit prior to HIV-1 diagnosis (cases) or matched gestational/postpartum time (controls). Cytokine/chemokine concentrations were compared between cases and controls using Wilcoxon rank-sum tests. Principal component analysis was used to create a summary score for closely correlated cytokines/chemokines. Associations with HIV-1 acquisition were analyzed using conditional logistic regression. Path analysis was used to evaluate hypothesized relationships between CXCL10, vaginal washing, Nugent score, and HIV-1 acquisition., Results: Conditional logistic regression analysis demonstrated an association between increased concentrations of CXCL10 and HIV-1 acquisition (odds ratio = 1.74, 95% confidence interval 1.04, 2.93; P = 0.034). Path analysis confirmed a positive independent association between higher concentrations of CXCL10 and HIV-1 acquisition (path coefficient = 0.37, 95% confidence interval 0.15, 0.59; P < 0.001)., Conclusion: HIV-1 acquisition was associated with increased cervical concentrations of CXCL10 in pregnant and postpartum women.

Background: Zika virus (ZIKV) was discovered over 70 years ago in East Africa, but little is known about its circulation and pathogenesis there., Methods: We screened 327 plasma samples collected 2-12 months after febrile illness in Western and coastal Kenya (1993-2016) for binding and neutralizing antibodies to distinguish ZIKV and dengue virus (DENV) responses, which we found were common in coastal Kenya., Results: Two cases had durable ZIKV-specific antibodies and 2 cases had ZIKV antibodies at similar levels as DENV antibodies., Conclusions: This suggests low-level ZIKV circulation in Kenya over 2 decades and sets a baseline for future surveillance efforts in East Africa., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

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., (Copyright © 2020 Elsevier Inc. All rights reserved.)