465 results on '"Barbra A Richardson"'
Search Results
2. Preferences and uptake of home-based HIV self-testing for maternal retesting in Kenya.
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Alison L Drake, Wenwen Jiang, Peninah Kitao, Shiza Farid, Barbra A Richardson, David A Katz, Anjuli D Wagner, Cheryl C Johnson, Daniel Matemo, GraceJohn Stewart, and John Kinuthia
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Medicine ,Science - Abstract
ObjectiveTo 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.DesignProspective cohort.MethodsBetween 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 ResultsOverall, 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 ConclusionsWhile most women preferred CB-RDT for maternal retesting, HB-HIVST was acceptable and feasible and could be used to expand HIV retesting options.
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- 2024
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3. Mobile solutions to Empower reproductive life planning for women living with HIV in Kenya (MWACh EMPOWER): Protocol for a cluster randomized controlled trial.
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Nancy Ngumbau, Jennifer A Unger, Brenda Wandika, Celestine Atieno, Kristin Beima-Sofie, Julia Dettinger, Emmaculate Nzove, Elizabeth K Harrington, Agnes K Karume, Lusi Osborn, Monisha Sharma, Barbra A Richardson, Aparna Seth, Jenna Udren, Noor Zanial, John Kinuthia, and Alison L Drake
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Medicine ,Science - Abstract
BackgroundWomen 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 designWe 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.DiscussionThe 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.
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- 2024
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4. Severe acute respiratory syndrome coronavirus 2 seroprevalence and longitudinal antibody response following natural infection in pregnancy: A prospective cohort study
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Alison L Drake, Jaclyn N Escudero, Morgan C Aurelio, Erica A Wetzler, Sascha R Ellington, Lauren B Zapata, Romeo R Galang, Margaret C Snead, Krissy Yamamoto, Carol C Salerno, Barbra A Richardson, Alexander L Greninger, Alisa B Kachikis, Janet A Englund, and Sylvia M LaCourse
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Medicine - Abstract
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.
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- 2023
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5. Simulated patient training to improve youth engagement in HIV care in Kenya: A stepped wedge cluster randomized controlled trial.
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Pamela K Kohler, Cyrus Mugo, Kate S Wilson, Hellen Moraa, Alvin Onyango, Kenneth Tapia, Kenneth Pike, Caren Mburu, Margaret Nduati, Brandon Guthrie, Barbra A Richardson, Tamara Owens, David Bukusi, Irene Inwani, Grace John-Stewart, and Dalton Wamalwa
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Public aspects of medicine ,RA1-1270 - Abstract
Youth living with HIV (YLHIV) report that negative interactions with health care workers (HCWs) affects willingness to return to care. This stepped wedge randomized trial evaluated effectiveness of a standardized patient actor (SP) HCW training intervention on adolescent engagement in care in Kenya. HCWs caring for YLHIV at 24 clinics received training on adolescent care, values clarification, communication, and motivational interviewing, with 7 SP encounters followed by facilitated feedback of videotaped interactions. Facilities were randomized to timing of the intervention. The primary outcome was defined as return within 3 months after first visit (engagement) among YLHIV who were either newly enrolled or who returned to care after >3 months out of care. Visit data was abstracted from electronic medical records. Generalized linear mixed models adjusted for time, being newly enrolled, and clustering by facility. YLHIV were surveyed regarding satisfaction with care. Overall, 139 HCWs were trained, and medical records were abstracted for 4,595 YLHIV. Median YLHIV age was 21 (IQR 19-23); 82% were female, 77% were newly enrolled in care, and 75% returned within 3 months. Half (54%) of trained HCWs remained at their clinics 9 months post-training. YLHIV engagement improved over time (global Wald test, p = 0.10). In adjusted models, the intervention showed no significant effect on engagement [adjusted Prevalence Ratio (aPR) = 0.95, 95% Confidence Interval (CI): 0.88-1.02]. Newly enrolled YLHIV had significantly higher engagement than those with prior lapses in care (aPR = 1.18, 95%CI: 1.05-1.33). Continuous satisfaction with care scores were significantly higher by wave 3 compared to baseline (coefficient = 0.38, 95%CI: 0.19-0.58). Despite provider skill improvement, there was no effect of SP training on YLHIV engagement in care. This may be due to temporal improvements or turnover of trained HCWs. Strategies to retain SP-training benefits need to address HCW turnover. YLHIV with prior gaps in care may need more intensive support. Registration CT #: NCT02928900. https://clinicaltrials.gov/ct2/show/NCT02928900.
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- 2023
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6. Impact of the COVID-19 pandemic on obstetrical care at a tertiary care facility in Mombasa, Kenya: Time-series analyses and staff perspectives.
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Jessica E Long, George Wanje, Nawal Aliyan, Dickson Okello, Barbra A Richardson, Nyambura Wanjiru-Korir, Khadija Shikely, Aisha Abubakar, Pauline Oginga, and R Scott McClelland
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Public aspects of medicine ,RA1-1270 - Abstract
The COVID-19 pandemic caused disruption in healthcare delivery due to reductions in both health facility capacity and care-seeking behavior. For women experiencing obstetric complications, access to comprehensive emergency obstetric care is critical for maternal and child health. In Kenya, pandemic-related restrictions began in March 2020 and were compounded by a healthcare worker strike in December 2020. We examined medical record data at Coast General Teaching and Referral Hospital, a large public hospital, and conducted staff interviews to understand how healthcare disruptions impacted care delivery and perinatal outcomes. Routinely collected data from all mother-baby dyads admitted to the Labor and Delivery Ward from January 2019 through March 2021 were included in interrupted time-series analyses. Outcomes included number of admissions and proportion of deliveries that resulted in caesarean sections and adverse birth outcomes. Interviews were conducted with nurses and medical officers to understand how the pandemic impacted clinical care. Pre-pandemic, the ward averaged 810 admissions/month, compared to 492 admissions/month post-pandemic (average monthly decrease: 24.9 admissions; 95% CI: -48.0, -1.8). The proportion of stillbirths increased 0.3% per month during the pandemic compared to the pre-pandemic period (95% CI: 0.1, 0.4). No significant differences were seen in the proportion of other adverse obstetrical outcomes. Interview results suggested that pandemic-related disruptions included reduced access to surgical theaters and protective equipment, and absence of COVID-19 guidelines. While these disruptions were perceived as impacting care for high-risk pregnancies, providers believed that overall quality of care did not diminish during the pandemic. However, they expressed concern about a likely increase in at-home births. In conclusion, while the pandemic had minimal adverse impact on hospital-based obstetrical outcomes, it reduced the number of patients able to access care. Emergency preparedness guidelines and public health messaging promoting timely obstetrical care are needed to ensure continuation of services during future healthcare disruptions.
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- 2023
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7. HIV and SARS-CoV-2 infection in postpartum Kenyan women and their infants.
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Emily R Begnel, Bhavna H Chohan, Ednah Ojee, Judith Adhiambo, Prestone Owiti, Vincent Ogweno, LaRinda A Holland, Carolyn S Fish, Barbra A Richardson, Adam K Khan, Rabia Maqsood, Efrem S Lim, Manish Sadarangani, Dara A Lehman, Jennifer Slyker, John Kinuthia, Dalton Wamalwa, and Soren Gantt
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Medicine ,Science - Abstract
BackgroundHIV 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.MethodsWe 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.ResultsSARS-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.ConclusionsThese 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.
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- 2023
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8. Data-informed stepped care to improve youth engagement in HIV care in Kenya: a protocol for a cluster randomised trial of a health service intervention
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Grace John-Stewart, Barbra A Richardson, Wenwen Jiang, Pamela Kohler, Seema K Shah, Irene N Njuguna, Kristin Beima-Sofie, Kawango Agot, Jessica Dyer, Jacinta Badia, Nok Chhun, Irene Inwani, and Nahida Chaktoura
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Medicine - Abstract
Introduction Adolescents and youth living with HIV (AYLHIV) have lower retention in care, adherence to treatment, and viral suppression compared with adults. Stepped care is a process by which clients are assigned to increasingly intensive services or ‘steps’ according to level of need. Differentiated care, in which stable clients access less frequent services, can be combined with stepped care to align needs and preferences of youth to promote optimal engagement in care.Methods and analysis This hybrid type I effectiveness implementation cluster randomised trial aims to evaluate a data-informed stepped care (DiSC) intervention for AYLHIV. AYLHIV ages 10–24 receiving care at 24 HIV treatment facilities in Kisumu, Homabay and Migori counties in Kenya will be enrolled. Twelve facilities will be randomised to the DiSC intervention, and 12 will provide standard care. A clinical assignment tool developed by the study team will be used at intervention sites to assign AYLHIV to one of four steps based on risk for loss to follow-up: differentiated care, standard care, counselling services or intensive support services. The primary clinical outcome is retention in care, specifically missed visits (failure to return within 30 days for any visit) and 12-month loss to follow-up. Implementation outcomes are based on the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Proportions of missed visits will be compared using mixed effect models clustered by facility and participant.Ethics and dissemination This study has been approved by the University of Washington Institutional Review Board (STUDY00011096), Maseno University Ethical Review Committee (MUERC/00917/20) and the Kenya National Commission for Science, Technology and Innovation (444824). AYLHIV provide written informed consent when legally permitted, or assent with caregiver permission for minors. Study staff will work with a Community Advisory Board, including youth members, to disseminate results via discussions, presentations, journal publications and local or international conferences.Trial registration number NCT05007717.
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- 2022
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9. Diagnostic performance of oral swabs for non-sputum based TB diagnosis in a TB/HIV endemic setting.
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Sylvia M LaCourse, Evans Seko, Rachel Wood, Wilfred Bundi, Gregory S Ouma, Janet Agaya, Barbra A Richardson, Grace John-Stewart, Steve Wandiga, and Gerard A Cangelosi
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Medicine ,Science - Abstract
ObjectiveWe evaluated diagnostic performance of oral swab analysis (OSA) for tuberculosis (TB) in a high HIV/TB burden setting in Kenya.MethodsIn this cross-sectional study, buccal swabs and sputum were collected from 100 participants with suspected TB in outpatient clinics in Kenya at enrollment and subsequent morning visits. Buccal swabs underwent IS6110-targeted qPCR analysis. Sputum was evaluated by Xpert MTB/RIF (Xpert) and culture. Diagnostic performance of OSA for TB diagnosis was evaluated relative to a combined reference of sputum Xpert and culture.ResultsAmong 100 participants, 54% were living with HIV (PLHIV). Twenty percent (20/100) of participants had confirmed TB (19/20 [95%] culture-positive, 17/20 [85%] Xpert-positive). Overall buccal swab sensitivity was 65.0% (95% CI 40.8-84.6%) vs. sputum Xpert/culture and 76.5% (95% CI 50.1-93.2%) vs. sputum Xpert alone. Specificity was 81.3% (95% CI 71.0-89.1%) and 81.9% (95% CI 72.0-89.5%) compared to sputum Xpert/culture and Xpert alone, respectively. Sensitivity among PLHIV (n = 54) with suspected TB was 83.3% (95% CI 35.9-99.6%) vs. sputum Xpert/culture and 100% (95% CI 47.8-100.0%) vs. sputum Xpert alone. Among participants with TB, mean OSA threshold quantitation cycle (Cq) value was lower (stronger signal) at subsequent morning compared to enrolment visit (33.4 SD ± 3.7 vs. 35.2 SD ± 2.9, p = 0.009).ConclusionsIn this pilot study, results confirm M. tuberculosis DNA is detectable in oral swabs including among PLHIV with fair diagnostic performance. Further work is needed to optimize OSA and evaluate its utility in diverse settings.
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- 2022
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10. Prevalence and correlates of intimate partner violence among women with HIV in serodifferent relationships in Nairobi, Kenya.
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Anne Kaggiah, Katherine Wilson, Barbra A Richardson, John Kinuthia, Carey Farquhar, and R Scott McClelland
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Medicine ,Science - Abstract
BackgroundIntimate 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.MethodsThis 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.ResultsOf 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.ConclusionThis 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.
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- 2022
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11. Azithromycin for the prevention of rehospitalisation and death among Kenyan children being discharged from hospital: a double-blind, placebo-controlled, randomised controlled trial
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Patricia B Pavlinac, PhD, Benson O Singa, MBChB, Kirkby D Tickell, MBBS, Rebecca L Brander, PhD, Christine J McGrath, PhD, Mary Amondi, BA, Joyce Otieno, DIP, Elizabeth Akinyi, BSc, Doreen Rwigi, BSc, Joseph D Carreon, MS, Stephanie N Tornberg-Belanger, MPH, Ruth Nduati, MMed, Joseph B Babigumira, PhD, Liru Meshak, MBChB, George Bogonko, MMed, Samuel Kariuki, PhD, Barbra A Richardson, PhD, Grace C John-Stewart, MD, and Judd L Walson, MD
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Public aspects of medicine ,RA1-1270 - Abstract
Summary: Background: Mass drug administration of azithromycin to children in sub-Saharan Africa has been shown to improve survival in high-mortality settings. The period after hospital discharge is a time of elevated risk unaddressed by current interventions and might provide an opportunity for targeting empirical azithromycin administration. We aimed to assess the efficacy of azithromycin administered at hospital discharge on risk of death and rehospitalisation in Kenyan children younger than 5 years. Methods: In this double-blind, placebo-controlled randomised trial, children were randomly assigned (1:1) to receive a 5-day course of azithromycin (oral suspension 10 mg/kg on day 1, followed by 5mg/kg per day on days 2–5) or identically appearing and tasting placebo at discharge from four hospitals in western Kenya. Children were eligible if they were aged 1–59 months at hospital discharge, weighed at least 2 kg, and had been admitted to hospital for any medical reason other than trauma, poisoning, or congenital anomaly. The primary outcome was death or rehospitalisation in the subsequent 6-month period in a modified intention-to-treat population, compared by randomisation group with Cox proportional hazards regression and Kaplan-Meier. Azithromycin resistance in Escherichia coli isolates from a random subset of children was compared by randomisation group with generalised estimating equations. This trial is registered with ClinicalTrials.gov, NCT02414399. Findings: Between June 28, 2016, and Nov 4, 2019, 1400 children were enrolled in the trial at discharge from hospital, with 703 (50·2%) randomly assigned to azithromycin and 697 (49·8%) to placebo. Among the 1398 children included in the modified intention-to-treat analysis (702 in the azithromycin group and 696 in the placebo group), the incidence of death or rehospitalisation was 20·4 per 100 child-years in the azithromycin group and 22·5 per 100 child-years in the placebo group (adjusted hazard ratio 0·91, 95·5% CI 0·64–1·29, p=0·58). Azithromycin resistance was common in commensal E coli isolates from enrolled children before randomisation (37·7% of 406 isolates) despite only 3·7% of children having received a macrolide antibiotic during the hospitalisation. Azithromycin resistance was slightly higher at 3 months after randomisation in the azithromycin group (26·9%) than in the placebo group (19·1%; adjusted prevalence ratio 1·41, 95% CI 0·95–2·09, p=0·088), with no difference observed at 6 months (1·17, 0·78–1·76, p=0·44). Interpretation: We did not observe a significant benefit of a 5-day course of azithromycin delivered to children younger than 5 years at hospital discharge despite the overall high risk of mortality and rehospitalisation. These findings highlight the need for more research into mechanisms and interventions for prevention of morbidity and mortality in the post-discharge period. Funding: Eunice Kennedy Shriver National Institute of Child Health & Human Development.
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- 2021
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12. SMS messaging to improve retention and viral suppression in prevention of mother-to-child HIV transmission (PMTCT) programs in Kenya: A 3-arm randomized clinical trial.
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John Kinuthia, Keshet Ronen, Jennifer A Unger, Wenwen Jiang, Daniel Matemo, Trevor Perrier, Lusi Osborn, Bhavna H Chohan, Alison L Drake, Barbra A Richardson, and Grace John-Stewart
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Medicine - Abstract
BackgroundPregnant 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 findingsWe 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.ConclusionsIntegrated 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 registrationClinicalTrials.gov number NCT02400671.
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- 2021
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13. Late antiretroviral refills and condomless sex in a cohort of HIV-seropositive pregnant and postpartum Kenyan women.
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McKenna C Eastment, John Kinuthia, Lei Wang, George Wanje, Katherine Wilson, Anne Kaggiah, Jane M Simoni, Kishorchandra Mandaliya, Danielle N Poole, Barbra A Richardson, Walter Jaoko, Grace John-Stewart, and R Scott McClelland
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Medicine ,Science - Abstract
IntroductionThe postpartum period can be challenging for women living with HIV. Understanding how the postpartum period impacts ART adherence and condomless sex could inform the development of comprehensive sexual and reproductive health and HIV services tailored to the needs of women living with HIV during this critical interval.MethodsIn a longitudinal cohort study of HIV-seropositive Kenyan women, late ART refills and self-reported condomless sex were compared between the woman's pregnancy and the postpartum period. Analyses were conducted using generalized estimating equations and adjusted for alcohol use, depressive symptoms, intimate partner violence (IPV), and having a recent regular partner. Effect modification was explored for selected variables.Results and discussion151 women contributed visits. Late ART refills occurred at 7% (32/439) of pregnancy visits compared to 18% (178/1016) during the postpartum period (adjusted relative risk [aRR] 2.44, 95% confidence interval [CI] 1.62-3.67). This association differed by women's education level. Women with ≥8 years of education had late ART refills more during the postpartum period than pregnancy (aRR 3.00, 95%CI 1.95-4.62). In contrast, in women with ConclusionImproved support for ART adherence during the postpartum period and addressing IPV to limit condomless sex could improve HIV treatment and prevention outcomes for HIV-seropositive women as well as their infants and sexual partners.
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- 2021
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14. Impact of a two-way short message service (SMS) to support maternally administered childhood mid-upper arm circumference monitoring and expand malnutrition screening in Kenya: the Mama Aweza trial protocol
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Jennifer A Unger, Barbra A Richardson, Kirkby D Tickell, Mareme M Diakhate, Jeanne L Goodman, Keshet Ronen, Carol Levin, Esther M Choo, Catherine Achieng, Mary Masheti, Benson O Singa, and Christine J McGrath
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Medicine - Abstract
Introduction Over 52 million children under 5 years of age become wasted each year, but only 17% of these children receive treatment. Novel methods to identify and deliver treatment to malnourished children are necessary to achieve the sustainable development goals target for child health. Mobile health (mHealth) programmes may provide an opportunity to rapidly identify malnourished children in the community and link them to care.Methods and analysis This randomised controlled trial will recruit 1200 children aged 6–12 months at routine vaccine appointments in Migori and Homa Bay Counties, Kenya. Caregiver–infant dyads will be randomised to either a maternally administered malnutrition monitoring system (MAMMS) or standard of care (SOC). Study staff will train all caregivers to measure their child’s mid-upper arm circumference (MUAC). Caregivers in the MAMMS arm will be given two colour coded and graduated insertion MUAC tapes and be enrolled in a mHealth system that sends weekly short message service (SMS) messages prompting caregivers to measure and report their child’s MUAC by SMS. Caregivers in the SOC arm will receive routine monitoring by community health volunteers coupled with a quarterly visit from study staff to ensure adequate screening coverage. The primary outcome is identification of childhood malnutrition, defined as MUAC
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- 2020
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15. Impact of preconception vaginal microbiota on women’s risk of spontaneous preterm birth: protocol for a prospective case-cohort study
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John Kinuthia, R Scott McClelland, Erica M Lokken, Walter Jaoko, Sujatha Srinivasan, David N Fredricks, Barbra A Richardson, Kishorchandra Mandaliya, Sophia Lannon, Hudson Alumera, Arthur Kemoli, Emily Fay, and G John-Stewart
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Medicine - Abstract
IntroductionBacterial vaginosis (BV) and vaginal microbiota disruption during pregnancy are associated with increased risk of spontaneous preterm birth (SPTB), but clinical trials of BV treatment during pregnancy have shown little or no benefit. An alternative hypothesis is that vaginal bacteria present around conception may lead to SPTB by compromising the protective effects of cervical mucus, colonising the endometrial surface before fetal membrane development, and causing low-level inflammation in the decidua, placenta and fetal membranes. This protocol describes a prospective case-cohort study addressing this hypothesis.Methods and analysisHIV-seronegative Kenyan women with fertility intent are followed from preconception through pregnancy, delivery and early postpartum. Participants provide monthly vaginal specimens during the preconception period for vaginal microbiota assessment. Estimated date of delivery is determined by last menstrual period and first trimester obstetrical ultrasound. After delivery, a swab is collected from between the fetal membranes. Placenta and umbilical cord samples are collected for histopathology. Broad-range 16S rRNA gene PCR and deep sequencing of preconception vaginal specimens will assess species richness and diversity in women with SPTB versus term delivery. Concentrations of key bacterial species will be compared using quantitative PCR (qPCR). Taxon-directed qPCR will also be used to quantify bacteria from fetal membrane samples and evaluate the association between bacterial concentrations and histopathological evidence of inflammation in the fetal membranes, placenta and umbilical cord.Ethics and disseminationThis study was approved by ethics committees at Kenyatta National Hospital and the University of Washington. Results will be disseminated to clinicians at study sites and partner institutions, presented at conferences and published in peer-reviewed journals. The findings of this study could shift the paradigm for thinking about the mechanisms linking vaginal microbiota and prematurity by focusing attention on the preconception vaginal microbiota as a mediator of SPTB.
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- 2020
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16. Alcohol use and viral suppression in HIV-positive Kenyan female sex workers on antiretroviral therapy.
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Jessica E Long, Barbra A Richardson, George Wanje, Kate S Wilson, Juma Shafi, Kishorchandra Mandaliya, Jane M Simoni, John Kinuthia, Walter Jaoko, and R Scott McClelland
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Medicine ,Science - Abstract
BackgroundExcessive alcohol intake has been associated with poor adherence to antiretroviral therapy (ART). The impact of alcohol on viral suppression is particularly important among groups at high risk of HIV transmission, such as female sex workers (FSWs). Few studies have directly evaluated the association between alcohol use and HIV viral load. We hypothesized that hazardous or harmful alcohol use is associated with detectable plasma viral load among HIV-positive FSWs.MethodsA prospective cohort study was conducted among HIV-positive FSWs in Mombasa, Kenya. Hazardous or harmful alcohol use was assessed yearly and defined as an Alcohol Use Disorders Identification Test (AUDIT) score ≥7. Detectable viral load was assessed every six months and defined as ≥180 c/mL. Adherence measures were collected monthly and included late ART refill (>48 hours) and self-reported adherence, using both a validated self-rating scale of ability to take medication and visual analog scale (VAS) of ART use in the last month. Generalized estimating equations were used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CI).ResultsThis analysis included 366 participants followed monthly between October 2012 and March 2018. At baseline, AUDIT scores indicated hazardous alcohol use (AUDIT 7-15) in 14.3%, harmful alcohol use (AUDIT 16-19) in 1.4%, and alcohol dependency (AUDIT ≥20) in 1.4% of participants. After adjusting for potential confounders, a combined exposure including hazardous, harmful, and dependent alcohol use was not associated with detectable viral load (aRR 1.10, 95%CI 0.63-1.92) or late ART refill (aRR 1.13, 95%CI 0.82-1.56), but was associated with lower self-rated ability to take medication (aRR 2.38, 95%CI 1.42-3.99) and a lower rate of self-reported perfect ART adherence by VAS (aRR 2.62, 95%CI 1.84-3.71).ConclusionsIn this FSW cohort, while participants reporting hazardous, harmful, or dependent alcohol use were not more likely to have a detectable viral load, they were more likely to report lower ART adherence. These results suggest that interventions targeting alcohol use among this population of FSWs may not have a large impact on viral suppression.
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- 2020
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17. Examining the relationship between diarrhea and linear growth in Kenyan HIV-exposed, uninfected infants.
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Emily L Deichsel, Grace C John-Stewart, Judd L Walson, Dorothy Mbori-Ngacha, Barbra A Richardson, Brandon L Guthrie, Carey Farquhar, Rose Bosire, and Patricia B Pavlinac
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Medicine ,Science - Abstract
BackgroundDiarrhea in infancy can compromise linear growth and this relationship is likely influenced by diarrhea severity, number of episodes, and the timing of those episodes. HIV exposed, uninfected infants (HEU) have higher risk of growth faltering, infectious morbidity and mortality than HIV-unexposed infants and may be representative of children particularly vulnerable to diarrhea-associated linear growth faltering.Methodology/principal findingsWe utilized data from a cohort of Kenyan HEU infants followed from birth to 12 months of age. Infant length and morbidity were ascertained at monthly study visits and sick visits. Longitudinal models estimated the association between diarrhea severity and length-for-age Z-score (LAZ) in the following month, at 12 months of age, and in 6-month intervals. The 372 enrolled infants experienced an average of 2.15 episodes (range: 0-8) of diarrhea and 0.54 episodes (0-4) of moderate-to-severe diarrhea (MSD) between birth and 12 months. Surviving infants had a mean LAZ of -0.97 (standard deviation: 1.2) at 12 months. MSD was significantly associated with an average loss of 0.14 (95% Confidence Interval [CI]: -0.24, -0.05, p = 0.003) in LAZ one month after the episode. Linear growth outcomes were not predicted by cumulative episodes of diarrhea, or timing of diarrhea during infancy.Conclusions/significanceDiarrhea severity influenced the relationship between diarrhea and subsequent linear growth. HEU infants with MSD may benefit from nutritional interventions following severe diarrhea to protect against linear growth faltering.
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- 2020
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18. Association between vaginal washing and vaginal bacterial concentrations.
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Michelle C Sabo, Jennifer E Balkus, Barbra A Richardson, Sujatha Srinivasan, Joshua Kimani, Omu Anzala, Jane Schwebke, Tina L Feidler, David N Fredricks, and R Scott McClelland
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Medicine ,Science - Abstract
Vaginal washing is a common practice associated with adverse outcomes including bacterial vaginosis (BV) and HIV infection. Prior studies have not examined the associations between vaginal washing and individual vaginal bacteria, or whether these associations are independent of the effect of vaginal washing on BV. The purpose of this study was to characterize the association between vaginal washing and the presence and concentrations of vaginal bacteria associated with optimal and sub-optimal vaginal states. The analysis utilized data from participants in the placebo arm of the Preventing Vaginal Infections trial, which enrolled HIV-uninfected women from the United States and Kenya. Detection of bacterial taxa associated with BV was compared between visits with versus without reported vaginal washing. The effect of vaginal washing on a number of vaginal bacteria differed substantially (p
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- 2019
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19. Predictors of mortality within the first year of initiating antiretroviral therapy in urban and rural Kenya: A prospective cohort study.
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Rachel A Silverman, Grace C John-Stewart, Ingrid A Beck, Ross Milne, Catherine Kiptinness, Christine J McGrath, Barbra A Richardson, Bhavna Chohan, Samah R Sakr, Lisa M Frenkel, and Michael H Chung
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Medicine ,Science - Abstract
IntroductionDespite increased treatment availability, HIV-infected individuals continue to start antiretroviral therapy (ART) late in disease progression, increasing early mortality risk.Materials and methodsNested prospective cohort study within a randomized clinical trial of adult patients initiating ART at clinics in urban Nairobi and rural Maseno, Kenya, between 2013-2014. We estimated mortality incidence rates following ART initiation and used Cox proportional hazards regression to identify predictors of mortality within 12 months of ART initiation. Analyses were stratified by clinic site to examine differences in mortality correlates and risk by location.ResultsAmong 811 participants initiated on ART, the mortality incidence rate within a year of initiating ART was 7.44 per 100 person-years (95% CI 5.71, 9.69). Among 207 Maseno and 612 Nairobi participants initiated on ART, the mortality incidence rates (per 100 person-years) were 12.78 (95% CI 8.49, 19.23) and 5.72 (95% CI 4.05, 8.09). Maseno had a 2.20-fold greater risk of mortality than Nairobi (95% CI 1.29, 3.76; P = 0.004). This association remained [adjusted hazard ratio (HR) = 2.09 (95% CI 1.17, 3.74); P = 0.013] when adjusting for age, gender, education, pre-treatment drug resistance (PDR), and CD4 count, but not when adjusting for BMI. In unadjusted analyses, other predictors (PConclusionsHigh short-term post-ART mortality was observed, partially due to low CD4 count and BMI at presentation, especially in the rural setting. Male gender, older age, and markers of lower socioeconomic status were also associated with greater mortality risk. Engaging patients earlier in HIV infection remains critical. PDR may influence short-term mortality and further studies to optimize management will be important in settings with increasing PDR.
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- 2019
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20. Higher prevalence of viral control in HIV-1-infected women in serodiscordant relationships.
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Kathryn Peebles, R Scott McClelland, Julie Overbaugh, Barbra A Richardson, Rose Bosire, James N Kiarie, Carey Farquhar, and Brandon L Guthrie
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Medicine ,Science - Abstract
BackgroundHIV-1-discordant couples that remain discordant despite repeated exposure may differ from the general population in their distribution of transmission risk factors, including low plasma viral load (PVL) in the infected partner even in the absence of antiretroviral therapy (ART).MethodsWe followed two cohorts of HIV-1-infected Kenyan women: females in discordant couples (FDC) and female sex workers (FSW). We compared the distribution of undetectable (ResultsWe evaluated 296 FDC and 220 FSW. At baseline, FDC were more likely to have undetectable (RR = 6.94, bootstrap 95% CI: 3.47, 20.81) and low PVL (RR = 3.53, bootstrap 95% CI: 2.57, 5.65) than FSW. Similarly, both repeat undetectable PVL (RR = 9.36, bootstrap 95% CI: 6.04, 10.97) and repeat low (RR = 4.99, bootstrap 95% CI: 2.33, 14.04) PVL were more likely among FDC than FSW during follow-up.DiscussionWe observed higher prevalence of viral control in FDC compared to FSW in the absence of ART, suggesting potentially higher prevalence of biological HIV resistance factors among discordant couples.
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- 2018
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21. Role of p16 testing in cervical cancer screening among HIV-infected women.
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Christine J McGrath, Rochelle Garcia, Trong T Trinh, Barbra A Richardson, Grace C John-Stewart, Evans Nyongesa-Malava, Nelly R Mugo, Emily H Glynn, Samah R Sakr, Hugo De Vuyst, and Michael H Chung
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Medicine ,Science - Abstract
p16 immunohistochemistry is used to evaluate for HPV-associated cervical intraepithelial neoplasia. The diagnostic performance of p16 in HIV infection is unclear.Between June-December 2009, HIV-infected women underwent Papanicolaou (Pap) smear, human papillomavirus (HPV) testing, visual inspection with acetic acid (VIA), and colposcopy-directed biopsy as the disease gold standard at a HIV clinic in Kenya. Pap smears were evaluated for p16 expression. Sensitivity, specificity, positive predictive value (PPV), and area under the receiver operating characteristic curve (AUC) of p16 to detect CIN2/3 on histology and the impact of immunosuppression and ART was assessed.Of 331 cervical samples with p16 expression, p16 sensitivity and specificity to detect CIN2/3 was 54.1% and 72.4% respectively, which was lower than Pap and HPV in sensitivity, but higher in specificity than Pap, HPV, and VIA. Combining tests and p16 reduced sensitivity and increased specificity of Pap from 90.5% to 48.7% and 51.4% to 81.7%; of VIA from 59.5% to 37.8% and 67.6% to 89.9%; and of HPV from 82.4% to 50.0% and 55.3% to 84.8%. Combination p16 increased the PPV of Pap from 34.9% to 43.4%; of HPV from 34.7% to 48.7%; and VIA from 34.9% to 51.9%. Adjunctive p16 did not change AUC (P>0.05). P16 performance was not altered by immunosuppression or ART use. Combining p16 with HPV and VIA reduced the variation in HPV and VIA performance associated with CD4 and ART.As an adjunctive test in HIV-infected women, p16 immunohistochemistry increased specificity and PPV of HPV and VIA for CIN2/3, and was not altered in performance by immunosuppression, ART, or age.
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- 2017
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22. High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women.
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Alex Carballo-Diéguez, Ivan C Balán, William Brown, Rebecca Giguere, Curtis Dolezal, Cheng-Shiun Leu, Mark A Marzinke, Craig W Hendrix, Jeanna M Piper, Barbra A Richardson, Cynthia Grossman, Sherri Johnson, Kailazarid Gomez, Stephanie Horn, Ratiya Pamela Kunjara Na Ayudhya, Karen Patterson, Cindy Jacobson, Linda-Gail Bekker, Suwat Chariyalertsak, Anupong Chitwarakorn, Pedro Gonzales, Timothy H Holtz, Albert Liu, Kenneth H Mayer, Carmen Zorrilla, Javier Lama, Ian McGowan, and Ross D Cranston
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Medicine ,Science - Abstract
Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)-if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18-64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ≥80% adherence to daily tablet, 41% having perfect adherence; 83% had ≥80% adherence to daily gel, 29% having perfect adherence; and 93% had ≥80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ≥80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations
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- 2017
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23. Partner Disclosure and Early CD4 Response among HIV-Infected Adults Initiating Antiretroviral Treatment in Nairobi Kenya.
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T Tony Trinh, Nelly Yatich, Richard Ngomoa, Christine J McGrath, Barbra A Richardson, Samah R Sakr, Agnes Langat, Grace C John-Stewart, and Michael H Chung
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Medicine ,Science - Abstract
BACKGROUND:Disclosure of HIV serostatus can have significant benefits for people living with HIV/AIDS. However, there is limited data on whether partner disclosure influences ART treatment response. METHODS:We conducted a retrospective cohort study of newly diagnosed, ART-naïve HIV-infected adults (>18 years) who enrolled at the Coptic Hope Center in Nairobi, Kenya between January 1st 2009 and July 1st 2011 and initiated ART within 3 months. Analysis was restricted to adults who reported to have either disclosed or not disclosed their HIV status to their partner. Analysis of CD4 response at 6 and 12 months post-ART was stratified by age group. RESULTS:Among 615 adults newly initiating ART with partner disclosure data and 12 month follow-up, mean age was 38 years and 52% were male; 76% reported that they had disclosed their HIV-status to their partner. Those who disclosed were significantly younger and more likely to be married/cohabitating than non-disclosers. At baseline, median CD4 counts were similar between disclosure groups. Among younger adults (< 38 years) those who disclosed had higher CD4 recovery than those who did not at 6 months post- ART (mean difference = 31, 95% CI 3 to 58 p = 0.03) but not at 12 months (mean difference = 17, 95% CI -19 to 52, p = 0.4). Among older adults (≥ 38years) there was no observed difference in CD4 recovery at 6 or 12 months between disclosure groups. CONCLUSION:Among younger adults, disclosure of HIV status to partners may be associated with CD4 recovery following ART.
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- 2016
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24. Cotrimoxazole Prophylaxis Discontinuation among Antiretroviral-Treated HIV-1-Infected Adults in Kenya: A Randomized Non-inferiority Trial.
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Christina S Polyak, Krista Yuhas, Benson Singa, Monica Khaemba, Judd Walson, Barbra A Richardson, and Grace John-Stewart
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Medicine - Abstract
Cotrimoxazole (CTX) prophylaxis is recommended by the World Health Organization (WHO) for HIV-1-infected individuals in settings with high infectious disease prevalence. The WHO 2006 guidelines were developed prior to the scale-up of antiretroviral therapy (ART). The threshold for CTX discontinuation following ART is undefined in resource-limited settings.Between 1 February 2012 and 30 September 2013, we conducted an unblinded non-inferiority randomized controlled trial of CTX prophylaxis cessation versus continuation among HIV-1-infected adults on ART for ≥ 18 mo with CD4 count > 350 cells/mm3 in a malaria-endemic region in Kenya. Participants were randomized and followed up at 3-mo intervals for 12 mo. The primary endpoint was a composite of morbidity (malaria, pneumonia, and diarrhea) and mortality. Incidence rate ratios (IRRs) were estimated using Poisson regression. Among 538 ART-treated adults screened, 500 were enrolled and randomized, 250 per arm. Median age was 40 y, 361 (72%) were women, and 442 (88%) reported insecticide-treated bednet use. Combined morbidity/mortality was significantly higher in the CTX discontinuation arm (IRR = 2.27, 95% CI 1.52-3.38; p < 0.001), driven by malaria morbidity. There were 34 cases of malaria, with 33 in the CTX discontinuation arm (IRR = 33.02, 95% CI 4.52-241.02; p = 0.001). Diarrhea and pneumonia rates did not differ significantly between arms (IRR = 1.36, 95% CI 0.82-2.27, and IRR = 1.43, 95% CI 0.54-3.75, respectively). Study limitations include a lack of placebo and a lower incidence of morbidity events than expected.CTX discontinuation among ART-treated, immune-reconstituted adults in a malaria-endemic region resulted in increased incidence of malaria but not pneumonia or diarrhea. Malaria endemicity may be the most relevant factor to consider in the decision to stop CTX after ART-induced immune reconstitution in regions with high infectious disease prevalence. These data support the 2014 WHO CTX guidelines.ClinicalTrials.gov NCT01425073.
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- 2016
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25. HIV-1 specific IgA detected in vaginal secretions of HIV uninfected women participating in a microbicide trial in Southern Africa are primarily directed toward gp120 and gp140 specificities.
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Kelly E Seaton, Lamar Ballweber, Audrey Lan, Michele Donathan, Sean Hughes, Lucia Vojtech, M Anthony Moody, Hua-Xin Liao, Barton F Haynes, Christine G Galloway, Barbra A Richardson, Salim Abdool Karim, Charlene S Dezzutti, M Juliana McElrath, Georgia D Tomaras, and Florian Hladik
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Medicine ,Science - Abstract
Many participants in microbicide trials remain uninfected despite ongoing exposure to HIV-1. Determining the emergence and nature of mucosal HIV-specific immune responses in such women is important, since these responses may contribute to protection and could provide insight for the rational design of HIV-1 vaccines.We first conducted a pilot study to compare three sampling devices (Dacron swabs, flocked nylon swabs and Merocel sponges) for detection of HIV-1-specific IgG and IgA antibodies in vaginal secretions. IgG antibodies from HIV-1-positive women reacted broadly across the full panel of eight HIV-1 envelope (Env) antigens tested, whereas IgA antibodies only reacted to the gp41 subunit. No Env-reactive antibodies were detected in the HIV-negative women. The three sampling devices yielded equal HIV-1-specific antibody titers, as well as total IgG and IgA concentrations. We then tested vaginal Dacron swabs archived from 57 HIV seronegative women who participated in a microbicide efficacy trial in Southern Africa (HPTN 035). We detected vaginal IgA antibodies directed at HIV-1 Env gp120/gp140 in six of these women, and at gp41 in another three women, but did not detect Env-specific IgG antibodies in any women.Vaginal secretions of HIV-1 infected women contained IgG reactivity to a broad range of Env antigens and IgA reactivity to gp41. In contrast, Env-binding antibodies in the vaginal secretions of HIV-1 uninfected women participating in the microbicide trial were restricted to the IgA subtype and were mostly directed at HIV-1 gp120/gp140.
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- 2014
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26. HIV-1 superinfection occurs less frequently than initial infection in a cohort of high-risk Kenyan women.
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Keshet Ronen, Connor O McCoy, Frederick A Matsen, David F Boyd, Sandra Emery, Katherine Odem-Davis, Walter Jaoko, Kishor Mandaliya, R Scott McClelland, Barbra A Richardson, and Julie Overbaugh
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Immunologic diseases. Allergy ,RC581-607 ,Biology (General) ,QH301-705.5 - Abstract
HIV superinfection (reinfection) has been reported in several settings, but no study has been designed and powered to rigorously compare its incidence to that of initial infection. Determining whether HIV infection reduces the risk of superinfection is critical to understanding whether an immune response to natural HIV infection is protective. This study compares the incidence of initial infection and superinfection in a prospective seroincident cohort of high-risk women in Mombasa, Kenya. A next-generation sequencing-based pipeline was developed to screen 129 women for superinfection. Longitudinal plasma samples at 2 years and one intervening time after initial HIV infection were analyzed. Amplicons in three genome regions were sequenced and a median of 901 sequences obtained per gene per timepoint. Phylogenetic evidence of polyphyly, confirmed by pairwise distance analysis, defined superinfection. Superinfection timing was determined by sequencing virus from intervening timepoints. These data were combined with published data from 17 additional women in the same cohort, totaling 146 women screened. Twenty-one cases of superinfection were identified for an estimated incidence rate of 2.61 per 100 person-years (pys). The incidence rate of initial infection among 1910 women in the same cohort was 5.75 per 100 pys. Andersen-Gill proportional hazards models were used to compare incidences, adjusting for covariates known to influence HIV susceptibility in this cohort. Superinfection incidence was significantly lower than initial infection incidence, with a hazard ratio of 0.47 (CI 0.29-0.75, p = 0.0019). This lower incidence of superinfection was only observed >6 months after initial infection. This is the first adequately powered study to report that HIV infection reduces the risk of reinfection, raising the possibility that immune responses to natural infection are partially protective. The observation that superinfection risk changes with time implies a window of protection that coincides with the maturation of HIV-specific immunity.
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- 2013
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27. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments.
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Craig W Hendrix, Beatrice A Chen, Vijayanand Guddera, Craig Hoesley, Jessica Justman, Clemensia Nakabiito, Robert Salata, Lydia Soto-Torres, Karen Patterson, Alexandra M Minnis, Sharavi Gandham, Kailazarid Gomez, Barbra A Richardson, and Namandje N Bumpus
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Medicine ,Science - Abstract
Oral and vaginal preparations of tenofovir as pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection have demonstrated variable efficacy in men and women prompting assessment of variation in drug concentration as an explanation. Knowledge of tenofovir concentration and its active form, tenofovir diphosphate, at the putative vaginal and rectal site of action and its relationship to concentrations at multiple other anatomic locations may provide key information for both interpreting PrEP study outcomes and planning future PrEP drug development.MTN-001 was designed to directly compare oral to vaginal steady-state tenofovir pharmacokinetics in blood, vaginal tissue, and vaginal and rectal fluid in a paired cross-over design.We enrolled 144 HIV-uninfected women at 4 US and 3 African clinical research sites in an open label, 3-period crossover study of three different daily tenofovir regimens, each for 6 weeks (oral 300 mg tenofovir disoproxil fumarate, vaginal 1% tenofovir gel [40 mg], or both). Serum concentrations after vaginal dosing were 56-fold lower than after oral dosing (p
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- 2013
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28. Male, mobile, and moneyed: loss to follow-up vs. transfer of care in an urban African antiretroviral treatment clinic.
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Kara G Marson, Kenneth Tapia, Pamela Kohler, Christine J McGrath, Grace C John-Stewart, Barbra A Richardson, Julia W Njoroge, James N Kiarie, Samah R Sakr, and Michael H Chung
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Medicine ,Science - Abstract
OBJECTIVES:The purpose of this study was to analyze characteristics, reasons for transferring, and reasons for discontinuing care among patients defined as lost to follow-up (LTFU) from an antiretroviral therapy (ART) clinic in Nairobi, Kenya. DESIGN:The study used a prospective cohort of patients who participated in a randomized, controlled ART adherence trial between 2006 and 2008. METHODS:Participants were followed from pre-ART clinic enrollment to 18 months after ART initiation, and were defined as LTFU if they failed to return to clinic 4 weeks after their last scheduled visit. Reasons for loss were captured through phone call or home visit. Characteristics of LTFU who transferred care and LTFU who did not transfer were compared to those who remained in clinic using log-binomial regression to estimate risk ratios. RESULTS:Of 393 enrolled participants, total attrition was 83 (21%), of whom 75 (90%) were successfully traced. Thirty-seven (49%) were alive at tracing and 22 (59%) of these reported having transferred their antiretroviral care. In the final model, transfers were more likely to have salaried employment [Risk Ratio (RR), 2.7; 95% confidence interval (CI), 1.2-6.1; p=0.020)] and pay a higher monthly rent (RR, 5.8; 95% CI, 1.3-25.0; p=0.018) compared to those retained in clinic. LTFU who did not transfer care were three times as likely to be men (RR, 3.1; 95% CI, 1.1-8.1; p=0.028) and nearly 4 times as likely to have a primary education or less (RR, 3.8; 95% CI, 1.3-10.6; p=0.013). Overall, the most common reason for LTFU was moving residence, predominantly due to job loss or change in employment. CONCLUSION:A broad definition of LTFU may include those who have transferred their antiretroviral care and thereby overestimate negative effects on ART continuation. Interventions targeting men and considering mobility due to employment may improve retention in urban African ART clinics. CLINICAL TRIALS:The study's ClinicalTrials.gov identifier is NCT00273780.
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- 2013
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29. Impact of helminth diagnostic test performance on estimation of risk factors and outcomes in HIV-positive adults.
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Michael B Arndt, Grace John-Stewart, Barbra A Richardson, Benson Singa, Lisette van Lieshout, Jaco J Verweij, Laura R Sangaré, Loice W Mbogo, Jacqueline M Naulikha, and Judd L Walson
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Medicine ,Science - Abstract
Traditional methods using microscopy for the detection of helminth infections have limited sensitivity. Polymerase chain reaction (PCR) assays enhance detection of helminths, particularly low burden infections. However, differences in test performance may modify the ability to detect associations between helminth infection, risk factors, and sequelae. We compared these associations using microscopy and PCR.This cross-sectional study was nested within a randomized clinical trial conducted at 3 sites in Kenya. We performed microscopy and real-time multiplex PCR for the stool detection and quantification of Ascaris lumbricoides, Necator americanus, Ancylostoma duodenale, Strongyloides stercoralis, and Schistosoma species. We utilized regression to evaluate associations between potential risk factors or outcomes and infection as detected by either method.Of 153 HIV-positive adults surveyed, 55(36.0%) and 20(13.1%) were positive for one or more helminth species by PCR and microscopy, respectively (p
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- 2013
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30. Determinants of use of insecticide treated nets for the prevention of malaria in pregnancy: Jinja, Uganda.
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Laura R Sangaré, Noel S Weiss, Paula E Brentlinger, Barbra A Richardson, Sarah G Staedke, Mpungu S Kiwuwa, and Andy Stergachis
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Medicine ,Science - Abstract
One established means of preventing the adverse consequences of malaria during pregnancy is sleeping under an insecticide treated net (ITN) throughout pregnancy. Despite increased access to this intervention over time, consistent ITN use during pregnancy remains relatively uncommon in sub-Saharan Africa.We sought to identify determinants of ITN use during pregnancy. Utilizing a population-based random sample, we interviewed 500 women living in Jinja, Uganda, who had been pregnant in the past year. ITN ownership at the start of pregnancy was reported by 359 women (72%) and 28 women (20%) acquired an ITN after the first trimester of pregnancy. Among 387 ITN owners, 73% reported either always sleeping under the ITN during all trimesters of pregnancy, or after acquiring their net. Owning more than 1 net was slightly associated with always sleeping under an ITN during pregnancy (RR: 1.13; 95% CI: 1.00, 1.28). Women who always slept under an ITN during pregnancy were more likely to be influenced by an advertisement on the radio/poster than being given an ITN free of charge (RR: 1.48; 95% CI: 1.24, 1.76). No differences were found between other socio-demographic factors, pregnancy history, ANC use or socio-cultural factors.While self-reported ITN ownership and use was common throughout pregnancy, we were unable to pinpoint why a sizable fraction of Ugandan women did not always adhere to recommendations for use of an ITN during pregnancy. More data are needed on the capacity of individual households to support the installation of ITNs which may provide insight into interventions targeted at improving the convenience and adherence of daily ITN use.
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- 2012
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31. Infant safety during and after maternal valacyclovir therapy in conjunction with antiretroviral HIV-1 prophylaxis in a randomized clinical trial.
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Alison L Drake, Alison C Roxby, James Kiarie, Barbra A Richardson, Anna Wald, Grace John-Stewart, and Carey Farquhar
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Medicine ,Science - Abstract
Maternal administration of the acyclovir prodrug valacyclovir is compatible with pregnancy and breastfeeding. However, the safety profile of prolonged infant and maternal exposure to acyclovir in the context of antiretrovirals (ARVs) for prevention of mother-to-child HIV-1 transmission (PMTCT) has not been described.Pregnant Kenyan women co-infected with HIV-1/HSV-2 with CD4 counts > 250 cells/mm(3) were enrolled at 34 weeks gestation and randomized to twice daily 500 mg valacyclovir or placebo until 12 months postpartum. Women received zidovudine from 28 weeks gestation and single dose nevirapine was given to women and infants at the time of delivery for PMTCT. Infant blood was collected at 6 weeks for creatinine and ALT. Breast milk specimens were collected at 2 weeks postpartum from 71 women in the valacyclovir arm; acyclovir levels were determined for a random sample of 44 (62%) specimens. Fisher's Exact and Wilcoxon rank-sum tests were used for analysis.One hundred forty-eight women were randomized and 146 mother-infant pairs were followed postpartum. PMTCT ARVs were administered to 98% of infants and all mothers. Valacyclovir was not associated with infant or maternal toxicities or adverse events, and no congenital malformations were observed. Infant creatinine levels were all normal (< 0.83 mg/dl) and median creatinine (median 0.50 mg/dl) and infant growth did not differ between study arms. Acyclovir was detected in 35 (80%) of 44 breast milk samples collected at 2 weeks postpartum. Median and maximum acyclovir levels were 2.62 and 10.15 mg/ml, respectively (interquartile range 0.6-4.19).Exposure to PMTCT ARVs and acyclovir after maternal administration of valacyclovir during pregnancy and postpartum to women co-infected with HIV-1/HSV-2 was not associated with an increase in infant or maternal toxicities or adverse events.ClinicalTrials.gov NCT00530777.
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- 2012
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32. A randomized controlled trial comparing the effects of counseling and alarm device on HAART adherence and virologic outcomes.
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Michael H Chung, Barbra A Richardson, Kenneth Tapia, Sarah Benki-Nugent, James N Kiarie, Jane M Simoni, Julie Overbaugh, Mena Attwa, and Grace C John-Stewart
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Medicine - Abstract
BackgroundBehavioral interventions that promote adherence to antiretroviral medications may decrease HIV treatment failure. Antiretroviral treatment programs in sub-Saharan Africa confront increasing financial constraints to provide comprehensive HIV care, which include adherence interventions. This study compared the impact of counseling and use of an alarm device on adherence and biological outcomes in a resource-limited setting.Methods and findingsA randomized controlled, factorial designed trial was conducted in Nairobi, Kenya. Antiretroviral-naïve individuals initiating free highly active antiretroviral therapy (HAART) in the form of fixed-dose combination pills (d4T, 3TC, and nevirapine) were randomized to one of four arms: counseling (three counseling sessions around HAART initiation), alarm (pocket electronic pill reminder carried for 6 months), counseling plus alarm, and neither counseling nor alarm. Participants were followed for 18 months after HAART initiation. Primary study endpoints included plasma HIV-1 RNA and CD4 count every 6 months, mortality, and adherence measured by monthly pill count. Between May 2006 and September 2008, 400 individuals were enrolled, 362 initiated HAART, and 310 completed follow-up. Participants who received counseling were 29% less likely to have monthly adherence ConclusionsIntensive early adherence counseling at HAART initiation resulted in sustained, significant impact on adherence and virologic treatment failure during 18-month follow-up, while use of an alarm device had no effect. As antiretroviral treatment clinics expand to meet an increasing demand for HIV care in sub-Saharan Africa, adherence counseling should be implemented to decrease the development of treatment failure and spread of resistant HIV.
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- 2011
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33. Determinants of use of intermittent preventive treatment of malaria in pregnancy: Jinja, Uganda.
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Laura R Sangaré, Andy Stergachis, Paula E Brentlinger, Barbra A Richardson, Sarah G Staedke, Mpungu S Kiwuwa, and Noel S Weiss
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Medicine ,Science - Abstract
Maternal malaria is associated with serious adverse pregnancy outcomes. One recommended means of preventing malaria during pregnancy is intermittent preventive therapy (IPTp) with sulfadoxine/pyrimethamine (SP). We sought to identify determinants of preventive use of SP during pregnancy among recently pregnant women in Uganda. Additionally, we characterized the timing of and indications for the administration of SP at antenatal care (ANC) visits and missed opportunities for SP administration.Utilizing a population-based random sample, we interviewed 500 women living in Jinja, Uganda who had been pregnant in the past year. Thirty-eight percent (192/500) of women received SP for the treatment of malaria and were excluded from the analysis of IPTp-SP. Of the remaining women, 275 (89.3%) reported at least two ANC visits after the first trimester and had an opportunity to receive IPTp-SP according to the Ugandan guidelines, but only 86 (31.3%) of these women received a full two-dose course of IPTp. The remaining 189 (68.7%) women missed one or more doses of IPTp-SP. Among the 168 women that were offered IPTp, 164 (97.6%) of them took the dose of SP.Use of IPTp in Uganda was found to be far below target levels. Our results suggest that women will take SP for IPTp if it is offered during an ANC visit. Missed opportunities to administer IPTp-SP during ANC were common in our study, suggesting provider-level improvements are needed.
- Published
- 2010
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34. Prevalence and correlates of helminth co-infection in Kenyan HIV-1 infected adults.
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Judd L Walson, Barclay T Stewart, Laura Sangaré, Loice W Mbogo, Phelgona A Otieno, Benjamin K S Piper, Barbra A Richardson, and Grace John-Stewart
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Arctic medicine. Tropical medicine ,RC955-962 ,Public aspects of medicine ,RA1-1270 - Abstract
Deworming HIV-1 infected individuals may delay HIV-1 disease progression. It is important to determine the prevalence and correlates of HIV-1/helminth co-infection in helminth-endemic areas.HIV-1 infected individuals (CD4>250 cells/ul) were screened for helminth infection at ten sites in Kenya. Prevalence and correlates of helminth infection were determined. A subset of individuals with soil-transmitted helminth infection was re-evaluated 12 weeks following albendazole therapy.Of 1,541 HIV-1 seropositive individuals screened, 298 (19.3%) had detectable helminth infections. Among individuals with helminth infection, hookworm species were the most prevalent (56.3%), followed by Ascaris lumbricoides (17.1%), Trichuris trichiura (8.7%), Schistosoma mansoni (7.1%), and Strongyloides stercoralis (1.3%). Infection with multiple species occurred in 9.4% of infections. After CD4 count was controlled for, rural residence (RR 1.40, 95% CI: 1.08-1.81), having no education (RR 1.57, 95% CI: 1.07-2.30), and higher CD4 count (RR 1.36, 95% CI: 1.07-1.73) remained independently associated with risk of helminth infection. Twelve weeks following treatment with albendazole, 32% of helminth-infected individuals had detectable helminths on examination. Residence, education, and CD4 count were not associated with persistent helminth infection.Among HIV-1 seropositive adults with CD4 counts above 250 cells/mm(3) in Kenya, traditional risk factors for helminth infection, including rural residence and lack of education, were associated with co-infection, while lower CD4 counts were not.
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- 2010
- Full Text
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35. Male perspectives on incorporating men into antenatal HIV counseling and testing.
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David A Katz, James N Kiarie, Grace C John-Stewart, Barbra A Richardson, Francis N John, and Carey Farquhar
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Medicine ,Science - Abstract
Male partner involvement in antenatal voluntary HIV counseling and testing (VCT) has been shown to increase uptake of interventions to reduce the risk of HIV transmission in resource-limited settings. We aimed to identify methods for increasing male involvement in antenatal VCT and determine male correlates of accepting couple counseling in these settings.We invited women presenting to a Nairobi antenatal clinic to return with their male partners for individual or couples VCT. Male attitudes towards VCT and correlates of accompanying female partners to antenatal clinic and receiving couple counseling were determined. Of 1,993 women who invited their partner, 313 (16%) returned with their partners to ANC. Men attending antenatal clinic were married (>99%), employed (98%), and unlikely to report prior HIV testing (14%). Wanting an HIV test (87%) or health information (11%) were the most commonly cited reasons for attending. Most (95%) men who came to antenatal clinic accepted HIV testing and 39% elected to receive counseling as a couple. Men who received counseling with partners were younger, had fewer children, and were less knowledgeable about prevention of mother-to-child HIV transmission (PMTCT) than those who received counseling individually (p
- Published
- 2009
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36. Immunization with single-cycle SIV significantly reduces viral loads after an intravenous challenge with SIV(mac)239.
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Bin Jia, Sharon K Ng, M Quinn DeGottardi, Michael Piatak, Eloísa Yuste, Angela Carville, Keith G Mansfield, Wenjun Li, Barbra A Richardson, Jeffrey D Lifson, and David T Evans
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Immunologic diseases. Allergy ,RC581-607 ,Biology (General) ,QH301-705.5 - Abstract
Strains of simian immunodeficiency virus (SIV) that are limited to a single cycle of infection were evaluated for the ability to elicit protective immunity against wild-type SIV(mac)239 infection of rhesus macaques by two different vaccine regimens. Six animals were inoculated at 8-week intervals with 6 identical doses consisting of a mixture of three different envelope variants of single-cycle SIV (scSIV). Six additional animals were primed with a mixture of cytoplasmic domain-truncated envelope variants of scSIV and boosted with two doses of vesicular stomatitis virus glycoprotein (VSV G) trans-complemented scSIV. While both regimens elicited detectable virus-specific T cell responses, SIV-specific T cell frequencies were more than 10-fold higher after boosting with VSV G trans-complemented scSIV (VSV G scSIV). Broad T cell recognition of multiple viral antigens and Gag-specific CD4(+) T cell responses were also observed after boosting with VSV G scSIV. With the exception of a single animal in the repeated immunization group, all of the animals became infected following an intravenous challenge with SIV(mac)239. However, significantly lower viral loads and higher memory CD4(+) T cell counts were observed in both immunized groups relative to an unvaccinated control group. Indeed, both scSIV immunization regimens resulted in containment of SIV(mac)239 replication after challenge that was as good as, if not better than, what has been achieved by other non-persisting vaccine vectors that have been evaluated in this challenge model. Nevertheless, the extent of protection afforded by scSIV was not as good as typically conferred by persistent infection with live, attenuated SIV. These observations have potentially important implications to the design of an effective AIDS vaccine, since they suggest that ongoing stimulation of virus-specific immune responses may be essential to achieving the degree of protection afforded by live, attenuated SIV.
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- 2009
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37. Tuberculosis Preventative Therapy Initiation and Completion Among Adolescents and Young Adults Living With HIV in Kenya
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Danae A. Black, Sylvia M. LaCourse, Irene N. Njuguna, Kristin M. Beima-Sofie, Caren W. Mburu, Cyrus Mugo, Janet Itindi, Alvin Onyango, Barbra A. Richardson, Dalton C. Wamalwa, and Grace C. John-Stewart
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Infectious Diseases ,Pharmacology (medical) - Published
- 2023
38. Programmatic Retention in Prevention of Mother-to-Child Transmission (PMTCT) Programs: Estimated Rates and Cofactors Using Different Nonretention Measures
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Wenwen, Jiang, Keshet, Ronen, Lusi, Osborn, Alison L, Drake, Jennifer A, Unger, Daniel, Matemo, Barbra A, Richardson, John, Kinuthia, and Grace, John-Stewart
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Infectious Diseases ,Pharmacology (medical) - Abstract
PMTCT programs serve women continuing and initiating 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 three measures of peripartum non-retention in Kenyan women living with HIV from pregnancy to 2-years postpartum.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 visits2 weeks after scheduled date). Predictors of non-retention were determined using Cox proportional hazards, log-binomial, and generalized estimating equation models.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 14.0%, 18.4% 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 (IQR 4.3%-23.5%). Younger age, unsuppressed viral load, unemployment, ART initiation in pregnancy, and non-disclosure were associated with non-retention 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%, p0.0001).Late visit attendance may be a sentinel indicator of LTFU. Identified cofactors of PMTCT programmatic retention may differ depending on retention measure assessed, highlighting need for standardized measures.
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- 2023
39. Predictors of intact HIV DNA levels among children in Kenya
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Jillian Neary, Carolyn S. Fish, Noah A.J. Cassidy, Dalton Wamalwa, Agnes Langat, Evelyn Ngugi, Sarah Benki-Nugent, Hellen Moraa, Barbra A. Richardson, Irene Njuguna, Jennifer A. Slyker, Dara A. Lehman, and Grace John-Stewart
- Subjects
Infectious Diseases ,Immunology ,Immunology and Allergy - Published
- 2023
40. Enteric Permeability, Systemic Inflammation, and Post-Discharge Growth Among a Cohort of Hospitalized Children in Kenya and Pakistan
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Kirkby D, Tickell, Donna M, Denno, Ali, Saleem, Asad, Ali, Zaubina, Kazi, Benson O, Singa, Catherine, Otieno, Charles, Mutinda, Victor, Ochuodho, Barbra A, Richardson, Kristjana H, Ásbjörnsdóttir, Stephen E, Hawes, James A, Berkley, and Judd L, Walson
- Subjects
Inflammation ,Tumor Necrosis Factor-alpha ,Interleukin-6 ,Gastroenterology ,Infant ,Aftercare ,Kenya ,Patient Discharge ,Permeability ,Lactulose ,Pediatrics, Perinatology and Child Health ,Humans ,Pakistan ,Child ,Child, Hospitalized - Abstract
To determine whether gut permeability is associated with post-discharge growth and systemic inflammation among hospitalized children in low- and middle-income countries.Children aged 2-23 months being discharged from Civil Hospital Karachi (Pakistan) and Migori County Referral Hospital (Kenya) underwent lactulose-rhamnose ratio (LRR) permeability testing and were compared to age-matched children from their home communities. Linear mixed effect models estimated the associations between LRR among discharged children with change in length-for-age (LAZ) and weight-for-age z score (WAZ) at 45, 90, and 180 days after discharge. Linear regression tested if relationships between LRR, systemic inflammation [C-reative protein (CRP), Cluster of Differentiation 14 (CD14), Tumour Necrosis Factor Alpha (TNFα), Interleukin-6 (IL-6)], and enterocyte damage [Intestinal Fatty-Acid Binding protein (I-FABP)] differed between the hospitalized and community groups.One hundred thirty-seven hospitalized and 84 community participants were included. The hospitalized group had higher log-LRR [0.43, 95% confidence interval (CI): 0.15-0.71, P = 0.003] than the community children. Adjustment for weight-for-length z score at discharge attenuated this association (0.31, 95% CI: 0.00-0.62, P = 0.049). LRR was not associated with changes in WAZ or LAZ in the post-discharge period. Associations between LRR and CRP (interaction P = 0.036), TNFα ( P = 0.017), CD14 ( P = 0.078), and IL-6 ( P = 0.243) differed between community and hospitalized groups. LRR was associated with TNFα ( P = 0.004) and approached significance with CD14 ( P = 0.078) and IL-6 ( P = 0.062) in community children, but there was no evidence of these associations among hospitalized children.Although increased enteric permeability is more prevalent among children being discharged from hospital compared to children in the community, it does not appear to be an important determinant of systemic inflammation or post-discharge growth among hospitalized children.
- Published
- 2022
41. Caregiver fears and assumptions about child HIV status drive not testing children for HIV
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Jillian Neary, Cyrus Mugo, Anjuli Wagner, Vincent Ogweno, Verlinda Otieno, Anita Otieno, Barbra A. Richardson, Elizabeth Maleche-Obimbo, Dalton Wamalwa, Grace John-Stewart, Jennifer Slyker, and Irene Njuguna
- Subjects
HIV Testing ,Infectious Diseases ,Caregivers ,Immunology ,Immunology and Allergy ,Humans ,HIV Infections ,Fear ,Child - Published
- 2023
42. Changes in vaginal bacteria and inflammatory mediators from periconception through early-postpartum in a cohort of HIV-negative Kenyan women
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Michelle C Sabo, Erica M Lokken, Sujatha Srinivasan, John Kinuthia, Barbra A Richardson, Tina L Fiedler, Matthew Munch, Sean Proll, Clayton Salano, Grace John-Stewart, Walter Jaoko, David N Fredricks, and R Scott McClelland
- Subjects
Infectious Diseases ,Immunology and Allergy - Abstract
Background Women’s increased risk of HIV acquisition during pregnancy and postpartum may be mediated by changes in vaginal microbiota and/or cytokines. Methods A cohort of 80 HIV-1-seronegative Kenyan women contributed 409 vaginal samples at six pregnancy timepoints: periconception, positive pregnancy test, first trimester, second trimester, third trimester, and postpartum. Concentrations of vaginal bacteria linked with HIV risk and Lactobacillus species were measured using quantitative polymerase chain reaction. Cytokines were measured by immunoassay. Results Using Tobit regression, later pregnancy timepoints were associated with lower concentrations of Sneathia spp. (p = 0.01), Eggerthella sp. Type 1 (p = 0.002) and Parvimonas sp. Type 2 (p = 0.02), and higher concentrations of L iners (p Conclusions Increases in proinflammatory cytokines, but not vaginal bacterial taxa linked with higher HIV risk, could provide an explanation for increased HIV susceptibility during pregnancy and postpartum.
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- 2023
43. Randomized controlled trial of a theory-informed mHealth intervention to support ART adherence and viral suppression among women with HIV in Mombasa, Kenya: preliminary efficacy and participant-level feasibility and acceptability
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Frances M. Aunon, George Wanje, Barbra A. Richardson, Linnet Masese, Thomas A. Odeny, John Kinuthia, Kishorchandra Mandaliya, Walter Jaoko, Jane M. Simoni, and R. Scott McClelland
- Subjects
Public Health, Environmental and Occupational Health - Abstract
Background Mobile Health (“mHealth”) interventions have shown promise in improving HIV treatment outcomes for stigmatized populations. This paper presents the findings from a randomized controlled trial to assess the efficacy, participant-level feasibility and acceptability of a theory-informed mHealth intervention, Motivation Matters!, designed to improve viral suppression and ART adherence among HIV-seropositive women who engage in sex work in Mombasa, Kenya. Methods A total of 119 women were randomized between the intervention and standard of care control. The primary outcome examined viral suppression (≤ 30 copies/mL) six months following ART initiation. ART adherence was assessed monthly using a visual analogue scale. Participant-level feasibility was measured through response rates to study text messages. Acceptability was assessed through qualitative exit interviews. Results Six months following treatment initiation, 69% of intervention and 63% of control participants were virally suppressed (Risk Ratio [RR] = 1.09, 95% Confidence Interval [95% CI] (0.83, 1.44). Among women who were viremic at baseline and endorsed engagement in sex work, 74% of women in the intervention arm compared with 46% of women in the control arm achieved viral suppression at month six RR = 1.61, 95% CI (1.02, 2.55). Adherence was higher in intervention versus control participants every month. All participants responded to at least one message, and there was a 55% overall response rate to intervention text messages. Qualitative exit interviews suggested high acceptability and perceived impact of the intervention. Conclusion The improvements in ART adherence and viral suppression, combined with encouraging data on feasibility and acceptability, provides preliminary evidence that Motivation Matters! could support ART adherence and viral suppression in women who engage in sex work. Trial registration This trial was registered with ClinicalTrials.gov (NCT02627365, 10/12/2015; http://clinicaltrials.gov).
- Published
- 2023
44. Cumulative Mycobacterium tuberculosis Infection Incidence (Measured Primarily by Tuberculin Skin Test) Among Infants With Human Immunodeficiency Virus Exposure: Observational Follow-up of an Isoniazid Prophylaxis Trial
- Author
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Sylvia M LaCourse, Jaclyn N Escudero, Jerphason Mecha, A J Warr, Barbra A Richardson, Naziat Carimo, Lisa M Cranmer, Elizabeth Maleche-Obimbo, Daniel Matemo, John Kinuthia, Thomas R Hawn, and Grace John-Stewart
- Subjects
Microbiology (medical) ,Tuberculin Test ,Incidence ,Brief Report ,Antitubercular Agents ,Infant ,HIV ,HIV Infections ,Mycobacterium tuberculosis ,Infectious Diseases ,Child, Preschool ,Isoniazid ,Humans ,Tuberculosis ,Follow-Up Studies - Abstract
Cumulative 24-month Mycobacterium tuberculosis infection incidence (measured primarily by tuberculin skin test [TST]) was high among human immunodeficiency virus exposed but uninfected infants (8.7 [95% confidence interval, 6.3–11.9] per 100 person-years). Trend for decreased TST positivity among infants at trial end (12 months postenrollment) randomized to isoniazid at 6 weeks of age was not sustained through observational follow-up to 24 months of age. Clinical Trials Registration NCT02613169.
- Published
- 2022
45. Risks of adverse perinatal outcomes in relation to maternal depressive symptoms: A prospective cohort study in Kenya
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Anna Larsen, Jillian Pintye, Felix Abuna, Amritha Bhat, Julia C. Dettinger, Laurén Gomez, Mary M. Marwa, Nancy Ngumbau, Ben Odhiambo, Amanda I. Phipps, Barbra A. Richardson, Salphine Watoyi, Joshua Stern, John Kinuthia, and Grace John‐Stewart
- Subjects
Epidemiology ,Pediatrics, Perinatology and Child Health - Published
- 2023
46. Derivation and Internal Validation of a Risk Score for Predicting Chlamydia trachomatis Infection in Kenyan Women Planning Conception
- Author
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Anne N. Pulei, Erica M. Lokken, John Kinuthia, Barbra A. Richardson, Kishorchandra Mandaliya, Walter Jaoko, and R. Scott McClelland
- Subjects
Microbiology (medical) ,Infectious Diseases ,Public Health, Environmental and Occupational Health ,Dermatology - Published
- 2023
47. Fertility Desire and Associations with Condomless Sex, Antiretroviral Adherence, and Transmission Potential in a Cohort of Kenyan Women Living with HIV in Sero-discordant Relationships: A Mixed Methods Study
- Author
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McKenna C. Eastment, John Kinuthia, Kenneth Tapia, George Wanje, Katherine Wilson, Anne Kaggiah, Jane M. Simoni, Kishorchandra Mandaliya, Danielle N. Poole, Barbra A. Richardson, Walter Jaoko, Grace John-Stewart, and R. Scott McClelland
- Subjects
Infectious Diseases ,Social Psychology ,Public Health, Environmental and Occupational Health - Abstract
For women living with HIV (WLH) in serodiscordant partnerships, decisions about childbearing can challenge condom use and antiretroviral adherence. In a prospective cohort of 148 WLH in serodiscordant partnerships, 58 (39%) wanted more children in the future but were not currently trying to conceive (fertility desire), and 32 (22%) were currently trying to become pregnant (fertility intent). Detection of prostate specific antigen (PSA) in vaginal secretions, a marker for recent condomless sex, was lowest in women with fertility desire and highest in women with fertility intent. Detectable viral load followed a similar pattern. Risk of HIV transmission, when condomless sex and PSA detection occurred concurrently, was three to fourfold higher at visits with fertility intent compared to visits with fertility desire. Qualitative interviews underscored the importance women place on childbearing and suggested that they had limited information about the role of antiretroviral therapy in reducing sexual HIV transmission.
- Published
- 2023
48. Risk‐based versus universal PrEP delivery during pregnancy: a cluster randomized trial in Western Kenya from 2018 to 2019
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John Kinuthia, Julia C. Dettinger, Joshua Stern, Nancy Ngumbau, Ben Ochieng, Laurén Gómez, Felix Abuna, Salphine Watoyi, Mary Marwa, Daniel Odinga, Anjuli D. Wagner, Barbra A. Richardson, Jillian Pintye, Jared M. Baeten, and Grace John‐Stewart
- Subjects
Infectious Diseases ,Public Health, Environmental and Occupational Health - Published
- 2023
49. The Impact of a Comic Book Intervention on East African-American Adolescents’ HPV Vaccine-Related Knowledge, Beliefs and Intentions
- Author
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Michelle B. Shin, Linda K. Ko, Anisa Ibrahim, Farah Bille Mohamed, John Lin, Isabelle Celentano, Megha Shankar, Fanaye Amsalu, Ahmed A. Ali, Barbra A. Richardson, Victoria M. Taylor, and Rachel L. Winer
- Subjects
Epidemiology ,Public Health, Environmental and Occupational Health - Published
- 2022
50. Contributions of side effects to contraceptive discontinuation and method switch among Kenyan women: a prospective cohort study
- Author
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Claire W. Rothschild, Barbra A. Richardson, Brandon L. Guthrie, John Kinuthia, Alison L. Drake, Jennifer A. Unger, Lisa S. Callegari, Tom Omurwa, Grace John-Stewart, James Mukabi, Peninah Kithao, and Erica L. Lokken
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Side effect ,Obstetrics ,business.industry ,Incidence (epidemiology) ,Hazard ratio ,Obstetrics and Gynecology ,Intrauterine device ,Kenya ,Confidence interval ,Discontinuation ,Contraceptives, Oral, Combined ,Contraception ,Pill ,medicine ,Humans ,Female ,Prospective Studies ,Prospective cohort study ,business ,Contraception Behavior - Abstract
To determine the contribution of specific contraceptive side effects to method switch and modern-method discontinuation among Kenyan women.A prospective cohort study.Five counties in Western Kenya.Women aged ≥18 years old and emancipated female minors ≥14 years old using modern, reversible contraception were recruited while attending 10 public health facilities.Patient-reported adverse effect symptoms, method switch and discontinuation were reported through weekly text message-based surveys for 24 weeks.Prevalence, hazards ratio (HR).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).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.Bleeding, weight changes, sexual problems associated with discontinuation of #contraception, but many continue despite side effects.
- Published
- 2022
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