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1.
J Int AIDS Soc ; 23(1): e25426, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31912985

RESUMO

INTRODUCTION: HIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout. METHODS: We used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women. RESULTS AND DISCUSSION: We identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation. CONCLUSIONS: Expanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.

2.
N Engl J Med ; 381(14): 1333-1346, 2019 10 03.
Artigo em Inglês | MEDLINE | ID: mdl-31577875

RESUMO

BACKGROUND: The safety, efficacy, and appropriate timing of isoniazid therapy to prevent tuberculosis in pregnant women with human immunodeficiency virus (HIV) infection who are receiving antiretroviral therapy are unknown. METHODS: In this multicenter, double-blind, placebo-controlled, noninferiority trial, we randomly assigned pregnant women with HIV infection to receive isoniazid preventive therapy for 28 weeks, initiated either during pregnancy (immediate group) or at week 12 after delivery (deferred group). Mothers and infants were followed through week 48 after delivery. The primary outcome was a composite of treatment-related maternal adverse events of grade 3 or higher or permanent discontinuation of the trial regimen because of toxic effects. The noninferiority margin was an upper boundary of the 95% confidence interval for the between-group difference in the rate of the primary outcome of less than 5 events per 100 person-years. RESULTS: A total of 956 women were enrolled. A primary outcome event occurred in 72 of 477 women (15.1%) in the immediate group and in 73 of 479 (15.2%) in the deferred group (incidence rate, 15.03 and 14.93 events per 100 person-years, respectively; rate difference, 0.10; 95% confidence interval [CI], -4.77 to 4.98, which met the criterion for noninferiority). Two women in the immediate group and 4 women in the deferred group died (incidence rate, 0.40 and 0.78 per 100 person-years, respectively; rate difference, -0.39; 95% CI, -1.33 to 0.56); all deaths occurred during the postpartum period, and 4 were from liver failure (2 of the women who died from liver failure had received isoniazid [1 in each group]). Tuberculosis developed in 6 women (3 in each group); the incidence rate was 0.60 per 100 person-years in the immediate group and 0.59 per 100 person-years in the deferred group (rate difference, 0.01; 95% CI, -0.94 to 0.96). There was a higher incidence in the immediate group than in the deferred group of an event included in the composite adverse pregnancy outcome (stillbirth or spontaneous abortion, low birth weight in an infant, preterm delivery, or congenital anomalies in an infant) (23.6% vs. 17.0%; difference, 6.7 percentage points; 95% CI, 0.8 to 11.9). CONCLUSIONS: The risks associated with initiation of isoniazid preventive therapy during pregnancy appeared to be greater than those associated with initiation of therapy during the postpartum period. (Funded by the National Institutes of Health; IMPAACT P1078 TB APPRISE ClinicalTrials.gov number, NCT01494038.).


Assuntos
Infecções Oportunistas Relacionadas com a AIDS/prevenção & controle , Antituberculosos/uso terapêutico , Infecções por HIV/tratamento farmacológico , Isoniazida/uso terapêutico , Complicações Infecciosas na Gravidez/tratamento farmacológico , Resultado da Gravidez , Tuberculose/prevenção & controle , Adolescente , Adulto , Antituberculosos/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Lactente , Mortalidade Infantil , Recém-Nascido , Recém-Nascido de muito Baixo Peso , Isoniazida/efeitos adversos , Testes de Função Hepática , Período Pós-Parto , Gravidez , Nascimento Prematuro/epidemiologia , Estudos Prospectivos , Adulto Jovem
3.
J Acquir Immune Defic Syndr ; 82(4): 377-385, 2019 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-31567725

RESUMO

BACKGROUND: Effects of prolonged nevirapine prophylaxis exposure on growth among HIV-exposed uninfected (HEU) infants are unknown. This study examines the impact of extended nevirapine prophylaxis from 6 weeks to 6 months on the growth of HEU infants followed for 18 months and also identifies correlates of incident wasting, stunting, underweight, and low head circumference in the HPTN 046 trial. METHODS: Intention-to-treat analysis examined the effect of extended nevirapine exposure on: weight-for-age Z-score, length-for-age Z-score, weight-for-length Z-score, and head circumference-for-age Z-score. Multivariable linear mixed-effects and Cox proportional hazard models were used to compare growth outcomes between the study arms and identify correlates of incident adverse growth outcomes, respectively. RESULTS: Compared to placebo, extended prophylactic nevirapine given daily from 6 weeks to 6 months did not affect growth in HEU breastfeeding (BF) infants over time (treatment × time: P > 0.05). However, overall growth declined over time (time effect: P < 0.01) when compared with WHO general population norms. Male sex was associated with higher risk of all adverse growth outcomes (P < 0.05), whereas short BF duration was associated with wasting (P = 0.03). Maternal antiretroviral therapy exposure was protective against underweight (P = 0.02). Zimbabwe tended to have worse growth outcomes especially stunting, compared to South Africa, Uganda and Tanzania (P < 0.05). CONCLUSIONS: It is reassuring that prolonged exposure to nevirapine for prevention-of-mother-to-child HIV transmission does not restrict growth. However, targeted interventions are needed to improve growth outcomes among at-risk HEU infants (i.e., male sex, short BF duration, lack of maternal antiretroviral therapy exposure, and resident in Zimbabwe).

4.
PLoS One ; 14(10): e0219415, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31647806

RESUMO

BACKGROUND: Despite recent efforts to scale-up lifelong combination antiretroviral therapy (cART) in sub-Saharan Africa, high rates of unsuppressed viremia persist among cART users, and many countries in the region fall short of the UNAIDS 2020 target to have 90% virally suppressed. We sought to determine the factors associated with unsuppressed viremia (defined for the purpose of this study as >200 copies/ml) among sub-Saharan African women on lifelong cART. METHODS: This cross-sectional analysis was based on baseline data of the PROMOTE longitudinal cohort study at 8 sites in Uganda, Malawi, Zimbabwe and South Africa. The study enrolled 1987 women living with HIV who initiated lifelong cART at least 1-5 years ago. Socio-demographic, clinical, and cART adherence data were collected. We used multivariable Poisson regression with robust variance to identify factors associated with unsuppressed viremia. RESULTS: At enrolment, 1947/1987 (98%) women reported taking cART. Of these, HIV-1 remained detectable in 293/1934 (15%), while 216/1934 (11.2%) were considered unsuppressed (>200 copies/ml). The following factors were associated with an increased risk of unsuppressed viremia: not having household electricity (adjusted prevalence risk ratio (aPRR) 1.74, 95% confidence interval (CI) 1.28-2.36, p<0.001); not being married (aPRR 1.32, 95% CI 0.99-1.78, p = 0.061), self-reported missed cART doses (aPRR 1.63, 95% CI 1.24-2.13, p<0.001); recent hospitalization (aPRR 2.48, 95% CI 1.28-4.80, p = 0.007) and experiencing abnormal vaginal discharge in the last three months (aPRR 1.88; 95% CI 1.16-3.04, p = 0.010). Longer time on cART (aPRR 0.75, 95% CI 0.64-0.88, p<0.001) and being older (aPRR 0.77, 95% CI 0.76-0.88, p<0.001) were associated with reduced risk of unsuppressed viremia. CONCLUSION: Socioeconomic barriers such as poverty, and individual barriers like not being married, young age, and self-reported missed doses are key predictors of unsuppressed viremia. Targeted interventions are needed to improve cART adherence among women living with HIV with this risk factor profile.

5.
J Acquir Immune Defic Syndr ; 77(4): 383-392, 2018 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-29239901

RESUMO

BACKGROUND: No randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of mother-to-child transmission throughout the breastfeeding period. SETTING: Fourteen sites in Sub-Saharan Africa and India. METHODS: A randomized, open-label strategy trial was conducted in HIV-1-infected women with CD4 counts ≥350 cells/mm (or ≥country-specific ART threshold if higher) and their breastfeeding HIV-1-uninfected newborns. Randomization at 6-14 days postpartum was to mART or infant nevirapine (iNVP) prophylaxis continued until 18 months after delivery or breastfeeding cessation, infant HIV-1 infection, or toxicity, whichever occurred first. The primary efficacy outcome was confirmed infant HIV-1 infection. Efficacy analyses included all randomized mother-infant pairs except those with infant HIV-1 infection at entry. RESULTS: Between June 2011 and October 2014, 2431 mother-infant pairs were enrolled; 97% of women were World Health Organization Clinical Stage I, median screening CD4 count 686 cells/mm. Median infant gestational age/birth weight was 39 weeks/2.9 kilograms. Seven of 1219 (0.57%) and 7 of 1211 (0.58%) analyzed infants in the mART and iNVP arms, respectively, were HIV-infected (hazard ratio 1.0, 96% repeated confidence interval 0.3-3.1); infant HIV-free survival was high (97.1%, mART and 97.7%, iNVP, at 24 months). There were no significant differences between arms in median time to breastfeeding cessation (16 months) or incidence of severe, life-threatening, or fatal adverse events for mothers or infants (14 and 42 per 100 person-years, respectively). CONCLUSIONS: Both mART and iNVP prophylaxis strategies were safe and associated with very low breastfeeding HIV-1 transmission and high infant HIV-1-free survival at 24 months.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Aleitamento Materno , Quimioprevenção/métodos , Infecções por HIV/prevenção & controle , Infecções por HIV/transmissão , Transmissão Vertical de Doença Infecciosa/prevenção & controle , África ao Sul do Saara , Pré-Escolar , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/patologia , Humanos , Índia , Lactente , Recém-Nascido , Período Pós-Parto , Resultado do Tratamento
6.
HIV Clin Trials ; 19(6): 209-224, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30890061

RESUMO

BACKGROUND: IMPAACT PROMISE 1077BF/FF was a randomized study of antiretroviral therapy (ART) strategies for pregnant and postpartum women with high CD4+ T-cell counts. We describe postpartum outcomes for women in the study who were randomized to continue or discontinue ART after delivery. METHODS: Women with pre-ART CD4+ cell counts ≥350 cells/mm3 who started ART during pregnancy were randomized postpartum to continue or discontinue treatment. Women were enrolled from India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. The primary outcome was a composite of progression to AIDS-defining illness or death. Log-rank tests and Cox regression models assessed treatment effects. Incidence rates were calculated per 100 person-years. A post hoc analysis evaluated WHO Stage 2/3 events. All analyses were intent-to-treat. FINDINGS: 1611 women were enrolled (June 2011-October 2014) and 95% were breastfeeding. Median age at entry was 27 years, CD4+ count 728 cells/mm3 and the majority of women were Black African (97%). After a median follow-up of 1.6 years, progression to AIDS-defining illness or death was rare and there was no significant difference between arms (HR: 0·55; 95%CI 0·14, 2·08, p = 0.37). WHO Stage 2/3 events were reduced with continued ART (HR: 0·60; 95%CI 0·39, 0·90, p = 0.01). The arms did not differ with respect to the rate of grade 2, 3, or 4 safety events (p = 0.61). INTERPRETATION: Serious clinical events were rare among predominately breastfeeding women with high CD4+ cell counts over 18 months after delivery. ART had significant benefit in reducing WHO 2/3 events in this population.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Terapia Antirretroviral de Alta Atividade , Infecções por HIV/tratamento farmacológico , Saúde Materna , Adulto , Aleitamento Materno , Contagem de Linfócito CD4 , Progressão da Doença , Feminino , Infecções por HIV/virologia , Humanos , Período Pós-Parto , Gravidez , Resultado do Tratamento , Adulto Jovem
7.
J Pediatric Infect Dis Soc ; 6(1): 105-108, 2017 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-26759497

RESUMO

Community circulation of oral poliovirus vaccine (OPV) likely begins with household transmission. We analyzed stool collected from Zimbabwean mothers who were infected with human immunodeficiency virus (HIV) and those who were uninfected with HIV 1 to 24 weeks after infant oral poliovirus vaccination. Overall, only 5% of the mothers had detectable OPV (16 of 304) despite high infant shedding rates. OPV shedding was similar between HIV-infected mothers and those who were uninfected (11 [6.4%] of 171 vs 5 [3.8%] of 133, respectively) and between mothers of HIV-infected infants and those of uninfected infants (2 [3.5%] of 57 vs 9 [6.3%] of 144, respectively). Mothers of vaccinated infants are unlikely to shed OPV, even when they are infected with HIV.


Assuntos
Países em Desenvolvimento , Infecções por HIV/transmissão , Infecções por HIV/virologia , Transmissão Vertical de Doença Infecciosa , Mães , Vacina Antipólio Oral , Eliminação de Partículas Virais , Adulto , Fármacos Anti-HIV/uso terapêutico , Cesárea , Quimioterapia Combinada , Feminino , Seguimentos , Humanos , Lactente , Masculino , Gravidez , Carga Viral , Zimbábue
8.
J Pediatr ; 181: 248-253.e3, 2017 02.
Artigo em Inglês | MEDLINE | ID: mdl-27866821

RESUMO

OBJECTIVE: To evaluate a novel technique designed to reduce the negative impact of motion artifacts in infant dual-energy X-ray absorptiometry (DXA) scans. STUDY DESIGN: Using cross-sectional data from a large multicenter study, we developed and tested advanced methods for infant scan analysis. Newborns (n = 750) received spine and whole-body DXA scans with up to 3 attempts to acquire a motion free scan. Precision of infant DXA was estimated from visits with multiple valid scans. Accuracy of regional reflection, fusion, and omission techniques was estimated by comparing modified scans to unmodified valid scans. The effectiveness of the acquisition and analysis protocol was represented by the reduction in rate of failure to acquire valid results from infant visits. RESULTS: For infant whole-body DXA, arm reflection and all fusion techniques caused no significant changes to bone mineral content, bone mineral density, bone area, total mass, fat mass, lean mass, and percentage fat. Leg reflection and arm/leg dual-reflection caused significant changes to total mass, but the percentage change remained small. For infant spine DXA, fusion and omission caused no significant changes. Advanced analysis techniques reduced the failure rate of whole-body scanning from 20.8% to 9.3% and the failure rate of spine scanning from 8.9% to 2.4%. CONCLUSIONS: Advanced analysis techniques significantly reduced the impact of motion artifacts on infant DXA scans. We suggest this protocol be used in future infant DXA research and clinical practice.


Assuntos
Absorciometria de Fóton/métodos , Composição Corporal , Densidade Óssea , Osso e Ossos/metabolismo , Estudos Transversais , Humanos , Lactente , Recém-Nascido , Reprodutibilidade dos Testes
9.
J Acquir Immune Defic Syndr ; 72 Suppl 2: S145-53, 2016 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-27355502

RESUMO

INTRODUCTION: Antiretroviral pre-exposure prophylaxis (PrEP) for the prevention of HIV acquisition is cost-effective when delivered to those at substantial risk. Despite a high incidence of HIV infection among pregnant and breastfeeding women in sub-Saharan Africa (SSA), a theoretical increased risk of preterm birth on PrEP could outweigh the HIV prevention benefit. METHODS: We developed a decision analytic model to evaluate a strategy of daily oral PrEP during pregnancy and breastfeeding in SSA. We approached the analysis from a health care system perspective across a lifetime time horizon. Model inputs were derived from existing literature and local sources. The incremental cost-effectiveness ratio (ICER) of PrEP versus no PrEP was calculated in 2015 U.S. dollars per disability-adjusted life year (DALY) averted. We evaluated the effect of uncertainty in baseline estimates through one-way and probabilistic sensitivity analyses. RESULTS: PrEP administered to pregnant and breastfeeding women in SSA was cost-effective. In a base case of 10,000 women, the administration of PrEP averted 381 HIV infections but resulted in 779 more preterm births. PrEP was more costly per person ($450 versus $117), but resulted in fewer disability-adjusted life years (DALYs) (3.15 versus 3.49). The incremental cost-effectiveness ratio of $965/DALY averted was below the recommended regional threshold for cost-effectiveness of $6462/DALY. Probabilistic sensitivity analyses demonstrated robustness of the model. CONCLUSIONS: Providing PrEP to pregnant and breastfeeding women in SSA is likely cost-effective, although more data are needed about adherence and safety. For populations at high risk of HIV acquisition, PrEP may be considered as part of a broader combination HIV prevention strategy.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Aleitamento Materno , Análise Custo-Benefício , Infecções por HIV/prevenção & controle , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Profilaxia Pré-Exposição/economia , Complicações Infecciosas na Gravidez/tratamento farmacológico , África ao Sul do Saara/epidemiologia , Fármacos Anti-HIV/economia , Feminino , Infecções por HIV/transmissão , Humanos , Lactente , Recém-Nascido , Gravidez
10.
J Clin Densitom ; 18(4): 525-32, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26073424

RESUMO

Reference populations from the United States (US) are often used around the world for representative measures of bone mineral density (BMD) by sex, age, and race. We examined BMD in adult black Zimbabwean women and compared it to that of US women (white and black). In a cross-sectional study, we recruited healthy black Zimbabwean women working at Parirenyatwa Hospital regardless of designation, who were not pregnant and had no diseases or medications known to affect BMD. Dual-energy X-ray absorptiometry scans of the left hip and lumbar spine (L1-L4) were performed for each participant by 1 operator, on 1 dual-energy X-ray absorptiometry machine. Results are presented for 289 participants aged 20-69 years, with a mean weight, height, and body mass index (BMI) of 71.7 ± 15.1 cm, 164.9 ± 6.3 kg, and 26.3 ± 5.3 kg/m(2), respectively. At 5% level of significance, age and BMD were weakly associated for the total lumbar spine (p ≤ 0.001) but not for the total hip (p = 0.890) and femur neck (p = 0.062). BMI and weight were positively correlated with BMD for all 3 sites (p ≤ 0.001). Compared to US white women, mean BMD for black Zimbabwean women in this study was 4.5%-7.4% lower for the lumbar spine but 2.0%-4.8% higher for the total hip and 0.2%-10.2% higher for the femur neck for 20-59 years. Compared to US black women, mean BMD for black Zimbabwean women was 9.1%-11.5% lower for the lumbar spine and 1.4%-8.1% lower for the total hip for 20-59 years. Black Zimbabwean women also had lower mean weight and BMI per decade age group as compared to US women. Differences in weight and BMI offer a possible explanation for the differences in BMD between black Zimbabwean women and US white and black women. Including adjustments for body frame when calculating Z-scores may accurately reflect BMD.


Assuntos
Densidade Óssea , Absorciometria de Fóton , Adulto , África ao Sul do Saara , Grupo com Ancestrais do Continente Africano , Estudos Transversais , Grupo com Ancestrais do Continente Europeu , Feminino , Quadril/diagnóstico por imagem , Humanos , Vértebras Lombares/diagnóstico por imagem , Estados Unidos , Zimbábue
11.
J Int Assoc Provid AIDS Care ; 13(4): 335-41, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25513030

RESUMO

Postnatal depression (PND) is a major problem in low- and middle-income countries (LMICs). A total of 210 postpartum mothers attending primary care urban clinics were screened for PND at 6 weeks postpartum using the Edinburgh Postnatal Depression Scale (EPDS) and Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition; DSM-IV) criteria for major depression. The HIV prevalence was 14.8%. Of the 210 enrolled postpartum mothers, 64 (33%) met DSM IV criteria for depression. Using trained peer coun- selors, mothers with PND (n = 58) were randomly assigned to either group problem-solving therapy (PST, n = 30) or amitriptyline (n = 28). Of the 58 mothers with PND, 49 (85%) completed 6 weeks of group PST (n = 27) or pharmacotherapy (n = 22). At baseline, the mean EPDS score for participants randomized to group PST was 17.3 (standard deviation [SD] 3.7), while the group randomized to amitriptyline had a mean EPDS score of 17.9 (SD 3.9; P = .581). At 6 weeks postintervention, the drop in mean EPDS score was greater in the PST group (8.22, SD 3.6) compared to the amitriptyline group (10.7, SD 2.7; P = .0097). Group PST using peer counselors is feasible, acceptable, and more effective compared to pharmacotherapy in the treatment of PND. Group PST could be integrated into maternal and child health clinics and preventing mother-to-child transmission of HIV programs in LMICs.


Assuntos
Depressão Pós-Parto/complicações , Depressão Pós-Parto/epidemiologia , Depressão Pós-Parto/terapia , Infecções por HIV/complicações , Psicoterapia de Grupo , Adulto , Amitriptilina/uso terapêutico , Antidepressivos/uso terapêutico , Conselheiros , Feminino , Humanos , Índice de Gravidade de Doença , Adulto Jovem , Zimbábue/epidemiologia
12.
J Acquir Immune Defic Syndr ; 67(5): 573-5, 2014 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-25247435

RESUMO

Recent human studies support historical animal studies that suggested an association between peripheral blood monocyte:lymphocyte (ML) ratio and tuberculosis (TB) disease. To evaluate generalizability of this finding, we modeled the association between peripartum ML ratio and incident TB disease within 18 months postpartum among 1202 HIV-infected women in South Africa, Tanzania, Uganda, and Zimbabwe. The ML ratio was associated with increased risk of TB disease independently to combination antiretroviral therapy, World Health Organization stage, or CD4 count (adjusted hazard ratio = 1.22, 95% confidence interval: 1.07 to 1.4, P = 0.003 per 0.1 unit increase in ML ratio).


Assuntos
Infecções por HIV/complicações , Infecções por HIV/imunologia , Linfócitos/imunologia , Monócitos/imunologia , Período Pós-Parto , Tuberculose/epidemiologia , Tuberculose/imunologia , Adulto , África/epidemiologia , Animais , Feminino , Humanos , Contagem de Leucócitos , Gravidez , Medição de Risco , Adulto Jovem
13.
Contraception ; 89(3): 209-14, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24332254

RESUMO

OBJECTIVE: The objective was to integrate enhanced family planning (FP) and prevention of mother-to-child HIV transmission services in order to help HIV-positive Zimbabwean women achieve their desired family size and spacing as well as to maximize maternal and child health. STUDY DESIGN: HIV-positive pregnant women were enrolled into a standard-of-care (SOC, n=33) or intervention (n=65) cohort, based on study entry date, and followed for 3 months postpartum. The intervention cohort received education sessions aimed at increasing FP use and negotiation power. Both groups received care from nurses with enhanced FP training. Outcomes included FP use, FP knowledge and HIV disclosure, and were assessed with Fisher's Exact Tests, binomial tests and t tests. RESULTS: The intervention cohort reported increased control over condom use (p=.002), increased knowledge about IUDs (p=.002), increased relationship power (p=.01) and increased likelihood of disclosing their HIV status to a partner (p=.04) and having that partner disclose to them (p=.04) when compared to the SOC cohort. Long-acting reversible contraception (LARC) use in both groups increased from ~2% at baseline to >80% at 3 months postpartum (p<.001). CONCLUSIONS: FP and sexual negotiation skills and knowledge, as well as HIV disclosure, increased significantly in the intervention cohort. LARC uptake increased significantly in both the intervention and SOC cohorts, likely because both groups received care from nurses with enhanced FP training. Successful service integration models are needed to maximize health outcomes in resource-constrained environments; this intervention is such a model that should be replicable in other settings in sub-Saharan Africa and beyond. IMPLICATIONS: This study provides a rigorously evaluated intervention to integrate FP education into ante- and postnatal care for HIV-positive women and also to train providers on FP. Results suggest that this intervention had significant effects on contraception use and communication with sexual partners. This intervention should be adaptable to other areas.


Assuntos
Serviços de Planejamento Familiar/métodos , Infecções por HIV/prevenção & controle , Infecções por HIV/transmissão , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Educação de Pacientes como Assunto , Complicações Infecciosas na Gravidez/virologia , Adulto , Estudos de Coortes , Preservativos , Anticoncepção/métodos , Revelação , Serviços de Planejamento Familiar/educação , Feminino , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Dispositivos Intrauterinos , Masculino , Cuidado Pós-Natal , Gravidez , Cuidado Pré-Natal , Parceiros Sexuais , Zimbábue
14.
J Int Assoc Provid AIDS Care ; 13(4): 335-41, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-23881909

RESUMO

Postnatal depression (PND) is a major problem in low- and middle-income countries (LMICs). A total of 210 postpartum mothers attending primary care urban clinics were screened for PND at 6 weeks postpartum using the Edinburgh Postnatal Depression Scale (EPDS) and Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition; DSM-IV) criteria for major depression. The HIV prevalence was 14.8%. Of the 210 enrolled postpartum mothers, 64 (33%) met DSM IV criteria for depression. Using trained peer coun- selors, mothers with PND (n = 58) were randomly assigned to either group problem-solving therapy (PST, n = 30) or amitriptyline (n = 28). Of the 58 mothers with PND, 49 (85%) completed 6 weeks of group PST (n = 27) or pharmacotherapy (n = 22). At baseline, the mean EPDS score for participants randomized to group PST was 17.3 (standard deviation [SD] 3.7), while the group randomized to amitriptyline had a mean EPDS score of 17.9 (SD 3.9; P = .581). At 6 weeks postintervention, the drop in mean EPDS score was greater in the PST group (8.22, SD 3.6) compared to the amitriptyline group (10.7, SD 2.7; P = .0097). Group PST using peer counselors is feasible, acceptable, and more effective compared to pharmacotherapy in the treatment of PND. Group PST could be integrated into maternal and child health clinics and preventing mother-to-child transmission of HIV programs in LMICs.


Assuntos
Depressão Pós-Parto/terapia , Infecções por HIV/psicologia , Resolução de Problemas , Psicoterapia de Grupo , Adolescente , Adulto , Amitriptilina/uso terapêutico , Antidepressivos Tricíclicos/uso terapêutico , Estudos de Coortes , Estudos de Viabilidade , Feminino , Humanos , Grupo Associado , Resultado do Tratamento , Adulto Jovem , Zimbábue
15.
J Acquir Immune Defic Syndr ; 65(3): 366-74, 2014 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-24189151

RESUMO

BACKGROUND: HPTN 046 compared the efficacy and safety of infant nevirapine (NVP) among HIV-exposed breastfed infants randomized at 6 weeks to 6 months to t NVP or placebo to prevent postnatal infection: we report final 18-month outcomes. METHODS: Randomized, placebo-controlled trial in 4 African countries. Infant diagnostic HIV testing was performed regularly from birth through 18 months. Kaplan-Meier analysis was used to assess 18-month cumulative infant HIV infection, HIV infection/or death, and mortality rates. RESULTS: Between 6 weeks and 6 months, postnatal HIV infection rates were significantly lower among infants receiving daily NVP from 6 weeks to 6 months 1.1% [95% confidence interval (CI): 0.2% to 1.8%], compared with placebo 2.4% (95% CI: 1.3% to 2.6%), P = 0.049, but not significantly lower thereafter. Eighteen-month postnatal infection rates were low: 2.2% (95% CI: 1.1% to 3.3%) versus 3.1% (95% CI: 1.9% to 4.4%), respectively, P = 0.28. Mortality and HIV infection/death did not differ between arms at any age. Infants of women receiving antiretroviral therapy (ART) for their own health had the lowest 18-month postnatal infection rates (0.5%, 95% CI: 0.0% to 1.1%). However, HIV infection/death rates at 18 months were not significantly different for infants of mothers on ART (3.7%, 95% CI: 1.9% to 5.5%), and infants of mothers with CD4 counts of ≥ 350 cells per cubic millimeter not receiving ART (4.8%, 95% CI: 2.7% to 6.8%; P = 0.46). There were no differences in adverse events between study arms. CONCLUSIONS: This trial demonstrated early but not late differences in postnatal HIV transmission among infants randomized at age 6 weeks to extended NVP or placebo, underscoring the importance of continued prophylaxis throughout breastfeeding.


Assuntos
Fármacos Anti-HIV/administração & dosagem , Fármacos Anti-HIV/efeitos adversos , Quimioprevenção/métodos , Infecções por HIV/prevenção & controle , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Nevirapina/administração & dosagem , Nevirapina/efeitos adversos , Adolescente , Adulto , África , Aleitamento Materno , Quimioprevenção/efeitos adversos , Método Duplo-Cego , Feminino , Infecções por HIV/transmissão , Infecções por HIV/virologia , HIV-1/isolamento & purificação , Humanos , Lactente , Recém-Nascido , Masculino , Placebos/administração & dosagem , Resultado do Tratamento , Adulto Jovem
16.
J Infect Dis ; 208(4): 672-8, 2013 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-23661792

RESUMO

BACKGROUND: With prolonged replication, attenuated polioviruses used in oral polio vaccine (OPV) can mutate into vaccine-derived poliovirus (VDPV) and cause poliomyelitis outbreaks. Individuals with primary humoral immunodeficiencies can become chronically infected with vaccine poliovirus, allowing it to mutate into immunodeficiency-associated VDPV (iVDPV). It is unclear if children perinatally infected with the human immunodeficiency virus (HIV), who have humoral as well as cellular immunodeficiencies, might be sources of iVDPV. METHODS: We conducted a prospective study collecting stool and blood samples at multiple time points from Zimbabwean infants receiving OPV according to the national schedule. Nucleic acid extracted from stool was analyzed by real-time polymerase chain reaction for OPV serotypes. RESULTS: We analyzed 825 stool samples: 285 samples from 92 HIV-infected children and 540 from 251 HIV-uninfected children. Poliovirus shedding was similar after 0-2 OPV doses but significantly higher in the HIV-infected versus uninfected children after ≥ 3 OPV doses, particularly within 42 days of an OPV dose, independent of seroconversion status. HIV infection was not associated with prolonged or persistent poliovirus shedding. HIV infection was associated with significantly lower polio seroconversion rates. CONCLUSIONS: HIV infection is associated with decreased mucosal and humoral immune responses to OPV but not the prolonged viral shedding required to form iVDPV.


Assuntos
Infecções por HIV/imunologia , Vacina Antipólio Oral/administração & dosagem , Vacina Antipólio Oral/imunologia , Poliovirus/isolamento & purificação , Eliminação de Partículas Virais , Adulto , Anticorpos Antivirais/sangue , Sangue/imunologia , Sangue/virologia , Fezes/virologia , Feminino , Humanos , Lactente , Estudos Longitudinais , Masculino , Estudos Prospectivos , RNA Viral/genética , RNA Viral/isolamento & purificação , Reação em Cadeia da Polimerase em Tempo Real , Zimbábue
17.
Lancet ; 379(9812): 221-8, 2012 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-22196945

RESUMO

BACKGROUND: Nevirapine given once-daily for the first 6, 14, or 28 weeks of life to infants exposed to HIV-1 via breastfeeding reduces transmission through this route compared with single-dose nevirapine at birth or neonatally. We aimed to assess incremental safety and efficacy of extension of such prophylaxis to 6 months. METHODS: In our phase 3, randomised, double-blind, placebo-controlled HPTN 046 trial, we assessed the incremental benefit of extension of once-daily infant nevirapine from age 6 weeks to 6 months. We enrolled breastfeeding infants born to mothers with HIV-1 in four African countries within 7 days of birth. Following receipt of nevirapine from birth to 6 weeks, infants without HIV infection were randomly allocated (by use of a computer-generated permuted block algorithm with random block sizes and stratified by site and maternal antiretroviral treatment status) to receive extended nevirapine prophylaxis or placebo until 6 months or until breastfeeding cessation, whichever came first. The primary efficacy endpoint was HIV-1 infection in infants at 6 months and safety endpoints were adverse reactions in both groups. We used Kaplan-Meier analyses to compare differences in the primary outcome between groups. This study is registered with ClinicalTrials.gov, number NCT00074412. FINDINGS: Between June 19, 2008, and March 12, 2010, we randomly allocated 1527 infants (762 nevirapine and 765 placebo); five of whom had HIV-1 infection at randomisation and were excluded from the primary analyses. In Kaplan-Meier analysis, 1·1% (95% CI 0·3-1·8) of infants who received extended nevirapine developed HIV-1 between 6 weeks and 6 months compared with 2·4% (1·3-3·6) of controls (difference 1·3%, 95% CI 0-2·6), equating to a 54% reduction in transmission (p=0·049). However, mortality (1·2% for nevirapine vs 1·1% for placebo; p=0·81) and combined HIV infection and mortality rates (2·3%vs 3·2%; p=0·27) did not differ between groups at 6 months. 125 (16%) of 758 infants given extended nevirapine and 116 (15%) of 761 controls had serious adverse events, but frequency of adverse events, serious adverse events, and deaths did not differ significantly between treatment groups. INTERPRETATION: Nevirapine prophylaxis can safely be used to provide protection from mother-to-child transmission of HIV-1 via breastfeeding for infants up to 6 months of age. FUNDING: US National Institutes of Health.


Assuntos
Fármacos Anti-HIV/uso terapêutico , Aleitamento Materno , Infecções por HIV/prevenção & controle , HIV-1 , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Nevirapina/administração & dosagem , Complicações Infecciosas na Gravidez/tratamento farmacológico , Administração Oral , Adulto , África ao Sul do Saara , Terapia Antirretroviral de Alta Atividade , Contagem de Linfócito CD4 , Método Duplo-Cego , Esquema de Medicação , Feminino , Infecções por HIV/tratamento farmacológico , Infecções por HIV/imunologia , Infecções por HIV/mortalidade , Humanos , Lactente , Gravidez , Complicações Infecciosas na Gravidez/imunologia , Adulto Jovem
18.
Pediatr Infect Dis J ; 31(2): 176-80, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22146742

RESUMO

BACKGROUND: Poliovirus eradication is dependent on maintaining adequate community-wide levels of serologic protection. Many African countries with conditions that favor continued wild poliovirus propagation also have a high prevalence of pediatric human immunodeficiency virus (HIV) infection. Data are limited regarding the degree of serologic immunity conferred on HIV-infected children after immunization with oral polio vaccine (OPV). METHODS: This was a cross-sectional study correlating HIV infection and neutralizing antibodies against poliovirus serotypes 1, 2, and 3 in 95 Zimbabwean children 2 months to 2 years of age, born to HIV-infected mothers, who received OPV according to the national schedule. RESULTS: HIV-infected children had significantly lower rates of seroconversion to all 3 poliovirus serotypes than HIV-uninfected children (60%, 67%, and 47% vs. 96%, 100%, and 82%, P = 0.001, 0.0003, and 0.015 for serotypes 1, 2, and 3 in HIV-infected and uninfected children, respectively, after ≥3 OPV doses). Among poliovirus seroconverters, HIV-infected children also had significantly lower geometric mean titers against serotypes 1 and 2 than HIV-uninfected children (geometric mean titers: 198 and 317 vs. 1193 and 1056, P = 0.032 and 0.050, for serotypes 1 and 2, respectively, after ≥3 OPV doses). In addition, HIV-infected children had significantly higher levels of total IgG and significantly lower CD4% and mean weight than HIV-uninfected children. Of note, none of the HIV-infected children were receiving antiretroviral therapy, and 71% had a CD4% indicating severe immunodeficiency. CONCLUSIONS: Pediatric HIV infection is associated with a poor serologic response to OPV, which could pose an obstacle to global polio eradication.


Assuntos
Infecções por HIV/imunologia , Poliomielite/prevenção & controle , Vacina Antipólio Oral/imunologia , Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Contagem de Linfócito CD4 , Pré-Escolar , Estudos Transversais , Feminino , Humanos , Imunoglobulina G/sangue , Lactente , Masculino , Vacina Antipólio Oral/administração & dosagem , Zimbábue
19.
J Trop Pediatr ; 58(1): 59-62, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-21504989

RESUMO

Studies investigating novel therapies in African infants report laboratory adverse events based on reference intervals from white Western infants. However, prior studies have shown that reference intervals differ based on ethnicity and geographic location. We calculated reference intervals for Zimbabwean infants by analyzing the hematologic and immunologic values found in 542 blood samples from 269 HIV-uninfected, black, Zimbabwean infants at 3, 5 and 9 months of age. Substantial proportions of the platelet counts (44%), hemoglobins (19%) and mean corpuscular volumes (41%) were outside published normal ranges. The majority (65%) of hemoglobin values qualified as a United States National Institutes of Health Division of AIDS adverse events. The majority (71%) of CD4% values indicated immunodeficiency by World Health Organization criteria. Hematologic and immunologic reference intervals used to evaluate toxicities in pediatric trials in sub-Saharan Africa need to be reevaluated to account for differences in ethnicity, geographic location, nutrition and socioeconomic status.


Assuntos
Testes Hematológicos/normas , Testes Imunológicos/normas , Monitorização Fisiológica/métodos , Distribuição de Qui-Quadrado , Feminino , Soronegatividade para HIV , Humanos , Lactente , Masculino , Estudos Prospectivos , Valores de Referência , Estatísticas não Paramétricas , Zimbábue
20.
AIDS ; 26(3): 325-33, 2012 Jan 28.
Artigo em Inglês | MEDLINE | ID: mdl-22112598

RESUMO

OBJECTIVE: Nevirapine and cotrimoxazole are associated with hematologic toxicities and skin-rash. Safety of their concurrent use for prophylaxis over extended periods among HIV-exposed uninfected infants has not been previously assessed. DESIGN: Secondary data analysis of the 'HIV Prevention Trials Network-046 protocol' (version 2.0), a phase-III, randomized, placebo-controlled trial that assessed efficacy and safety of nevirapine prophylaxis against breast milk transmission of HIV-1. METHODS: Trial infants received 6-month study nevirapine/placebo, and standard-of-care peripartum single-dose nevirapine+/- zidovudine 'tail', and cotrimoxazole prophylaxis from 6 weeks through breastfeeding cessation. Adverse events were monitored using United States Division of AIDS Toxicity Tables (2004). Risk of neutropenia, anemia and skin-rash in the cotrimoxazole + nevirapine and the cotrimoxazole + placebo groups were compared using negative-binomial regression. RESULTS: Incidence of neutropenia and/or anemia, and skin-rash was highest during the first 6 weeks of life and declined, thereafter, regardless of study group. Time to first adverse event after 6 weeks was similar in cotrimoxazole + nevirapine and cotrimoxazole + placebo groups: hazard ratio (95% confidence interval) was 1.26 (0.96-1.66) for neutropenia and/or anemia (all grades), 1.27 (0.80-2.03) for neutropenia and/or anemia (grade ≥3) and 1.16 (0.46-2.90) for skin-rash (grade ≥2). There were no statistically significant differences in immediate (6 weeks-6 months) and long-term (6-12 months) adverse event risk among infants on cotrimoxazole + nevirapine versus cotrimoxazole + placebo. CONCLUSION: Extended nevirapine and cotrimoxazole prophylaxis through 6 months of age among HIV-exposed uninfected infants did not appear to increase the immediate or long-term risk of neutropenia, anemia or skin-rash. Concurrent use beyond 6 months, however, needs to be evaluated.


Assuntos
Anemia/induzido quimicamente , Fármacos Anti-HIV/administração & dosagem , Exantema/induzido quimicamente , Soropositividade para HIV/tratamento farmacológico , HIV-1/efeitos dos fármacos , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Neutropenia/induzido quimicamente , Nevirapina/administração & dosagem , Combinação Trimetoprima e Sulfametoxazol/administração & dosagem , Adulto , Fármacos Anti-HIV/efeitos adversos , Western Blotting , Aleitamento Materno/efeitos adversos , Esquema de Medicação , Erupção por Droga/etiologia , Feminino , Soropositividade para HIV/epidemiologia , Soropositividade para HIV/transmissão , Humanos , Lactente , Recém-Nascido , Masculino , Leite Humano/virologia , Nevirapina/efeitos adversos , Gravidez , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Combinação Trimetoprima e Sulfametoxazol/efeitos adversos , Uganda/epidemiologia
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