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Postpartum depression (PPD) is a prevalent and debilitating disease that may affect medication adherence and thus maternal health and vertical transmission among women with HIV. We assessed the feasibility of a trial of interpersonal psychotherapy (IPT) versus antidepressant medication (ADM) to treat PPD and/or anxiety among postpartum women with HIV in Lusaka, Zambia.Between 29 October 2019 and 8 September 2020, we pre-screened women 6-8 weeks after delivery with the Edinburgh Postnatal Depression Scale (EPDS) and diagnosed PPD or anxiety with the Mini International Neuropsychiatric Interview. Consenting participants were randomized 1:1 to up to 11 sessions of IPT or daily self-administered sertraline and followed for 24 weeks. We assessed EPDS score, Clinical Global Impression-Severity of Illness (CGI-S) and medication side effects at each visit and measured maternal HIV viral load at baseline and final study visit. Retention, visit adherence, change in EPDS, CGI-S and log viral load were compared between groups with t-tests and Wilcoxon signed rank tests; we report mean differences, relative risks and 95% confidence intervals. A participant satisfaction survey assessed trial acceptability.78/80 (98%) participants were retained at the final study visit. In the context of the COVID-19 pandemic, visit adherence was greater among women allocated to ADM (9.9 visits, SD 2.2) versus IPT (8.9 visits, SD 2.4; p = 0.06). EPDS scores decreased from baseline to final visit overall, though mean change was greater in the IPT group (-13.8 points, SD 4.7) compared to the ADM group (-11.4 points, SD 5.5; p = 0.04). Both groups showed similar changes in mean log viral load from baseline to final study visit (mean difference -0.43, 95% CI -0.32, 1.18; p = 0.48). In the IPT group, viral load decreased significantly from baseline (0.9 log copies/ml, SD 1.7) to final visit (0.2 log copies/ml, SD 0.9; p = 0.01).This pilot study demonstrates that a trial of two forms of PPD treatment is feasible and acceptable among women with HIV in Zambia. IPT and ADM both improved measures of depression severity; however, a full-scale trial is required to determine whether treatment of PPD and anxiety improves maternal-infant HIV outcomes.

OBJECTIVE To assess plasma and vaginal inflammation in three antenatal groups (HIV-uninfected women, HIV-infected women entering care on preconceptional ART, and HIV-infected women not on preconceptional ART) and whether these measures are associated with spontaneous preterm birth (sPTB). DESIGN Case--control study nested within a pregnancy cohort in Lusaka, Zambia. METHODS We analyzed 11 pro-inflammatory and two anti-inflammatory markers in 207 women with paired plasma and vaginal specimens collected between 16 and 20 gestational weeks. Among 51 HIV-infected women, we repeated the assays in 24-34-week samples. We used confirmatory factor analysis to create inflammation scores and compared them among the three groups. RESULTS At baseline, HIV-infected women not on ART had higher vaginal pro-inflammatory scores than HIV-uninfected women [mean 0.37 (95% CI -0.06 to 0.80) vs. -0.02 (-0.32 to 0.27), P = 0.02]. In repeat testing, women not on preconceptional ART had an increase in vaginal inflammation between the baseline and 24-34-week visits compared with those continuing preconceptional ART [mean 0.62 (95% CI -0.80 to 4.20) vs. -0.07 (-2.78 to 2.11), P = 0.04]. In multivariate analyses, baseline vaginal inflammation predicted sPTB (aOR 1.5; 95% CI 1.0-2.3; P = 0.02). Plasma inflammation did not differ by HIV or ART exposure and was not associated with sPTB. CONCLUSION Women not receiving ART at entry into pregnancy care had more vaginal inflammation than women entering on treatment. They also experienced an increase in vaginal inflammation between the two sampling timepoints, possibly as a consequence of ART initiation. Vaginal (but not systemic) inflammation was associated with sPTB and offers a potential mechanistic insight into this important adverse birth outcome.

A Lactobacillus-deficient, anaerobe-rich vaginal microbiome has been associated with local inflammation and spontaneous preterm birth (sPTB), but few studies have assessed this association in the setting of HIV. We performed metagenomic sequencing and inflammatory marker assays on vaginal swabs collected in pregnancy. We grouped samples into 7 metagenomic clusters (mgClust) using the non-redundant VIRGO catalogue, and derived inflammatory scores by factor analysis. Of 221 participants, median Shannon diversity index (SDI) was highest in HIV+ with detectable viral load (1.31, IQR: 0.85–1.66; p Gardnerella metagenomic subspecies > 50% predicted sPTB (RR 2.6; 95%CI: 1.1, 6.4) and was higher in HIV+ (23% vs. 10%; p = 0.001). A novel Gardnerella metagenomic subspecies more abundant in women with HIV predicted sPTB. The risk of sPTB among women with HIV may be mediated by the vaginal microbiome and inflammation, suggesting potential targets for prevention.

A trial of progesterone to prevent preterm birth among HIV-infected Zambian women [Improving Pregnancy Outcomes with Progesterone (IPOP)] found no treatment effect, but the risk of the primary outcome was among the lowest ever documented in women with HIV. In this secondary analysis, we compare the risks of preterm birth (37 weeks), stillbirth, and a composite primary outcome comprising the two in IPOP versus an observational pregnancy cohort [Zambian Preterm Birth Prevention Study (ZAPPS)] in Zambia, to evaluate reasons for the low risk in IPOP.Both studies enrolled women before 24 gestational weeks, during August 2015-September 2017 (ZAPPS) and February 2018-January 2020 (IPOP). We used linear probability and log-binomial regression to estimate risk differences and risk ratios (RR), before and after restriction and standardization with inverse probability weights.The unadjusted risk of composite outcome was 18% in ZAPPS (N = 1450) and 9% in IPOP (N = 791) (RR = 2.0; 95% CI = 1.6, 2.6). After restricting and standardizing the ZAPPS cohort to the distribution of IPOP baseline characteristics, the risk remained higher in ZAPPS (RR = 1.6; 95% CI = 1.0, 2.4). The lower risk of preterm/stillbirth in IPOP was only partially explained by measured risk factors.Possible benefits in IPOP of additional monetary reimbursement, more frequent visits, and group-based care warrant further investigation.

To evaluate the effect of HIV co-infection on non-treponemal titers during pregnancy in women with syphilis.This is a secondary analysis of pregnant women with syphilis in the prospective, observational Zambian Preterm Birth Prevention Study (ZAPPS). Treponemal (Treponema pallidum particle agglutination) and non-treponemal (rapid plasma reagin; RPR) testing were performed on serum biospecimens, resulting in 47 participants with serologically confirmed syphilis (27 HIV-positive, 20 HIV-negative). The primary outcome, achievement of RPR titer seroreduction during pregnancy, was analyzed by logistic regression. Secondary outcomes included overall titer reduction, seroreduction rate, serologic cure, and adverse pregnancy outcomes.Seroreduction of RPR titer occurred in 78% (21/27) of women with HIV versus 45% (9/20) of women without (adjusted odds ratio 4.66; 95% confidence interval [CI] 1.14 - 19.08). Overall RPR titer reduction, rate of seroreduction per week, and the proportion achieving serologic cure each trended higher among women with HIV compared with those without HIV. There was a trend toward decreased stillbirth incidence in participants achieving seroreduction (odds ratio 0.15, 95% CI 0.01-1.58).HIV co-infection in this cohort of Zambian women with syphilis was associated with greater odds of RPR titer seroreduction during pregnancy. Pregnant women with syphilis and HIV may not be at increased risk for a delayed syphilis treatment response compared with women without HIV.

Objectives We investigated whether a woman's role in household decision-making was associated with receipt of services to prevent mother-to-child HIV transmission (PMTCT). Methods We conducted a secondary analysis of the PEARL study, an evaluation of PMTCT effectiveness in Cameroon, Cote d'Ivoire, South Africa, and Zambia. Our exposure of interest was the women's role (active vs. not active) in decision-making about her healthcare, large household purchases, children's schooling, and children's healthcare (i.e., four domains). Our primary outcomes were self-reported engagement at three steps in PMTCT: maternal antiretroviral use, infant antiretroviral prophylaxis, and infant HIV testing. Associations found to be significant in univariable logistic regression were included in separate multivariable models. Results From 2008 to 2009, 613 HIV-infected women were surveyed and provided information about their decision-making roles. Of these, 272 (44.4%) women reported antiretroviral use; 281 (45.9%) reported infant antiretroviral prophylaxis; and 194 (31.7%) reported infant HIV testing. Women who reported an active role were more likely to utilize infant HIV testing services, across all four measured domains of decision-making (adjusted odds ratios [AORs] 2.00-2.89 all p

Vaginal dysbiosis has been shown to increase the risk of some adverse birth outcomes. HIV infection may be associated with shifts in the vaginal microbiome. We characterized microbial communities in vaginal swabs collected between 16–20 gestational weeks in the Zambian Preterm Birth Prevention Study to investigate whether HIV and its treatment alter the microbiome in pregnancy. We quantified relative abundance and diversity of bacterial taxa by whole-genome shotgun sequencing and identified community state types (CST) by hierarchical clustering. Associations between exposures—HIV serostatus (HIV+ vs HIV-) and preconceptional ART (ART+ vs ART-)—and microbiome characteristics were tested with rank-sum, and by linear and logistic regression, accounting for sampling by inverse-probability weighting. Of 261 vaginal swabs, 256 (98%) had evaluable sequences; 98 (38%) were from HIV+ participants, 55 (56%) of whom had preconceptional ART exposure. Major CSTs were dominated by: L. crispatus (CST 1; 17%), L.] iners (CST 3; 32%), Gardnerella vaginalis (CST 4-I; 37%), G. vaginalis & Atopobium vaginae (CST 4-II; 5%), and other mixed anaerobes (CST 4-III; 9%). G. vaginalis was present in 95%; mean relative abundance was higher in HIV+ (0.46±0.29) compared to HIV- participants (0.35±0.33; rank-sum p = .01). Shannon diversity was higher in HIV+/ART+ (coeff 0.17; 95%CI (0.01,0.33), p = .04) and HIV+/ART- (coeff 0.37; 95%CI (0.19,0.55), p < .001) participants compared to HIV-. Anaerobe-dominant CSTs were more prevalent in HIV+/ART+ (63%, AOR 3.11; 95%CI: 1.48,6.55, p = .003) and HIV+/ART- (85%, AOR 7.59; 95%CI (2.80,20.6), p < .001) compared to HIV- (45%). Restricting the comparison to 111 women in either CST 3 (L. iners dominance) or CST 1 (L. crispatus dominance), CST 3 frequency was similar in HIV- (63%) and HIV+/ART- participants (67%, AOR 1.31; 95%CI: (0.25,6.90), p = .7), but higher in HIV+/ART+ (89%, AOR 6.44; 95%CI: (1.12,37.0), p = .04). Pregnant women in Zambia, particularly those with HIV, had diverse anaerobe-dominant vaginal microbiota.

Objective To evaluate the association between severity of prior low birth weight (LBW) delivery and adverse perinatal outcomes in the subsequent delivery among an HIV-prevalent urban African population. Methods A retrospective cohort study was conducted among 41 109 women who had undergone two deliveries in Lusaka, Zambia, between February 1, 2006, and May 31, 2013. The relationship between prior LBW delivery (

There are approximately 284,500 adolescent and adult women living with human immunodeficiency virus (HIV) in the United States. It is estimated that approximately 8500 of these women give birth annually. While the rate of perinatal transmission in the United States has decreased by more than 90% since the early 1990s, potentially preventable HIV transmission events still occur and cause significant morbidity and mortality.The aim of this review was to summarize the current data regarding perinatal HIV transmission timing and risk factors, current management recommendations, and implications of timing of transmission on patient management.Literature review.This review reiterates that the risk of perinatal HIV transmission can be reduced to very low levels by following current recommendations for screening for HIV in all pregnant women and properly treating HIV-infected mothers, as well as using evidence-based labor management practices.Familiarity with the pathogenesis of HIV transmission is important for obstetric care providers to appropriately manage HIV-infected women in pregnancy, intrapartum, and the postpartum period.

Objective To evaluate whether maternal HIV serostatus and plasma viral load (VL) are associated with midtrimester cervical length (CL). Methods The Zambian Preterm Birth Prevention Study (ZAPPS) is an ongoing prospective cohort that began enrolling in Lusaka in August 2015. Pregnant women undergo ultrasound to determine gestational age and return for CL measurement at 16-28 weeks. We evaluated crude and adjusted associations between dichotomous indicators and short cervix (≤2.5 cm) via logistic regression, and between VL and CL as a continuous variable via linear regression. Results This analysis includes 1171 women enrolled between August 2015 and September 2017. Of 294 (25.1%) HIV-positive women, 275 (93.5%) had viral load performed close to CL measurement; of these, 148 (53.8%) had undetectable virus. Median CL was 3.6 cm (IQR 3.5-4.0) and was similar in HIV-infected (3.7 cm, IQR 3.5-4.0) versus uninfected (3.6 cm, IQR 3.5-4.0) participants (P=0.273). The odds of short CL were similar by HIV serostatus (OR 0.64; P=0.298) and detectable VL among those infected (OR 2.37, P=0.323). We observed no association between log VL and CL via linear regression (-0.12 cm; P=0.732). Conclusion We found no evidence of association between HIV infection and short CL.

As antiretroviral therapy (ART) expands in resource-limited settings, understanding the impact of ART on pregnancy outcomes is critical. We analyzed women who became pregnant on ART while enrolled in a clinical trial (HPTN 052, ACTG A5208, and ACTG A5175); the majority of women were from Africa, with a median age of 29 years. Eligible women were on ART at conception and had a documented date of a last menstrual period and a pregnancy outcome. The primary outcome was non-live birth (stillbirth; spontaneous abortion; elective termination; or ectopic pregnancy) versus live birth. Preterm birth (

To evaluate if a pilot programme to prevent mother-to-child transmission (PMTCT) of the human immunodeficiency virus (HIV) was associated with changes in early childhood survival at the population level in rural Zambia.Combination antiretroviral regimens were offered to pregnant and breastfeeding, HIV-infected women, irrespective of immunological status, at four rural health facilities. Twenty-four-month HIV-free survival among children born to HIV-infected mothers was determined before and after PMTCT programme implementation using community surveys. Households were randomly selected and women who had given birth in the previous 24 months were asked to participate. Mothers were tested for HIV antibodies and children born to HIV-infected mothers were tested for viral deoxyribonucleic acid. Multivariable models were used to determine factors associated with child HIV infection or death.In the first survey (2008-2009), 335 of 1778 women (18.8%) tested positive for HIV. In the second (2011), 390 of 2386 (16.3%) tested positive. The 24-month HIV-free survival in HIV-exposed children was 0.66 (95% confidence interval, CI: 0.63-0.76) in the first survey and 0.89 (95% CI: 0.83-0.94) in the second. Combination antiretroviral regimen use was associated with a lower risk of HIV infection or death in children (adjusted hazard ratio: 0.33, 95% CI: 0.15-0.73). Maternal knowledge of HIV status, use of HIV tests and use of combination regimens during pregnancy increased between the surveys.The PMTCT programme was associated with an increased HIV-free survival in children born to HIV-infected mothers. Maternal utilization of HIV testing and treatment in the community also increased.Évaluer si un programme pilote pour prévenir la transmission mère-enfant (PTME) du virus de l'immunodéficience humaine (VIH) est associé à des changements en matière de survie du jeune enfant au sein de la population dans les régions rurales de la Zambie.Des thérapies antirétrovirales combinées ont été proposées à des femmes infectées par le VIH, enceintes et allaitantes, indépendamment de leur statut immunologique, dans quatre centres de santé ruraux. La survie sans VIH à 24 mois chez les enfants nés de mères infectées par le VIH a été déterminée avant et après la mise en œuvre du programme PTME à l'aide d'enquêtes communautaires. Les ménages ont été choisis de manière aléatoire, et il a été demandé aux femmes qui avaient accouché au cours des 24 derniers mois, d'y participer. On a testé la présence d'anticorps anti-VIH chez les mères et d'acide désoxyribonucléique viral chez les enfants nés de mères infectées par le VIH. Des modèles à variables multiples ont été utilisés pour déterminer les facteurs associés à l'infection par le VIH ou au décès de l'enfant.Dans la première étude (2008–2009), 335 femmes parmi 1778 (18,8%) ont été testées positives à l'infection par le VIH. Dans la deuxième étude (2011), 390 femmes parmi 2386 (16,3%) ont été testées positives. La survie sans VIH à 24 mois chez les enfants exposés au VIH était de 0,66 (intervalle de confiance de 95%, IC: 0,63–0,76) dans la première étude et de 0,89 (IC de 95%: 0,83–0,94) dans la seconde. La combinaison de la thérapie antirétrovirale était associée à un risque inférieur d'infection par le VIH ou de décès chez les enfants (rapport de risques ajusté: 0,33, IC de 95%: 0,15–0,73). La connaissance du statut VIH des mères, l'utilisation des tests de dépistage du VIH et des traitements combinés pendant la grossesse ont augmenté entre les études.Le programme PTME était associé à une augmentation de la survie sans VIH chez les enfants nés de mères infectées par le VIH. L'utilisation par les mères du dépistage et du traitement contre le VIH a également augmenté au sein de la communauté.Evaluar si un programa piloto para prevenir la transmisión maternoinfantil (PTMI) del virus de la inmunodeficiencia humana (VIH) está asociado a cambios en la supervivencia en la primera infancia a nivel de población en las zonas rurales de Zambia.Se ofreció una combinación de tratamientos antirretrovirales a mujeres embarazadas y lactantes infectadas por el VIH, independientemente de su estado inmunológico, en cuatro centros de salud rurales. Mediante encuestas en la comunidad se determinó una supervivencia sin VIH de veinticuatro meses entre los niños nacidos de madres infectadas por el VIH antes y después de la implementación del programa PTMI. Los hogares se seleccionaron al azar y se pidió que participaran las mujeres que habían dado a luz en los 24 meses anteriores. Las madres se sometieron a una prueba para detectar los anticuerpos contra el VIH y se realizó una prueba del ácido desoxirribonucleico viral a los niños nacidos de madres infectadas con VIH. Se utilizaron modelos multivariables para determinar los factores asociados con la infección o muerte por VIH del niño.En la primera encuesta (2008–2009), 335 de 1778 mujeres (18,8 %) dieron positivo en el VIH. En la segunda (2011), dieron positivo 390 de 2386 (16,3 %). La supervivencia sin VIH de 24 meses en los niños expuestos al VIH fue del 0,66 (intervalo de confianza del 95 %, IC: 0,63–0,76) en la primera encuesta y del 0,89 (IC del 95 %: 0,83–0,94) en la segunda. La combinación de un tratamiento antirretroviral se asoció con un menor riesgo de infección por VIH o muerte en los niños (razón de riesgo ajustada: 0,33, IC del 95 %: 0,15–0,73). El conocimiento de las madres de su estado serológico, el uso de pruebas para el VIH y los tratamientos combinados durante el embarazo aumentaron en el tiempo transcurrido entre las encuestas.El programa PTMI estuvo asociado a un aumento de la supervivencia sin VIH en los niños nacidos de madres infectadas por el VIH. La utilización materna de la prueba y el tratamiento del VIH en la comunidad también aumentó.تقييم ما إذا كان البرنامج التجريبي لتوقي انتقال فيروس العوز المناعي البشري من الأم إلى الطفل مرتبطاً بالتغيرات في البقاء على قيد الحياة في مرحلة الطفولة المبكرة على صعيد السكان في المناطق الريفية في زامبيا.تم تقديم نظم العلاج التوليفي بمضادات الفيروسات القهقرية إلى النساء الحوامل والمرضعات المصابات بعدوى فيروس العوز المناعي البشري، بغض النظر عن حالتهن المناعية، في أربعة مرافق صحية ريفية. وتم تحديد بقاء الأطفال في سن 24 شهراً على قيد الحياة دون الإصابة بفيروس العوز المناعي البشري بين الأطفال الذين ولدوا لأمهات مصابات بعدوى فيروس العوز المناعي البشري قبل تنفيذ برنامج توقي الانتقال من الأم إلى الطفل وبعده باستخدام دراسات استقصائية مجتمعية. وتم اختيار الأسر المعيشية عشوائياً ومطالبة النساء اللاتي ولدن خلال الأربع والعشرين شهراً السابقة بالمشاركة. وتم اختبار الأمهات للكشف عن أضداد فيروس العوز المناعي البشري، وتم اختبار الأطفال الذين ولدوا لأمهات مصابات بفيروس العوز المناعي البشري للكشف عن الحمض الريبي النووي منزوع الأكسجين الفيروسي. وتم استخدام نماذج متعددة المتغيرات لتحديد العوامل المرتبطة بإصابة الطفل بعدوى فيروس العوز المناعي البشري أو وفاته.كانت نتيجة اختبار 335 سيدة من إجمالي 1778 سيدة (18.8 %) في الدراسة الاستقصائية الأولى (من 2008 إلى 2009) إيجابية لفيروس العوز المناعي البشري. وكانت نتيجة اختبار 390 سيدة من إجمالي 2386 سيدة (16.3 %) في الدراسة الاستقصائية الثانية (2011) إيجابية. وكان بقاء الأطفال في سن 24 شهراً على قيد الحياة دون الإصابة بفيروس العوز المناعي البشري في الأطفال المعرضين لفيروس العوز المناعي البشري 0.66 (فاصل الثقة 95 %، فاصل الثقة: 0.63 –0.76) في الدراسة الاستقصائية الأولى و0.89 (فاصل الثقة: 95 %، فاصل الثقة: 0.83 –0.94) في الدراسة الاستقصائية الثانية. وكان استخدام نظام العلاج التوليفي بمضادات الفيروسات القهقرية مرتبطاً بانخفاض مخاطر الإصابة بعدوى فيروس العوز المناعي البشري أو الوفاة في الأطفال (نسبة المخاطر المصححة: 0.33، فاصل الثقة: 95 %، فاصل الثقة: 0.15 –0.73). وازدادت معرفة الأمهات بحالة فيروس العوز المناعي البشري واستخدام اختبارات فيروس العوز المناعي البشري واستخدام نظم العلاج التوليفي أثناء الحمل بين الدراسات الاستقصائية.ارتبط برنامج توقي الانتقال من الأم إلى الطفل بازدياد بقاء الأطفال الذين ولدوا لأمهات مصابات بعدوى فيروس العوز المناعي البشري على قيد الحياة دون الإصابة بفيروس العوز المناعي البشري. وازداد كذلك استخدام الأمهات لاختبارات فيروس العوز المناعي البشري وعلاجه في المجتمع المحلي.评估赞比亚农村防止艾滋病毒（HIV）母婴传播的试点计划（PMTCT）是否在人口水平上与儿童早期存活的改变有关。在四个农村卫生设施，对于处于怀孕和哺乳期并感染艾滋病毒的妇女，无论其免疫状态如何均提供联合抗逆转录病毒治疗方案。使用社区调查确定PMTCT计划实施之前和之后HIV感染母亲生育的孩子中24月无HIV存活情况。随机选择家庭，并要求在之前24个月生育的妇女参与调查。母亲接受HIV抗体检测，HIV感染母亲所生婴儿接受病毒脱氧核糖核酸检测。使用多变量模型确定与儿童HIV感染或死亡相关的因素。在第一次调查中（2008–2009年），1778名妇女中有335名（18.8%）检测HIV阳性。在第二次调查中（2011年），2386名中有390（16.3%）名检测阳性。在第一次调查中HIV暴露儿童中24月无HIV存活率为0.66（95%置信区间，CI：0.63–0.76），在第二次中为0.89（95% CI：0.83–0.94）。使用联合抗逆转录疗法与更低HIV感染或儿童死亡风险相关（校正危险比：0.33，95% CI：0.15–0.73）。在两次调查之间，母亲HIV知识的状态、使用HIV检测和在怀孕期间使用联合治疗方案的情况有所增强。PMTCT计划与HIV感染母亲所生儿童更高的无HIV生存率有关。社区中母亲使用HIV检测和治疗也有增加。Определить, связана ли пилотная программа по предотвращению передачи от матери к ребенку (ППМР) вируса иммунодефицита человека (ВИЧ) с изменениями в уровне выживаемости в раннем детском возрасте в сельских районах Замбии.В четырех сельских медицинских учреждениях беременным и кормящим ВИЧ-инфицированным женщинам предлагалась комбинированная антиретровирусная терапия вне зависимости от их иммунологического статуса. До и после реализации программы ППМР на основе исследований общин были определены уровни 24-месячной выживаемости без ВИЧ среди детей, рожденных от ВИЧ-инфицированных матерей. Домохозяйства выбирались случайным образом, и женщинам, родившим в течение последних 24 месяцев, предлагалось принять участие в исследовании. Матери были протестированы на наличие антител к ВИЧ, а дети, рожденные от ВИЧ-инфицированных матерей, были проверены на наличие ДНК ВИЧ. Для определения факторов, связанных с инфицированием детей ВИЧ или смертью, использовались многопараметрические модели.В первом исследовании (2008–2009 гг.) 335 из 1778 женщин (18,8%) имели положительный результат на ВИЧ. Во втором исследовании (2011 г.) положительный результат показали 390 из 2386 (16,3%) обследованных женщин. Уровень 24-месячной выживаемости без ВИЧ у детей, подверженных ВИЧ, составил 0,66 (95% доверительный интервал, ДИ: 0,63–0,76) в первом исследовании и 0,89 (95% ДИ: 0,83–0,94) – во втором. Применение комбинированной антиретровирусной терапии сопровождалось более низким риском инфицирования ВИЧ или смерти у детей (скорректированное отношение рисков: 0,33, 95% ДИ: 0,15–0,73). Осведомленность матерей о ВИЧ-статусе, использование тестов на ВИЧ и применение комбинированной терапии во время беременности возросло в период между исследованиями.Программа ППМР сопровождалась увеличением выживаемости без ВИЧ у детей, рожденных от ВИЧ-инфицированных матерей. Также увеличилось число матерей в сельских общинах, проходящих проверку и лечение ВИЧ-инфекции.

OBJECTIVE: To evaluate the effectiveness of maternal combination antiretroviral prophylaxis for prevention of mother-to-child transmission of HIV (PMTCT) in a program setting. DESIGN: Prospective cohort study. SETTING: Nine primary care clinics in rural Zambia. PARTICIPANTS: Two hundred and eighty-four HIV-infected pregnant women at at least 28 weeks gestation initiating PMTCT services between April 2009 and January 2011 and their newborn infants. INTERVENTION: In four intervention sites PMTCT comprised universal combination antiretroviral prophylaxis (i.e. irrespective of CD4 cell count) from pregnancy until the cessation of breastfeeding. In five control sites women received antenatal zidovudine and peripartum nevirapine the standard of care at the time. Prophylaxis during breastfeeding was not available in control sites. MAIN OUTCOME MEASURE: Cumulative infant HIV infection and death at 12 months postpartum. RESULTS: At 12 month postpartum one of 104 (1.0%) infants born to mothers at the intervention sites were HIV-infected compared with 14 of 116 (12.1%) receiving care in the control sites [relative risk (RR): 12.6 95% CI: 2.2-73.1; P = 0.005]. When we considered the composite outcome of HIV infection or death similar trends were observed in the overall study population (RR: 3.4 95% CI: 1.6-7.6; P = 0.002) and in a sub-analysis of women with CD4 cell count more than 350 cells/mul (RR: 3.2; 95% CI: 1.1-9.6; P = 0.04). CONCLUSION: When compared with PMTCT services based on antenatal zidovudine and peripartum nevirapine the provision of maternal combination prophylaxis imparted measurable health benefits to HIV-exposed infants. Implementation research is needed to further tailor and optimize these strategies for similar field settings.

In Lusaka, Zambia, where malaria prevalence is low, national guidelines continue to recommend that all pregnant women receive sulfadoxine-pyrimethamine (SP) for malaria prophylaxis monthly at every scheduled antenatal care visit after 16 weeks of gestation. Human immunodeficiency virus (HIV)-positive women should receive co-trimoxazole prophylaxis for HIV and not SP, but many still receive SP. We sought to determine whether increased dosage of SP is still associated with a reduced risk of low birth weight (LBW) in an area where malaria transmission is low. Our secondary objective was to determine whether any association between SP and LBW is modified by receipt of antiretroviral therapy (ART). We analyzed data routinely collected from a cohort of HIV-positive pregnant women with singleton births in Lusaka, Zambia, between February 2006 and December 2012. We used a log-Poisson model to estimate the risk of LBW by dosage of SP and to determine whether the association between SP and LBW varied by receipt of ART. Risk of LBW declined as the number of doses increased and appeared lowest among women who received three doses (adjusted risk ratio [ARR] = 0.78; 95% confidence interval [CI] = 0.64-0.95). In addition, women receiving combination ART had a higher risk of delivering an LBW infant compared with women receiving no treatment or prophylaxis (ARR = 1.18; 95% CI = 1.09-1.28), but this risk was attenuated among women who were receiving SP (risk ratio = 1.09; 95% CI = 0.99-1.21). SP was associated with a reduced risk of LBW in HIV-positive women, including those receiving ART, in a low malaria prevalence region.

Preterm birth (PTB) is the most common cause of neonatal death worldwide and the second leading cause of under-5 mortality. Low- and middle-income countries (LMICs) bear a disproportionate burden of this disease. An estimated 1 million preterm infants die in the neonatal period each year and many of those who survive face lifelong disability. In this review, we explore the global burden of PTB through an examination of risk factors and predisposing clinical conditions found in LMICs. We then discuss current interventions available to prevent PTB and/or mitigate its clinical sequelae. A major finding of this review is that although the majority of the global PTB disease burden is shouldered by LMICs, very little of the research evidence for its prevention and treatment derives from these settings. Primary research and implementation studies that involve LMIC populations are urgently needed.

Background Although generic anti-retroviral drugs are in common use throughout the developing world, studies comparing their clinical effectiveness with that of proprietary formulations are lacking. Methods We analysed observational data from a large cohort of adults on anti-retroviral therapy (ART) to assess potential differences between generic and proprietary zidovudine (ZDV) formulations in post-90-day mortality, ‘programme failure’ (a composite of death, follow-up losses and withdrawals) and other clinical outcomes. We accounted for drug exposure in three ways: an ‘initial dispensation’ approach that categorized patients according to the first prescription; ‘time-varying’ approach that attributed an outcome to the formulation taken at the time of event; and ‘predominant exposure’ approach that considered only those with >75% exposure to either brand or generic ZDV. Proprietary formulations were used as the reference group in all adjusted Cox proportional hazard regressions. Results Among 14 736 patients eligible for analysis, 7277 (49%) initiated a generic formulation of ZDV and 7459 (51%) initiated a proprietary formulation. When categorized according to initial dispensation, no difference in post-90-day mortality was observed between the two groups [adjusted hazard ratio (AHR): 0.93, 95% confidence interval (CI): 0.77–1.12]. Similar findings were noted when drug formulation was treated as a time-varying exposure (AHR: 1.15, 95% CI: 0.89–1.48) when analysis was limited to those with a predominant exposure to one formulation or the other (AHR: 0.59, 95% CI: 0.24–1.49). Results were consistent across all approaches when programme failure was considered as an outcome. No longitudinal differences were detected between formulations for CD4 response, weight change and haemoglobin concentration. Generic ZDV formulations were associated with slight decreases in single-drug substitution. Conclusions In this large programmatic cohort of adults starting ZDV-based first-line therapy, clinical outcomes appeared similar among patients on generic or proprietary formulations. These findings support continued use of generic anti-retroviral drug formulations in resource-constrained settings.

HIV-1 protease inhibitors (PIs) have antimalarial activity in vitro and in murine models. The potential beneficial effect of HIV-1 PIs on malaria has not been studied in clinical settings. We used data from Adult AIDS Clinical Trials Group A5208 sites where malaria is endemic to compare the incidence of clinically diagnosed malaria among HIV-infected adult women randomized to either lopinavir/ritonavir (LPV/r)-based antiretroviral therapy (ART) or to nevirapine (NVP)-based ART. We calculated hazard ratios and 95% confidence intervals. We conducted a recurrent events analysis that included both first and second clinical malarial episodes and also conducted analyses to assess the sensitivity of results to outcome misclassification. Among the 445 women in this analysis, 137 (31%) received a clinical diagnosis of malaria at least once during follow-up. Of these 137, 72 (53%) were randomized to LPV/r-based ART. Assignment to the LPV/r treatment group ( n = 226) was not consistent with a large decrease in the hazard of first clinical malarial episode (hazard ratio = 1.11 [0.79 to 1.56]). The results were similar in the recurrent events analysis. Sensitivity analyses indicated the results were robust to reasonable levels of outcome misclassification. In this study, the treatment with LPV/r compared to NVP had no apparent beneficial effect on the incidence of clinical malaria among HIV-infected adult women. Additional research concerning the effects of PI-based therapy on the incidence of malaria diagnosed by more specific criteria and among groups at a higher risk for severe disease is warranted.

In resource-limited settings, CD4 testing is a barrier to antiretroviral therapy initiation in pregnancy. We used logistic regression to identify predictors of CD4+ cell count ≤ 350 cells/uL in 20,233 pregnant women. The best-performing model included any 3 of: age ≥ 28 years old, hemoglobin ≤ 9.8 g/dL, gestational age ≤ 30 weeks, weight ≤ 64kg, history of tuberculosis or previous death of an infant prior to one year old. Sensitivity was 45.7% (95% CI: 44.5-47.0), specificity 70.7% (95% CI: 69.6-71.8), and misclassification rate 41.4% (95% CI: 40.5-42.2). CD4 triage remains a critical element of maternal HIV care and PMTCT.

BACKGROUND: Single-dose nevirapine (NVP) is the simplest antiretroviral regimen for the prevention of mother-to-child HIV transmission (PMTCT) in resource-limited settings. We evaluated NVP coverage among HIV-infected delivering women in Cote dIvoire. METHODS: A cross-sectional survey of mother-infant pairs was conducted between November 2007 and September 2008 in 10 randomly selected facilities providing delivery services in the country. All sites used at least NVP for PMTCT. Anonymous HIV test and blood collection for NVP concentration measurement were performed in labor wards. NVP coverage was defined as the proportion of maternal and infant NVP intake confirmed by cord blood chromatography and direct observation. RESULTS: A total of 9953 deliveries were enrolled. Median maternal age was 25 years and the median number of antenatal care (ANC) visits was 3. Of the 9747 women (97.9%) who made at least 1 ANC visit 5880 (60.3%) received an HIV test proposal 5135 (87.3%) accepted it and 251 (4.9%) were diagnosed HIV infected; 176 of them (70.1%) received antiretroviral prophylaxis according to the medical record. Using anonymous cord blood surveillance HIV prevalence was 5.9% (570 of 9646) maternal NVP coverage was 24.3% (138 of 570) and maternal and infant NVP coverage was 17.9% (102 of 570). In multivariate analysis maternal NVP coverage was associated with 2-3 ANC visits [adjusted odds ratio (aOR): 2.61; 95% confidence interval (CI): 1.27 to 5.39] or >/= 4 ANC visits (aOR: 3.84; 95% CI: 1.86 to 7.90) (ref.

Neonatal male circumcision (NMC) is being scaled up in Zambia and elsewhere in Southern Africa as a long-term HIV prevention strategy. We conducted 12 focus group discussions with 129 parents and grandparents in Lusaka, recruited from two sites providing free NMC services and information about NMC, to explore the acceptability of circumcising newborn boys. Most participants recognized the benefits of circumcision for HIV prevention, and the advantages of circumcising their children and grandchildren at a young age. Fear of negative outcomes, concerns about pain, and issues around cultural identity may challenge NMC uptake. To effectively promote the service, the upper age limit for NMC must be emphasized, and fathers must be targeted by messaging campaigns.

BACKGROUND In July 2007, amid some controversy over cost, Zambia was the first African country to introduce tenofovir (TDF) as a component of first-line antiretroviral therapy (ART) on a wide scale. METHODS We compared drug substitutions, mortality, and "programmatic failure" among adults starting TDF-, zidovudine (ZDV)-, and stavudine (d4T)-containing ART. Programmatic failure was defined as death, withdrawal, or loss to follow-up. RESULTS Between July 2007 and January 2009, 10,485 adults initiated ART (66% on TDF, 23% on ZDV, 11% on d4T), with a median follow-up time of 239 (interquartile range 98, 385) days. Those starting TDF were more likely to be male and more likely to have indicators of severe disease at baseline. In adjusted Cox proportional hazards models, ZDV- (adjusted hazard ratio [AHR] = 2.74, 95% confidence interval [CI] = 2.30-3.28) and d4T-based regimens (AHR = 1.92, 95% CI = 1.55-2.38) were associated with higher risk for drug substitution when compared with TDF-based regimens. Similar hazards were noted for overall mortality (ZDV: AHR = 0 .81, 95% CI = 0.62-1.06; d4T: AHR = 1.03, 95% CI = 0.74-1.43) and programmatic failure (ZDV: AHR = 0.99, 95% CI = 0.88-1.11; d4T: AHR = 1.11, 95% CI = 0.96-1.28) when compared with TDF. CONCLUSIONS TDF is associated with similar clinical and programmatic outcomes as ZDV and d4T but appears to be better tolerated. Although further evaluation is needed, these results are encouraging and support Zambia's policy decision.

Objective: HIV-infected women need access to safe and effective contraception. Recent animal and human data suggest that hormonal contraception may accelerate HIV disease progression. Methods: We compared the incidence of HIV disease progression among antiretroviral therapy-naive women with and without exposure to hormonal contraception at 13 sites in Africa and Asia. Disease progression was defined as becoming eligible for antiretroviral therapy or death. Results: Between 1 August 2002 and 31 December 2007, the MTCT-Plus programs enrolled 7846 women. In total, 4109 (52%) women met eligibility criteria for this analysis and contributed 5911 person-years of follow-up (median follow-up, 379 days; interquartile range, 121–833). At baseline, 3064 (75%) women reported using either no contraception or a nonhormonal method, whereas 823 (20%) reported using implants/injectables and 222 (5%) reported using oral contraceptive pills. The disease progression outcome was met by 944 (29%) women (rate, 18.3/100 woman-years). Neither implants/injectables (adjusted hazard ratio 1.0, 95% confidence interval 0.8–1.1) nor oral contraceptive pills (adjusted hazard ratio 0.8, 95% confidence interval 0.6–1.1) were associated with disease progression. Treating contraceptive method as a time-varying exposure did not change this negative finding. Conclusion: This multicountry cohort analysis provides some reassurance that hormonal contraception is not associated with HIV disease progression. Further research is needed to address the contraceptive needs of HIV-infected women.

A single dose of tenofovir/emtricitabine (TDF/FTC) during labor significantly reduces peripartum nevirapine-associated viral drug resistance when measured by consensus HIV sequencing. It is unknown whether this effect extends to HIV subpopulations of25-50%. We conducted a randomized trial of single-dose TDF/FTC added to peripartum nevirapine to reduce drug resistance associated with nonnucleoside reverse transcriptase inhibitors (NNRTIs). To detect mutations for NNRTIs comprisingor = 2% of the viral population, we used an oligonucleotide ligation assay (OLA) at codons 103, 106, 181, and 190 of HIV reverse transcriptase. To assess development of drug resistance mutations to our study intervention, OLA was also performed at codons 65 and 184. Among the 328 women included in the 2-week analysis, those receiving TDF/FTC were less likely to have NNRTI resistance by OLA (RR = 0.40, 95% CI = 0.21-0.77). A similar trend was observed among the 315 women included in the 6-week analysis (RR = 0.45, 95% CI = 0.31-0.66). Only two (1%) specimens had detectable K65R by OLA. Both were at 6 weeks postpartum; one was detected in the intervention arm and one in the control arm (p = 0.96). M184V was not detected. The ability of single-dose TDF/FTC to protect against peripartum NVP-induced NNRTI resistance extends to minority populations. This efficacy is achieved without significant selection of TDF- or FTC-resistant viruses.

BACKGROUND:: HIV-infected women need access to safe contraception. We hypothesized that women using depomedroxyprogesterone acetate (DMPA) contraception would have faster HIV disease progression than women using oral contraceptive pills (OCPs) and nonhormonal methods. METHODS:: In a previously reported trial we randomized 599 HIV-infected women to the intrauterine device (IUD) or hormonal contraception. Women randomized to hormonal contraception chose between OCPs and DMPA. This analysis investigates the relationship between exposure to hormonal contraception and HIV disease progression [defined as death becoming eligible for antiretroviral therapy (ART) or both]. RESULTS:: Of the 595 women not on ART at the time of randomization 302 were allocated to hormonal contraception of whom 190 (63%) initiated DMPA and 112 (37%) initiated OCPs. Women starting IUD OCPs or DMPA were similar at baseline. Compared with women using the IUD the adjusted hazard of death was not significantly increased among women using OCPs [1.24; 95% confidence interval (CI) 0.42-3.63] or DMPA (1.83; 95% CI 0.82-4.08). However women using OCPs (adjusted hazard ratio (AHR) 1.69; 95% CI 1.09-2.64) or DMPA (AHR 1.56; 95% CI 1.08-2.26) trended toward an increased likelihood of becoming eligible for ART. Women exposed to OCPs (AHR 1.67; 95% CI 1.10-2.51) and DMPA (AHR 1.62; 95% CI 1.16-2.28) also had an increased hazard of meeting our composite disease progression outcome (death or becoming ART eligible) than women using the IUD. CONCLUSION:: In this secondary analysis exposure to OCPs or DMPA was associated with HIV disease progression among women not yet on ART. This finding if confirmed elsewhere would have global implications and requires urgent further investigation.

The objective were to determine the impact of adjuvant single-dose peripartum tenofovir/emtricitabine (TDF/FTC) on intrapartum/early postpartum HIV transmission. In the setting of routine short-course zidovudine (ZDV) and peripartum nevirapine (NVP) for perinatal HIV prevention participants were randomized to single-dose TDF (300 mg)/FTC (200 mg) or to no intervention in labor. Six-week infant HIV infection was compared according to actual-use drug regimens. Of 397 women randomized 355 (89%) had infants who were alive and active at 6 weeks postpartum. Of these 18 (5.1%) were infected in utero and 6 (1.8%) were infected intrapartum/early postpartum. Among the 243 who used ZDV and NVP intrapartum/early postpartum transmission was not reduced among infants whose mothers received TDF/FTC compared with those who did not (2 of 123 [1.6%] vs. 3 of 109 [2.8%]; P = 0.67). Among the 49 infants whose mothers did not receive antenatal ZDV but who had confirmed NVP ingestion transmission similarly did notdiffer (0 of 19 [0%] vs. 1 of 26 [3.4%]). TDF/FTC was not significantly associated with reduced overall transmission (odds ratio [OR] = 0.7 95% confidence interval [CI]: 0.3 to 1.6) even when other antiretroviral drugs were considered (adjusted OR = 0.8 95% CI: 0.3 to 1.8). Adjuvant peripartum single-dose TDF/FTC did not reduce perinatal transmission. Whether a higher dose might be effective remains unknown but should be studied in settings in which NVP is used without antenatal ZDV. (authors)

To determine whether prior exposure to single-dose nevirapine (NVP) for prevention of mother-to-child HIV transmission (PMTCT) is associated with attenuated CD4 cell response, death, or clinical treatment failure in women starting antiretroviral therapy (ART) containing non-nucleoside reverse transcriptase inhibitors (NNRTI).Open cohort evaluation of outcomes for women in program sites across Zambia. HIV treatment was provided according to Zambian/World Health Organization guidelines.Peripartum NVP exposure status was known for 6740 women initiating NNRTI-containing ART, of whom 751 (11%) reported prior use of NVP for PMTCT. There was no significant difference in mean CD4 cell change between those exposed or unexposed to NVP at 6 (+202 versus +182 cells/microl; P = 0.20) or 12 (+201 versus +211 cells/microl; P = 0.60) months. Multivariable analyses showed no significant differences in mortality [adjusted hazard ratio (HR), 1.2; 95% confidence interval (CI), 0.8-1.8] or clinical treatment failure (adjusted HR, 1.1; 95% CI, 0.8-1.5). Comparison of recent NVP exposure with remote exposure suggested a less favorable CD4 cell response at 6 (+150 versus +219 cells/microl; P = 0.06) and 12 (+149 versus +215 cells/microl; P = 0.39) months. Women with recent NVP exposure also had a trend towards elevated risk for clinical treatment failure (adjusted HR, 1.6; 95% CI, 0.9-2.7).Exposure to maternal single-dose NVP was not associated with substantially different short-term treatment outcomes. However, evidence was suggestive that exposure within 6 months of ART initiation may be a risk factor for poor treatment outcomes, highlighting the importance of ART screening and initiation early in pregnancy.

Objective To investigate the association between HIV, antiretroviral therapy (ART), and pregnancy-associated hypertension (PAH) in an HIV-endemic setting. Methods A retrospective cohort study was undertaken of pregnant women for whom information was recorded between February 2006 and December 2012 in the Zambia Electronic Perinatal Record System, which captures data from 25 facilities in Lusaka, Zambia. PAH was defined as eclampsia, pre-eclampsia, hypertension, or elevated blood pressure (> 140/80 mm Hg) during delivery admission. Logistic regression estimated the odds of PAH among women by HIV serostatus, and by most recent CD4 T lymphocyte count and ART status among women with HIV infection. Results Among 249 771 women included in the analysis, 5354 (2.1%) had PAH. Compared with women without HIV infection, women with HIV infection not receiving ART had lower odds of PAH (adjusted odds ratio [AOR] 0.86, 95% confidence interval 0.78–0.95), whereas those with HIV infection who had initiated ART had higher odds of PAH (AOR 1.15, 95% CI 1.01–1.32). No association was found between PAH and timing of ART initiation or CD4 lymphocyte count. Conclusion In a large African urban cohort, women with untreated HIV infection had the lowest odds of PAH. Treatment with ART could increase PAH risk beyond that of women without HIV infection and those with untreated infection.

Minimizing time to HIV viral suppression is critical in pregnancy. Integrase strand transfer inhibitors (INSTIs), like raltegravir, are known to rapidly suppress plasma HIV RNA in nonpregnant adults. There are limited data in pregnant women.We describe time to clinically relevant reduction in HIV RNA in pregnant women using INSTI-containing and non-INSTI-containing antiretroviral therapy (ART) options.We conducted a retrospective cohort study of pregnant HIV-infected women in the United States from 2009 through 2015. We included women who initiated ART, intensified their regimen, or switched to a new regimen due to detectable viremia (HIV RNA40 copies/mL) at ≥20 weeks gestation. Among women with a baseline HIV RNA permitting 1-log reduction, we estimated time to 1-log RNA reduction using the Kaplan-Meier estimator comparing women starting/adding an INSTI in their regimen vs other ART. To compare groups with similar follow-up time, we also conducted a subgroup analysis limited to women with ≤14 days between baseline and follow-up RNA data.This study describes 101 HIV-infected pregnant women from 11 US clinics. In all, 75% (76/101) of women were not taking ART at baseline; 24 were taking non-INSTI containing ART, and 1 received zidovudine monotherapy. In all, 39% (39/101) of women started an INSTI-containing regimen or added an INSTI to their ART regimen. Among 90 women with a baseline HIV RNA permitting 1-log reduction, the median time to 1-log RNA reduction was 8 days (interquartile range [IQR], 7-14) in the INSTI group vs 35 days (IQR, 20-53) in the non-INSTI ART group (P.01). In a subgroup of 39 women with first and last RNA measurements ≤14 days apart, median time to 1-log reduction was 7 days (IQR, 6-10) in the INSTI group vs 11 days (IQR, 10-14) in the non-INSTI group (P.01).ART that includes INSTIs appears to induce more rapid viral suppression than other ART regimens in pregnancy. Inclusion of an INSTI may play a role in optimal reduction of HIV RNA for HIV-infected pregnant women presenting late to care or failing initial therapy. Larger studies are urgently needed to assess the safety and effectiveness of this approach.

Given the ambitious targets to reduce pediatric AIDS worldwide, ongoing assessment of programs to prevent mother-to-child HIV transmission (PMTCT) is critical. The concept of a "PMTCT cascade" has been used widely to identify bottlenecks in program implementation; however, most efforts to reconstruct the cascade have relied on facility-based approaches that may limit external validity.We analyzed data from the PEARL household survey, which measured PMTCT effectiveness in 26 communities across Zambia, South Africa, Cote d'Ivoire, and Cameroon. We recruited women who reported a delivery in the past 2 years. Among mothers confirmed to be HIV infected at the time of survey, we reconstructed the PMTCT cascade with self-reported participant information. We also analyzed data about the child's vital status; for those still alive, HIV testing was performed by DNA polymerase chain reaction testing.Of the 976 eligible women, only 355 (36%) completed every step of the PMTCT cascade. Among the 621 mother-child pairs who did not, 22 (4%) reported never seeking antenatal care, 103 (17%) were not tested for HIV during pregnancy, 395 (64%) reported testing but never received their HIV-positive result, 48 (8%) did not receive maternal antiretroviral prophylaxis, and 53 (9%) did not receive infant antiretroviral prophylaxis. The lowest prevalence of infant HIV infection or death was observed in those completing the cascade (10%, 95% confidence interval: 7% to 12%).Future efforts to measure population PMTCT impact should incorporate dimensions explored in the PEARL study-including HIV testing of HIV-exposed children in household surveys-to better understand program effectiveness.

Objectives. HIV-infected women living in resource-constrained nations like Zambia are now accessing antiretroviral therapy and thus may live long enough for HPV-induced cervical cancer to manifest and progress. We evaluated the prevalence and predictors of cervical squamous intraepithelial lesions (SIL) among HIV-infected women in Zambia. Methods. We screened 150 consecutive, non-pregnant HIV-infected women accessing HIV/AIDS care services in Lusaka, Zambia. We collected cervical specimens for cytological analysis by liquid-based monolayer cytology (ThinPrep Pap Test®) and HPV typing using the Roche Linear Array® PCR assay. Results. The median age of study participants was 36 years (range 23–49 years) and their median CD4+ count was 165/μL (range 7–942). The prevalence of SIL on cytology was 76% (114/150), of which 23.3% (35/150) women had low-grade SIL, 32.6% (49/150) had high-grade SIL, and 20% (30/150) had lesions suspicious for squamous cell carcinoma (SCC). High-risk HPV types were present in 85.3% (128/150) women. On univariate analyses, age of the participant, CD4+ cell count, and presence of any high-risk HPV type were significantly associated with the presence of severely abnormal cytological lesions (i.e., high-grade SIL and lesions suspicious for SCC). Multivariable logistic regression modeling suggested the presence of any high-risk HPV type as an independent predictor of severely abnormal cytology (adjusted OR: 12.4, 95% CI 2.62–58.1, p =0.02). Conclusions. The high prevalence of abnormal squamous cytology in our study is one of the highest reported in any population worldwide. Screening of HIV-infected women in resource-constrained settings like Zambia should be implemented to prevent development of HPV-induced SCC.

Each year about 2 million babies are born to HIV-1- infected women. Despite widespread knowledge of proven methods to prevent mother-to-child transmission (MTCT) of the virus most infants at risk of contracting the infection from their mothers receive no prophylactic intervention. This inaction leads to the infection and ultimate death of about 800 000 children per year. It has been known since 1994 that MTCT is largely preventable and interventions appropriate for use in the developing world have been available since 1999. Singledose intrapartum and neonatal nevirapine—the simplest and perhaps most effective of the short-course antiretroviral regimens studied—has been available free of charge from the manufacturer since 2000. Nevertheless few women have access to MTCT-prevention services. In the more than 3 years since its inception the donation programme has shipped only 189 000 courses of the drug a tiny fraction (

To evaluate the safety of combination antiretroviral therapy (ART) in conception and pregnancy in different health systems.A pilot ART registry to measure the prevalence of birth defects and adverse pregnancy outcomes in South Africa and Zambia.HIV-infected pregnant women on ART prior to conception were enrolled until delivery, and their infants were followed until 1 year old.Between October 2010 and April 2011, 600 women were enrolled. The median CD4 cell count at study enrollment was lower in South Africa than Zambia (320 vs. 430 cells/μl; P 0.01). The most common antiretroviral drugs at the time of conception included stavudine, lamivudine, and nevirapine. There were 16 abortions (2.7%), one ectopic pregnancy (0.2%), 12 (2.0%) stillbirths, and 571 (95.2%) live infants. Deliveries were more often preterm (29.7 vs. 18.4%; P = 0.01) and the infants had lower birth weights (2900 vs. 2995 g; P = 0.11) in Zambia compared to South Africa. Thirty-six infants had birth defects: 13 major and 23 minor. There were more major anomalies detected in South Africa and more minor ones in Zambia. No neonatal deaths were attributed to congenital birth defects.An Africa-specific, multi-site antiretroviral drug safety registry for pregnant women is feasible. Different prevalence for preterm delivery, delivery mode, and birth defect types between women on preconception ART in South Africa and Zambia highlight the potential impact of health systems on pregnancy outcomes. As countries establish ART drug safety registries, documenting health facility limitations may be as essential as the specific ART details.

At the start of 2007 an estimated 2.3 million children in sub-Saharan Africa were infected with HIV most of whom had acquired the virus around the time of birth. As services in the region move toward more complicated and efficacious drug regimens for prevention of mother-to-child transmission of HIV (PMTCT) acceptability is a critical component to overall program effectiveness. Several studies have observed poor follow-up among patients concerned about stigma or disclosure of their HIV status. The risk of viral drug resistance after use of drugs such as nevirapine (NVP) may only add to a patients reluctance to adhere to specific PMTCT drug regimens. We evaluated a pilot program designed specifically to link PMTCT services provided routinely as part of antenatal care to long-term HIV care and treatment in Lusaka Zambia. Kanyama Health Center is among the largest of the Lusaka Districts 24 primary care centers and the site of robust government programs for PMTCT and antiretroviral therapy (ART). To link PMTCT to HIV care and treatment we implemented specific referral procedures. This began with a scripted talk on the benefits of long-term HIV care and the importance of CD4+ cell count screening. All women were encouraged to enroll into long-term HIV care and treatment. Women interested in enrollment that day were escorted by community health workers to the on-site HIV care and treatment facility and seen immediately. (excerpt)

Neonatal male circumcision (NMC) is not routinely practiced in Zambia, but it is a promising long-term HIV prevention strategy. We studied the feasibility and safety of three different NMC methods.We enrolled healthy newborns in a controlled trial of the Mogen, Gomco, and Plastibell devices. Doctors, nurses, and clinical officers were trained to perform Mogen, Gomco, and Plastibell techniques. Each provider performed at least 10 circumcisions using each device. Neonates were reviewed at 1 and 6 weeks after circumcision for adverse events.Between October 2009 and March 2011, 17 providers (5 physicians, 9 nurse midwives, and 3 clinical officers) without previous NMC experience were trained, and 640 circumcisions were performed. The median infant birth weight was 3.2 kg (interquartile range: 2.9-3.5 kg), and median age at the time of procedure was 11 days (interquartile range: 7-18 days); 149 babies (23.3%) were exposed to HIV. The overall adverse event rate was 4.9% (n = 31/630), and the moderate-severe adverse event rate was 4.1% (n = 26/630). Rates did not significantly differ by method. Most providers (65%) preferred Mogen clamp over Gomco and Plastibell.Doctors, nurses, and clinical officers can be trained to safely provide NMC in a programmatic setting. The 3 studied techniques had comparable safety profiles. Mogen clamp was the preferred device for most providers.

BACKGROUND: The effectiveness of prevention of mother-to-child transmission of HIV (PMTCT) programs depends on the successful coverage of a series of interventions through pregnancy intrapartum and postpartum. Routine monitoring systems based on service data and limited to women on the PMTCT program may overestimate intervention coverage at multiple points along this cascade. METHODS: Cord blood specimens with individually linked anonymous demographic and pregnancy data were collected from 3 delivery services in the Western Cape Province South Africa and screened for HIV. Seropositive specimens were tested for the presence of antiretrovirals. Comparisons were drawn between documented service data and cord blood findings for HIV seroprevalence and antenatal antiretroviral coverage. RESULTS: A total of 3034 specimens were tested for HIV 507 (16.7%) of which were HIV seropositive. Of these 470 (92.7%) were tested for the presence of antiretrovirals of whom 58.1% had evidence of a standard of care maternal antiretroviral regimen and 73.6% some form of antenatal antiretroviral prophylaxis. Cord blood antiretroviral coverage was lower than that reported by service data. Incomplete antenatal HIV testing accounted for an estimated 46.2% of missed opportunities for transmission reduction. DISCUSSION: Even in this well-resourced setting HIV screening and ensuring antenatal compliance with prescribed regimens were the most immediate priorities for reducing vertical transmission. Cord blood surveillance offers a unique opportunity to explore missed opportunities using methods not currently possible from routine antenatal and PMTCT program reporting.

BACKGROUND: Health facility characteristics associated with effective prevention of mother-to-child transmission of HIV (PMTCT) coverage in sub-Saharan are poorly understood. METHODOLOGY/PRINCIPAL FINDINGS: We conducted surveys in health facilities with active PMTCT services in Cameroon, Cote d'Ivoire, South Africa, and Zambia. Data was compiled via direct observation and exit interviews. We constructed composite scores to describe provision of PMTCT services across seven topical areas: antenatal quality, PMTCT quality, supplies available, patient satisfaction, patient understanding of medication, and infrastructure quality. Pearson correlations and Generalized Estimating Equations (GEE) to account for clustering of facilities within countries were used to evaluate the relationship between the composite scores, total time of visit and select individual variables with PMTCT coverage among women delivering. Between July 2008 and May 2009, we collected data from 32 facilities; 78% were managed by the government health system. An opt-out approach for HIV testing was used in 100% of facilities in Zambia, 63% in Cameroon, and none in Côte d'Ivoire or South Africa. Using Pearson correlations, PMTCT coverage (median of 55%, (IQR: 33-68) was correlated with PMTCT quality score (rho = 0.51; p = 0.003); infrastructure quality score (rho = 0.43; p = 0.017); time spent at clinic (rho = 0.47; p = 0.013); patient understanding of medications score (rho = 0.51; p = 0.006); and patient satisfaction quality score (rho = 0.38; p = 0.031). PMTCT coverage was marginally correlated with the antenatal quality score (rho = 0.304; p = 0.091). Using GEE adjustment for clustering, the, antenatal quality score became more strongly associated with PMTCT coverage (p

HIV protease inhibitors (PIs) show antimalarial activity in vitro and in animals. Whether this translates into a clinical benefit in HIV-infected patients residing in malaria-endemic regions is unknown. We studied the incidence of malaria, as defined by blood smear positivity or a positive Plasmodium falciparum histidine-rich protein 2 antigen test, among 444 HIV-infected women initiating antiretroviral treatment (ART) in the OCTANE trial (A5208; ClinicalTrials.gov: NCT00089505). Participants were randomized to treatment with PI-containing vs. PI-sparing ART, and were followed prospectively for ≥48 weeks; 73% also received cotrimoxazole prophylaxis. PI-containing treatment was not associated with protection against malaria in this study population.

Although tenofovir (TDF) is a common component of antiretroviral therapy (ART), recent evidence suggests inferior outcomes when it is combined with nevirapine (NVP).We compared outcomes among patients initiating TDF + emtricitabine or lamivudine (XTC) + NVP, TDF + XTC + efavirenz (EFV), zidovudine (ZDV) + lamuvidine (3TC) + NVP, and ZDV + 3TC + EFV. We categorized drug exposure by initial ART dispensation by a time-varying analysis that accounted for drug substitutions and by predominant exposure (75% of drug dispensations) during an initial window period. Risks for death and program failure were estimated using Cox proportional hazard models. All regimens were compared with ZDV + 3TC + NVP.Between July 2007 and November 2010, 18,866 treatment-naive adults initiated ART: 18.2% on ZDV + 3TC + NVP, 1.8% on ZDV + 3TC + EFV, 36.2% on TDF + XTC + NVP, and 43.8% on TDF + XTC + EFV. When exposure was categorized by initial prescription, patients on TDF + XTC + NVP [adjusted hazard ratio (AHR): 1.45; 95% confidence interval (CI): 1.03 to 2.06] had a higher post-90-day mortality. TDF + XTC + NVP was also associated with an elevated risk for mortality when exposure was categorized as time-varying (AHR: 1.51; 95% CI: 1.18 to 1.95) or by predominant exposure over the first 90 days (AHR: 1.91, 95% CI: 1.09 to 3.34). However, these findings were not consistently observed across sensitivity analyses or when program failure was used as a secondary outcome.TDF + XTC + NVP was associated with higher mortality when compared with ZDV + 3TC + NVP but not consistently across sensitivity analyses. These findings may be explained in part by inherent limitations to our retrospective approach, including residual confounding. Further research is urgently needed to compare the effectiveness of ART regimens in use in resource-constrained settings.

OBJECTIVES: To determine the impact of time between initiating highly active antiretroviral therapy (HAART) and delivery-duration of antenatal HAART-on perinatal HIV infection. DESIGN: We conducted a retrospective cohort analysis of pregnant HIV-infected women in Lusaka Zambia. Women in our cohort were receiving HAART and had an infant HIV polymerase chain reaction test between 3 and 12 weeks of life. METHODS: We examined factors associated with infant HIV infection and performed a locally weighted regression analysis to examine the effect of duration of antenatal HAART on perinatal HIV infection. RESULTS: : From January 2007 to March 2010 1813 HIV-infected pregnant women met inclusion criteria. Mean gestational age at first antenatal visit was 21 weeks (SD +/- 6) median CD4+ cell count was 231 cells per microliter (interquartile range: 164-329) and median duration of antenatal HAART was 13 weeks (interquartile range 8-19). Fifty-nine (3.3%) infants were HIV infected. Duration of antenatal HAART was the most important predictor of perinatal HIV transmission. Compared with women initiating HAART at least 13 weeks before delivery women on HAART for

Objective To characterize prenatal and delivery care in an urban African setting. Methods The Zambia Electronic Perinatal Record System (ZEPRS) was implemented to record demographic characteristics, past medical and obstetric history, prenatal care, and delivery and newborn care for pregnant women across 25 facilities in the Lusaka public health sector. Results From June 1, 2007, to January 31, 2010, 115 552 pregnant women had prenatal and delivery information recorded in ZEPRS. Median gestation age at first prenatal visit was 23 weeks (interquartile range [IQR] 19–26). Syphilis screening was documented in 95 663 (83%) pregnancies: 2449 (2.6%) women tested positive, of whom 1589 (64.9%) were treated appropriately. 111 108 (96%) women agreed to HIV testing, of whom 22% were diagnosed with HIV. Overall, 112 813 (98%) of recorded pregnancies resulted in a live birth, and 2739 (2%) in a stillbirth. The median gestational age was 38 weeks (IQR 35–40) at delivery; the median birth weight of newborns was 3000 g (IQR 2700–3300 g). Conclusion The results demonstrate the feasibility of using a comprehensive electronic medical record in an urban African setting, and highlight its important role in ongoing efforts to improve clinical care.

HIV-infected women in sub-Saharan Africa are at substantial risk of unintended pregnancy and sexually transmitted infections (STIs). Linkages between HIV and reproductive health services are advocated. We describe implementation of a reproductive health counseling intervention in 16 HIV clinics in Lusaka, Zambia. Between November 2009 and November 2010, 18,407 women on antiretroviral treatment (ART) were counseled. The median age was 34.6 years (interquartile range (IQR): 29.9–39.7), and 60.1% of women were married. The median CD4+ cell count was 394 cells/uL (IQR: 256–558). Of the women counseled, 10,904 (59.2%) reported current modern contraceptive use. Among contraceptive users, only 17.7% reported dual method use. After counseling, 737 of 7,503 women not previously using modern contraception desired family planning referrals, and 61.6% of these women successfully accessed services within 90 days. Unmet contraceptive need remains high among HIV-infected women. Additional efforts are needed to promote reproductive health, particularly dual method use.

Context Few studies have objectively evaluated the coverage of services to prevent transmission of human immunodeficiency virus (HIV) from mother to child. Objective To measure the coverage of services to prevent mother-to-child HIV transmission in 4 African countries. Design, Setting, and Patients Cross-sectional surveillance study of mother-infant pairs using umbilical cord blood samples collected between June 10, 2007, and October 30, 2008, from 43 randomly selected facilities (grouped as 25 service clusters) providing delivery services in Cameroon, Cote d’Ivoire, South Africa, and Zambia. All sites used at least single-dose nevirapine to prevent mother-to-child HIV transmission and some sites used additional prophylaxis drugs. Main Outcome Measure Population nevirapine coverage, defined as the proportion of HIV-exposed infants in the sample with both maternal nevirapine ingestion (confirmed by cord blood chromatography) and infant nevirapine ingestion (confirmed by direct observation). Results A total of 27 893 cord blood specimens were tested, of which 3324 were HIV seropositive (12%). Complete data for cord blood nevirapine results were available on 3196 HIV-seropositive mother-infant pairs. Nevirapine coverage varied significantly by site (range: 0%-82%). Adjusted for country, the overall coverage estimate was 51% (95% confidence interval [CI], 49%-53%). In multivariable analysis, failed coverage of nevirapine-based services was significantly associated with maternal age younger than 20 years (adjusted odds ratio [AOR], 1.44; 95% CI, 1.18-1.76) and maternal age between 20 and 25 years (AOR, 1.28; 95% CI, 1.07-1.54) vs maternal age of older than 30 years; 1 or fewer antenatal care visits (AOR, 2.91; 95% CI, 2.40-3.54), 2 or 3 antenatal care visits (AOR, 1.93; 95% CI, 1.60-2.33), and 4 or 5 antenatal care visits (AOR, 1.56; 95% CI, 1.34-1.80) vs 6 or more antenatal care visits; vaginal delivery (AOR, 1.22; 95% CI, 1.03-1.44) vs cesarean delivery; and infant birth weight of less than 2500 g (AOR, 1.34; 95% CI, 1.11-1.62) vs birth weight of 3500 g or greater. Conclusion In this random sampling of sites with services to prevent mother-to-child HIV transmission, only 51% of HIV-exposed infants received the minimal regimen of single-dose nevirapine.

BACKGROUND: The objective of the study was to evaluate whether providing antiretroviral therapy (ART) integrated in antenatal care (ANC) clinics resulted in a greater proportion of treatment-eligible women initiating ART during pregnancy compared with the existing approach of referral to ART. ANALYSIS DESIGN AND METHODS: The evaluation used a stepped-wedge design and included all HIV-infected ART-eligible pregnant women in eight public sector clinics in Lusaka district Zambia. Main outcome indicators were the proportion of treatment-eligible pregnant women enrolling into HIV care within 60 days of HIV diagnosis and of these the proportion initiating ART during pregnancy. Adjusted odds ratios (AORs) and confidence intervals (CIs) for enrollment and initiation proportions were estimated through a logistic regression model accounting for clinical site cluster and time effects. RESULTS: Between 16 July 2007 and 31 July 2008 13917 women started antenatal care more than 60 days before the intervention rollout and constituted the control cohort; 17 619 started antenatal care after ART integrated into ANC and constituted the intervention cohort. Of the 1566 patients found eligible for ART a greater proportion enrolled while pregnant and within the 60 days of HIV diagnosis in the intervention cohort (376/846 44.4%) compared with the control cohort (181/716 25.3%) AOR 2.06 95% CI (1.27-3.34); and initiated ART while pregnant in the intervention cohort (278/846 32.9%) compared with the control cohort (103/716 14.4%) AOR 2.01 95% CI (1.37-2.95). CONCLUSION: An integrated ART in ANC strategy doubled the proportion of treatment-eligible women initiating ART while pregnant.

BACKGROUND: The provision of food supplementation to food-insecure patients initiating antiretroviral therapy (ART) may improve adherence to medications. METHODS: A home-based adherence support program at 8 government clinics assessed patients for food insecurity. Four clinics provided food supplementation and 4 acted as controls. The analysis compared adherence (assessed by medication possession ratio) CD4 and weight gain outcomes among food-insecure patients enrolled at the food clinics with those enrolled at the control clinics. RESULTS: Between May 1 2004 and March 31 2005 636 food- insecure adults were enrolled. Food supplementation was associated with better adherence to therapy. Two hundred fifty-eight of 366 (70%) patients in the food group achieved a medication possession ratio of 95% or greater versus 79 of 166 (48%) among controls (relative risk = 1.5; 95% confidence interval: 1.2 to 1.8). This finding was unchanged after adjustment for sex age baseline CD4 count baseline World Health Organization stage and baseline hemoglobin. We did not observe a significant effect of food supplementation on weight gain or CD4 cell response. CONCLUSIONS: This analysis suggests that providing food to food-insecure patients initiating ART is feasible and may improve adherence to medication. A large randomized study of the clinical benefits of food supplementation to ART patients is urgently needed to inform international policy.

Objective: To examine the association between baseline renal insufficiency and mortality among adults initiating antiretroviral therapy (ART) in an urban African setting. Design: Open cohort evaluation. Methods: We examined mortality according to baseline renal function among adults initiating ART in Lusaka Zambia. Renal function was assessed by the Cockcroft-Gault method the Modification of Diet in Renal Disease equation and serum creatinine. Results: From April 2004 to September 2007 25 779 individuals started ART with an available creatinine measurement at baseline. When creatinine clearance was calculated by the Cockcroft-Gault method 8456 (33.5%) had renal insufficiency: 73.5% were mild (60-89 ml/min) 23.4% moderate (30-59 ml/min) and 3.1% severe (

Summary Background Intrapartum and neonatal single-dose nevirapine are essential components of perinatal HIV prevention in resource-constrained settings, but can induce resistance to other non-nucleoside reverse transcriptase inhibitor drugs. We aimed to investigate whether this complication would be reduced with a single peripartum intervention of tenofovir and emtricitabine. Methods We randomly assigned 400 HIV-infected pregnant women who sought care at two public-sector primary health facilities in Lusaka, Zambia. One was excluded, 200 were assigned to receive a single oral dose of 300 mg tenofovir disoproxil fumarate with 200 mg emtricitabine under direct observation, and 199 to receive no study drug. Short-course zidovudine and intrapartum nevirapine were offered to all HIV-infected women, according to the local standard of care. Women who met national criteria for antiretroviral therapy were referred for care and not enrolled. Our primary study outcome was resistance to non-nucleoside reverse transcriptase inhibitors at 6 weeks after delivery. We used standard population sequencing to determine HIV genotypes. Analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00204308. Findings Of the 200 women who were randomly assigned to the intervention, 14 were lost to follow-up or withdrew from the study, two did not take study drug according to protocol, and one specimen was lost; 23 of 199 controls were lost to follow-up or withdrew from the study, and three specimens were lost. Women given the intervention were 53% less likely than controls to have a mutation that conferred resistance to non-nucleoside reverse transcriptase inhibitors at 6 weeks after delivery (20/173 [12%] vs 41/166 [25%]; risk ratio [RR] 0·47, 95% CI 0·29–0·76). We noted postpartum anaemia, the most common serious adverse event in mothers, in four women in each group. 20 of 198 (10%) infants in the intervention group and 23 of 199 (12%) controls had a serious adverse event, mostly due to septicaemia (n=22) or pneumonia (n=8); these events did not differ between groups, and none were judged to be caused by the study intervention. Interpretation A single dose of tenofovir and emtricitabine at delivery reduced resistance to non-nucleoside reverse transcriptase inhibitors at 6 weeks after delivery by half; therefore this treatment should be considered as an adjuvant to intrapartum nevirapine.

The Zambian Ministry of Health provides pediatric antiretroviral therapy (ART) at primary care clinics in Lusaka, where, despite scale-up of perinatal prevention efforts, many children are already infected with the human immunodeficiency virus (HIV).To report early clinical and immunologic outcomes of children enrolled in the pediatric treatment program.Open cohort assessment using routinely collected clinical and outcome data from an electronic medical record system in use at 18 government primary health facilities in Lusaka, Zambia. Care was provided primarily by nurses and clinical officers ("physician extenders" akin to physician assistants in the United States). Patients were children (16 years of age) presenting for HIV care between May 1, 2004, and June 29, 2007.Three-drug ART (zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz) for children who met national treatment criteria.Survival, weight gain, CD4 cell count, and hemoglobin response.After enrollment of 4975 children into HIV care, 2938 (59.1%) started ART. Of those initiating ART, the median age was 81 months (interquartile range, 36-125), 1531 (52.1%) were female, and 2087 (72.4%) with World Health Organization stage information were in stage III or IV. At the time of analysis, 158 children (5.4%) had withdrawn from care and 382 (13.0%) were at least 30 days late for follow-up. Of the remaining 2398 children receiving ART, 198 (8.3%) died over 3018 child-years of follow-up (mortality rate, 6.6 deaths per 100 child-years; 95% confidence interval [CI], 5.7-7.5); of these deaths, 112 (56.6%) occurred within 90 days of therapy initiation (early mortality rate, 17.4/100 child-years; post-90-day mortality rate, 2.9/100 child-years). Mortality was associated with CD4 cell depletion, lower weight-for-age, younger age, and anemia in multivariate analysis. The mean CD4 cell percentage at ART initiation among the 1561 children who had at least 1 repeat measurement was 12.9% (95% CI, 12.5%-13.3%) and increased to 23.7% (95% CI, 23.1%-24.3%) at 6 months, 27.0% (95% CI, 26.3%-27.6%) at 12 months, 28.0% (95% CI, 27.2%-28.8%) at 18 months, and 28.4% (95% CI, 27.4%-29.4%) at 24 months.Care provided by clinicians such as nurses and clinical officers can result in good outcomes for HIV-infected children in primary health care settings in sub-Saharan Africa. Mortality during the first 90 days of therapy is high, pointing to a need for earlier intervention.

Prevention of mother-to-child human immunodeficiency virus (HIV) transmission (PMTCT) programs have nearly eliminated mother-to-child transmission of HIV in developed countries, but progress in resource-limited countries has been slow. A key factor limiting the scale-up of PMTCT programs is lack of knowledge of HIV serostatus. Increasing the availability and acceptability of HIV testing and counseling services will encourage more women to learn their status, providing a gateway to PMTCT interventions. Key factors contributing to the scale-up of testing and counseling include a policy of provider-initiated testing and counseling with right to refuse (opt-out); group pretest counseling; rapid HIV testing; innovative staffing strategies; and community and male involvement. Integration of testing and counseling within the community and all maternal and child health settings are critical for scaling-up and for linking women and their families to care and treatment services. This paper will review best practices needed for expansion of testing and counseling in PMTCT settings in resource-limited countries.

Objective The purpose of this study was to determine whether the intrauterine contraceptive device (IUD) is effective and safe among women who are infected with the human immunodeficiency virus (HIV). Study Design We randomly assigned 599 postpartum, HIV-infected women in Zambia to receive either a copper IUD or hormonal contraception and followed them for at least 2 years. Results Women who were assigned randomly to hormonal contraception were more likely to become pregnant than those who were assigned randomly to receive an IUD (rate, 4.6/100 vs 2.0/100 woman-years; hazards ratio, 2.4; 95% CI, 1.3-4.7). One woman who was assigned to the IUD experienced pelvic inflammatory disease (crude rate, 0.16/100 woman-years; 95% CI, 0.004-868); there was no pelvic inflammatory disease among those women who were assigned to hormonal contraception. Clinical disease progression (death or CD4+ lymphocyte count dropping below 200 cells/μL) was more common in women who were allocated to hormonal contraception (13.2/100 woman-years) than in women who were allocated to the IUD (8.6/100 woman-years; hazard ratio, 1.5; 95% CI, 1.04-2.1). Conclusion The IUD is effective and safe in HIV-infected women. The unexpected observation that hormonal contraception was associated with more rapid HIV disease progression requires urgent further study.

One quarter of pregnant women in Zambia are infected with HIV. Understanding how knowledge of HIV relates to personal risk perception and avoidance of risky behaviors is critical to devising effective HIV prevention strategies. In conjunction with a large clinical trial in Lusaka, Zambia, we surveyed postpartum women who had been tested for HIV but did not know their status before undergoing the questionnaire. Of 858 women for whom complete data were available, 248 (29%) were HIV infected. Women 22 years of age or older (adjusted odds ratio [AOR], 1.7; 95% confidence interval [CI], 1.1-2.5), women reportingor =2 sexual partners in their lifetime (AOR, 1.8; 95% CI, 1.3-2.5), and women reporting a history of a sexually transmitted infection (AOR, 2.7; 95% CI, 1.7-4.3) were more likely to be HIV infected. Having hador =2 lifetime sexual partners was a marker for perception of high personnel risk for HIV infection (AOR, 1.5; 95% CI, 1.1-2.1). However, there was no relationship between perceived risk of HIV infection and actual HIV status. In fact, 127 (52%) of 245 women who stated that they were at no or low risk for HIV infection were HIV infected. Living in an area of high HIV seroprevalence like Zambia seems to be the greatest risk factor for infection in unselected pregnant women. Before significant inroads can be made in decreasing the incidence of HIV infection among pregnant women, population-based strategies that involve men must be implemented.