Objective To assess the impact of routine antenatal HIV testing for preventing mother-to-child transmission of HIV (PMTCT) in urban Zimbabwe. Methods Community counsellors were trained in routine HIV testing policy using a specific training module from June 2005 through November 2005. Key outcomes during the first 6 months of routine testing were compared with the prior 6-month "opt-in" period, and clients were interviewed. Findings Of the 4551 women presenting for antenatal care during the first 6 months of routine HIV testing, 4547 (99.9%) were tested for HIV compared with 3058 (65%) of 4700 women during the last 6 months of the opt-in testing (P < 0.001), with a corresponding increase in the numbers of HIV-infected women identified antenatally (926 compared with 513, P < 0.001). During routine testing, more HIV-infected women collected results compared to the opt-in testing (908 compared with 487, P < 0.001) resulting in a significant increase in deliveries by HIV-infected women (256 compared with 186, P = 0.001); more mother/infant pairs received antiretroviral prophylaxis (n = 256) compared to the opt-in testing (n = 185); and more mother/infant pairs followed up at clinics (105 compared with 49, P = 0.002). Women were satisfied with counselling services and most (89%) stated that offering routine testing is helpful. HIV-infected women reported low levels of spousal abuse and other adverse social consequences.
The Shona version of the EPDS is a reliable and valid tool to screen for PND among HIV-infected and un-infected women in Zimbabwe. Screening for PND should be integrated into routine antenatal and postnatal care in areas with high HIV prevalence.
Summary
Background
Nevirapine given once-daily for the first 6, 14, or 28 weeks of life to infants exposed to HIV-1via 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 primaryefficacy 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.
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.
BACKGROUNDThe 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.
METHODSIn 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.
RESULTSA 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 personyears 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).
CONCLUSIONSThe 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.
Our data indicate a high burden of PND among women in Zimbabwe. It is feasible to screen for PND in primary care clinics using peer counselors. Screening for PND and access to mental health interventions should be part of routine antenatal care for all women in Zimbabwe.
Objective
Integrate enhanced family planning (FP) and prevention of mother-to-child HIV transmission (PMTCT) 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 three months post-partum. 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, binomial, and t-tests.
Results
The intervention cohort reported increased control over condom use (p=0.002), increased knowledge about IUDs (p=0.002), increased relationship power (p=0.01), and increased likelihood of disclosing their HIV status to a partner (p=0.04) and having that partner disclose to them (p=0.04), when compared to the SOC cohort. Long-acting reversible contraception (LARC) use in both groups increased from ~2% at baseline to >80% at three months post-partum (p<0.001).
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.
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