OBJECTIVES: To identify factors affecting recruitment into a randomised trial involving HIV infected pregnant women. To compare the population enrolled in a Phase III trial to that enrolled during the same period in a parallel longitudinal cohort, and to assess the generalisability of the trial results. MATERIAL AND METHODS: The PACTG 316 trial was initiated in the USA and subsequently extended to Europe. Based on their involvement in an ongoing European cohort study, clinicians in 27 antenatal HIV reference centres in Italy, Spain, Sweden, UK, Belgium, Germany, Switzerland, Netherlands and Denmark were asked to participate. In centres with local, national and American approval, eligible women attending antenatal clinics were offered the chance to take part in the trial, which aimed to evaluate the additional use of nevirapine during labour and neonatally to reduce HIV mother-to-child transmission (MTCT). HIV-infected women who did not enrol in the trial were enrolled in the European Collaborative Study (ECS). Reasons for non-randomisation were recorded. Clinical and laboratory information on mother-child pairs were collected according to a standard protocol. RESULTS: Between February 1999 and June 2000, 247 women were enrolled in the ECS cohort and 118 were randomised in the 316 trial. Reasons for non-randomisation included the presence of the placebo arm, randomisation procedures and delays in obtaining approval from the various regulatory bodies. Women in the trial were younger, and their HIV disease was less advanced than those included in the ECS. The MTCT rate in the ECS was higher than in the trial. CONCLUSIONS: Differences between women who participated in the trial and those who did not had an effect on the absolute vertical transmission rate, but not on the relative effectiveness of the intervention assessed within the trial. Extrapolation of the trial MTCT rates to the general HIV infected population may be inappropriate.
Aims: To compare clinical status, mother-to-child transmission (MTCT) rates, use of prevention of (PMTCT) interventions and pregnancy outcomes between HIV-infected injecting drug users (IDUs) and non-IDUs. Design and setting: Prospective cohort study conducted in 7 HIV/AIDS Centres in Ukraine, 2000-2010. Participants: Pregnant HIV-infected women, identified before/during pregnancy or intrapartum, and their live-born infants (n = 6200); 1028 women followed post-partum. Measurements: Maternal and delivery characteristics, PMTCT prophylaxis, MTCT rates, preterm delivery (PTD), low birth weight (LBW). Findings: Of 6200 women, 1111 (18%) reported current/previous IDU. The proportion of IDUs diagnosed with HIV before conception increased from 31% in 2000/01 to 60% in 2008/9 (p
BACKGROUND: Despite the availability of effective interventions for the prevention of mother-to-child transmission (PMTCT), questions remain regarding implementation of programmes in settings with limited resources. This article sets out to describe the first 2 years of the implementation of the national PMTCT programme in Ukraine. METHODS: National data sources and data from a cohort of pregnant HIV-infected women delivering in 13 centres in Ukraine since 2000 were analysed. RESULTS: Interventions for prevention of MTCT have been implemented as a national programme within Ukraine's well developed infrastructure for maternal and child health. Implementation of an 'opt-out' model of counselling and HIV testing in antenatal clinics resulted in a 97% uptake of women who agreed to be HIV tested. In 2002, approximately 91% of HIV-positive pregnant women received ARV prophylaxis (mainly single-dose nevirapine or short-course zidovudine) for PMTCT. The MTCT rate has decreased from 30% in 2000 to 10% in 2002. The need to scale-up prevention interventions in pregnant women with risky behaviour and late access to medical services was identified in a review of the national programme in 2003. CONCLUSIONS: Further implementation of a comprehensive approach for the prevention of HIV infection in infants, including more extensive ART regimen, as recommended by WHO, would help Ukraine to achieve the strategic goal of virtual elimination of HIV infection in infants by 2010.