ObjectiveThe objective of this trial was to determine the effectiveness of 1.0% C31G (SAVVY) in preventing male-to-female vaginal transmission of HIV infection among women at high risk.Methodology/Principal FindingsThis was a Phase 3, double-blind, randomized, placebo-controlled trial. Participants made up to 12 monthly visits for HIV testing, adverse event reporting, and study product supply. The study was conducted between March 2004 and February 2006 in Accra and Kumasi, Ghana. We enrolled 2142 HIV-negative women at high risk of HIV infection, and randomized them to SAVVY or placebo gel. Main outcome measures were the incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate specimens and adverse events. We accrued 790 person-years of follow-up in the SAVVY group and 772 person-years in the placebo group. No clinically significant differences in the overall frequency of adverse events, abnormal pelvic examination findings, or abnormal laboratory results were seen between treatment groups. However, more participants in the SAVVY group reported reproductive tract adverse events than in the placebo group (13.0% versus 9.4%). Seventeen HIV seroconversions occurred; eight in participants randomized to SAVVY and nine in participants receiving placebo. The Kaplan-Meier estimates of the cumulative probability of HIV infection through 12 months were 0.010 in the SAVVY group and 0.011 in the placebo group (p = 0.731), with a hazard ratio (SAVVY versus placebo) of 0.88 (95% confidence interval 0.33, 2.27). Because of a lower-than-expected HIV incidence, we were unable to achieve the required number of HIV infections (66) to obtain the desired study power.Conclusions/SignificanceSAVVY was not associated with increased adverse events overall, but was associated with higher reporting of reproductive adverse events. Our data are insufficient to conclude whether SAVVY is effective at preventing HIV infection relative to placebo.Trial RegistrationClinicalTrials.gov NCT00129532
BackgroundData pertaining to risk factors associated with stillbirths and very low Apgar scores is very sparse. This study was conducted to determine the prevalence of, and examine the socio-demographic and obstetric factors associated with stillbirths and very low Apgar scores among vaginal births in a tertiary health facility, Ghana.MethodsA retrospective cross-sectional review of vaginal deliveries conducted at a teaching hospital in Ghana from 1st January to 31st December, 2009. Background characteristics and obstetric history of the mother as well as the vital status of the baby at birth were extracted. Risk factors associated with stillbirths and very low Apgar scores were examined using binomial regression with a log-link function, and population attributable fractions calculated for significant risk factors.ResultsOf the 8,758 deliveries which met the inclusion criteria, 5.9% of the babies were stillbirths, and 6.5% and 1.9% of live births had very low Apgar scores in the first and fifth minutes respectively. Preterm delivery, hypertensive disorders in pregnancy, breech delivery and vacuum extraction were significant risk factors for stillbirths and very low Apgar scores in the fifth minute of life. Low birth weight was also a significant risk factor for very low Apgar scores.ConclusionThe prevalence of stillbirths and very low Apgar scores were high. Improving the quality of obstetric care during labour and delivery may help improve these adverse vaginal birth outcomes.
ObjectivesTo estimate the incremental costs of visual inspection with acetic acid (VIA) and cryotherapy at cervical cancer screening facilities in Ghana; to explore determinants of costs through modelling; and to estimate national scale-up and annual programme costs.MethodsResource-use data were collected at four out of six active VIA screening centres, and unit costs were ascertained to estimate the costs per woman of VIA and cryotherapy. Modelling and sensitivity analysis were used to explore the influence of observed differences between screening facilities on estimated costs and to calculate national costs.ResultsIncremental economic costs per woman screened with VIA ranged from 4.93 US$ to 14.75 US$, and costs of cryotherapy were between 47.26 US$ and 84.48 US$ at surveyed facilities. Under base case assumptions, our model estimated the costs of VIA to be 6.12 US$ per woman and those of cryotherapy to be 27.96 US$. Sensitivity analysis showed that the number of women screened per provider and treated per facility was the most important determinants of costs. National annual programme costs were estimated to be between 0.6 and 4.0 million US$ depending on assumed coverage and adopted screening strategy.ConclusionWhen choosing between different cervical cancer prevention strategies, the feasibility of increasing uptake to achieve economies of scale should be a major concern.
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