15 Month follow up of African children following vaginal cleansing with benzalkonium chloride of their HIV infected mothers during late pregnancy and delivery.

OBJECTIVES: To study mother to child HIV-1 transmission (MTCT) and infant mortality following benzalkonium chloride (BC) disinfection. METHODS: A randomised, double blind phase II placebo controlled trial. Women testing positive for HIV-1 infection in prenatal care units in Abidjan, Côte d'Ivoire, and Bobo-Dioulasso, Burkina Faso, from November 1996 to April 1997 were eligible, with their informed consent. Women self administered daily a vaginal suppository of 1% BC (53) or matched placebo (54) from 36 weeks of pregnancy, plus a single dose during labour. The neonate was bathed with 1% BC solution or placebo within 30 minutes after birth. MTCT rate was assessed based on repeated polymerase chain reaction (PCR) and serology results. For the present analysis, children were followed up to 15 months. RESULTS: A total of 107 women were enrolled. Of 103 eligible liveborn children, 23 were HIV infected, 75 uninfected, and five of indeterminate status. MTCT transmission rate was 24.2% overall (95% confidence interval (CI): 14.3% to 30.4%). On an intent to treat basis, the transmission rate did not differ between the two groups (23.5%, CI 13.8 to 38.5, in the BC group and 24.8%, CI 15.0 to 39.6, in the placebo group at 15 months). Similarly, there was no difference in mortality at 15 months (22.9%, CI 13.7 to 36.9, in the BC group and 16.5%, CI 9.0 to 29.4, in the placebo group). CONCLUSION: This analysis failed to suggest any benefit of BC disinfection on mother to child HIV transmission or perinatal and infant mortality.

Sexual and reproductive life of women informed of their HIV seropositivity: a prospective cohort study in Burkina Faso.

BACKGROUND: In the context of the DITRAME-ANRS 049 research program that evaluated interventions aimed at reducing mother-to-child transmission of HIV (MTCT) in Bobo-Dioulasso (Burkina Faso), Voluntary HIV counseling and testing (VCT) services were established for pregnant women. HIV-infected women were advised to disclose their HIV serostatus to their male partners who were also offered VCT, to use condoms to reduce sexual transmission, and to choose an effective contraception method to avoid unwanted pregnancies. This study aimed at assessing how HIV test results were shared with male sexual partners, the level of use of modern contraceptive methods, and the pregnancy incidence among these women informed of the risks surrounding sexual and reproductive health during HIV infection. METHODS: From 1995 to 1999, a quarterly prospective follow-up of a cohort of HIV-positive women. RESULTS: Overall, 306 HIV-positive women were monitored over an average period of 13.5 months following childbirth, accounting for a total of 389 person-years. The mean age at enrollment in the cohort was 25.1 (standard deviation, 5.2 years). In all, 18% of women informed their partners, 8% used condoms at each instance of sexual intercourse to avoid HIV transmission, and 39% started using hormonal contraception. A total of 48 pregnancies occurred after HIV infection was diagnosed, an incidence of 12.3 pregnancies per 100 person-years. Pregnancy incidence was 4 per 100 person-years in the first year of monitoring and this rose significantly to 18 per 100 person-years in the third year. The only predictor of the occurrence of a pregnancy after HIV diagnosis was the poor outcome of the previous pregnancy (stillbirth, infant death). Severe immunodeficiency and change in marital status were the only factors that prevented the occurrence of a pregnancy after HIV diagnosis. CONCLUSION: Our study shows a poor rate of HIV test sharing and a poor use of contraceptive methods despite regular advice and counseling. Pregnancy incidence remained comparable with the pregnancy rate in the general population. To improve this situation, approaches for involving husbands or partners in VCT and prevention of MTCT interventions should be developed, evaluated, and implemented.

[Impaired fertility in women infected with HIV-1. Implications for sentinel serosurveillance]. / Réduction de la fertilité chez les femmes infectées par le VIH-1. Implications pour la sérosurveillance sentinelle.

BACKGROUND: Given the relationship between HIV infection and fertility, antenatal clinic-based HIV prevalence may not provide a good estimate of the community HIV prevalence. The objective of this work was to evaluate the impact of HIV infection on fertility among women attending antenatal clinics in Bobo-Dioulasso (Burkina Faso), and to discuss possible implications on HIV sentinel surveillance. METHODS: In the context of a phase II/III clinical trial of a short course of Zidovudine during pregnancy (DITRAME - ANRS 049 trial) we consecutively proposed voluntary counselling and HIV testing (VCT) to 1349 women aged at least 18 years, carrying a pregnancy of 7 months or less and living in Bobo-Dioulasso. During pre-test counselling session, a standardised questionnaire was administered to collect detailed information regarding socio-demographic characteristics and obstetrical history. Blood samples were then taken and tested for HIV after written informed consent. RESULTS: Mean age (+/- standard deviation) at first sexual intercourse was similar among HIV-infected (HIV+) (16.7+/- 2; n=83) and HIV-negative (HIV-) women (16.9+/- 2; n=1336). However, HIV+ women aged 25 years and above had, on the average fewer pregnancies (3.8+/- 1.5; n=37) than HIV- women (5.0+/- 2.3; n=567), p<0.01. Similarly, these HIV+ women had, on average, less live births (2.8+/- 1.3; n=35) than HIV- ones (3.7+/- 2.1; n=555), p=0.02. Other sexual and obstetrical characteristics such as maternal age, proportion of primigravidae, stillbirths or spontaneous abortions were comparable between HIV+ and HIV- women. CONCLUSIONS: Our data suggest that the level of fertility of HIV+ women aged 25 years and above is significantly lower than for HIV- women. Therefore, HIV+ women in this age group are likely to be under-represented among antenatal clinic attendees. These findings suggest adjusting antenatal clinic-based HIV sentinel surveillance data for age and fertility in order to derive a good estimate of the community HIV prevalence.

Stabilization of HIV infection rates in urban Burkina Faso, 1995-1999.

The objectives of this study were to monitor the trends of the HIV epidemic between 1995 and 1999 among pregnant women in Bobo-Dioulasso, the second largest town of Burkina Faso, and to discuss the possible effect of preventive interventions (condom availability) on sexual transmission of HIV in this context. Age-specific trends in HIV prevalence obtained from sentinel surveillance programme were analysed. Among antenatal clinic attendees, HIV prevalence was 7.5% (n=401) in 1995, 10% (n=200) in 1996, 7.6% (n=448) in 1997, 8.4% (n=642) in 1998 and 5.3% (n=716) in 1999 without demonstrated temporal trend (P=0.12). The average number of condoms available per person (aged 15-49 years) per year increased from 0.6 in 1992 to 5.7 in 1995 and 6.0 in 1999. Anonymous surveys are less subject to selection bias and suggest a stabilization of the HIV prevalence around 7.3% in Bobo-Dioulasso. Distribution of condoms could explain at least, partly, this stabilization of the HIV epidemic.

Living with HIV: women's experience in Burkina Faso, West Africa.

Our study aimed at studying HIV-infected women's experience with sharing serostatus with their partner and their group support. A survey was carried out among 79 seropositive women involved in a therapeutic trial in Bobo-Dioulasso, following freely consented prenatal HIV testing. The study revealed that women are reluctant to inform their partners and fear being stigmatized by relatives and friends. The major concern reported was health consequences and most women wished to receive care. The non-governmental organizations supporting people living with HIV were not known by these women, but providing this information raised a high interest and many women considered joining them soon and getting themselves involved. These community-based organizations, lead by qualified and highly motivated volunteers, could facilitate a better social integration of HIV infected women in Burkina Faso.

Seroprevalence of syphilis among women attending urban antenatal clinics in Burkina Faso, 1995-8. The DITRAME Study Group. DIminunation de la TRAnsmission Mère-Enfant.

OBJECTIVES: To describe annual trends in syphilis seroprevalence and to identify risk factors of syphilis among pregnant women receiving antenatal care in Bobo-Dioulasso, Burkina Faso. METHODS: Women were recruited between January 1995 and July 1998 in three antenatal clinics where counselling and HIV testing services had been established in the context of a trial evaluating a short course of zidovudine to reduce mother to child transmission of HIV (ANRS 049 trial). Sociodemographic variables were collected during HIV pretest counselling sessions. Syphilis diagnosis was considered when serum was positive with both rapid plasma reagin and Treponema pallidum haemagglutination assay (TPHA) tests. RESULTS: Overall, 10,980 pregnant women were screened. Syphilis seroprevalence was 0.24% (95% confidence interval (CI): 0.15-0.35) without changes over time. HIV prevalence was 8.8% (CI: 8.3-9.3). In a multivariable analysis, having casual sex partners (odds ratio (OR) = 4.48; CI: 1.62-12.38), being HIV seropositive (OR = 2.62; CI: 1.02-6.74), and being illiterate (OR = 3.78; CI: 1.24-11.48) were independent risk factors for syphilis infection. CONCLUSIONS: This study suggests low syphilis seroprevalence in this city of Burkina Faso. Sexually transmitted disease programmes should be reinforced to offer free access to syphilis screening and treatment in order to eliminate this disease, in coordination with HIV prevention and care.

[HBs antigen carrier state in pregnant women in Bobo Dioulasso (Burkina Faso)]. / Portage de l'antigène HBs chez les femmes enceintes a Bobo-Dioulasso (Burkina Faso).

The aim of this study was to evaluate the prevalence rate and the risk factors for the carriage of hepatitis B markers in pregnant women in Bobo Dioulasso, Burkina Faso. Out of 917 pregnant women recruited during antenatal care, 98 (10.7%) were HBs antigen positive. Among these ones, 18.2% carded HBe antigen, 66.7% antiHBe antibodies and 95.6% antiHBc antibodies. Two risk factors were identified: maternal age of 23 and 28 (RR = 2.33, chi2 =12.21, p = 0.005) and widowage (Fisher test RR = 6.43, p = 0.0016). This high prevalence of HBs antigen calls for systematic screening for hepatitis B during antenatal care along with an immunization policy toward women of reproductive age and newborns.

Prevention of mother-to-child transmission of HIV in developing countries: recommendations for practice. The Ghent International Working Group on Mother-To-Child Transmission of HIV.

OBJECTIVES: Different approaches to prevent mother-to-child transmission of HIV are being evaluated in developing countries. The first trials using a short regimen of zidovudine have been successful in Thailand, Côte d'Ivoire and Burkina Faso. International and local strategies are now being considered. The Ghent International Working Group on Mother-to-Child Transmission of HIV developed public health policy options to integrate these interventions into basic and maternal and child health (MCH) services. METHODS: The following tasks were undertaken: a critical review of randomized trials; an international pooled analysis of late postnatal transmission of HIV through breastfeeding; a review of the cost-effectiveness and cost-benefit of antiretroviral prophylaxis; a feasibility assessment of preventive strategies, including a postal survey on HIV voluntary counselling and testing (VCT) of pregnant women; the identification of requirements and research priorities for prenatal, obstetric and paediatric care. These projects provided the background for a three-day workshop in Ghent, Belgium, in November 1997. Conclusions were further refined, based on 1998 research findings. RESULTS: A summary of relevant evidence and ten public health recommendations are reported. VCT for pregnant women, a short regimen of zidovudine together with alternatives to breastfeeding currently represent the best option to reduce vertical transmission in most developing countries. The primary goal of the integrated package supporting these interventions is to alleviate overall maternal and infant morbidity and mortality. CONCLUSION: Prevention of mother-to-child transmission of HIV should now be considered for integration into basic health and MCH services of selected countries, with the involvement of governments and donor agencies.

Anaemia during pregnancy in Burkina Faso, west Africa, 1995-96: prevalence and associated factors. DITRAME Study Group.

We report the results of a cross-sectional study carried out in 1995-96 on anaemia in pregnant women who were attending two antenatal clinics in Bobo-Dioulasso, Burkina Faso, as part of a research programme including a clinical trial of zidovudine (ZDV) in pregnancy (ANRS 049 Clinical Trial). For women infected with human immunodeficiency virus (HIV) in Africa, anaemia is of particular concern when considering the use of ZDV to decrease mother-to-child transmission of HIV. The objectives were to determine the prevalence of and risk factors for maternal anaemia in the study population, and the effect of HIV infection on the severity of maternal anaemia. HIV counselling and testing were offered to all women, and haemograms were determined for those women who consented to serological testing. Haemoglobin (Hb) levels were available for 2308 of the 2667 women who accepted HIV testing. The prevalence of HIV infection was 9.7% (95% confidence interval (CI): 8.6-10.8%). The overall prevalence of anaemia during pregnancy (Hb level < 11 g/dl) was 66% (95% CI: 64-68%). The prevalence of mild (10 g/dl < or = Hb < 11 g/dl), moderate (7 g/dl < or = Hb < 10 g/dl) and severe (Hb < 7 g/dl) anaemia was 30.8%, 33.5% and 1.7%, respectively. The prevalence of anaemia was 78.4% in HIV-infected women versus 64.7% in HIV-seronegative women (P < 0.001). Although the relative risk of HIV-seropositivity increased with the severity of anaemia, no significant association was found between degree of anaemia and HIV serostatus among the study women with anaemia. Logistic regression analysis showed that anaemia was significantly and independently related to HIV infection, advanced gestational age, and low socioeconomic status. This study confirms the high prevalence of anaemia during pregnancy in Burkina Faso. Antenatal care in this population must include iron supplementation. Although HIV-infected women had a higher prevalence of anaemia, severe anaemia was infrequent, possibly because few women were in the advanced stage of HIV disease. A short course regimen of ZDV should be well tolerated in this population.

HIV infection among pregnant women in Bobo-Dioulasso, Burkina Faso: comparison of voluntary and blinded seroprevalence estimates.

The objective of our study was to estimate the prevalence of HIV infection among pregnant women in Bobo-Dioulasso (Burkina Faso) according to 2 survey methods. Unlinked anonymous HIV screening was performed among women attending 2 antenatal clinics. Voluntary and confidential HIV counselling and testing were offered to women attending 2 other antenatal clinics in the same time period, September-October 1996. Voluntary HIV testing was performed in the context of a clinical trial on mother-to-child transmission of HIV (ANRS 049 clinical trial) with an acceptance rate of HIV testing of 93%. The first survey recruited 200 women and the second, 424. The mean age (24.6 years vs 24.8 years) and the mean number of pregnancies (3.1 vs 3.3) of women were comparable, in the 2 studies (P=0.69 and P=0.26, respectively). Prevalence of HIV infection in the blinded survey was estimated at 10.0% (95% confidence interval (CI): 6.4-15.2), while it was 9.4% (95% CI: 6.9-12.7) in the voluntary HIV screening programme. These 2 estimates were not statistically different (P=0.82). In the voluntary screening study, the prevalence of HIV infection was significantly different between age groups 15-24 years and 25-49 years (13.9% vs 4.5%, P < 0.001). In the age group 25-49 years, the prevalence of HIV infection estimated in the blinded study and in the voluntary screening study were significantly different (10.5% vs 4.5%, P=0.04) suggesting a potential participation bias among pregnant women of older age in the voluntary, confidential HIV screening group. In conclusion, for the purpose of HIV surveillance, the most reliable method for HIV prevalence remains the unlinked, anonymous testing.

PIP: This study examines the prevalence of HIV infection among the pregnant women in Bobo-Dioulasso, Burkina Faso, through a comparison of voluntary and blinded seroprevalence estimates. Research methodology involves unlinked and anonymous HIV screening survey of 200 pregnant women attending two antenatal clinics from September 25 to October 1996. HIV serological tests were conducted and voluntary HIV screening were offered during the time period. Results showed that prevalence of HIV were statistically similar in both anonymous screening survey (10.0%) and confidential HIV counseling and testing study (9.4%). However, prevalence of HIV infection showed a difference between age groups 15-24 years and 25-49 years in the voluntary screening, suggestive of a possible participation bias with the method. The study concludes that unlinked anonymous HIV testing is the method of choice for HIV surveillance.

Serological diagnosis of human immuno-deficiency virus in Burkina Faso: reliable, practical strategies using less expensive commercial test kits.

Reported are the results of a cross-sectional survey in Burkina Faso to identify reliable, practical strategies for the serological diagnosis of HIV-1 and/or HIV-2 infections, using less-expensive commercial test kits in various combinations, as an alternative to the conventional Western blot (WB) test, which costs US$ 60. Serum samples, collected from blood donors, patients with acquired immunodeficiency syndrome (AIDS) and pregnant women, were tested between December 1995 and January 1997. Twelve commercial test kits were available: five Mixt enzyme-linked immunosorbent assays (ELISA), three Mixt rapid tests, and four additional tests including monospecific HIV-1 and HIV-2 ELISA. The reference strategy utilized a combination of one ELISA or one rapid test with WB, and was conducted following WHO criteria. A total of 768 serum samples were tested; 35 were indeterminate and excluded from the analysis. Seroprevalence of HIV in the remaining 733 sera was found to be 37.5% (95% confidence interval: 34.0-41.1). All the ELISA tests showed 100% sensitivity, but their specificities ranged from 81.4% to 100%. GLA (Genelavia Mixt) had the highest positive delta value, while ICE HIV-1.0.2 (ICE) produced the most distinct negative results. Among the rapid tests, COM (CombAIDS-RS) achieved 100% sensitivity and SPO (HIV Spot) 100% specificity. Various combinations of commercial tests, according to recommended WHO strategies I, II, III, gave excellent results when ICE was included in the sequence. The best combination of tests for strategy II, which achieved 100% sensitivity and specificity, was to use ICE and COM, the cost of which was US$ 2.10, compared with US$ 55.60 for the corresponding conventional strategy. For strategy III, the best combination, which achieved 100% sensitivity and specificity, was to use ICE, ZYG (Enzygnost Anti HIV-1/HIV-2 Plus) and COM, the cost of which was US$ 2.90 (19.2 times lower than the corresponding strategy requiring WB). No rapid test combination showed 100% sensitivity and specificity. Our results indicate that the serodiagnosis of HIV in Burkina Faso is possible by using reliable, less-expensive strategies which do not require Western blot testing. Moreover, there is a choice of strategies for laboratories working with or without an ELISA chain.

[Maternal HIV infection and the anthropometric characteristics of children at birth in Burkina Faso. DITRAME Study Group]. / Infection maternelle par le VIH et paramètres anthropométriques de l'enfant à la naissance au Burkina Faso.

The aim of this study was to investigate the relationship between maternal HIV status and the anthropometric characteristics of children at birth. A cross-sectional study was conducted in Bobo-Dioulasso from January 1995 to May 1996. We included all mother-child pairs seen postpartum for whom the HIV status of the mother had been determined at an antenatal visit and anthropometric measurements had been taken for the child at birth. Birth weights below 2,500 g were classed as "low", body lengths of less than 47 cm at birth were described as "small birth size" and head circumferences of less than 33 cm were classed as "small". We included 956 mothers and 956 children in the survey. Low birth-weights were recorded more frequently among children born to HIV-infected mothers than among those born to uninfected mothers (23. 37% versus 15.6%; p = 0.006). Mean birth-weight, birth size and head circumference did not differ significantly between the children of HIV-infected and uninfected mothers. In multivariate analysis, HIV infection and primiparity were independently associated with low birth-weight. Maternal HIV infection was the only factor associated with small birth size. There was no relationship between head circumference and maternal HIV status. Thus, maternal HIV infection appears to be associated with low birth-weight and small birth size.

6-month efficacy, tolerance, and acceptability of a short regimen of oral zidovudine to reduce vertical transmission of HIV in breastfed children in Côte d'Ivoire and Burkina Faso: a double-blind placebo-controlled multicentre trial. DITRAME Study Group. DIminution de la Transmission Mère-Enfant.

BACKGROUND: Zidovudine reduces the rate of vertical transmission of HIV in non-breastfed populations. We assessed the acceptability, tolerance, and 6-month efficacy of a short regimen of oral zidovudine in African populations practising breastfeeding. METHODS: A randomised double-blind placebo-controlled trial was carried out in public clinics of Abidjan, Côte d'Ivoire, and Bobo-Dioulasso, Burkina Faso. Eligible participants were women aged 18 years or older, who had confirmed HIV-1 infection and pregnancy of 36-38 weeks duration, and who gave written informed consent. Exclusion criteria were severe anaemia, neutropenia, abnormal liver function, and sickle-cell disease. Women were randomly assigned zidovudine (n=214; 300 mg twice daily until labour, 600 mg at beginning of labour, and 300 mg twice daily for 7 days post partum) or matching placebo (n=217). The primary outcome was the diagnosis of HIV-1 infection in the infant on the basis of sequential DNA PCR tests at days 1-8, 45, 90, and 180. We compared the probability of infection at a given age in the two groups. Analyses were by intention to treat. FINDINGS: Women were enrolled between September, 1995, and February, 1998, when enrolment to the placebo group was stopped. Analysis was based on 421 women and 400 lifeborn infants. Baseline demographic, clinical, and laboratory characteristics were similar in the two groups. The Kaplan-Meier probability of HIV infection in the infant at 6 months was 18.0% in the zidovudine group (n=192) and 27.5% in the placebo group (n=197; relative efficacy 0.38 [95% CI 0.05-0.60]; p=0.027). Adjustment for centre, period of recruitment, mode of delivery, maternal CD4-cell count, duration of labour, prolonged rupture of membranes, and duration of breastfeeding did not change the treatment effect. The proportions of women taking more than 80% of the planned maximum dose were 75% before delivery, 81% during labour, and 83% post partum, without statistical difference between the groups. No major adverse biological or clinical event was reported in excess among women and children of the zidovudine group. INTERPRETATION: A short course of oral zidovudine given during the peripartum period is well accepted and well tolerated, and provides a 38% reduction in early vertical transmission of HIV-1 infection despite breastfeeding.

Evaluation of 2 techniques of HIV pre-test counselling for pregnant women in west Africa. DITRAME Study Group.

This study compares the effect of group and individual pre-test counselling on uptake of HIV voluntary counselling and testing (VCT) by African pregnant women and knowledge about HIV/AIDS in 2 antenatal clinics of Bobo-Dioulasso, Burkina Faso. Pre-test counselling was offered to 3958 pregnant women, 927 by group counselling and 3031 by individual counselling. Acceptance of the test improved with individual counselling, which was already high with group counselling (93.3% versus 89.4%). The return rate for results was independent of the pre-test counselling technique. At post-test session, knowledge about HIV/AIDS was better after group than individual counselling, except for reporting the existence of an asymptomatic stage of HIV infection. At a public health level, group pre-test counselling can be easily integrated into existing sessions of antenatal care counselling, routinely performed by the current clinic staff. Our findings may help programme managers in the field of maternal and child health to choose optimal options of pre-test counselling adapted to local circumstances in resource-poor settings.

Potential source of human exposure to Mycobacterium bovis in Burkina Faso, in the context of the HIV epidemic.

OBJECTIVE: To identify potential sources of human Mycobacterium bovis infection in Bobo-Dioulasso, Burkina Faso. METHODS: A tuberculin survey among 174 cattle was performed. Mycobacteriologic identification in 64 samples of pooled milk, and in 199 tissue samples collected from the slaughterhouse of Bobo-Dioulasso, Burkina Faso, was also done. We retrospectively analyzed the distribution of tuberculosis (TB) cases on 1140 clinical records according to professional occupation and to ethnic group. The frequency of pulmonary and extrapulmonary TB was related to potential exposure and route of transmission of M. bovis from animals. RESULTS: Out of six herds (total 170 bovines), only one was free of any positive tuberculin test. Among 199 bovines which had been slaughtered over four consecutive nights, 38 (19%) had morphologic lesions suggestive of TB; 17 (45%) of those were positive for acid-fast bacilli by microscopic examination on one of their lesions, and 20 samples (53%) presented a positive culture for a pathogenic mycobacterium, including M. bovis and M. tuberculosis. In the retrospective analysis, Peuls more frequently had a pulmonary form of disease. This may be related to the route of transmission. CONCLUSIONS: Attention has to be paid to human TB of bovine origin in Burkina Faso. The identification of M. tuberculosis in milk and in tissue samples raises the question of the transmission of TB from humans to cattle.

Safety and acceptability of vaginal disinfection with benzalkonium chloride in HIV infected pregnant women in west Africa: ANRS 049b phase II randomized, double blinded placebo controlled trial. DITRAME Study Group.

OBJECTIVES: To study the tolerance and acceptability in Africa of a perinatal intervention to prevent vertical HIV transmission using benzalkonium chloride disinfection. DESIGN: A randomized, double blinded phase II trial. SETTING: Prenatal care units in Abidjan (Côte d'Ivoire) and Bobo-Dioulasso (Burkina Faso). PATIENTS: Women accepting testing and counselling who were seropositive for HIV-1 and under 37 weeks of pregnancy were eligible. A total of 108 women (54 in each group) enrolled from November 1996 to April 1997, with their informed consent. INTERVENTION: Women self administered daily a vaginal suppository of 1% benzalkonium chloride or matched placebo from 36 weeks of pregnancy, and a single intrapartum dose. The neonate was bathed with 1% benzalkonium chloride solution or placebo within 30 minutes after birth. MAIN OUTCOME MEASURES: Adverse events were recorded weekly, with a questionnaire and speculum examination in women through delivery, and examination of the neonate through day 30. The incidence of genital signs and symptoms in the women and cutaneous or ophthalmological events in newborns were compared between groups on an intent to treat basis. RESULTS: The median duration of prepartum treatment was 21 days (range 0-87 days). Compliance was 87% for prepartum and 69% for intrapartum treatment, and 88% for the neonatal bath, without differences between the two groups. In women, the most frequent event was leucorrhoea; the incidence of adverse events did not differ between treatment groups. In children, the incidence of dermatitis and conjunctivitis did not differ between the benzalkonium chloride and placebo groups (p = 0.16 and p = 0.29, respectively). CONCLUSION: Vaginal disinfection with benzalkonium chloride is a feasible and well tolerated intervention in west Africa. Its efficacy in preventing vertical HIV transmission remains to be demonstrated.