TY - JOUR
T1 - Control of sexually transmitted diseases for AIDS prevention in Uganda
T2 - A randomised community trial
AU - Wawer, Maria J.
AU - Sewankambo, Nelson K.
AU - Serwadda, David
AU - Quinn, Thomas C.
AU - Paxton, Lynn A.
AU - Kiwanuka, Noah
AU - Wabwire-Mangen, Fred
AU - Li, Chuanjun
AU - Lutalo, Thomas
AU - Nalugoda, Fred
AU - Gaydos, Charlotte A.
AU - Moulton, Lawrence H.
AU - Meehan, Mary O.
AU - Ahmed, Saifuddin
AU - Gray, Ronald H.
N1 - Funding Information:
The study was supported by grants RO1 AI34826 and RO1 AI34826S, National Institute of Allergy and Infectious Diseases, and grant 5P30HD06826, National Institute of Child Health and Development, US National Institutes of Health; the Rockefeller Foundation; the World Bank Uganda STI Project; and John Snow Inc, grant 5024–30. Some drugs and laboratory tests were provided by Pfizer Inc, Bayer Inc, Abbott Laboratories, Roche Molecular Systems, and the Calypte Biomedical Corporation.
PY - 1999/2/13
Y1 - 1999/2/13
N2 - Background. The study tested the hypothesis that community-level control of sexually transmitted disease (STD) would result in lower incidence of HIV-1 infection in comparison with control communities. Methods. This randomised, controlled, single-masked, community-based trial of intensive STD control, via home-based mass antibiotic treatment, took place in Rakai District, Uganda. Ten community clusters were randomly assigned to intervention or control groups. All consenting residents aged 15-59 years were enrolled; visited in the home every 10 months; interviewed; asked to provide biological samples for assessment of HIV-1 infection and STDs; and were provided with mass treatment (azithromycin, ciprofloxacin, metronidazole in the intervention group, vitamins/anthelmintic drug in the control). Intention-to-treat analyses used multivariate, paired, cluster-adjusted rate ratios. Findings. The baseline prevalence of HIV-1 infection was 15.9%, 6602 HIV-1-negative individuals were enrolled in the intervention group and 6124 in the control group, 75.0% of intervention-group and 72.6% of control-group participants provided at least one follow-up sample for HIV-1 testing. At enrolment, the two treatment groups were similar in STD prevalence rates. At 20-month follow-up, the prevalences of syphilis (352/6238 [5.6%) vs 359/5284 [6.8%]; rate ratio 0.80 [95% CI 0.71-0.89]) and trichomoniasis (182/1968 [9.3%] vs 261/1815 [14.4%]; rate ratio 0.59 [0.38-0.91]) were significantly lower in the intervention group than in the control group. The incidence of HIV-1 infection was 1.5 per 100 person-years in both groups (rate ratio 0.97 [0.81-1.16]). In pregnant women, the follow-up prevalences of trichomoniasis, bacterial vaginosis, gonorrhoea, and chlamydia infection were significantly lower in the intervention group than in the control group. No effect of the intervention on incidence of HIV-1 infection was observed in pregnant women or in stratified analyses. Interpretation. We observed no effect of the STD intervention on the incidence of HIV-1 infection. In the Rakai population, a substantial proportion of HIV-1 acquisition appears to occur independently of treatable STD cofactors.
AB - Background. The study tested the hypothesis that community-level control of sexually transmitted disease (STD) would result in lower incidence of HIV-1 infection in comparison with control communities. Methods. This randomised, controlled, single-masked, community-based trial of intensive STD control, via home-based mass antibiotic treatment, took place in Rakai District, Uganda. Ten community clusters were randomly assigned to intervention or control groups. All consenting residents aged 15-59 years were enrolled; visited in the home every 10 months; interviewed; asked to provide biological samples for assessment of HIV-1 infection and STDs; and were provided with mass treatment (azithromycin, ciprofloxacin, metronidazole in the intervention group, vitamins/anthelmintic drug in the control). Intention-to-treat analyses used multivariate, paired, cluster-adjusted rate ratios. Findings. The baseline prevalence of HIV-1 infection was 15.9%, 6602 HIV-1-negative individuals were enrolled in the intervention group and 6124 in the control group, 75.0% of intervention-group and 72.6% of control-group participants provided at least one follow-up sample for HIV-1 testing. At enrolment, the two treatment groups were similar in STD prevalence rates. At 20-month follow-up, the prevalences of syphilis (352/6238 [5.6%) vs 359/5284 [6.8%]; rate ratio 0.80 [95% CI 0.71-0.89]) and trichomoniasis (182/1968 [9.3%] vs 261/1815 [14.4%]; rate ratio 0.59 [0.38-0.91]) were significantly lower in the intervention group than in the control group. The incidence of HIV-1 infection was 1.5 per 100 person-years in both groups (rate ratio 0.97 [0.81-1.16]). In pregnant women, the follow-up prevalences of trichomoniasis, bacterial vaginosis, gonorrhoea, and chlamydia infection were significantly lower in the intervention group than in the control group. No effect of the intervention on incidence of HIV-1 infection was observed in pregnant women or in stratified analyses. Interpretation. We observed no effect of the STD intervention on the incidence of HIV-1 infection. In the Rakai population, a substantial proportion of HIV-1 acquisition appears to occur independently of treatable STD cofactors.
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U2 - 10.1016/S0140-6736(98)06439-3
DO - 10.1016/S0140-6736(98)06439-3
M3 - Article
C2 - 10028980
AN - SCOPUS:0032994454
SN - 0140-6736
VL - 353
SP - 525
EP - 535
JO - The Lancet
JF - The Lancet
IS - 9152
ER -