Control of sexually transmitted diseases for AIDS prevention in Uganda: a randomised community trial

• Published in: The Lancet (British edition) Vol. 353; no. 9152; pp. 525 - 535
• Main Authors: Wawer, Maria J, Sewankambo, Nelson K, Serwadda, David, Quinn, Thomas C, Kiwanuka, Noah, Li, Chuanjun, Lutalo, Thomas, Nalugoda, Fred, Gaydos, Charlotte A, Moulton, Lawrence H, Ahmed, Saifuddin, Gray, Ronald H, Paxton, Lynn A, Wabwire-Mangen, Fred, Meehan, Mary O
• Format: Journal Article
• Language: English
• Published: London Elsevier Ltd 13.02.1999; Lancet; Elsevier Limited
• Subjects: Acquired immune deficiency syndrome; AIDS; Biological and medical sciences; HIV; Human immunodeficiency virus; Human viral diseases; Infectious diseases; Medical research; Medical sciences; Sexually transmitted diseases; STD; Tropical medicine; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Uganda; Africa; Infection; Human; Immunopathology; Randomization; Sexually transmitted disease; Surveillance; Viral disease; AIDS; Multivariate analysis; Immune deficiency; Incidence
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(98)06439-3

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. 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. 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% Cl 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. 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.