Control of sexually transmitted diseases for AIDS prevention in Uganda: a randomised community trial. Rakai Project Study Group.
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.


RESULTS
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.


CONCLUSIONS
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.
Wawer
M J
MJ
Centre for Population and Family Health, Columbia University School of Public Health, New York 10032, USA.
Sewankambo
N K
NK
Serwadda
D
D
Quinn
T C
TC
Paxton
L A
LA
Kiwanuka
N
N
Wabwire-Mangen
F
F
Li
C
C
Lutalo
T
T
Nalugoda
F
F
Gaydos
C A
CA
Moulton
L H
LH
Meehan
M O
MO
Ahmed
S
S
Gray
R H
RH
D000163:Acquired Immunodeficiency Syndrome / Q000453:epidemiology / Q000517:prevention & control*; D000293:Adolescent; D000328:Adult; D000890:Anti-Infective Agents / Q000627:therapeutic use; D016000:Cluster Analysis; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D015497:HIV-1; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy / Q000453:epidemiology; D015995:Prevalence; D012307:Risk Factors; D012749:Sexually Transmitted Diseases / Q000188:drug therapy* / Q000453:epidemiology; D013997:Time Factors; D014454:Uganda / Q000453:epidemiology
D000890:Anti-Infective Agents