Grosskurth H, Mosha F, Todd J, Senkoro K, Newell J, Klokke A, Changalucha J, West B, Mayaud P, Gavyole A
African Medical and Research Foundation, Mwanza, Tanzania.
AIDS. 1995 Aug;9(8):927-34. doi: 10.1097/00002030-199508000-00015.
To determine baseline HIV prevalence in a trial of improved sexually transmitted disease (STD) treatment, and to investigate risk factors for HIV. To assess comparability of intervention and comparison communities with respect to HIV/STD prevalence and risk factors. To assess adequacy of sample size.
Twelve communities in Mwanza Region, Tanzania: one matched pair of roadside communities, four pairs of rural communities, and one pair of island communities. One community from each pair was randomly allocated to receive the STD intervention following the baseline survey.
Approximately 1000 adults aged 15-54 years were randomly sampled from each community. Subjects were interviewed, and HIV and syphilis serology performed. Men with a positive leucocyte esterase dipstick test on urine, or reporting a current STD, were tested for urethral infections.
A total of 12,534 adults were enrolled. Baseline HIV prevalences were 7.7% (roadside), 3.8% (rural) and 1.8% (islands). Associations were observed with marital status, injections, education, travel, history of STD and syphilis serology. Prevalence was higher in circumcised men, but not significantly after adjusting for confounders. Intervention and comparison communities were similar in the prevalence of HIV (3.8 versus 4.4%), active syphilis (8.7 versus 8.2%), and most recorded risk factors. Within-pair variability in HIV prevalence was close to the value assumed for sample size calculations.
The trial cohort was successfully established. Comparability of intervention and comparison communities at baseline was confirmed for most factors. Matching appears to have achieved a trial of adequate sample size. The apparent lack of a protective effect of male circumcision contrasts with other studies in Africa.
在一项改善性传播疾病(STD)治疗的试验中确定HIV基线流行率,并调查HIV的危险因素。评估干预社区和对照社区在HIV/STD流行率及危险因素方面的可比性。评估样本量是否充足。
坦桑尼亚姆万扎地区的12个社区:一对路边社区、四对农村社区和一对岛屿社区。在基线调查后,从每对社区中随机分配一个社区接受STD干预。
从每个社区中随机抽取约1000名15 - 54岁的成年人。对受试者进行访谈,并进行HIV和梅毒血清学检测。对尿液白细胞酯酶试纸检测呈阳性或报告当前患有STD的男性进行尿道感染检测。
共纳入12534名成年人。HIV基线流行率分别为7.7%(路边社区)、3.8%(农村社区)和1.8%(岛屿社区)。观察到与婚姻状况、注射史、教育程度、出行、STD病史和梅毒血清学有关联。包皮环切男性的流行率较高,但在调整混杂因素后无显著差异。干预社区和对照社区在HIV流行率(3.8%对4.4%)、活动性梅毒(8.7%对8.2%)以及大多数记录的危险因素方面相似。HIV流行率在配对社区内的变异性接近样本量计算所假定的值。
试验队列成功建立。在大多数因素方面,干预社区和对照社区在基线时的可比性得到证实。配对似乎实现了一个样本量充足的试验。男性包皮环切术明显缺乏保护作用这一现象与非洲的其他研究形成对比。