A community randomized controlled trial to investigate impact of improved STD management and behavioural interventions on HIV incidence in rural Masaka, Uganda: trial design, methods and baseline findings
A community randomized controlled trial to investigate impact of improved STD management and behavioural interventions on HIV incidence in rural Masaka, Uganda: trial design, methods and baseline findings
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DOI：
10.1046/j.1365-3156.2002.00963.x
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发表时间：
2002-12-01
影响因子：
3.3
通讯作者：
Whitworth, JAG
中科院分区：
文献类型：
--
作者：
Kamali, A;Kinsman, J;Whitworth, JAG
目的 描述单独的行为干预以及与改进的性传播疾病 (STD) 管理相结合的研究设计、方法和基线结果，旨在降低 HIV 发病率和其他 STD。 设计 对乌干达西南部 18 个农村社区（约 96 000 名成年人）进行的三臂社区随机对照试验 (RCT)。通过社区教育、会议和信息传单，在 12 个社区（A 组和 B 组）实施了标准化行为干预。其中六个社区还通过政府和私人卫生单位（B 组）改善了性病管理。 C 组社区接受常规政府卫生服务。影响评估是通过对每个社区 750-1000 名成年人进行的三份问卷调查和血清学调查进行的，间隔时间为 18-24 个月。主要结果指标是艾滋病毒发病率，次要指标是梅毒和单纯疱疹病毒 2 型发病率、淋病奈瑟菌和沙眼衣原体患病率以及性行为变化。 结果 大约 15 000 名成年人（符合条件的人口的 72%）在基线时入组。所有臂型的 HIV 基线患病率均为 9-10%，人口和行为特征以及 STD 患病率也相似。在干预社区，共有 391 995 人参加了 81 502 项活动（每个目标成人 6.1 个），分发了 164 063 份传单（每人 2.6 个）和 1 586 270 个安全套（每个成人 16.5 个安全套）。在 STD 社区中，5 年期间共发现 12 239 例 STD 病例（65% 为女性）（每 100 名成人 7.7 例/年）。 结论 这是该类型中第一个包含行为成分的社区随机对照试验。研究组之间存在公平的基线可比性，过程数据表明干预措施得到了充分实施。
Objective To describe study design, methods and baseline findings of a behavioural intervention alone and in combination with improved management of sexually transmitted diseases (STDs) aimed at reducing HIV incidence and other STDs.Design A three-arm community randomized controlled trial (RCT) of 18 rural communities ( approximately 96 000 adults) in SW Uganda. A standardized behavioural intervention was implemented in 12 communities ( arms A and B) through community-based education, meetings and information leaflets. Six of these communities in addition received improved STD management through government and private health units ( arm B). Arm C communities received routine government health services. Impact assessment was through three questionnaire and serological surveys of 750-1000 adults in each community at 18-24-month intervals. The primary outcome measure was HIV incidence and secondary measures were syphilis and herpes simplex virus type 2 incidence, prevalence of Neisseria gonorrhoea and Chlamydia trachomatis and sexual behaviour changes.Results Approximately 15 000 adults (72% of eligible population) were enrolled at baseline. HIV baseline prevalence rates were 9-10% in all arms and demographic and behavioural characteristics and STD prevalence were also similar. In intervention communities, there were 391 995 attendance at 81 502 activities (6.1 per target adult), 164 063 leaflets distributed (2.6 per person) and 1 586 270 condoms (16.5 condoms per adult). In the STD communities a total of 12 239 STD cases (65% women) were seen over a 5-year period (7.7 per 100 adults/year).Conclusion This is the first community RCT of its type with a behavioural component. There is fair baseline comparability between study arms and process data suggest that interventions were adequately implemented.