A cluster randomized-controlled trial to determine the effectiveness of Stepping Stones in preventing HIV infections and promoting safer sexual behaviour amongst youth in the rural Eastern Cape, South Africa: trial design, methods and baseline findings
A cluster randomized-controlled trial to determine the effectiveness of Stepping Stones in preventing HIV infections and promoting safer sexual behaviour amongst youth in the rural Eastern Cape, South Africa: trial design, methods and baseline findings
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DOI：
10.1111/j.1365-3156.2005.01530.x
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发表时间：
2006-01-01
影响因子：
3.3
通讯作者：
Duvvury, N
中科院分区：
文献类型：
--
作者：
Jewkes, R;Nduna, M;Duvvury, N
目的描述的研究设计，方法和基线调查结果的行为干预试验，旨在减少HIV incidence.METHOD一个集群随机对照试验（RCT）在南非农村70个村庄进行。在35个社区举办了两个讲习班，每个社区有20名男子和20名妇女参加，在3至12周的时间里举行了17次会议（50小时），实施了一项名为“垫脚石”的行为干预措施。对照组社区的个人参加了一次关于艾滋病毒和安全性行为的会议，时间约为3小时。通过两次问卷调查和每隔12个月的血清学调查进行了影响评估。主要结果是艾滋病毒发病率，次要措施包括知识、态度和性行为的变化。定性研究也进行了10名男子和10名妇女从两个地点接受干预研究对象为2776人（农村1人，城市1人），对照组为来自同一个村庄的5男5女，研究对象分别在研究前和研究后9-12个月接受了3次访谈干预组1409例，对照组1367例。干预组妇女的艾滋病毒基线流行率为9.8%，对照组为12.8%;干预组男子的艾滋病毒基线流行率为1.7%，对照组为2.1%。两组的人口统计学和行为特征相似。在干预组中，59.9%的参与者参加了75%以上的会议。在对照组中，66.3%的人参加了control session.CONCLUSION这是在撒哈拉以南非洲进行的第三个随机对照试验，评估使用艾滋病毒发病率作为主要结果的行为干预。由于许多发展中国家都采用了这种干预措施，因此这一点特别重要。研究组之间有良好的基线可比性，讲习班的过程数据表明，干预措施是可行的，并得到充分实施。
OBJECTIVE To describe the study design, methods and baseline findings of a behavioural intervention trial aimed at reducing HIV incidence.METHOD A cluster randomized-controlled trial (RCT) conducted in 70 villages in rural South Africa. A behavioural intervention, Stepping Stones, was implemented in 35 communities in two workshops of 20 men and 20 women in each community who met for 17 sessions (50 h) over a period of 3-12 weeks. Individuals in the control arm communities attended a single session of about 3 h on HIV and safer sex. Impact assessment was conducted through two questionnaire and serological surveys at 12-month intervals. The primary outcome was HIV incidence and secondary measures included changes in knowledge, attitude and sexual behaviours. Qualitative research was also undertaken with 10 men and 10 women from two sites receiving the intervention (one rural and one urban) and five men and five women from one village in the control arm. They were interviewed individually three times prior to the workshops and then 9-12 months later.RESULTS A total of 2776 participants (1409 intervention and 1367 control) were enrolled at baseline and had an interview, and HIV sero-status was established. HIV baseline prevalence rates in women were 9.8% in the intervention arm and 12.8% in the control arm. In men the prevalence was 1.7% in the intervention arm and 2.1% in the control arm. Demographic and behavioural characteristics were similar in the two arms. In the intervention groups 59.9% of participants attended more than 75% of the sessions. In the control group 66.3% attended the control session.CONCLUSION This is the third RCT to be conducted in sub-Saharan Africa evaluating a behavioural intervention using HIV incidence as a primary outcome. It is of particular interest as the intervention in question is used in many developing countries. There is good baseline comparability between the study arms and the process data on the workshops suggested that the interventions were feasible and adequately implemented.