Increasing Uptake of Voluntary Medical Male Circumcision Among Men Aged 20-34 Years in Njombe & Tabora Regions, Tanzania: A Cluster Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10,782
- 试验地点
- 2
- 主要终点
- Impact of intervention on proportion of male clients aged 20-34 years (ratio of the geometric mean proportion of clients aged 20-34 years in the 10 intervention facilities versus that in the 10 control facilities)
研究概览
简要总结
Tanzania launched a National Strategy for scaling-up voluntary medical male circumcision in 2010, and aims to circumcise 2.8 million males by 2015. In September 2009, Jhpiego's Maternal and Child Health Integrated Program (MCHIP) launched a PEPFAR-funded voluntary medical male circumcision (VMMC) program which has circumcised over 110,000 males in Njombe and Iringa regions by June 2012. In line with the national strategy, the target age for the program was 10-34 years, but 80% of clients were aged 10-19 years. There is an urgent need to increase the proportion of older men (aged 20 years and above) who become circumcised, to have greatest impact on the HIV epidemic.
详细描述
In order to maintain high client flow in sites, the Iringa service delivery model is flexible in terms of how, where and when services are delivered. Approaches include:
i) Static sites: These sites offer regularly scheduled VMMC services several days a week. Services are offered year round rather than periodically. Volume tends to be low (20-50 clients a week).
ii) Outreach sites: VMMC services are offered periodically at health facilities. A team composed of providers 'borrowed' from other regional health facilities visits the sites for a 2-3 week period and offers VMMC 6 days a week. This is typically a high volume setting, in which 40-120 circumcisions are performed a day, depending on the number of beds which can be set up.
iii) Campaign: Campaigns happen 2-3 times a year, and may include both static and outreach sites. Campaigns are high volume, concerted approaches to VMMC where multiple facilities are running coordinated VMMC service delivery.
These services are complemented by demand creation activities (mass media, interpersonal activities and outreach activities) designed to recruit and motivate new clients, and a text messaging information system which is advertised through radio and other means, providing potential clients advice on where VMMC is offered, the benefits of VMMC, and post-surgery reminders for wound care, follow-up visits and safer sex. The intensity of the demand creation depends on the size of campaign. In general, static sites do not have any demand creation but outreach and campaigns do.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 10 Years 至 50 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •an outreach VMMC health facility,
- •a site selected by Jhpiego for outreach VMMC campaign,
- •a site that has not had previous outreach services (to enable the results to be generalizable to future new outreach) or have not had VMMC outreach services in the previous 6 months, and
- •physically distant from other potential study sites to minimise contamination (spill over) of activities in the intervention communities into control communities.
- •The parent sites from different clusters must be at least 20km away from each other, regardless of whether they are randomised to be control or intervention sites.
- •Uncircumcised males
- •given an informed consent to participate in the study
排除标准
- •Circumcised males
研究组 & 干预措施
Control
Individuals receiving the standard Ministry of Health Package
Intervention
Individuals receiving the targeted demand creation strategy to increase adult men taking up VMMC
干预措施: A targeted demand creation Activities (Behavioral)
结局指标
主要结局
Impact of intervention on proportion of male clients aged 20-34 years (ratio of the geometric mean proportion of clients aged 20-34 years in the 10 intervention facilities versus that in the 10 control facilities)
时间窗: 5-6 weeks of demand creation activities
Cluster-level summary methods will be used to assess the impact of the intervention\[19\]. The primary outcome will be the unadjusted "prevalence ratio", estimated as the .
次要结局
- Comparison of population attending for circumcision with general male population (proportion of males reporting the below risk factors will be compared to proportion of males reporting the same in the 2010 Tanzania Demographic and Health Survey)(5-6 weeks)
研究者
Mwita Wambura
Researcher
National Institute for Medical Research, Tanzania