Male Circumcision for HIV Prevention in Kenya: Seeking Effective Strategies to Recruit Older Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,785
- 试验地点
- 2
- 主要终点
- The rate of uptake of VMMC services among men in 4 study arms
研究概览
简要总结
The purpose of this study is to evaluate the impact of two interventions - Inter-Personal Communication [IPC] and Dedicated Service Outlets [DSOs] - in recruiting men aged 25-39 years for Voluntary Medical Male Circumcision (VMMC) services.
详细描述
STUDY AIMS Aim 1: Assess the rate of uptake of VMMC services by men aged 25-39 years exposed to Inter-Personal Communication (IPC) vs. Designated (older men only) Service Outlets (DSO) vs. IPC and DSO interventions combined vs. no intervention.
Aim 2: Determine through testing of unlinked de-identified blood from bleeding vessels from the surgical wound, the proportion of men whose HIV status is unknown who are HIV infected (Sub-study 1).
Aim 3: Determine the cost of providing VMMC among the three interventions relative to each other and to no intervention.
MAIN STUDY DESIGN: The study proposes to conduct a cluster randomized-controlled trial, with Locations forming the unit of randomization. Within the selected Locations, the study shall randomly select approximately 16% (209) of the villages which will be sufficient to generate the required sample size.
Sample size Determination:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Uncircumcised men
- •Aged 25 - 39 years
- •Residents of the study village (has been living in the physical structure such as a compound or homestead identified during the enumeration and who has been consuming or making some contribution to food and other shared household resources).
- •Intend to continue living in the village for the 9 months after enrollment, which is the estimated duration of data collection.
- •Give written consent to participate in the study and the interventions.
排除标准
- •Circumcised men
- •Aged <25- or >39 years
- •Non-resident of target villages
- •Plans to move away from the village within 9 months after enrollment
- •Does not give consent to participate in the study
研究组 & 干预措施
Inter-personal Communication (IPC)
Interpersonal communication will entail delivery of intervention massages that are custom-made to address individual participants' specific barriers and facilitators of VMMC. RAs will discuss with uncircumcised men why they have not gone for VMMC using the 'VMMC Demand Creation Toolkit'. The aim will be to fully address their barriers and re-enforce their facilitators. RAS will be trained behavioral counselors, circumcised men, female partners, CHWs, or any other cadre of individuals identified during the formative phase.
干预措施: Inter-personal Communication (IPC) (Other)
Dedicated Service Outlets (DSO)
RAs shall visit all households with eligible men to inform them about the availability of, and give information on location of DSO sites in the Location. DSOs are sites: where services are offered exclusively to men aged ≥25 years by male service providers in the same age bracket; providing services in the evenings/weekends/designated days of the week, and through special mobile services for older men. DSO sites we will strive to shorten the waiting time to ≤ three hours. They will be informed that all other VMMC sites continue to serve all men regardless of age (i.e., including older men) while DSO sites will only serve men aged ≥25 years. RAs will respond to questions using 'All You Need to Know About VMMC' booklet, the same way current recruiters do.
干预措施: Dedicated Service Outlets (DSO) (Other)
Combined IPC & DSO
Both Inter-personal Communication (IPC) and Dedicated Service Outlets (DSO) interventions (as described above) will be implemented concurrently. This will be done to determine the effect of both interventions delivered jointly compared to each delivered singly, and compared to no intervention.
干预措施: Inter-personal Communication (IPC) (Other)
Combined IPC & DSO
Both Inter-personal Communication (IPC) and Dedicated Service Outlets (DSO) interventions (as described above) will be implemented concurrently. This will be done to determine the effect of both interventions delivered jointly compared to each delivered singly, and compared to no intervention.
干预措施: Dedicated Service Outlets (DSO) (Other)
Control
In these Locations, participants will only be given the 'All You Need to Know About VMMC' booklet at the time of enrollment, which is the standard of care.
结局指标
主要结局
The rate of uptake of VMMC services among men in 4 study arms
时间窗: Three months post intervention
We will assess the rate of uptake of VMMC services by men aged 25-39 years exposed to (i) Inter-personal communication (IPC) intervention vs. (ii) Designated (older men only) Service Outlets (DSO) intervention vs. (iii) IPC and DSO interventions combined vs. (iv) No intervention.
次要结局
- Prevalence of HIV among VMMC clients who decline HIV testing(Three months post intervention)
研究者
Kawango Agot
Director
Impact Research & Development Organization