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临床试验/NCT06364891
NCT06364891已完成不适用

Assessing the Impact of a Segment-targeted Mobilization Model Supported by a Digital VMMC Platform on Uptake of VMMC Services in Zambia

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 150,383 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150,383
试验地点
2
主要终点
Total number of VMMC's conducted in intervention vs control

研究概览

简要总结

VMMC has been identified as a crucial intervention by UNAIDS to achieve the 2030 global target of a 90% reduction in new HIV infections compared with 2010 levels. CIDRZ, a key partner to the Ministry of Health, has worked with DesireLine to develop a mobile application that supports mobilisers to segment potential clients and provide them with targeted messaging based on their segmentation type. The hypothesis of our proposed study is that targeted interventions addressing the barriers for each of the seven segments, assisted by the Digital Mobilization Tool, will better meet the needs of potential clients and therefore improve uptake of VMMC services, specifically among the three most-resistant segments.

The objective of this study is to evaluate the effect of a segment-targeted mobilization intervention supported by the VMMC NEXUS Digital Mobilization Tool on the uptake of VMMC services at 30 intervention sites, compared with 30 control sites.

The research questions are:

  1. What is the effect of segment-targeted mobilization interventions designed to address the specific psycho-behavioral barriers each of the seven segments face, supported by the VMMC NEXUS Digital Mobilization Tool, on the overall numbers of men receiving VMMC in each site?
  2. What is the effect of the same on the numbers of men by segment receiving VMMC in each site?
  3. What is the effect of the same on the numbers of men by age receiving VMMC in each site?

Secondary goals will be the following, to the extent possible:

  • Assess the incremental cost of the intervention, including by MC
  • Assess and document process learnings from the intervention
  • Develop a workplan to enable national and regional scale-up of the mobilization model and NEXUS Digital Mobilization Tool if demonstrated as effective

详细描述

Study design

The study is a cluster randomised study. Programmatic data will be collected at 60 health-facility sites offering VMMC:

  • 30 sites randomly selected as intervention sites
  • 30 sites randomly selected as control sites Mobilizers associated with the intervention sites will mobilize men for VMMC using the segment targeted interventions for all seven segments, supported by the VMMC NEXUS Digital Mobilization Tool. At the control sites, mobilizers will use the current standard of care tools to engage men for VMMC; these tools are not digital and do not contain the targeted messaging for the three most-resistant segments. One study-supported mobilizer will be placed in each of the 60 sites to support mobilization of men for VMMC in the intervention and control sites as described above.

Mobilizer Training and Specialization The 60 mobilizers (one for each site, control or intervention) will be compensated with a monthly stipend and all will be trained on the basics of VMMC as an HIV prevention method and active listening approaches to educating clients about VMMC.

Mobilizers at the 30 intervention sites additionally will be trained on the VMMC segmentation and barriers men face to getting VMMC. Also they will be trained on use of the VMMC NEXUS Digital Mobilization Tool and on outreach approaches to the three most-resistant segments of men. Data entered by the mobilizers supporting the intervention sites as a part of their routine use of the VMMC NEXUS Digital Mobilization Tool to support their mobilization efforts will be monitored by the CIDRZ program team. Ongoing oversight and support will be provided to all mobilizers as part of routine management for both control and intervention sites.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • living in the catchment area 18 or older

排除标准

  • 未提供

研究组 & 干预措施

Control

Other

Mobilisers in the control arm have been sensitised to the segmentation process but only have access to paper based resources.

干预措施: VMMC NEXUS Digital application (Other)

Intervention

Other

Mobilisers in the intervention sites will be trained to use a digital mobile application to assist with segmenting clients and providing them with targeted messaging.

干预措施: VMMC NEXUS Digital application (Other)

结局指标

主要结局

Total number of VMMC's conducted in intervention vs control

时间窗: at 12 months

The study will compare the difference in total number of VMMC's conducted in the intervention versus the control arm

Total number of VMMC's by age

时间窗: at 12 months

The total number of VMMC's conducted in both the intervention and control arm will be compared and stratified by age group.

Total number of VMMC's by segment

时间窗: at 12 months

The total number of VMMC's conducted in both the intervention and control arm will be compared by segment (ie the specific group type the men have been assigned to).

次要结局

  • Process evaluation(12 months)
  • Costing(12 months)
  • Develop a workplan and handbook to allow for the intervention to be scaled up elsewhere.(3 months post study completion)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolyn Bolton

Principle Investigator

University of Alabama at Birmingham

研究点 (2)

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