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临床试验/NCT03944395
NCT03944395Unknown不适用

Assessing the Effectiveness and Feasibility of Voluntary Assisted Partner Notification Services in High HIV Burden Districts of Malawi: a Pragmatic, Non-Randomized Stepped-Wedge Study

Lighthouse Trust1 个研究点 分布在 1 个国家目标入组 1,785 人开始时间: 2018年5月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1,785
试验地点
1
主要终点
Proportion of eligible index clients offered VAPN services

研究概览

简要总结

To evaluate effectiveness of voluntary assisted partner notification (VAPN) in real-world programmatic settings, a non-randomized, stepped wedge study in high volume facilities in 6 high HIV burden focus districts (Blantyre, Zomba, Chikwawa, Machinga, Mangochi and Lilongwe urban) is proposed. The primary objective is to compare the percentage of contacts tested during the standard of care (SOC) phase (i.e., using passive family referral services (FRS) index testing methodology) with the percentage of contacts tested during the SOC plus VAPN phase, by 1, 2, and 3 months after the initial contact with the index client. Assessment of feasibility will be achieved through documentation of operational lessons learned during implementation. Findings will contribute to ongoing policy discussions whether Malawi should adopt VAPN in its national HIV testing guidelines

详细描述

The over-arching goal of this study is to evaluate the effectiveness and feasibility of the voluntary assisted partner notification (VAPN) intervention in real-world programmatic settings in high burden facilities in 6 priority districts in Malawi.

The primary objective is to compare effectiveness of standard of care (SOC) (i.e., use of the family referral services (FRS)) with SOC plus VAPN in reaching contacts of index clients with HIV testing services. The percentage of contacts who receive HIV testing services within 1, 2, and 3 months of the initial offer of services to the index client will be compared between the SOC phase and the intervention phase (SOC plus VAPN).

Secondary objectives include:

  1. To evaluate feasibility of implementing VAPN in real-world programmatic settings in high burden facilities in 6 priority districts in Malawi. Two key quantitative measures of feasibility will be used as follows:
  • What is the cumulative percentage of eligible index clients offered VAPN services by study end?
  • To what extent were the interventions implemented with fidelity? For example, a key measure of the fidelity of the Client Referral VAPN option is to assess what percentage of contacts, who did not return for their scheduled first appointment at the clinic, were subsequently traced according to the specified algorithm (i.e., up to 5 phone calls, and up to 2 home visits)?
  1. To monitor trends in HIV diagnostic yield from SOC plus VAPN over time.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Assisted Partner notification services

Other

Voluntary assisted partner notification (VAPN) services will be offered at facilities according to a stepped wedge design. Once VAPN services are activated at a facility, HIV positive individuals will be offered four options (3 voluntary assisted partner notification options and 1 standard of care option) for inviting their contacts, which they can choose to accept or decline.

干预措施: Assisted Partner Notification Services (Other)

结局指标

主要结局

Proportion of eligible index clients offered VAPN services

时间窗: 10 months

Number of eligible index clients who are offered VAPN divide by the number of all eligible index clients identified for enrolment

次要结局

  • Proportion of contacts who returned for HIV testing(10 months)

研究者

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

Hannock Tweya, PhD, MSc

Director of Monitoring, Evaluation and Research

Lighthouse Trust

研究点 (1)

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