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临床试验/NCT03018002
NCT03018002Unknown不适用

Intervention for Sustained Testing and Retention Among HIV-infected Patients

University of Nevada, Las Vegas1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年7月1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
400
试验地点
1
主要终点
Linkage in care

研究概览

简要总结

The purpose of this study is to evaluate the comparative effectiveness of a congregation, clinic and integrated case management-based intervention for sustainable testing and retention on linkage to care, engagement, retention and viral load suppression of women and children infected with HIV.

详细描述

Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of iSTAR, a community-based social network intervention that combines trained church-based Health Advisors and clinic-based staff and uses motivational interview skills and clinic- quality improvement approaches (Intervention Group; IG) versus a clinic-based approach (Control group; CG) on linkage, engagement, retention and viral suppression among HIV-infected women and children. Eighteen health facilities in identified local government areas in Benue state, north-central Nigeria will be randomly assigned to either the IG (N=9 health facilities) or the CG (N=9 health facilities). A total of 10,000 pregnant women will be screened and 400 HIV-infected participants will be enrolled over a 24-month period. The primary outcome will be the difference in the rate of linkage and engagement between the groups. The secondary outcome will be the difference in rate of retention and viral suppression among participants. Additionally, we will conduct network, mediation/moderation analysis to examine the roles of intermediate variables such as health team cohesion, turnovers, attitudes, leadership and dynamic adaptation on iSTAR implementation and sustainment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

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

入选标准

  • •HIV-infected pregnant women identified during baby showers programs at participating worship centers.

排除标准

  • •HIV-infected women already on treatment

研究组 & 干预措施

Control group

No Intervention

HIV-infected participants identified from the churches randomized to CG will be referred to PEPFAR-supported HIV clinics that provide comprehensive care including counseling, laboratory testing, ART and ongoing support during treatment as the standard of care. The study team will not be involved in their care beyond data collection.

iSTAR

Experimental

HIV-infected participants identified from the churches clustered within the randomized health facilities will receive interventions from the study team.

干预措施: iSTAR (Other)

结局指标

主要结局

Linkage in care

时间窗: 1 month

Linkage in care is defined as the percentage of participants with at least one HIV medical care visit following HIV diagnosis.

Retention in care

时间窗: 12 months

Retention is defined as the percentages of participants with two or more documented viral load measurement during the 12 months following enrollment.

次要结局

  • ART Initiation(1 month)
  • Viral Suppression(12 months)

研究者

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

Echezona Ezeanolue

Professor of Public Health and Pediatrics

University of Nevada, Las Vegas

研究点 (1)

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