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临床试验/NCT03537872
NCT03537872已完成不适用

PROvide MIner-friendly SErvices for Integrated TB/HIV Care in Lesotho Study (PROMISE Study)

Columbia University5 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2018年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
248
试验地点
5
主要终点
Proportion of newly diagnosed HIV-positive participants initiated on ART (ART Initiation)

研究概览

简要总结

The PROvide MIner-friendly SErvices for Integrated TB/HIV Care (PROMISE) study will assess the effectiveness, feasibility, and acceptability of integrated tuberculosis (TB)/HIV services provided in miner-friendly service venues in Lesotho that address barriers to early HIV diagnosis and antiretroviral therapy (ART) initiation, concurrent isoniazid preventive therapy (IPT), and retention in HIV care for migrant miners and their families in the context of President's Emergency Plan For AIDS Relief (PEPFAR) programming. The study will evaluate family-focused, integrated TB/HIV services for Basotho migrant miners and family members provided six days per week in miner-friendly service venues (MF), compared to public sector health facilities (PS), which will deliver usual integrated care for the management of TB and HIV.

The ultimate goals of the project are to 1) improve health outcomes among migrant miners and their families, a hard-to-reach population that represents a hotspot of TB/HIV transmission, in Lesotho and in PEPFAR programs more broadly; and 2) strengthen the implementation science research capacity of national and local institutions.

详细描述

TB is the most common opportunistic infection and a leading cause of death among people living with HIV (PLHIV). Early ART and IPT have been shown to reduce TB incidence, morbidity, and mortality among PLHIV, including those with high CD4 counts, and are recommended by the World Health Organization (WHO) as core strategies to reduce the burden of TB among PLHIV. Basotho migrant miners, who travel between their homes in Lesotho and work in South African mines, and their families are at elevated risk of HIV and TB, however, their testing, engagement, and retention in care and treatment are suboptimal. Implementation science research is urgently needed to determine an effective strategy for improving early detection of HIV and early initiation of ART and IPT among migrant miners and their families.

The PROMISE study is a mixed-methods implementation science study that will evaluate a miner-friendly intervention strategy to implement early ART and concurrent IPT for PLHIV. The study will assess the effectiveness, feasibility, and acceptability of integrated TB/HIV services for migrant miners and their family members provided in miner-friendly service venues (MF).

A prospective cohort study design will be used to evaluate the effectiveness of family-focused, integrated TB/HIV services for Basotho migrant miners and family members provided six days per week in miner-friendly service venues, compared to public sector health facilities (PS), which will deliver usual integrated care for the management of TB and HIV. All participants will be assessed at the time of HIV testing (baseline), and at months 3, 6, and 9.

Through implementing and measuring this enhanced TB/HIV service delivery model for miners and their families, study findings will have important implications on programs and policies broadly for PEPFAR, and specifically in Lesotho, for the organization and delivery of integrated TB/HIV services to migrant miners and their families. Findings will inform the development of more tailored interventions to promote HIV diagnosis, early ART, and IPT among miners with HIV, with possible implications for other types of mobile populations; enhance scientific awareness about the unique challenges facing miners in the context of their migration and high TB/HIV co-morbidity; and guide future efforts to develop differentiated service delivery models and integrated HIV/TB services in populations with a high prevalence of HIV and TB.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Tested HIV-positive at MF site within one week of study enrollment
  • Currently working or have worked in a South African mine, or are a family member of a miner (first-degree relative)
  • Not on ART or IPT prior to testing HIV positive at the study site within the past week
  • No history of IPT use
  • 15 years or older
  • Basotho origin
  • Capacity for consent

排除标准

  • Active TB
  • Unwilling to provide a phone number or adhere to study procedures
  • PS Cohort Inclusion Criteria:
  • Tested HIV-positive at either the OPD or voluntary counseling and testing (VCT) clinic on-site within one week of study enrollment
  • Not on ART or IPT prior to testing HIV positive at the study site within the past week
  • No history of IPT use
  • 15 years or older
  • Basotho origin
  • Capacity for consent
  • PS Cohort Exclusion Criteria:
  • Tested HIV-positive at other points of service, including antenatal clinic, labor & delivery, and TB clinics
  • Active TB
  • Unwilling to provide a phone number or adhere to study procedures
  • Health Care Provider Inclusion Criteria:
  • 15 years or older
  • Health care provider in MF or PS site
  • Worked in the clinic for at least 3 months
  • Capacity for consent

结局指标

主要结局

Proportion of newly diagnosed HIV-positive participants initiated on ART (ART Initiation)

时间窗: Up to 3 weeks after 9-month interview

Participants will complete interviewer-administered questionnaires and data will be abstracted from their medical records to assess ART initiation. This is designed to determine if participants at MF are more likely to initiate ART compared to those at PS.

Proportion of newly diagnosed HIV-positive participants on ART initiated on IPT (IPT initiation)

时间窗: Up to 3 weeks after 9-month interview

Participants will complete interviewer-administered questionnaires and data will be abstracted from their medical records to assess IPT initiation. This is designed to compare if participants on ART at MF are more likely to initiate IPT compared to those at PS.

次要结局

  • Proportion of newly diagnosed HIV-positive participants initiated on ART with plasma viral load <1000 copies/ml at 6 months after ART initiation(Up to 3 weeks after 9-month interview)
  • CD4 count at enrollment(Up to 3 weeks after 9-month interview)
  • Time to IPT initiation(Up to 3 weeks after 9-month interview)
  • Time to ART initiation(Up to 3 weeks after 9-month interview)
  • Proportion of participants completed IPT among those who initiated IPT(Up to 3 weeks after 9-month interview)
  • Proportion of newly diagnosed HIV-positive participants initiated on ART retained in care at 6 and 9 months at original clinic(Up to 3 weeks after 9-month interview)
  • Percentage of positive IsoScreen tests at the first study visit after IPT initiation(Up to 9 months post baseline interview)
  • Percentage of total prescribed doses of IPT ingested, by self-report, averaged across study visits(Up to 9 months post baseline interview)
  • Percentage of total prescribed doses of ART ingested, by self-report, averaged across study visits(Up to 9 months post baseline interview)

研究者

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

Andrea Howard

Associate Professor of Epidemiology

Columbia University

研究点 (5)

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