Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study (PRospective Study of Adherence in M/XDR-TB Implementation Science) Aim 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- TB treatment outcomes
研究概览
简要总结
The goal of the proposed study is to enhance adherence and retention in care for M/XDR-TB HIV patients through enhanced standard of care, targeted transition to outpatient medication self-administration prior to hospital discharge, and use of community adherence groups, with an overarching goal of promoting patient engagement in a care continuum.
详细描述
Tuberculosis (TB) remains the leading cause of morbidity and mortality worldwide among people living with HIV (1). Globally, the incidence of multidrug-resistant tuberculosis (MDR-TB) and extensively drug resistant tuberculosis (XDR-TB), the most drug-resistant forms of TB, has approximately doubled over the past fifteen years (1-3). Nowhere has this increased incidence generated more concern than in South Africa where interactions between TB and generalized HIV epidemics are causing 'explosive' TB incidence (4-6) and case-fatality are threatening to undermine the progress reached with antiretroviral therapy (ART) (7, 8).
Medication adherence, a key predictor of outcomes in M/XDR-TB and HIV treatment, is understudied in high burden TB-HIV settings (9-11). Patient losses during transitions in the care continuum are frequent (12), increase mortality and limit control of the linked epidemics. Demands of M/XDR-TB HIV treatment are severe including extraordinary pill burden, severe adverse effects, lengthy treatment, isolation and stigma with few parallels in modern medicine (13-15).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •MTB culture positive with at least isoniazid and rifampicin resistance OR Molecular drug susceptibility test confirming resistance to at least isoniazid and rifampicin OR Polymerase chain reaction test (Xpert MTB/RIF) result showing MTB positive and RIF resistance. OR MTB positive with Rifampicin monoresistance
- •Initiating treatment for M/XDR-TB which includes Bedaquiline (BDQ) or Moxifloxacin/Levaquin
- •Have capacity for informed consent
- •HIV Positive Patients: on ART or initiating ART within the following 4 weeks as per clinician recommendation
排除标准
- •Discretion of IOR or clinician
研究组 & 干预措施
Control
Participants assigned to the control arm will undergo treatment and care for MDR/XDR-TB as per the South African Department of Health guidelines.
Intervention
Participants assigned to the intervention arm will undergo extensive counselling, participants will be provided with an electronic pillbox that monitors their adherence to one of their TB and one of their ART medication. Based on the recordings provided by the wisepill device we will determine if a participant is adherent to their medication and intervene with counselling, phone calls, home visits and relevant referrals.
干预措施: Wisepill device (Device)
结局指标
主要结局
TB treatment outcomes
时间窗: 9-24 months
The number of participants with TB treatment outcomes as assessed by death or culture conversion.
Adherence in M/XDR-TB HIV outcomes
时间窗: 9-24 months
The number of participants that are adherent to their TB and ARV medication as assessed by: * the use of wisepill device (electronic pill box). 2 wisepill devices are provided to participants in the intervention arm, one for their ART medication and one for their TB medication (namely Bedaquiline). * By self reporting via 7-day recall and 30-day recall * By self reporting via Visual analogue scale
Retention in care
时间窗: 9-24 months
Retention in care will be assessed by loss to follow-up.
次要结局
未报告次要终点
研究者
Dr Nesri Padayatchi
Deputy Director
Centre for the AIDS Programme of Research in South Africa