Start TB Patients on ART and Retain on Treatment: Combination Intervention Package to Enhance Antiretroviral Therapy Uptake and Retention During TB Treatment in Lesotho
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 12
- 主要终点
- Percentage of TB/HIV patients newly registered during period of observation who initiate ART during TB treatment
研究概览
简要总结
The purpose of the START Study is to identify an effective, cost-effective, acceptable intervention that addresses programmatic, structural and psychosocial barriers to ART initiation and retention during TB treatment, with the ultimate goal of improving health outcomes among HIV-infected TB patients in Lesotho. The study is a two-arm cluster randomized trial, randomized at the TB/HIV clinic level, which includes twelve TB/HIV clinics in Berea district. Clinics are randomized to deliver the combination intervention package (CIP) or standard of care (SOC), with stratification by facility type. The experimental intervention will be delivered to all HIV-infected TB patients in TB/HIV clinics randomly assigned to CIP. In TB/HIV clinics assigned to SOC, usual care procedures for ART initiation and retention will be delivered.
Study hypotheses focus on the effectiveness of the CIP on HIV- and TB-related outcomes.
Compared to HIV-infected TB patients attending SOC clinics, HIV-infected TB patients at CIP clinics will have superior HIV- and TB-related outcomes, including:
- Greater ART initiation during TB treatment
- Shorter time to ART initiation
- Greater retention in ART care
- Higher adherence to ART
- Greater change in CD4+ count
- Greater TB treatment success (completion and cure)
- Greater sputum smear conversion
- Higher adherence to TB treatment
Additionally, CIP delivery will have an incremental cost-effectiveness ratio more favorable than alternative resource uses.
详细描述
Among people living with HIV (PLWH), tuberculosis (TB) is the most common opportunistic illness and a leading cause of death, accounting for nearly a quarter of HIV-related deaths worldwide. Initiating antiretroviral therapy (ART) early during TB treatment significantly increases survival, and World Health Organization (WHO) guidelines recommend ART initiation for all PLWH as soon as possible after TB treatment initiation, regardless of CD4+ count. Yet in the African Region, only 42% of TB patients known to be living with HIV were on ART in 2010, and retention in ART programs has been limited. In Lesotho, only 27% of HIVinfected TB patients received ART in 2010. There is an urgent need to identify programmatic interventions that increase the proportion of HIV-infected TB patients on ART, shorten the duration between TB diagnosis and ART initiation, and improve adherence to medications and retention in care amongst HIV-infected TB patients in Lesotho.
Lesotho, a small, landlocked country completely surrounded by South Africa, is among the world's poorest nations with one of the world's most severe epidemics of HIV and tuberculosis (TB). There is strong evidence that TB patients who are also infected with HIV have better survival rates if they begin antiretroviral therapy (ART) soon after starting TB treatment; however, there are many patients who do not initiate ART within the recommended timeframe, and who do not remain in care.
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
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected
- •On TB treatment
- •Initiating ART within 2 months of TB treatment initiation
- •Aged 18 or older
- •English- or Sesotho-speaking
- •Capable of informed consent
- •Measurement Cohort Participant
排除标准
- •Children under age of 18
- •Patients diagnosed with Multi Drug Resistant-TB (MDR-TB)
- •Key Informats: Three groups of key informats (KI) will be recruited.
- •Key Informants ART Early-Initiators Inclusion Criteria:
- •A measurement cohort participant
- •Initiaing ART within the first 8 weeks of TB treatment
- •Key Informants ART Non/Late-Initiators Inclusion Criteria:
- •A measurement cohort participant
- •did not initiate ART during TB treatment or initiating ART >= 2 months after TB treatment initiation
- •Key Informants Healthcare Workers Inclusion Criteria:
- •Nurse or VHW working in a CIP clinic or VHW working in the community and affiliated with CIP clinic
- •Aged 18 or older
- •English- or Sesotho-speaking
- •Capable informed consent
结局指标
主要结局
Percentage of TB/HIV patients newly registered during period of observation who initiate ART during TB treatment
时间窗: Up to 9 months
To examine ART initiation based on review of clinic registers.
Participants with cure + treatment completion at end of TB treatment
时间窗: Up to 9 months
To examine TB treatment success as defined by WHO, based on review of TB register and treatment cards.
Percentage of participants who attended 6 month clinic visit (within 1 month window) and reported ART use
时间窗: Up to 6 months after TB treatment initiation
To examine ART retention. Deaths and transfers will be considered not retained.
次要结局
- Days from TB treatment initiation to date of ART initiation(Up to 9 months)
- Ratio of the incremental costs of the CIP to incremental effectiveness(Up to 2 years)
- Change in CD4+ count(Up to 6 months after initial CD4 count)
- Percentage of total prescribed doses ingested for ART(Up to 9 months)
- Percentage of smear positive pulmonary TB cases that converted to smear negative after eight weeks of treatment(Up to 8 weeks from initiation of TB treatment)
- Percentage of total prescribed doses ingested for TB treatment(Up to 9 months)