TB Screening Improves Preventive Therapy Uptake Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,719
- 试验地点
- 1
- 主要终点
- Microbiologically-confirmed incident TB and all-cause mortality
研究概览
简要总结
HIV-infected people have an increased risk of developing active tuberculosis (TB). To reduce the burden of TB among people living with HIV (PLHIV), the World Health Organization (WHO) recommends systematic TB screening followed by 1) confirmatory TB testing for all those who screen positive and 2) TB preventive therapy (TPT) for all TPT-eligible PLHIV who screen negative.
The objective of the TB Screening Improves Preventive Therapy Uptake (TB SCRIPT) trial is to determine whether TB screening based on C-reactive protein (CRP) levels, measured using a rapid and low-cost point-of-care (POC) assay, improves TPT uptake and clinical outcomes of PLHIV, relative to symptom-based TB screening.
详细描述
The overall objective of the TB SCRIPT trial is to evaluate the effectiveness and cost-effectiveness of POC CRP-based TB screening, which is the next step required for successful scale-up of both systematic TB screening and TPT. The study's central hypothesis is that compared to symptom-based TB screening, a TB screening strategy based on CRP levels measured at the point-of-care will improve TPT uptake, thereby reducing TB incidence and its associated mortality among PLHIV.
To test this hypothesis, the investigators will conduct an individual randomized control trial enrolling PLHIV presenting to clinics in Uganda for routine antiretroviral therapy (ART) initiation. Eligible participants will be randomized to either POC CRP-based TB screening (intervention arm) or symptom-based TB screening (control arm). In both arms, screen-positive participants will undergo confirmatory TB testing; participants found to have prevalent TB will be initiated on standard TB treatment. In both arms, screen-negative participants will be assessed for TPT eligibility; TPT-eligible participants will be initiated on standard TPT. All participants will be followed for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
盲法说明
Masking will be maintained by administering finger prick tests to all participants, irrespective of trial arm. Intervention arm participants will have CRP levels measured from blood obtained by finger prick. Control arm participants will have beta-human chorionic gonadotropin (beta-hCG) levels measured from blood obtained by finger prick.
Only participants, study investigators and routine clinical care providers will be masked. Study staff performing TB screening in accordance with the participant's randomization assignment and activities downstream of TB screening (i.e., confirmatory TB testing, TPT eligibility assessment) will not be masked. The database administrator will have access to the randomized assignments.
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
- •Age ≥ 18 years
- •Confirmed HIV+ test result
- •CD4 T lymphocyte count of ≤ 350 cells/μL
- •Capacity to provide written (or witnessed verbal, if illiterate) informed consent
排除标准
- •Completed treatment for active pulmonary or extra-pulmonary TB within the past 2 years
- •Completed a full course of TPT within the past year
- •Actively taking any internationally-approved medication for TB treatment for any reason, within 2 weeks of study entry
- •Prior history of combined ART for HIV treatment for any duration (does not include single-dose ART for prevention of vertical transmission of HIV)
- •Currently resides 25 km outside their enrollment site, plans to move 25 km outside their enrollment site in the next 2 years, or plans to transfer their HIV care from their current enrollment site
研究组 & 干预措施
Symptom-based TB screening
Participants randomized to the control arm will undergo symptom-based TB screening at study entry. Participants reporting ≥1 TB symptom (current cough, fever, night sweats, weight loss) will be regarded as screen-positive and will be referred for confirmatory TB testing, in accordance with WHO guidelines. Participants with none of the 4 TB symptoms will be regarded as screen-negative and will be assessed for TPT eligibility.
POC CRP-based TB screening
Participants randomized to the intervention arm will undergo POC CRP-based TB screening at study entry. Participants with elevated POC CRP levels (≥8 mg/L) will be regarded as screen-positive and will be referred for confirmatory TB testing. Participants with non-elevated POC CRP levels (<8 mg/L) will be regarded as screen-negative and will be assessed for TPT eligibility.
干预措施: CRP, point-of-care assay (Device)
结局指标
主要结局
Microbiologically-confirmed incident TB and all-cause mortality
时间窗: two years
Time to first diagnosis of microbiologically-confirmed incident TB or death from any cause
次要结局
- Prevalent TB diagnosis: number microbiologically-confirmed prevalent TB cases detected by screening test(two years)
- Prevalent TB treatment: Number treated for prevalent TB(two years)
- Prevalent TB treatment: number with microbiologically-confirmed prevalent TB completing treatment(two years)
- TB incidence: drug resistant TB(two years)
- TPT uptake: number screen-negatives prescribed TPT(two years)
- TPT uptake: number initiated on TPT(two years)
- TB incidence: number diagnosed(two years)
- TB incidence: incidence(two years)
- TB incidence: Time to microbiologically-confirmed incident TB diagnosis(two years)
- Mortality: number of deaths from any cause(two years)
- TB incidence: incidence rate(two years)
- TB incidence: drug resistant TB among people receiving TPT(two years)
- Mortality: all-cause death rate(two years)
- Mortality: number who died from TB(two years)
- Prevalent TB diagnosis: number microbiologically-confirmed prevalent TB cases missed by screening test(two years)
- Prevalent TB treatment: time to treatment of microbiologically-confirmed prevalent TB(two years)
- TPT uptake: number completing TPT(two years)
- Mortality: time to death from any cause(two years)
- TPT uptake: number screen-positives prescribed TPT(two years)
- TPT uptake: time to TPT initiation(two years)
- Prevalent TB diagnosis: number diagnosed with microbiologically-confirmed prevalent TB(two years)