Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis: an Open-label Randomized Non-inferiority Trial in Lesotho and Blantyre District, Malawi
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 610
- 试验地点
- 2
- 主要终点
- HIV viral suppression <400 copies/mL
研究概览
简要总结
SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS) disease, in a routine primary and secondary care setting in southern Africa with regard to HIV viral suppression (VL <400 copies/mL) 26 weeks after enrolment.
详细描述
In this randomized controlled trial (RCT) two different, guideline-approved algorithms for antiretroviral therapy (ART) initiation in people living with HIV (PLHIV) with presumptive Tuberculosis (TB), but no signs of central nervous system (CNS) disease will be compared. In one arm, same-day initiation (SDI) of ART will be applied ("ART first") for all participants independent of the status or results of initial TB investigations. In the other arm, an approach with deferral of ART initiation until TB is excluded or confirmed and TB treatment initiated will be applied ("TB results first"). The direct comparison of the two approaches in a pragmatic, two-country RCT conducted in a representative high-prevalence setting will provide evidence on the open question of optimal timing of ART initiation in the large subgroup of PLHIV with presumptive TB outside the CNS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 years or older
- •HIV-positive
- •Not taking ART (naïve or reported no ART intake since 90 days or more)
- •Presenting with one or more TB symptoms according to W4SS
- •Unknown TB status
- •Planning to continue care at the study facility for at least 30 weeks
- •Willing and able to consent (age 18 years or older) or assent with guardian consent (age 12 to 17 years)
排除标准
- •Medical condition requiring admission or referral to a higher level health facility at enrolment
- •Symptoms or clinical signs suggestive for diseases of the CNS
- •Positive cryptococcal antigen test (CrAg)
- •Reporting to be pregnant
- •Taking TB treatment, TB preventive therapy (TPT) or treatment against cryptococcal meningitis
结局指标
主要结局
HIV viral suppression <400 copies/mL
时间窗: 26 (22 - 40) weeks after enrolment
HIV viral suppression \<400 copies/mL (obtained from routine laboratory reports at study facility, from laboratory reports of referral facility in case of transfer out, or from dried blood spot (DBS) sample for participants without documented clinic visit but found during home visit tracing)
次要结局
- Retention in care(26 (22 - 30) weeks after enrolment)
- Engagement in care(26 (22 - 30) weeks after enrolment)
- Disengagement from care(26 (22 - 30) weeks after enrolment)
- Lost to follow-up(26 (22 - 30) weeks after enrolment)
- Non-traumatic mortality(during the first 30 weeks after enrolment)
- TB-Immune reconstitution inflammatory syndrome (IRIS)(during the first 30 weeks after enrolment)
- Serious adverse events (SAEs)(during the first 30 weeks after enrolment)
- Incidence of TB disease (microbiologically confirmed and/or clinical diagnosis)(during the first 30 weeks after enrolment)
- HIV viral suppression(at 26 (22 - 40) weeks)