ThiPhiSA: New Pathways to Prevention From Community TB Screening in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Completion of a course of TB preventive therapy (TPT)
研究概览
简要总结
This study will compare community-delivered, multi-month dispensing of tuberculosis preventive therapy (TPT) to standard-of-care clinic-based TPT delivery in a population of South African adults who are recommended to receive TB preventive therapy.
We hypothesize that persons receiving multi-month dispensing of TPT in the community will have a higher rate of TPT completion at 3 months than persons receiving TPT via standard of care with monthly clinic-based refills.
详细描述
The research objective is to understand and overcome key barriers to tuberculosis preventive therapy (TPT) delivery and completion in South Africa in the setting of 3HP scale-up. (3HP: short-course TPT consisting of 3 months weekly isoniazid[H] plus rifapentine [P]). The study will investigate these factors through a trial comparing community-delivered TPT, to clinic-based TPT and qualitative research investigating barriers to TPT completion and exploring task-shifted TPT delivery.
Aim 1: To determine the effect of community-based initiation and delivery of TPT on TPT completion.
Hypothesis: Community-delivered TPT will be associated with higher initiation and completion of TPT than standard of care clinic-based TPT.
Approach: Persons eligible for TPT will be identified through the Triage+ TB study and other community-based TB screening activities. Eligible persons will be randomized at the household level to 1) Immediate initiation of TPT & full 12 weeks delivery at once, or 2) Immediate initiation of TPT, 2-week supply, and referral to clinic for TPT completion. TPT adherence and completion will be measured by a combination of self-report, pill count, and serum drug level indicators.
Aim 2: To determine factors associated with TPT initiation and completion in people eligible for TPT identified in community settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •≥18 years of age
- •Living in the study catchment area
- •Eligible for TPT according to South African National guidelines(5), i.e. are a) living with HIV or b) are a close contact of a person with TB disease (defined by a person that resides in the same house as a person with TB), c) and in either case
- •Have screened negative for TB disease in the last 6 months, through TB TRIAGE+ Trial, other household contact tracing, or other community TB screening
- •Negative TB screening at enrolment (if TB TRIAGE+ screening was more than 3 months ago)
- •Willing and able to provide written or verbal consent
- •Participants whom have not received TPT in the last 12 months; this was confirmed verbally with participants during the enrolment process.
排除标准
- •Less than 18 years of age.
- •Pregnant or planning on pregnancy within next three months
- •Planning on moving or relocating from the area within the next three months
- •Positive for active TB
- •Currently on TB treatment
研究组 & 干预措施
Investigational: Community-based TB preventive therapy (TPT)
Participants in the community arm will receive a multi-month dispensing packet at enrollment with the complete 3 month supply of TPT (3HP: 3 months of weekly isoniazid and rifapentine).
干预措施: Community-delivered TB preventive therapy (TPT) - 3 months weekly isoniazid plus rifapentine (3HP) (Other)
Standard-of-Care Tuberculosis Preventative Therapy (TPT)
Participants in the standard of care arm will receive a referral letter to their local Department of Health (DoH) clinic to continue TPT. They will be instructed to present to the DoH clinic within 2 weeks to receive their continuation doses of TPT per current South African DoH standard of care (refills administered monthly).
干预措施: Clinic-link TPT (Other)
结局指标
主要结局
Completion of a course of TB preventive therapy (TPT)
时间窗: 3 months, extended to 16 weeks as needed
TPT completion defined as taking 11 doses of 3HP (3 months weekly isoniazid \[H\] plus rifapentine \[P\] ) within 16 weeks of 3HP initiation. The outcome will be measured as a composite outcome including: self-report of doses taken, periodic pill counts, one-time serum drug level of isoniazid.
Completion of a Course of TB Preventive Therapy (TPT)
时间窗: 3 months, extended to 16 weeks as needed
TPT completion defined as taking 11 doses of 3HP (3 months weekly isoniazid \[H\] plus rifapentine \[P\] ) within 16 weeks of 3HP initiation. The outcome is measured as a composite outcome including: self-report of doses taken, periodic pill counts, one-time serum drug level of isoniazid. (Eight participants with contraindication to 3HP received 6H TPT. Completion of 6H was defined as taking 24 weeks within 9 months)
Number of TPT Doses by Week 16
时间窗: Enrollment to week 16
The number of TPT doses taken by week 16
次要结局
- Overall adherence with TPT(3 months, extended to 16 weeks as needed)
- Predictors of TPT adherence(3 months, extended to 16 weeks as needed)
- Adverse events(3 months, extended to 16 weeks as needed)
- Participant satisfaction with the assigned TPT delivery method(3 months, extended to 16 weeks as needed)
- Overall Adherence With TPT(3 months, extended to 16 weeks as needed)
- Participant Satisfaction With the Assigned TPT Delivery Method(3 months, extended to 16 weeks as needed)
- Adverse Events(3 months, extended to 16 weeks as needed)
研究者
Adrienne E Shapiro
Assistant Professor, Global Health
University of Washington