Indigenous Health Professions Program, McGill University, Montreal, Quebec, Canada.
Research & Development Unit, Komfo Anokye Teaching Hospital, Kumasi, Ghana.
Clin Infect Dis. 2023 Jul 5;77(1):84-93. doi: 10.1093/cid/ciad164.
Adherence to tuberculosis preventive treatment (TPT) is an important determinant of clinical benefit. We assessed the association of participant behaviors early in TPT with subsequent discontinuation.
We used data from a phase 3 randomized trial and the preceding phase 2 trial to compare 4 months of rifampin to 9 months of isoniazid for TPT. We excluded participants whose providers discontinued TPT due to adverse events or tuberculosis disease. We analyzed 4 outcomes: discontinuing TPT within the first month of treatment, discontinuing TPT between the first and second month, discontinuing TPT after the second month, and completing treatment but not per protocol. We analyzed the association of outcomes with regimen and participant characteristics and 4 behavioral predictors of discontinuation recorded at the month 1 and month 2 follow-up visits: reporting symptoms of intolerance, missing >20% of doses, rescheduling appointments, and not bringing their medication bottle.
Overall, 6656 participants were included (phase 3, 5848; phase 2, 808), of whom 4318 (64.9%) completed treatment per protocol. Participant characteristics were inconsistently associated with discontinuation. Phase 3 trial participants with 1, 2, or 3-4 behavioral predictors at the month 1 follow-up had 5.0 (95% confidence interval, 3.6-6.7), 18.6 (13.3-26.1), and 79.4 (38.2-165.0), respectively, higher odds of discontinuing before the second month. The corresponding number of predictors at the month 2 follow-up had 1.8 (1.4-2.2), 4.7 (3.6-6.2), and 7.4 (4.6-11.9) higher odds of discontinuing before completing treatment; phase 2 findings were similar.
Four behavioral predictors recorded early in therapy were more strongly associated with subsequent discontinuation than participant characteristics, particularly when more than 1 behavioral predictor was recorded. Clinical Trials Registration. NCT00170209; NCT00931736.
结核病预防治疗（TPT）的依从性是临床获益的重要决定因素。我们评估了 TPT 早期参与者的行为与随后停药的关系。
我们使用了一项 3 期随机试验和之前的 2 期试验的数据，比较了 4 个月的利福平与 9 个月的异烟肼用于 TPT。我们排除了因不良反应或结核病而停止 TPT 的参与者。我们分析了 4 个结果：治疗的第一个月内停止 TPT、第一个月和第二个月之间停止 TPT、第二个月后停止 TPT 以及完成治疗但不符合方案。我们分析了方案和参与者特征以及在第 1 个月和第 2 个月随访时记录的 4 个行为预测因素与结果的关系：报告不耐受症状、漏服超过 20%的剂量、重新安排预约和不携带药物瓶。
总体而言，共有 6656 名参与者被纳入（3 期 5848 名，2 期 808 名），其中 4318 名（64.9%）按方案完成了治疗。参与者的特征与停药不一致。在第 1 个月随访时，3 期试验中有 1、2 或 3-4 个行为预测因素的参与者在第二个月之前停药的几率分别为 5.0（95%置信区间，3.6-6.7）、18.6（13.3-26.1）和 79.4（38.2-165.0）；在第 2 个月随访时，有 1.8（1.4-2.2）、4.7（3.6-6.2）和 7.4（4.6-11.9）个预测因素的参与者在完成治疗前停药的几率更高；2 期的结果相似。
治疗早期记录的 4 个行为预测因素与随后的停药比参与者特征更密切相关，特别是当记录了多个行为预测因素时。临床试验注册。NCT00170209；NCT00931736。
