Visek Caitlin, Mukiibi James, Nantale Mariam, Nalutaaya Annet, Biché Patrick, Sung Joowhan, Kayondo Francis, Akampurira Joab, Mukiibi Michael, Kiyonga Rogers, Katamba Achilles, Kendall Emily A
Division of Infectious Diseases, Johns Hopkins University School of Medicine, 1830 E. Monument st, 4th Floor, Baltimore, MD, 21205, USA.
Uganda Tuberculosis Implementation Research Consortium, Walimu, Unit 4, Plot 5-7, Coral Crescent, Kololo, P. O. Box 9924, Kampala, Uganda.
Infect Dis Poverty. 2025 Jul 15;14(1):68. doi: 10.1186/s40249-025-01338-0.
A "trace" result from the Xpert Ultra molecular tuberculosis test indicates Mycobacterium tuberculosis DNA detection but may not always signify tuberculosis disease. Little is known about the experiences of individuals with trace results who are not immediately treated. We surveyed patients with trace results to better understand their experiences and preferences related to their uncertain tuberculosis status.
We enrolled adults and adolescents with trace Xpert Ultra sputum results, plus individuals with positive (at a semiquantitative level greater than trace) results ("positive controls") and with negative results ("negative controls"), from community-screening and clinic settings in Kampala, Uganda between February 2021 and December 2024. After an extensive clinical, laboratory, and radiographic evaluation, participants not recommended to start tuberculosis treatment immediately were closely monitored with interval reassessments. Starting in September 2021, surveys captured participants' perceptions and preferences related to their uncertain tuberculosis status at baseline and one and six months later. We compared categorial variables using Pearson's chi-squared test or Fisher's exact test with a significance level of 0.05.
A total of 329 people with trace sputum (PWTS), 241 positive controls, and 279 negative controls were enrolled. Among PWTS surveyed, 22% (28/129) and 23% (30/129) thought they were likely to have or develop tuberculosis, respectively, and most reported low associated anxiety initially (80%, 263/329) and during follow-up. While 53% (174/329) would have favored treatment at baseline if not in the study, only 30% (41/136) of those who remained untreated were inclined toward treatment at six months. Participants chose a sensitive hypothetical test, even with high false-positivity risk, over one with lower sensitivity.
Most PWTS in our study reported a low self-perceived likelihood of having or developing tuberculosis and low anxiety during follow up. Deferring treatment for PWTS is acceptable to most patients when sufficient testing and monitoring are available; in other contexts, upfront treatment may be preferable.
Xpert Ultra分子结核检测的“痕量”结果表明检测到结核分枝杆菌DNA，但这并不总是意味着患有结核病。对于未立即接受治疗的痕量结果个体的经历知之甚少。我们对有痕量结果的患者进行了调查，以更好地了解他们与不确定结核状态相关的经历和偏好。
我们纳入了2021年2月至2024年12月期间在乌干达坎帕拉的社区筛查和诊所环境中，痰标本Xpert Ultra检测结果为痕量的成人和青少年，以及检测结果为阳性（半定量水平高于痕量）的个体（“阳性对照”）和检测结果为阴性的个体（“阴性对照”）。在进行广泛的临床、实验室和影像学评估后，未被建议立即开始抗结核治疗的参与者接受密切监测，并定期重新评估。从2021年9月开始，调查收集了参与者在基线、1个月和6个月时对其不确定结核状态的认知和偏好。我们使用Pearson卡方检验或Fisher精确检验比较分类变量，显著性水平为0.05。
共纳入329名痰标本痕量者（PWTS）、241名阳性对照者和279名阴性对照者。在接受调查的PWTS中，分别有22%（28/129）和23%（30/129）认为自己可能患有或会发展为结核病，大多数人报告最初（80%，263/329）以及随访期间相关焦虑程度较低。虽然如果不在研究中，53%（174/329）的人在基线时会倾向于接受治疗，但在6个月时仍未接受治疗的人中只有30%（41/136）倾向于接受治疗。参与者选择了一种敏感性较高的假设性检测，即使其假阳性风险较高，而不是选择敏感性较低的检测。
我们研究中的大多数PWTS报告自我感觉患结核病或发展为结核病的可能性较低，且随访期间焦虑程度较低。当有足够的检测和监测时，大多数患者可以接受对PWTS推迟治疗；在其他情况下，可能更倾向于直接治疗。
