Patient experiences of tuberculosis treatment deferral after a trace Xpert Ultra result: a prospective cohort study.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.