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Randomized Controlled Trial
. 2019 Feb 4;19(1):110.
doi: 10.1186/s12879-019-3738-4.

Test and Treat TB: a pilot trial of GeneXpert MTB/RIF screening on a mobile HIV testing unit in South Africa

Ingrid V Bassett  1   2   3   4 , Leah S Forman  5 , Sabina Govere  6 , Hilary Thulare  6 , Simone C Frank  7   8 , Bright Mhlongo  6 , Elena Losina  7   9   10   11   12
Affiliations
Randomized Controlled Trial

Test and Treat TB: a pilot trial of GeneXpert MTB/RIF screening on a mobile HIV testing unit in South Africa

Ingrid V Bassett et al. BMC Infect Dis. .

Abstract

Background: Community-based GeneXpert MTB/RIF testing may increase detection of prevalent TB in the community and improve rates of TB treatment completion.

Methods: We conducted a pilot randomized trial to evaluate the impact of GeneXpert screening on a mobile HIV testing unit. Adults (≥18y) underwent rapid HIV testing and TB symptom screening and were randomized to usual mobile unit care (providing sputum on the mobile unit sent out for GeneXpert testing) or the "Test & Treat TB" intervention with immediate GeneXpert testing. Symptomatic participants in usual care produced sputum that was sent for hospital-based GeneXpert testing; participants were contacted ~ 7 days later with results. In the "Test & Treat TB" intervention, HIV-infected or HIV-uninfected/TB symptomatic participants underwent GeneXpert testing on the mobile unit. GeneXpert+ participants received expedited TB treatment initiation, monthly SMS reminders and non-cash incentives. We assessed 6-month TB treatment outcomes.

Results: 4815 were eligible and enrolled; median age was 27 years (IQR 22 to 35). TB symptoms included cough (5%), weight loss (4%), night sweats (4%), and fever (3%). 42% of eligible participants produced sputum (intervention: 56%; usual care: 26%). Seven participants tested GeneXpert+, six in the intervention (3%, 95% CI 1%, 5%) and one in usual care (1%, 95% CI 0%, 6%). 5 of 6 intervention participants completed TB treatment; the GeneXpert+ participant in usual care did not.

Conclusion: GeneXpert MTB/RIF screening on a mobile HIV testing unit is feasible. Yield for GeneXpert+ TB was low, however, the "Test & Treat TB" strategy led to high rates of TB treatment completion.

Trial registration: This study was registered on November 21, 2014 at ClinicalTrials.gov ( NCT02298309 ).

Keywords: Community-based screening; GeneXpert MTB/RIF; Test & Treat; Tuberculosis.

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Conflict of interest statement

Ethics approval and consent to participate

Participants provided written consent for study participation. The study was approved by the University of KwaZulu-Natal Biomedical Research Ethics Committee (BE421/14, Durban, South Africa) and the Partners Institutional Review Board (2014P001173, Boston, MA).

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant Flow. Of 7361 individuals (intervention: 3478; usual care: 3883) screened over 20 months, 4815 (intervention: 2441; usual care: 2374) were eligible and enrolled. The main reason for ineligibility was unwillingness to visit one of the follow-up clinics (2119, 88%). Other reasons for ineligibility included: age < 18 years (241, 10%); no regular access to a cell phone (96, 4%); pregnant (85, 4%); currently on TB treatment (34, 1%). Being unable to receive texts, unwilling to participate in the study, not comfortable getting tested, or not comfortable sharing results comprised < 1% of ineligibility. In the intervention arm, 250 (10%) participants were HIV-positive, 219 (9%) were TB-symptomatic, and 37 (2%) were both HIV-positive and TB symptomatic. Of those eligible to give a sputum sample, 240 (56%) successfully produced sputum and 6 (3%) tested GeneXpert-positive. In the usual care arm, 176 (7%) participants were HIV-positive, 205 (9%) were TB-symptomatic, and 29 (1%) were both HIV-positive and TB symptomatic. Of those eligible to give a sputum sample, 91 (26%) successfully produced sputum and 1 (1%) tested GeneXpert-positive
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