Access to antiretroviral therapy (ART) has been broadly expanded in resource-poor settings, but multiple studies have documented high attrition rates during the period from HIV testing to ART initiation. New evidence-based strategies are needed to safely and effectively streamline ART initiation procedures to improve retention. Among patients with minimal symptoms, multiple studies have demonstrated that same-day HIV testing and ART initiation is associated with superior outcomes, compared with standard care. However, same-day treatment has not been systematically evaluated in patients who present with cough, fever, night sweats, or weight loss, because current tests are not sensitive enough to rule out smear-negative TB. At the end of 2016, the next generation Xpert Ultra test will become commercially available. Ultra has a limit of detection that is 10-fold lower than standard Xpert. If it is demonstrated that Ultra is highly sensitive and has a high negative predictive value for ruling out TB in real-world conditions, then the paradigm for management of smear and Xpert-negative patients could shift to a same-day test, with same-day ART or TB treatment in place of the current standard of care. We propose a randomized trial to compare outcomes with standard and same-day treatment among patients with TB symptoms at HIV diagnosis. The standard group will receive Xpert + Ultra testing with 48-hour results; these tests will be conducted on both spot and early-morning specimens. Those with negative test results will receive standard evaluation, including chest x-ray and a trial of empiric antibiotics, prior to ART initiation. The same-day group will receive Xpert, Ultra testing and chest x-ray with same-day results, and blood draw for routine baseline lab tests. They will receive same- day treatment with either TB medication or ART, based on Day 0 test results. They will return on Day 1 for repeat sputum testing, results of baseline laboratory tests, and for medication changes, if indicated based on test results. Both groups will receive liquid culture as the diagnostic gold standard; those with TB will start ART according to WHO guidelines.
Three specific aims are proposed:
The first aim i s to compare the proportion of participants in the standard and same-day groups who are in care with an undetectable viral load (<200 copies/ml) at 48 weeks after HIV testing.
The second aim i s to compare mortality in each group at 48 weeks after HIV testing.
The third aim i s to compare the cost and cost-effectiveness of standard and same-day treatment. If this model of same-day treatment for symptomatic patients is effective, it could serve as a model for other resource-poor settings.
The proposed research is relevant to public health because initiation of treatment and retention in care is sub-optimal throughout the cascade of HIV care worldwide. The proposed intervention is innovative because it aims to change the paradigm for the management of symptomatic patients who are newly diagnosed with HIV. This is relevant to the mission of the NIH, because improved retention in care and viral suppression is critical to the success of HIV treatment programs worldwide.
| Guiteau Moise, Colette; Rivera, Vanessa R; Hennessey, Kelly A et al. (2018) A Successful Model of Expedited Antiretroviral Therapy for Clinically Stable Patients Living With HIV in Haiti. J Acquir Immune Defic Syndr 79:70-76 |
| Rivera, V R; Jean-Juste, M-A; Gluck, S C et al. (2017) Diagnostic yield of active case finding for tuberculosis and HIV at the household level in slums in Haiti. Int J Tuberc Lung Dis 21:1140-1146 |
