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Table 2 Summary of trials of interventions to reduce early mortality among HIV-positive people starting antiretroviral therapy

From: Evaluation of a point-of-care tuberculosis test-and-treat algorithm on early mortality in people with HIV accessing antiretroviral therapy (TB Fast Track study): study protocol for a cluster randomised controlled trial

Study Setting Randomisation level Study population (main criteria) Intervention Outcome(s) Expected date of results
PrOMPTa[24] Gabon, Mozambique, South Africa, Uganda Individual CD4 count <50 and body mass index <18; no previous TB treatment; aged ≥18 years; Sputum smear negative; and not fulfilling World Health Organization criteria for smear-negative TB. 4-drug TB treatment, followed by ART within 2 weeks. Comparator: ART alone Primary: all-cause mortality in the first 24 weeks after initiation of ART, CD4 cell increase, safety, HIV viral suppression, TB incidence after ART initiation N/A
REMEMBER [25] Brazil, Haiti, India, Kenya, Malawi, Peru, South Africa, Tanzania, Zimbabwe Individual CD4 count <50; aged ≥13 years; Karnofsky ≥30; no previous TB treatment (within 96 weeks). Those with confirmed or probable TB excluded. ART initiation within 3 days and 4-drug TB treatment within 7 days of ART start. Comparator: ART initiation within 3 days Primary: survival at 24 weeks; survival over 96 weeks; time to AIDS progression; AIDS-free survival at 24 and 28 weeks; HIV viral load at 2, 24 and 48 weeks; safety May 2016
REMSTART [27] Tanzania, Zambia Individual Initially CD4 count <100, broadened to <200 following slow enrolment; aged ≥18 years. All screened for TB at enrolment with Xpert MTB/RIF Rapid initiation of ART, screening for cryptococcal antigen, weekly home visits for 4 weeks by lay workers and rescreening for TB using Xpert MTB/RIF at 6 weeks. Comparator: standard of care Primary: all-cause mortality at 12 months, patient retention, hospital admission, outpatient attendances, TB, cryptococcal meningitis, ART adherence Dec 2014
REALITY [28] Kenya, Malawi, Uganda, Zimbabwe Individual CD4 count <100, aged ≥5 years 2x2x2 factorial: a) intensified ART (triple therapy plus raltegravir) for 12 weeks; b) multidrug prophylaxis against co-infections (isoniazid, pyridoxine, co-trimoxazole and fluconazole for 12 weeks; azithromycin for 5 days; single dose albendazole); c) ready-to-use supplementary food for 12 weeks. Comparator: standard of care including co-trimoxazole, with isoniazid and pyridoxine after 12 weeks Primary: mortality over the first 24 weeks after starting ART, mortality at 48 weeks after starting ART, safety, endpoints relating to the specific mechanisms of action of each intervention Aug 2015
STATIS [26] Cambodia, Côte d’Ivoire, Uganda, Vietnam Individual CD4 count <100; starting ART; aged ≥18 years. Excluded if overt evidence of TB Empirical treatment. Comparator: extensive TB screening (point of care urine lipoarabinomannan, sputum Xpert MTB/RIF, chest radiograph for all at enrolment and those with TB symptoms or signs at all follow-up visits) Primary: composite of (i) 24-week all-cause mortality and (ii) 24-week incidence of invasive bacterial infections; incidence of TB; safety Jun 2017
TB Fast Track [23] South Africa Clinic CD4 count ≤150; not on ART and willing to start ART; aged ≥18 years. No pre-screening for TB prior to enrolment Management strategy to identify those at highest risk of TB, so that they can start TB treatment immediately, followed by ART. Comparator: standard of care Primary: 6-month mortality, severe morbidity over 6 months, time to initiation of ART, retention in ART care, safety Dec 2015
  1. aTerminated early due to insufficient enrolment. All CD4 counts are measured in cells/μL ART antiretroviral therapy, TB tuberculosis.