Sizanani: A Randomized Trial of Health System Navigators to Improve Linkage to HIV and TB Care in South Africa

Abstract

Background A fraction of HIV-diagnosed individuals promptly initiate antiretroviral therapy (ART). We evaluated the efficacy of health system navigators for improving linkage to HIV and TB care among newly-diagnosed HIV-infected outpatients in Durban, South Africa. Methods We conducted a randomized controlled trial (Sizanani Trial, NCT01188941) among adults (≥18y) at four sites. Participants underwent TB screening and randomization into a health system navigator intervention or usual care. Intervention participants had an in-person interview at enrollment and received phone calls and text messages over four months. We assessed nine-month outcomes via medical records and the National Population Registry. Primary outcome was completion of at least three months of ART or six months of TB treatment for co-infected participants. Results 4,903 participants were enrolled and randomized; 1,899 (39%) were HIV-infected, with 1,146 (60%) ART-eligible and 523 (28%) TB co-infected at baseline. In the intervention, 212 (39% of outcome-eligible) reached primary outcome, compared to 197 (42%) in usual care (RR 0.93, 95% CI 0.80, 1.08). 131 (14%) HIV-infected intervention participants died compared to 119 (13%) in usual care; death rates did not differ between arms (RR 1.06 (0.84, 1.34). In the as-treated analysis, participants reached for ≥5 navigator calls were more likely to achieve study outcome. Conclusions ~ 40% of ART-eligible participants in both study arms reached the primary outcome nine months after HIV diagnosis. Low rates of engagement in care, high death rates, and lack of navigator efficacy highlight the urgency of identifying more effective strategies for improving HIV and TB care outcomes.

Linkage to care among adults being investigated for tuberculosis in South Africa: pilot study of a case manager intervention

“… 14 Linkage to care (HIV and TB) in our study was higher compared with Sizanani, a randomised control trial in South Africa done between 2010 and 2013 using health navigators sending short messaging service reminders to newly diagnosed HIV-positive people to link into TB and HIV care. 10 This difference is probably because linkage to care was defined differently in Sizanani compared with our study. Standardised definitions of linkage to care would facilitate making comparisons and setting standards.…”

“…Standardised definitions of linkage to care would facilitate making comparisons and setting standards. 10 …”

“… 16 The limited information available around the reasons for non-linkage to HIV care suggest that the problem is not simply a failure of clinic staff to communicate results but rather a multifactorial challenge with health system, individual and structural components. 10 …”

Patient navigators for people with chronic disease: A systematic review

“…Secondary outcomes more frequently included patient-reported outcomes, including physical and mental health status, quality of life, and psychological distress. Other patient-oriented outcomes were reported as secondary outcomes: diagnostic outcomes of cancer screening and follow-up were reported in three studies[ 114 – 116 ], use of acute care was reported in four studies [ 101 , 104 , 109 , 117 ], mortality in two [ 102 , 104 ] and rate of opportunistic infections was reported in one study[ 113 ] Costs were considered in six studies [ 71 , 73 , 116 , 118 – 120 ].…”

Clinic-Based Urinary Lipoarabinomannan as a Biomarker of Clinical Disease Severity and Mortality Among Antiretroviral Therapy-Naive Human Immunodeficiency Virus-Infected Adults in South Africa

“…We conducted a prospective, clinic-based, cohort study by enrolling consecutive, newly diagnosed, antiretroviral therapy (ART)-naive HIV-infected adults in the ambulatory clinical areas of 2 hospitals and 2 municipal health centers in KwaZulu-Natal, South Africa from October 2011 to January 2014 [ 17 , 18 ]. The study was designed to assess the diagnostic accuracy and prognostic value of point-of-care urinary LAM screening, regardless of TB-related symptoms, at the time of HIV diagnosis in an outpatient setting, and we have previously reported the diagnostic accuracy results [ 11 , 12 ].…”