Economic support to improve TB treatment outcomes in South Africa : a pragmatic cluster randomized controlled trial

Lutge, Elizabeth Eleanor (2013-12)

Thesis (PhD)--Stellenbosch University, 2013.

Thesis

ENGLISH ABSTRACT: This thesis focused on the provision of economic support to improve the outcomes of patients on TB treatment. Although the association between poverty and tuberculosis is generally acknowledged, there is little evidence to guide the use of economic interventions to improve tuberculosis control. In South Africa, a high burden country with extensive poverty, such evidence is particularly important. The first part of this thesis is a Cochrane systematic review of evidence from randomized controlled trials regarding the effectiveness of economic support among patients with tuberculosis. Eleven trials were included: ten conducted among marginalised groups in the United States on economic support for people on prophylactic treatment for latent TB; and one from Timor-Leste on economic support for patients with active TB. The review found that the use of economic interventions in patients with latent TB may increase the return rate for reading tuberculin skin test results, probably improves clinic re-attendance for initiation or continuation of prophylaxis and may improve completion of prophylaxis, compared to normal care. However, it is uncertain if economic support improves treatment completion in patients with active TB (low quality evidence). The second part of the thesis reports the findings of a pragmatic, cluster randomized controlled trial to evaluate the feasibility and effectiveness of delivering economic support to patients on treatment for active TB in South Africa. Patients with drug sensitive pulmonary TB were offered a monthly voucher valued at ZAR120 until completion of treatment or a maximum of eight months. Patients in control clinics received usual TB care. A parallel process evaluation provided contextual information to explain the trial findings. The qualitative component of this evaluation consisted of in-depth interviews with a sample of trial participants, including patients, nurses and health managers, to assess responses to the voucher and its administration. The quantitative component included a survey of patients’ household expenditure to assess patients’ levels of poverty and the effects of the voucher on these, and an analysis of the goods on which patients spent their vouchers. 4091 patients were included in the trial: 1984 in the control arm (10 clinics) and 2107 in the intervention arm (10 clinics). Intention to treat analysis showed a small but non-significant improvement in treatment success rates in intervention clinics (intervention 76.2%; control 70.7%; risk difference 5.6% (-1.2; 12.3%), p = 0.107). Fidelity to the intervention was low, partly because nurses preferred to issue vouchers based on perceived financial need, rather than on eligibility. Logistical difficulties in delivering vouchers to clinics also undermined fidelity. The vouchers did not significantly increase patients’ household expenditure, but were experienced by patients as helpful, especially in providing more food with which to take their tablets. Factors related to the administration of economic support may undermine its effectiveness in improving TB treatment outcomes. Further research is needed to explore how best to deliver such economic support to those eligible to receive it, particularly in low and middle income countries where the burden of tuberculosis is highest.

AFRIKAANSE OPSOMMING: Hierdie tesis was toegespits op die verlening van ekonomiese steun om die uitkomste van pasiënte op tuberkulose- (TB-) behandeling te verbeter. Hoewel die verband tussen armoede en TB in die algemeen erken word, is daar nie veel bewyse om die gebruik van ekonomiese intervensies ter verbetering van TB-beheer te staaf nie. In Suid-Afrika – ’n land met ’n hoë TB-las en wydverspreide armoede – is sulke bewyse veral belangrik. Die eerste deel van hierdie tesis behels ’n sistematiese Cochrane-oorweging van bewysmateriaal afkomstig van verewekansigde, gekontroleerde proewe oor die doeltreffendheid van ekonomiese steun aan pasiënte met tuberkulose. Altesame 11 proewe is ingesluit: Tien is gedoen onder gemarginaliseerde groepe in die Verenigde State met die fokus op ekonomiese ondersteuning aan mense wat profilaktiese behandeling vir latente TB ontvang het. Een, van Timor-Leste, was gefokus op ekonomiese ondersteuning aan pasiënte met aktiewe tuberkulose. Die ondersoek het aan die lig gebring dat, vergeleke met normale sorg, die gebruik van ekonomiese intervensies by pasiënte met latente tuberkulose tog die omdraaikoers vir die lees van tuberkulien-veltoetsresultate kan verhoog, waarskynlik hertoelating tot klinieke vir die inisiëring of voortsetting van profilakse verbeter, en die voltooiing van profilakse kan verbeter. Die tweede gedeelte van die tesis behels ’n verslag oor die bevindings van ’n pragmatiese, trosverewekansigde gekontroleerde proef, om te bepaal hoe doenlik en doeltreffend dit sou wees om ekonomiese steun te verleen aan pasiënte wat in Suid-Afrika vir aktiewe tuberkulose behandel word. Pasiënte met middelsensitiewe pulmonêre tuberkulose het tot en met die voltooiing van hul behandeling, of tot ’n maksimum van agt maande, ’n maandelikse koopbewys ter waarde van ZAR120 ontvang. Pasiënte in kontroleklinieke het die gewone TB-sorg ontvang. ’n Parallelle prosesevaluering het kontekstuele inligting voorsien ter verklaring van die bevindinge van die proef. Die kwalitatiewe komponent van hierdie evaluering het bestaan uit diepte-onderhoude met ’n steekproef van alle deelnemers aan die proefneming, insluitend pasiënte, verpleegpersoneel en gesondheidsbestuurders, om hul reaksies te bepaal op die koopbewys self sowel as op die administrasie daarvan. Die kwantitatiewe komponent het ’n opname oor pasiënte se huishoudelike besteding ingesluit, ter vasstelling van hul armoedevlak en die moontlike uitwerking van die koopbewys daarop, asook ’n ontleding van die goedere waarop pasiënte hul koopbewyse bestee het. Altesame 4 091 pasiënte is by die proef ingesluit – 1 984 in die kontrole-afdeling (10 klinieke) en 2 107 in die intervensie-afdeling (10 klinieke). ’n Voorneme-om-te-behandel- (ITT-) ontleding toon ’n klein dog nie-betekenisvolle verbetering in behandelingsuksessyfers in intervensieklinieke (intervensie 76,2%; kontrole 70,7%; risikoverskil 5,6% (-1,2; 12,3%), p = 0.107). Getrouheid aan die intervensie was laag – deels omdat verpleegkundiges verkies het om die koopbewyse op grond van veronderstelde finansiële behoeftigheid eerder as volgens die studiekriteria uit te deel. Die koopbewyse het nie pasiënte se huishoudelike besteding beduidend verhoog nie, maar pasiënte het dit wél as nuttig ervaar, veral omdat hulle daarmee meer kos kon koop om saam met hul pille in te neem. Faktore wat verband hou met die administrasie van ekonomiese ondersteuning kan die doeltreffendheid van sodanige steun in die verbetering van TB-behandelingsuitkomste ondermyn. Verdere navorsing word vereis om te verken wat die beste manier sou wees om sodanige ekonomiese steun te bied aan diegene wat daarvoor in aanmerking kom, veral in lae- en middel-inkomstelande, waar die TB-las die hoogste is.

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