The START Study to evaluate the effectiveness of a combination intervention package to enhance antiretroviral therapy uptake and retention during TB treatment among TB/HIV patients in Lesotho: rationale and design of a mixed-methods, cluster-randomized tr

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Howard, Andrea A. ; Hirsch-Moverman, Yael ; Frederix, Koen ; Daftary, Amrita ; Saito, Suzue ; Gross, Tal ; Wu, Yingfeng ; Maama, Llang Bridget (2016)
  • Publisher: Co-Action Publishing
  • Journal: Global Health Action (issn: 1654-9880, eissn: 1654-9716)
  • Related identifiers: doi: 10.3402/gha.v%v.31543
  • Subject: Global Health | TB/HIV integration; implementation science; cost-effectiveness; acceptability; TB treatment success | RC306-320.5

Background: Initiating antiretroviral therapy (ART) early during tuberculosis (TB) treatment increases survival; however, implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap.Objective: The Start TB Patients on ART and Retain on Treatment (START) Study is a mixed-methods, cluster-randomized trial aimed at evaluating the effectiveness, cost-effectiveness, and acceptability of a combination intervention package (CIP) to improve early ART initiation, retention, and TB treatment success among TB/HIV patients in Berea District, Lesotho.Design: Twelve health facilities were randomized to receive the CIP or standard of care after stratification by facility type (hospital or health center). The CIP includes nurse training and mentorship, using a clinical algorithm; transport reimbursement and health education by village health workers (VHW) for patients and treatment supporters; and adherence support using text messaging and VHW. Routine data were abstracted for all newly registered TB/HIV patients; anticipated sample size was 1,200 individuals. A measurement cohort of TB/HIV patients initiating ART was recruited; the target enrollment was 384 individuals, each to be followed for the duration of TB treatment (6–9 months). Inclusion criteria were HIV-infected; on TB treatment; initiated ART within 2 months of TB treatment initiation; age ≥18; English- or Sesotho-speaking; and capable of informed consent. The exclusion criterion was multidrug-resistant TB. Three groups of key informants were recruited from intervention clinics: early ART initiators; non/late ART initiators; and health care workers. Primary outcomes include ART initiation, retention, and TB treatment success. Secondary outcomes include time to ART initiation, adherence, change in CD4+ count, sputum smear conversion, cost-effectiveness, and acceptability. Follow-up and data abstraction are complete.Discussion: The START Study evaluates a CIP targeting barriers to early ART implementation among TB/HIV patients. If the CIP is found effective and acceptable, this study has the potential to inform care for TB/HIV patients in high-burden, resource-limited countries in sub-Saharan Africa.Keywords: TB/HIV integration; implementation science; cost-effectiveness; acceptability; TB treatment success(Published: 27 June 2017) Citation: Glob Health Action 2016, 9: 31543 - http://dx.doi.org/10.3402/gha.v9.31543Supplementary material: To access the supplementary material for this article, please see Supplementary files under ‘Article Tools’
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