2016 Articles
The START Study to evaluate the effectiveness of a
combination intervention package to enhance
antiretroviral therapy uptake and retention during TB
treatment...
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
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31543-202962-1-PB.pdf application/pdf 488 KB Download File
Also Published In
- Title
- Global Health Action
- DOI
- https://doi.org/10.3402/gha.v9.31543
More About This Work
- Academic Units
- International Center for AIDS Care and Treatment Programs
- Epidemiology
- Health Policy and Management
- Published Here
- November 10, 2016
Notes
Full title: 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 trial