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The START Study to evaluate the effectiveness of a combination intervention package to enhance antiretroviral therapy uptake and retention during TB treatment...

Andrea A. Howard; Yael Hirsch-Moverman; Koen Frederix; Amrita Daftary; Suzue Saito; Tal Gross; Yingfeng Wu; Llang Bridget Maama

Title:
The START Study to evaluate the effectiveness of a combination intervention package to enhance antiretroviral therapy uptake and retention during TB treatment...
Author(s):
Howard, Andrea A.
Hirsch-Moverman, Yael
Frederix, Koen
Daftary, Amrita
Saito, Suzue
Gross, Tal
Wu, Yingfeng
Maama, Llang Bridget
Date:
Type:
Articles
Department(s):
International Center for AIDS Care and Treatment Programs
Epidemiology
Health Policy and Management
Volume:
9
Persistent URL:
Book/Journal Title:
Global Health Action
Geographic Area:
Lesotho
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
Abstract:
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
Subject(s):
Antiretroviral agents
HIV infections--Complications
Tuberculosis--Treatment
Combination drug therapy
Medicine
Publisher DOI:
https://doi.org/10.3402/gha.v9.31543
Item views
223
Metadata:
text | xml
Suggested Citation:
Andrea A. Howard, Yael Hirsch-Moverman, Koen Frederix, Amrita Daftary, Suzue Saito, Tal Gross, Yingfeng Wu, Llang Bridget Maama, , The START Study to evaluate the effectiveness of a combination intervention package to enhance antiretroviral therapy uptake and retention during TB treatment..., Columbia University Academic Commons, .

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