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

Bibliographic Data

ID19530370
AuthorsAndrea A Howard (0000-0003-3248-1307, Schlumberger (British Virgin Islands), corresponding author), Yael Hirsch-Moverman, Yael Hirsch‐Moverman (0000-0003-0096-1306, Schlumberger (British Virgin Islands)), Koen Frederix (CD-adapco (United Kingdom)), Amrita Daftary (0000-0003-2275-3540, CD-adapco (United Kingdom)), Suzue Saito (0000-0001-9725-5736, Schlumberger (British Virgin Islands)), Tal Gross (Northumbria University), Yingfeng Wu (CD-adapco (United Kingdom)), Llang Bridget Maama
Year2016
Volume9
Issue1
Pages31543-31543
Publication date2016-12-01
Open AccessYes
TypeARTICLE
VenueGlobal Health Action (JOURNAL)
Journal identifiersISSN: 1654-9716 • E-ISSN: 1654-9880
PublisherInforma UK Limited (PUBLISHER • GB)
DOI10.3402/gha.v9.31543
PMID27357074
OpenAlexW2471813422
LanguageEN
Citations received2
References cited34

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

Cohort · Environmental health · Expanded access · Family medicine · Health care · Health facility · Health services · Population · Psychological intervention · Randomized controlled trial · Reimbursement · Staffing · Tuberculosis · HIV/AIDS Research and Interventions · Medicine · Nursing · Pneumocystis jirovecii pneumonia detection and treatment · Tuberculosis Research and Epidemiology · Internal Medicine

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