Cited by 141HIV/AIDS Research and InterventionsHIV/AIDS drug development and treatmentHealth Policy Implementation Science

Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial

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Amanyire, Gideon, Semitala, Fred C, Namusobya, Jennifer, Katuramu, Richard, Kampiire, Leatitia, Wallenta, Jeanna, Charlebois, Edwin, Camlin, Carol +6 more·2016·The Lancet HIV

Abstract

Background In Africa, up to 30% of HIV-infected patients who are clinically eligible for antiretroviral therapy (ART) do not start timely treatment. We assessed the effects of an intervention targeting prevalent health systems barriers to ART initiation on timing and completeness of treatment initiation. Methods In this stepped-wedge, non-blinded, cluster-randomised controlled trial, 20 clinics in southwestern Uganda were randomly assigned in groups of five clinics every 6 months to the intervention by a computerised random number generator. This procedure continued until all clinics had crossed over from control (standard of care) to the intervention, which consisted of opinion-leader-led training and coaching of front-line health workers, a point-of-care CD4 cell count testing platform, a revised counselling approach without mandatory multiple pre-initiation sessions, and feedback to the facilities on their ART initiation rates and how they compared with other facilities. Treatment-naive, HIV-infected adults (aged ≥18 years) who were clinically eligible for ART during the study period were included in the study population. The primary outcome was ART initiation 14 days after first clinical eligibility for ART. This study is registered with ClinicalTrials.gov, number NCT01810289. Findings Between April 11, 2013, and Feb 2, 2015, 12 024 eligible patients visited one of the 20 participating clinics. Median CD4 count was 310 cells per μL (IQR 179-424). 3753 of 4747 patients (weighted proportion 80%) in the intervention group had started ART by 2 weeks after eligibility compared with 2585 of 7066 patients (38%) in the control group (risk difference 41·9%, 95% CI 40·1-43·8). Vital status was ascertained in a random sample of 208 patients in the intervention group and 199 patients in the control group. Four deaths (2%) occurred in the intervention group and five (3%) occurred in the control group. Interpretation A multicomponent intervention targeting health-care worker behaviour increased the probability of ART initiation 14 days after eligibility. This intervention consists of widely accessible components and has been tested in a real-world setting, and is therefore well positioned for use at scale. Funding National Institute of Allergy and Infectious Diseases (NIAID) and the President's Emergency Fund for AIDS Relief (PEPFAR).

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Authors
Amanyire, G., Semitala, F. C., Namusobya, J., Katuramu, R., Kampiire, L., Wallenta, J., Charlebois, E., Camlin, C., Kahn, J., Chang, W., Glidden, D., Kamya, M., Havlir, D., & Geng, E.
Affiliations
  • Makerere University (UG)
  • University of California, San Francisco (US)
Corresponding author
Geng, Elvin
Venue
The Lancet HIV
Publisher
Elsevier BV
Published
2016-11
Volume
3
Issue
11
Pages
e539-e548
ISSN
2352-3018 (ISSN-L)
OpenAlex
W2512229472
Cited by
141
References
5
Citations by year
2026: 8 · 2025: 12 · 2024: 13 · 2023: 10 · 2022: 18 · 2021: 14 · 2020: 15 · 2019: 23 · 2018: 12 · 2017: 13 · 2016: 3
FWCI
15.70
Type
journal article
Language
en
Open access
Locations
  • The Lancet HIV (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • eScholarship (California Digital Library) (submittedVersion)
Funders
  • National Institute of Mental Health (P30MH062246)
  • National Institute of Allergy and Infectious Diseases (U01AI099959, UM1AI069496)
Topics
  • Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
  • Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
  • Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
Keywords
antiretroviral therapy initiation, HIV, health professions education, point-of-care CD4 testing, Uganda, Africa, multicomponent intervention, health system strengthening
MeSH terms
Adult, Africa, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Uganda, HIV Infections, Treatment Outcome, CD4 Lymphocyte Count, Anti-HIV Agents, Viral Load, Antiretroviral Therapy, Highly Active, Young Adult, Time-to-Treatment

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