Trial reportLancet (London, England)2010
Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial.
Trial report in Lancet (London, England), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 124 papers, 13 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
"Safeguard the Household" - A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country
Addressing Gaps in the Hypertension and Diabetes Care Continuum in Rural Bangladesh Through mHealth and Decentralized Primary Care: The Dinajpur Study
Who cites it
124 citing papers in PubMed, 13 syntheses or guidelines pooled it, 252 citations in OpenAlex.
- Implementation strategies for infection prevention and control promotion for nurses in Sub-Saharan Africa: a systematic review.Implementation science : IS · 2019Pooled it
- Barriers and facilitators to the implementation of doctor-nurse substitution strategies in primary care: a qualitative evidence synthesis.The Cochrane database of systematic reviews · 2019Pooled it
- Nurses as substitutes for doctors in primary care.The Cochrane database of systematic reviews · 2018Pooled it
- Specification of implementation interventions to address the cascade of HIV care and treatment in resource-limited settings: a systematic review.Implementation science : IS · 2017Pooled it
- Feasibility of antiretroviral treatment monitoring in the era of decentralized HIV care: a systematic review.AIDS research and therapy · 2017Pooled it
- Non-medical prescribing versus medical prescribing for acute and chronic disease management in primary and secondary care.The Cochrane database of systematic reviews · 2016Pooled it
- Task shifting from doctors to non-doctors for initiation and maintenance of antiretroviral therapy.The Cochrane database of systematic reviews · 2014Pooled it
- Quality of care provided by mid-level health workers: systematic review and meta-analysis.Bulletin of the World Health Organization · 2013Pooled it
- Non-physician clinician provided HIV treatment results in equivalent outcomes as physician-provided care: a meta-analysis.Journal of the International AIDS Society · 2013Pooled it
- Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.PloS one · 2013Pooled it
- Quantifying and addressing losses along the continuum of care for people living with HIV infection in sub-Saharan Africa: a systematic review.Journal of the International AIDS Society · 2012Pooled it
- Guidelines for improving entry into and retention in care and antiretroviral adherence for persons with HIV: evidence-based recommendations from an International Association of Physicians in AIDS Care panel.Annals of internal medicine · 2012Guideline
- Interventions to increase antiretroviral adherence in sub-Saharan Africa: a systematic review of evaluation studies.The Lancet. Infectious diseases · 2011Pooled it
- Trial
- Computer-Based Counseling Program (CARE+ Kenya) to Promote Prevention and HIV Health for People Living With HIV/AIDS: A Randomized Controlled Trial.AIDS education and prevention : official publication of the International Society for AIDS Education · 2019Trial
- Treatment of chronic hepatitis B in sub-Saharan Africa: 1-year results of a pilot program in Ethiopia.BMC medicine · 2018Trial
- High rates of viral suppression in adults and children with high CD4+ counts using a streamlined ART delivery model in the SEARCH trial in rural Uganda and Kenya.Journal of the International AIDS Society · 2017Trial
- Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial.PLoS medicine · 2017Trial
- Trial
- Systematic Motorcycle Management and Health Care Delivery: A Field Trial.American journal of public health · 2016Trial
64 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Commented on by
- Erratum issued
Authors and funding
19 authors at 7 institutions in 2 countries.
Funding
Abstract
backgroundExpanded access to combination antiretroviral therapy (ART) in resource-poor settings is dependent on task shifting from doctors to other health-care providers. We compared outcomes of nurse versus doctor management of ART care for HIV-infected patients.
methodsThis randomised non-inferiority trial was undertaken at two South African primary-care clinics. HIV-positive individuals with a CD4 cell count of less than 350 cells per microL or WHO stage 3 or 4 disease were randomly assigned to nurse-monitored or doctor-monitored ART care. Patients were randomly assigned by stratified permuted block randomisation, and neither the patients nor those analysing the data were masked to assignment. The primary objective was a composite endpoint of treatment-limiting events, incorporating mortality, viral failure, treatment-limiting toxic effects, and adherence to visit schedule. Analysis was by intention to treat. Non-inferiority of the nurse versus doctor group for cumulative treatment failure was prespecified as an upper 95% CI for the hazard ratio that was less than 1.40. This study is registered with ClinicalTrials.gov, number NCT00255840.
findings408 patients were assigned to doctor-monitored ART care and 404 to nurse-monitored ART care; all participants were analysed. 371 (46%) patients reached an endpoint of treatment failure: 192 (48%) in the nurse group and 179 (44%) in the doctor group. The hazard ratio for composite failure was 1.09 (95% CI 0.89-1.33), which was within the limits for non-inferiority. After a median follow-up of 120 weeks (IQR 60-144), deaths (ten vs 11), virological failures (44 vs 39), toxicity failures (68 vs 66), and programme losses (70 vs 63) were similar in nurse and doctor groups, respectively.
interpretationNurse-monitored ART is non-inferior to doctor-monitored therapy. Findings from this study lend support to task shifting to appropriately trained nurses for monitoring of ART.
fundingNational Institutes of Health; United States Agency for International Development; National Institute of Allergy and Infectious Diseases.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.