Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial

Abstract

Summary Background Expanded access to combination antiretroviral therapy (ART) in the resource-poor setting is dependent on “task-shifting” from doctors to other health care providers. We compared “doctor-initiated-nurse-monitored” care to the current standard of care, “doctor-initiated-doctor-monitored” ART. Methods A randomised strategy trial to determine whether treatment outcomes of “nurse-monitored” ART were non-inferior to “doctor-monitored” ART was conducted at two South African primary-care clinics. HIV-positive individuals with a CD4 count of <350cells/mm3 or WHO stage 3 or 4 disease were eligible. The primary objective was a composite end-point of treatment limiting events, incorporating mortality, viral failure, treatment-limiting toxicities and visit schedule adherence. Intention-to-treat analyses were performed. This study is registered with ClinicalTrials.gov, NCT00255840. Findings The hazard ratio for composite failure was 1.09 (95% CI= 0.89-1.33) which lay within the limits for non-inferiority. The analysis was performed on 812 HIV-positive adults with either doctor-(n=408) or nurse-monitored ART (n=404). At baseline 573 (70%) patients were female, 282 (34.7%) had prior AIDS diagnoses and the median CD4 was 164 cells/mm3. After a median follow-up of 24.3 months, deaths (10 vs. 11), virological failures (44 vs. 39), CD4 gain (270 vs. 248 cells/mm3), toxicity failures (68 vs. 66) and program losses (70 vs. 63) were similar in nurse and doctor arms respectively. 371(46%) patients reached an endpoint of treatment failure; 192(47.5%) and 179(43.9%) in the nurse and doctor arms respectively. Interpretation Nurse-monitored ART was shown to be non-inferior to doctor-monitored therapy. This study supports task-shifting to appropriately trained nurses for monitoring ART.

Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration

“…The same issues apply to HIV/AIDS, and there is a strong rationale to extend existing eff orts to ensure quality of care for HIV to patients with NCDs. 60 Simplifi ed monitoring and treatment regimens, 61 point-of-care tests, 62 decentralisation of care to the periphery, shifting of tasks from doctors to nurses, 63 and use of adherence counsellors instead of provider-controlled directly observed treatment 64 have all supported improved adherence. 65 The best-buy options for countries to reduce preventable deaths from NCDs include management of cardiometabolic risk in high-risk individuals at the primary health-care level.…”

NIMART rollout to primary healthcare facilities increases access to antiretrovirals in Johannesburg: An interrupted time series analysis

“…Decentralisation of ART through down-referral and NIMART services has also shown to be cost-effective, increase access and strengthen retention of patients on ART owing to the closer proximity to their homes and decreased costs. [7,8,10,11] The main study limitation was that we used public health facility data, which are sometimes incomplete; however, data quality tracing and verification were applied in order to verify the DHIS data with the PHC data sources.…”

“…[10,11] In the past 3 years, the SA government has been responsible for national initiatives aimed at increasing ART access. The HIV Counselling and Testing (HCT) campaign was launched in July 2010 with a target of testing 15 million people by June 2011, and in April 2010 there was a presidential mandate that ARVs be made available at all the country's 5 500 health facilities and that nurses be trained to prescribe and manage patients on the life-prolonging drugs.…”

The 2010 South African guidelines for the management of HIV and AIDS: A review

“…In a randomised trial (N=812) in South Africa, doctormanaged ART-related care was compared with nurse-managed care. 23 Nurses were as good as doctors in providing care. The actively sick were excluded from recruitment, and this study therefore lends support to nurses in the caring of well HIV patients.…”