Fairall L, Bachmann MO, Lombardi C, et al. Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial. Lancet 2012 Aug15 [Epub ahead of print].
To assess the effects of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) program, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralize care, on mortality, viral suppression, and other health outcomes and quality indicators.
Thirty-one public-sector clinics in Free State, South Africa.
Cluster-randomized trial at the level of the clinic.
Investigators recruited two cohorts of patients. Cohort 1: HIV-infected adults ≥16 years of age who were eligible (<200 CD4 cells/µL) or likely to become eligible for ART (200-350 CD4 cells/µL) during the 12-month follow-up period. Cohort 2: HIV-infected adults ≥16 years of age who had been on ART for at least six months. In clinics with >100 eligible patients, participants were randomly sampled. In smaller clinics, all eligible patients were invited to participate.
For cohort 1 the primary outcome measure was time from enrollment to death (censored at 12-18 months). For cohort 2, the primary outcome was the proportion with undetectable viral loads (<400 copies per mL) one year after enrollment. Secondary outcomes for both were measures of health status (changes in weight and CD4 cell counts, viral loads, hospital admissions, and inpatient days) and indicators of quality of care. Additionally in Cohort 2, time to death (censored at 12-18 months) was a secondary outcome.
This was an evaluation of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) program, which is a complex health systems intervention with educational and organizational components. It trains nurses to assume responsibility for ART initiation and represcribing. It combines an educational outreach training model (Practical Approach to Lung Health in South Africa; PALSA and PALSA PLUS) with additional organizational components. STRETCH is designed to rationalize ART and other services for people with HIV infection, to treat patients already stabilized on ART at clinics close to their homes, to increase the number of clinics in which ART can be begun, and to raise the number of clinics and nurses providing high-quality pre-treatment care.
Participants were enrolled from 31 public-sector clinics in the Free State between January 2008 and June 2009. The clinics were randomized, using a stratified random sampling scheme, to either STRETCH or usual and customary care. Sample size was calculated in Cohort 1 to provide 90% power to detect a 6 percentage point difference between participants at intervention and control clinics with 95% confidence and for Cohort 2 to provide 90% power to detect a 6% equivalence limit with 95% confidence.
Sixteen clinics were assigned to be intervention clinics and 15 to be control clinics. In Cohort 1, 5,390 patients were enrolled from intervention clinics and 3,862 from control clinics and followed for a median of 16.3 months. Of the patients with known vital status, 997 (20%) who attended the intervention clinics died compared to 747 (19%) who had attended control clinics (p=0.532). There were no differences between the two groups among those that presented with 200-350 CD4 cells/µL and those who presented with <200 CD4 cells/µL. Time to death did not differ between the two groups.
In Cohort 2, 3,029 participants were enrolled from intervention clinics and 3,202 from control clinics. Viral suppression one year after enrollment did not differ between intervention and control patients (p=0.534), and the prespecified equivalence limit of 6% was met. Gains in CD4 cell count and weight and probability of switching ART drugs were higher in the intervention group than in the control group.
Shifting of the primary responsibility for ART from physicians to primary-care nurses did not decrease survival of patients not yet taking ART and did not result in differences in the proportion of patients who maintained viral suppression who were already taking ART at enrollment.
The overall risk of bias in this trial is low. Randomization was done with nine strata, one for each referral hospital in the province, to avoid confounding of outcomes by variation in care provided by doctors in each hospital. Within each stratum, clinics were randomly assigned to intervention or control according to sequences of random numbers in a random number table. Given the intervention, it was not possible to conceal allocation or to blind participants, personnel or outcome assessors, but outcomes were unlikely to have been affected by this. Analysis was by intention to treat, and attrition bias is unlikely.
This well-done study demonstrates that task shifting responsibility for initiating and providing on-going ART from physicians to primary-care nurses can be successfully done in a public-sector system in South Africa without worsening clinical outcomes. Notably, nurses in the intervention group had little trouble with task shifting of renewing prescriptions from doctors, which relieved doctors of a heavy burden and enabled them to focus on referred patients who were seriously ill. These findings are consistent with earlier, smaller trials from Uganda,(1) Kenya(2) and South Africa.(3) It should be noted, however, that STRETCH is a complex, multifaceted intervention, and the likelihood that these results can be reproduced will depend on how faithfully all intervention components can be reproduced. South Africa has moved forward with this intervention, and since the trial ended in 2010, national policy has changed to promote nurse initiation and management of ART.(4)
In the South Africa context, clinical management of ART care can be successfully shifted from physicians to primary-care nurses. Additional earlier studies suggest that this can also be accomplished in other parts of sub-Saharan Africa. However, fidelity to all facets of the intervention will be key to achieving the same degree of success seen in this study. The World Health Organization is currently considering evidence regarding task shifting interventions, and is expected to provide guidance in 2013.
- Jaffar S, Amuron B, Foster S, et al. Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial. Lancet 2009; 374: 2080-89.
- Sanne I, Orrell C, Fox MP, et al. Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial. Lancet 2010; 376: 33-40.
- Selke HM, Kimaiyo S, Sidle JE, et al. Task-shifting of antiretroviral delivery from health care workers to persons with HIV/AIDS: clinical outcomes of a community-based program in Kenya. J Acquir Immune Defic Syndr 2010; 55: 483-90.
- Colvin CJ, Fairall L, Lewin S, et al. Expanding access to ART in South Africa: the role of nurse initiated treatment. S Afr Med J 2010; 100: 210-11.