PUBLIC HEALTH EVALUATION Clinical Trial
Official title:
Impact of Task Shifting Type II for ART Delivery on Patient and Process Outcomes in Uganda
PUBLIC HEALTH EVALUATION PROTOCOL on Impact of Task Shifting Type II for ART Delivery on Patient and Process Outcomes in Uganda
SECTION 1: PROTOCOL SUMMARY Title: Impact of Task Shifting Type II for ART Delivery on
Patient and Process Outcomes in Uganda Rationale: Health care worker shortages remain a major
impediment to the scale-up of antiretroviral therapy (ART) in sub-Saharan Africa [1].
Sub-Saharan Africa suffers from the world's most pronounced crisis in human resources for
health with 36 of 57 countries currently facing significant health worker shortages [2]. The
health workforce crisis is further exacerbated by the HIV epidemic which thwarts efforts to
expand and provide universal access to HIV/AIDS prevention, care and treatment. The shortage
of health workers in sub-Saharan Africa presents a great challenge in service delivery,
particularly in the scale up of antiretroviral therapy. According to the World Health
Organization the global deficit of trained health care workers needed to provide essential
health services in order to achieve the Millennium Development Goals, including the scaling
up of biomedical interventions for HIV/AIDS is greater than 4 million [2]. In an attempt to
meet the demand for ART services, the World Health Organization is coordinating a global
effort to strengthen and expand the current health workforce and recommends task shifting as
one potential strategy to meet the enormous demand for health care workers to provide
HIV/AIDS care and treatment. This is particularly important at this time when patients are
staying on ART for longer periods. Task shifting will allow physicians to see only severely
ill patients thus freeing up their time for other duties. In addition, more patients can
initiate ART because there are more available health workers to attend to them. There is
however a need for empirical evidence to support the implementation of task shifting. For
example, one critical question is whether candidate health worker cadres for task shifting of
ART initiation and monitoring, will perform as well as doctors/clinicians. Country-specific
evidence regarding this question is necessary for developing a task-shifting policy before
initiating policy reforms in Uganda. Under PEPFAR funding a Public Health Evaluation (PHE)
will be conducted in selected health facilities to determine the impact of implementing the
WHO Global Recommendations and Guidelines on Task Shifting of HIV treatment from doctors and
clinical officers to nurses.
Although task shifting for HIV treatment occurs de facto in several countries [3-10] , it is
rarely institutionalized or allowed by national policies. Reliable data are necessary to
better understand how and whether to include this strategy in national policy and operational
guidelines.
The Investigators propose to conduct a randomized field intervention study to address the
question of whether nurse-initiated and monitored ART is associated with inferior outcomes
compared with clinician-initiated and maintained ART in treatment-naive, HIV positive
individuals.
The findings of this study will contribute knowledge of how best to increase access to
quality life-saving HIV treatment as well as improve health care worker skills and strengthen
health system efficiency.
Primary Objectives:
To compare the following outcomes among HIV-infected individuals on antiretroviral therapy
initiated and monitored by nurses and those initiated and monitored by clinicians at 6 and 12
months post ART initiation:
- virologic failure (≥ 1000 viral copies/ml)
- toxicity failure
- patient retention
- all-cause mortality
Secondary Objectives:
1. Compare immunological responses at time points 6 and 12 months post ART initiation
2. Compare accuracy of staging HIV-infected patients according to the WHO treatment
guidelines as process outcomes among provider groups
Tertiary Objectives:
Test for HIV-1 drug resistance mutations (primary and secondary) among persons newly
initiated on ART.
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