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About
Providing effective anti-HIV therapy in developing countries is challenging. This study will evaluate new strategies for delivering anti-HIV medications to people in South Africa. These strategies include using specially trained nurses to administer therapy (rather than doctors), treating all HIV infected members of a household at the same time, and having community members observe patients taking their medications.
Full description
The benefit of antiretroviral therapy is well established but limited to wealthy nations. A predefined, simple sequence of treatment regimens focused on extending the durability of limited treatment options has the best potential to be implemented in resource poor countries. South Africa has 15% of the world's HIV/AIDS patients and a limited number of physicians to treat them (l per 1,600 and less than 5 infectious diseases specialists). HIV patient care in the primary care setting must therefore be delivered by personnel other than doctors. Further, treatment strategies should include entire households to ensure maximum adherence and minimize sharing of drugs.
This study will have two parts. The first part will compare a first-line antiretroviral therapy regimen administered and monitored by primary health care sisters (nurses) with the same regimen administered by doctors. The second part of the study will determine if community-based directly observed therapy (DOT) is significantly superior to continued clinic-based treatment support for patients who have failed first-line therapy, as measured by cumulative virology failure rate. The project will also evaluate the cost and economic impact of a predetermined schedule of antiretroviral therapy; treatment outcomes in terms of morbidity, opportunistic and endemic infections, and mortality; and factors contributing to treatment failure, including toxicity, resistance, compliance, and treatment interruption.
In Part 1, households will be randomly assigned to receive first-line antiretroviral therapy under the monitoring and care of either an HIV-trained medical doctor supported by adherence counselors or an HIV-trained primary health care sister (nurse with training in diagnosis and treatment prescription). Members of the household who are HIV infected will receive stavudine, lamivudine, and efavirenz (nevirapine or nelfinavir may be used for special populations).
Participants who fail first-line antiretroviral therapy in Part 1 of the study will be entered into Part 2 of the study. Participants in Part 2 will receive zidovudine, didanosine, and lopinavir/ritonavir. Participants will be randomly assigned to have their treatment monitored through either a clinic-based treatment support group or through community-based directly observed treatment (DOT). For the DOT arm, a community member will observe therapy for at least one dose a day, five days a week, at the home or work of the participant.
HIV infected children age 3 months to 16 years who live in a participating household will also be included in the study. These children will receive first-line treatment with clinic visits monitored by either the assigned sister (nurse) or doctor along with their households. In Part 2, children will be provided with a second-line treatment regimen with continued daily monitoring of doses in the household.
The study will last 5 years.
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Inclusion Criteria for the first person in the household who enters the study:
Inclusion Criteria for children between 3 and 16 years old in a household that has been entered in the study:
Exclusion Criteria:
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Data sourced from clinicaltrials.gov
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