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Responsible DART trial closure
After the DART trial closes around 2,800 patients will move to national HIV care programmes throughout 2009. Careful and responsible closure has been an important consideration since the trial began, with plans put in place to ensure that participants can continue to access antiretroviral (ARV) drugs after the study. DART was started before ARVs drugs were widely available in Africa; these drugs are now available in most African countries.
The governments of Uganda and Zimbabwe pledged to provide access to ARV drugs for DART participants after the trial finishes. Around 2,000 participants are based in Uganda, the majority at clinics that have other free treatment programmes available. Around 800 participants are based in Zimbabwe where the existing DART clinic has been developed into a national HIV treatment centre.
Most participants will transfer to national programmes between January and March 2009. Participants with more advanced HIV and women who are pregnant or have recently given birth will remain under DART care until September 2009.
National care programmes for DART participants
Entebbe, Uganda
The Medical Research Council (MRC) unit in Entebbe runs the DART clinic, which is based at Entebbe Hospital. Patients enrolled here will move to the national TREAT program (see boxed text below) and will have access to a clinic at Entebbe Hospital. The MRC unit will also establish a DART follow-up group for patients who are willing to be enrolled and to remain in follow-up.
The TREAT Program in Uganda
The Joint Clinical Research Centre (JCRC) in Uganda established the TREAT program (Timetable for Regional Expansion of Antiretroviral Therapy (TREAT) Program) to expand the provision of HIV care and treatment across the country.
The major objective of the program is to build capacity, establish a framework for countrywide quality ARV provision and develop essential infrastructure. Services are delivered in a variety of settings ranging from hospitals to workplace clinics. There are currently 65 clinics across Uganda. For more information, visit www.jcrc.co.ug
Kampala, Uganda
There are two DART clinics in Kampala, at the Joint Clinical Research Centre (JCRC) and the Academic Alliance (AA). JCRC patients will either remain at the centre or will move to an alternative TREAT clinic. AA patients will be treated at the Infectious Disease Institute General Adult Clinic or at an alternative TREAT clinic.
Harare, Zimbabwe
The DART clinic in Zimbabwe is located at the University of Zimbabwe Clinical Research Centre (UZ-CRC) at the Parirenyatwa Hospital. The Ministry of Health in Zimbabwe has agreed to adopt UZ-CRC as a national clinic and a centre for excellence and participants will be able to continue their treatment here. Alternatively, patients can be treated at other Ministry of Health welfare facilities or roll-out clinics. ARV drugs can also be accessed through alternative studies, charitable clinics or personal medical insurance.
Transfer of clinical data
Data from the study will be provided to the clinical teams taking over the patient’s care. DART participants are taking a number of combinations of ARV drugs. In Uganda, the TREAT program is able to provide all of the ARV combinations being used in DART. In Zimbabwe, all ARVs used in DART are available either through the national Ministry of Health or through the Clinton Foundation. In both countries, participants may choose to transfer to clinics outside of the control of DART investigators. In such cases the new clinic will be responsible for the drug combinations received after DART.
Plans for staff after DART closure
The DART team is highly skilled and as many staff as possible will be retained to run the DART follow-up group, manage second-line ARV studies and to run UZ-CRC as a national treatment centre. Plans are also being made to redeploy staff into future HIV research projects and other non-research clinical activities.
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