Book 5: Care and treatment

Trial participants must be provided with treatment and care for HIV/ AIDS and its associated complications if they become HIV infected during the course of an HIV preventive vaccine trial. Sponsors and investigators should ensure that participants have access to a package of high-quality treatment and care that includes antiretroviral therapy (ART). Furthermore, sponsors and investigators should build the capacity of trial-linked health care centres to deliver services to the host community, and ensure that there is a contribution of lasting benefit to host communities. Considerations for sponsors and investigators to ensure access to treatment and care include: taking active steps to promote the welfare of trial participants and to reduce inequities in health care between participants in sponsor and host countries.

16.1 Sponsors and investigators must ensure that treatment and care for HIV infection is provided to participants who become HIV-infected during the course of an HIV vaccine trial.

16.1.1 Treatment and care for HIV-infected participants will require many components. These include: Ongoing counselling; baseline screening and immune monitoring; preventive methods and means; prevention and treatment of opportunistic infections and common morbidity; treatment for other STIs; tuberculosis prevention and treatment; physician visits; nutrition; palliative care, including pain control and spiritual care; referral to social and community support; family planning; home-based care, and antiretroviral therapy (ART).

16.2 Critical considerations in determining sponsor/ investigator obligations to ensure treatment, and the components of treatment and care that should be assured, are:

1. The context of the trial, including the sponsor-host collaboration, and the resources of the sponsor;
2. The design of the trial, including whether it is a multinational trial with an arm in a sponsor country;
3. The active promotion of the welfare of trial participants;
4. The need to reduce inequities in access to health care for participants from sponsor and host countries;
5. Establishment of a fair distribution of the overall risks and benefits of the research;
6. The availability or development of mechanisms, or infrastructure, to ensure the provision of treatment components to participants that are not routinely available in South Africa (e. g. ART); vii. International human rights standards; and viii. Sound estimations, as judged by known facts or other studies, of the probability and magnitude of potential risks to participants, including:
   • The possibility that participants will have false beliefs about vaccine efficacy and engage in increased high-risk behaviour, and
   • The theoretical possibility that participants who are vaccinated and subsequently exposed to HIV may be more susceptible to infection or disease.

16.3 In early debate forums held in South Africa consensus was not achieved on the obligations of sponsors, or on the components of an acceptable package of treatment and care, including whether ART should be provided.

16.3.1 Some consensus existed that trial participants should receive better treatment and care than would be available to them in the current public health care system in South Africa. That is, they should be provided with treatment and care that reflects an improvement over what they would ordinarily obtain. This corresponds with the standard for collaborative international research articulated in Book 1, 11.4.4 vi.

16.3.2 Some argued that sponsors and investigators are obligated to provide, or ensure access to, treatment for HIV infection based on the potential for a false belief in vaccine efficacy, and increased risk behaviour; arguing that the obligation to treat HIV infection rests on compensation for injury related to trial participation. Others argued that sponsors and investigators are obligated to ensure access to treatment based on considerations of distributive justice, and the need to reduce inequities in health care for participants in multinational trials.

16.4 At a meeting commissioned by the Interim National Health Research Ethics Committee in February 20035 there was agreement that:

16.4.1 Sponsors and investigators should provide, or ensure access to, high-quality treatment and care for participants who become infected during the course of an HIV preventive vaccine trial, including ART (see Point 16.1.1).

16.4.2 Trial participants who become HIV-infected after the end of the trial, or persons who are identified as HIV-infected at screening for participation in a trial, should be referred to existing health care services, with the understanding that there will be progressive implementation of a programme of state-supported ART (see Point 16.4.9).

16.4.3 Trial participants who become infected during the course of a trial, then withdraw from the trial but continue with appropriate follow-up, are eligible for the same treatment and care they would have received had they not withdrawn.

16.4.4 Prior to the initiation of any trial sponsors should ensure that resources are contributed towards the treatment and care of trial participants.

16.4.5 Alternatively a national trust fund, and a national mechanism could be established to facilitate provision of treatment and care for HIV infected trial participants.

16.4.6 Treatment and care for participants who become infected during a trial should be provided according to the South African HIV Clinician's Society Guidelines, until such time that national government guidelines are in place.

16.4.7 The guidelines for treatment and care for trial participants who become HIV-infected should be regularly reviewed.

16.4.8 Capacity of trial-linked health care service centres in the host community should be strengthened. That is, the 'local standard of care' in the host community should be improved so that it is provided with a contribution of lasting benefit. Community representatives should play a key role in determining how such capacity is built, to ensure that this is optimally responsive to the health needs and priorities of the participating community. 6 The capacity of community representatives to participate meaningfully in such deliberations should be actively built (see Points 3 and 5).

16.4.9 Provision of high-quality care for HIV infection to trial participants may act as an incentive to participate, and may introduce some inequalities in access to health care. However, provision of high-quality care is considered to reflect active promotion of the welfare and the fair treatment of participants in HIV preventive vaccine trials.