Current status of policies of care provision in HIV prevention trials

1. Current status of policies of care provision in HIV prevention trials Catherine Hankins Associate Director, Strategic Information and Chief Scientific Advisor to UNAIDS Geneva, June 21, 2005

2. 2000 Guidelines

3. July 2003 Intercurrent infections

4. World Bank Global Fund to fight AIDS, Tuberculosis and Malaria CDC NIH ANRS IAVI MRC Sponsor positions

5. Neither support research directly but countries can use resources to develop relevant infrastructure which can beused for both routine medical care and research GFATM cannot direct country applications, but can providefeedback to individual countries concerning specificsubmissions World Bank can act, along with other development partners, as a global advocate toensure that vaccine, microbicide and behavioural trialsare part of prevention, care and treatment services provided in a country World Bank MAP; Global Fund to fight AIDS, Tuberculosis and Malaria

6. CDC Global AIDS Program assists countries to develop national HIV prevention programs and to improve treatment, care and support for people living with HIV through the development of local infrastructure to strengthen the countries’ capacity to address their own HIV epidemic Both the NIH Guide and Q & A document put on the NIH website for its grant/contract applicants address the narrow situation of provision of antiretroviral therapy (ART) post NIH-funded ART trials CDC, NIH

7. ANRS ethical charter, based on French law, which governs all research that it funds in developing countries: protects study participants and outlines the relative roles of investigators, sponsors and local authorities ensures that similar standards apply to international study participants as to domestic ones and provides commitments that: participants during trials will receive treatment and care, including for illnesses which may not be the focus of the study national country programs will provide ART where required; documented agreements between researchers and country representatives are favoured but these may be difficult to implement; people who become infected during the conduct of such trials must be eligible for ART through national programs. If this is not assured, the trial will not be funded by the ANRS. 2 year review on implementation of the charter will be completed in mid-July 2005 ANRS

8. Investment in infrastructure and capacity building by governments, research sponsors and donors should leave communities better off once studies have been completed Trial participants who seroconvert will be provided with comprehensive HIV-related treatment, care and support, including ART as recommended by agreed treatment guidelines IAVI made an initial undertaking to ensure the provision of ART & related care for a period of 5 years from the initiation of treatment. Funding for ART will be supported through an Escrow Account, a fund held in trust by an appropriate financial agent, or other appropriate national scheme. This has not been activated yet. IAVI cannot provide treatment and care to potential volunteers who screen out due to HIV infection prior to enrolment but will refer them to agreed local services. IAVI

9. US$ 1 million for care and treatment for seroconverters in the Thai vaccine trial First funds have been placed in the account to go to the Thai Ministry of Health for the eventual years of therapy USG Department of Defence

10. Like ANRS, will only choose sites where the infrastructure exists to complement the study requirements or where the study can actually strengthen local service provision. The MRC/DIFD Microbicide Development Programme (MDP) program in 2003 identified the following principles: participants identified with medical conditions including STI and HIV at enrolment or during the study will receive diagnosis, assessment and referral appropriate to the local site the principal investigator at the site will take responsibility for ensuring effective treatment for STI excluding HIV either through the project or referral to local services MRC

11. MRC/DFID MDP will not provide ART for seroconvertors in prevention trials, but principal investigators at sites will assist in identifying referral mechanisms for appropriate support and care in the local context. The level of treatment and care must be equivalent to the national standard available in the host country. Written agreementsfor ART should be made with the host countries of the research unless the staff/institutions working on MDP are directly or so closely linked to ART clinics that it would be like having an agreement with yourself (e.g. Johannesburg, Mazabuka (Zambia) and Africa Centre (KZN) MRC/DFID MDP

12. Counsellors provide VCT, at screening and at four other visits during the trial, and promote, demonstrate use and provide male and female condoms and strengthen women's negotiating skills as best they can. Trained in national programmes, experienced, plus training through south to south exchange within MDP. Currently addressing request from site staff for training in disclosure. No current need for sterile injecting equipment. Sometimes local infrastructure has to be developed for provision of services other than drugs. For instance, in some microbicide trial sites, no access to voluntary counselling and testing (VCT) or MTCT services existed. These had to be developed first before studies could commence enrolment. MRC/DFID MDP: prevention counselling and other services

13. The HSV-2 HIV transmission study among HIV discordant couples and the cellulose sulfate trial will provide ART to people who acquire HIV infection. They must meet WHO guidelines for initiation of ART during follow-up and there must be no local sources of ART available for these studies. For Tenofovir and diaphragm studies, these issues are currently being discussed (June 2005): should treatment and care be included for HIV prevention trial participants who seroconvert? If so, should this be extended to include partners, families or households? What would be the extent and duration of such treatment and care? The Bill and Melinda Gates Foundation

14. What you do for those who screen out as HIV-positive can help provide the solution for needs for eventual ART for people who seroconvert during a trial Current status of policies of care provision in HIV prevention trials: evolution Important to document processes, agreements, solutions, modifications and make these available to other communities, researchers, advocates and funders. Conclusion