(New HIV Vaccine and Microbicide Advocacy Society)
Echoes from South Africa - relevance to Nigeria: Standard of Care for clinical trials
Florita Durueke, Gabriel Adeyemo, Morenike Folayan
New HIV Vaccine and Microbicide Advocacy Society
Civil Society organisations working for HIV vaccine development and access recently held a three days meeting leading up to the two days summit to discuss standard of care in HIV Prevention in the era of Pre-exposure prophylaxis (PrEP). The pre-summit was held from the 31st of October and 1st of November 2017 to enable civil society organisations with representatives from South Africa, Nigeria, Kenya, Uganda, Zimbabwe and Malawi, to articulate their position on the issue. The position of the CSO was presented during the summit held on the 2nd and 3rd of November 2017. Both meetings were held in Cape Town, South Africa.
At the meeting, members of the civil society organisations argued that clinical trial participants are at the center of HIV prevention research. They must be provided with a level of care that includes all the known effective HIV prevention tools irrespective of what the national guideline says. The researchers should provide the participants the highest standard of care and. This will provide opportunities for advocates to continue to engage the government for public rolls out of these products. Sadly an effective tool like PrEP is only access through demonstration projects in Africa, yet Sub-Saharan Africa is the hub of the HIV epidemic crisis. Access to PrEP only through demonstration projects only further widens the inequity problem associated with access to health care in the region. Government needs to continue to engage with civil society organization on how to address PrEP access including how to mitigate barriers to PrEP access. Post-trial access was identified as a big issue for the community - what happens to the participants when the demonstration study is concluded?
The position of the civil society was corroborated by ethical and legal perspectives and discussions on the issue. Legally, access to appropriate standard of care is a human right issue. The law requires that the government must provide reasonable standard of care that is feasible and within the financial capacity of the country especially for the most vulnerable populations. Ethically, the right thing to do during clinical trials is that the highest standard of care should be provided for the research participants irrespective of the national guidelines. The modality for the delivery of the highest standard of care can be discussed between the regulatory authorities and the researchers.
In South Africa, the recruitment of participants at one site for the ongoing HVTN 702 vaccine trial was halted to await the outcome of the summit on what the recommended standard of care to adopt for the trials. Sadly, despite the World Health Organisation’s recommendation on access to PrEP for all those at substantial risk of HIV acquisition including women, scientists in South Africa were still willing to withhold access of women to PrEP based on the failure of women to use PrEP during two international trials, and the result of a meta-analysis of PrEP data that demonstrate uncertainty on PrEP efficacy for women. These restrictive conservative view of scientists further highlights the need for multi-stakekholder discussion and engagement in decision making on behalf of community members.
The summit resulted in a paradigm shift as the National Institute for Health, the major funders of HIV prevention research, including HIV vaccine research, demonstrated commitment to the provision of PrEP for the trial participants engaged in all the clinical trials in South Africa. Modalities for delivery will be discussed through community engagement.
The meeting highlights critical lessons for Nigeria. While there are no HIV prevention clinical trials being conducted in Nigeria currently, Nigeria is a potential site for implementation study of HIV prevention research including HIV Vaccine research. The Walter Reeds Institution in Nigeria are putting together multiple preparatory studies for conduct of future HIV vaccine research. The National Institute of Medical Research, Lagos is also very interested in the conduct of HIV Vaccine research in collaboration with the Medical Research Council of South Africa. The Institute of Human Virology, Nigeria, had also hosted a demonstration project for HIV Vaccine research in the immediate past. It is very important for Nigeria to take proactive steps in developing its own guidelines on standard of care for HIV prevention research. The New HIV Vaccine and Microbicide Research lead the process of developing a Standard of Care guideline in 2004 following the PrEP controversies that ensued in the country back them. It is time to review and update this document in view of the evolving development in the field of HIV prevention research.
PrEP is currently accessed by sero-discordant couples in Nigeria through the ongoing research implemented by the National Agency for the Control of AIDS through its partners at Calabar, Anambra and Jos. PEPFAR, through USAID and CDC in Nigeria, will also be providing PrEP to populations at high risk for HIV infection at its project sites. Persons at high risk for HIV have a right to access PrEP in line with the 2016 national guideline on the use of antiretroviral drugs in Nigeria. Sadly, there is no antiretroviral drug licensed for use for PrEP in Nigeria thereby creating inequity to PrEP access for those who need it and want it in Nigeria. Also, key stakeholders are currently not trained on its prescription, monitoring and use. The essential drug list on Nigeria needs to be updated to include drugs found effective for the prevention of HIV infection also. We advocates in Nigeria shall continue to push and advocate for the roll-out of PrEP in Nigeria as a legal and ethical imperative for the respect of the human rights of Nigerians.
Florita Durueke, Gabriel Adeyemo, Morenike Folayan
New HIV Vaccine and Microbicide Advocacy Society
Civil Society organisations working for HIV vaccine development and access recently held a three days meeting leading up to the two days summit to discuss standard of care in HIV Prevention in the era of Pre-exposure prophylaxis (PrEP). The pre-summit was held from the 31st of October and 1st of November 2017 to enable civil society organisations with representatives from South Africa, Nigeria, Kenya, Uganda, Zimbabwe and Malawi, to articulate their position on the issue. The position of the CSO was presented during the summit held on the 2nd and 3rd of November 2017. Both meetings were held in Cape Town, South Africa.
At the meeting, members of the civil society organisations argued that clinical trial participants are at the center of HIV prevention research. They must be provided with a level of care that includes all the known effective HIV prevention tools irrespective of what the national guideline says. The researchers should provide the participants the highest standard of care and. This will provide opportunities for advocates to continue to engage the government for public rolls out of these products. Sadly an effective tool like PrEP is only access through demonstration projects in Africa, yet Sub-Saharan Africa is the hub of the HIV epidemic crisis. Access to PrEP only through demonstration projects only further widens the inequity problem associated with access to health care in the region. Government needs to continue to engage with civil society organization on how to address PrEP access including how to mitigate barriers to PrEP access. Post-trial access was identified as a big issue for the community - what happens to the participants when the demonstration study is concluded?
The position of the civil society was corroborated by ethical and legal perspectives and discussions on the issue. Legally, access to appropriate standard of care is a human right issue. The law requires that the government must provide reasonable standard of care that is feasible and within the financial capacity of the country especially for the most vulnerable populations. Ethically, the right thing to do during clinical trials is that the highest standard of care should be provided for the research participants irrespective of the national guidelines. The modality for the delivery of the highest standard of care can be discussed between the regulatory authorities and the researchers.
In South Africa, the recruitment of participants at one site for the ongoing HVTN 702 vaccine trial was halted to await the outcome of the summit on what the recommended standard of care to adopt for the trials. Sadly, despite the World Health Organisation’s recommendation on access to PrEP for all those at substantial risk of HIV acquisition including women, scientists in South Africa were still willing to withhold access of women to PrEP based on the failure of women to use PrEP during two international trials, and the result of a meta-analysis of PrEP data that demonstrate uncertainty on PrEP efficacy for women. These restrictive conservative view of scientists further highlights the need for multi-stakekholder discussion and engagement in decision making on behalf of community members.
The summit resulted in a paradigm shift as the National Institute for Health, the major funders of HIV prevention research, including HIV vaccine research, demonstrated commitment to the provision of PrEP for the trial participants engaged in all the clinical trials in South Africa. Modalities for delivery will be discussed through community engagement.
The meeting highlights critical lessons for Nigeria. While there are no HIV prevention clinical trials being conducted in Nigeria currently, Nigeria is a potential site for implementation study of HIV prevention research including HIV Vaccine research. The Walter Reeds Institution in Nigeria are putting together multiple preparatory studies for conduct of future HIV vaccine research. The National Institute of Medical Research, Lagos is also very interested in the conduct of HIV Vaccine research in collaboration with the Medical Research Council of South Africa. The Institute of Human Virology, Nigeria, had also hosted a demonstration project for HIV Vaccine research in the immediate past. It is very important for Nigeria to take proactive steps in developing its own guidelines on standard of care for HIV prevention research. The New HIV Vaccine and Microbicide Research lead the process of developing a Standard of Care guideline in 2004 following the PrEP controversies that ensued in the country back them. It is time to review and update this document in view of the evolving development in the field of HIV prevention research.
PrEP is currently accessed by sero-discordant couples in Nigeria through the ongoing research implemented by the National Agency for the Control of AIDS through its partners at Calabar, Anambra and Jos. PEPFAR, through USAID and CDC in Nigeria, will also be providing PrEP to populations at high risk for HIV infection at its project sites. Persons at high risk for HIV have a right to access PrEP in line with the 2016 national guideline on the use of antiretroviral drugs in Nigeria. Sadly, there is no antiretroviral drug licensed for use for PrEP in Nigeria thereby creating inequity to PrEP access for those who need it and want it in Nigeria. Also, key stakeholders are currently not trained on its prescription, monitoring and use. The essential drug list on Nigeria needs to be updated to include drugs found effective for the prevention of HIV infection also. We advocates in Nigeria shall continue to push and advocate for the roll-out of PrEP in Nigeria as a legal and ethical imperative for the respect of the human rights of Nigerians.
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