Introduction:

HIV positive individuals are living longer, healthier and more productive lives with the advent of anti-retroviral therapies that are becoming more affordable worldwide. Those individuals who are healthy, and establishing stable relationships, are desiring children, desiring a family. This is especially true within cultures where great emphasis, as well as social and cultural identity is placed on childbearing. Most interestingly, HIV-serodiscordant couples knowingly risk HIV transmission to their uninfected partner in order to achieve pregnancy. This can be a contributing factor in the HIV epidemic, particularly in HIV-high burden countries – and within settings where pharmaceutical product integrity, and management of their usage are less reliable. Current recommendations and guidelines developed through societies and governmental agencies for example, in Europe, North America (US and Canada), UK and South Africa, consider that pre-exposure prophylaxis (PrEP) with timed unprotected intercourse should be offered to the HIV negative partner in HIV-serodiscordant couples who are planning a pregnancy. Although assisted reproductive services may be considered for HIV-serodiscordant couples, these innovative technologies are often dismissed in some settings due to barriers (cost, social) to access within the health sectors in either High or in Low & Middle Income Countries (LMICs.)  If one uses an ELSI perspective, should these innovative interventions be assumed to be only for those found to be infertile/subfertile, and thus dismissed or considered as a last resort for use in HIV+ or HIV sero-discordant couples? Is there an assumption that most couples are capable of natural pregnancy?

Recent WHO prevalence data on infertility, has found that the burden of infertility remains high in LMICs, and within settings of high HIV prevalence. Thus, is an assumption of fertility without a reproductive evaluation, and simply providing PrEP, a concern?  What are the risks associated with long term, but intermittent, use of PrEP over long periods of time by the HIV negative partner on fertilization, implantation and on the growing embryo?  

The objective of the workshop would be to look at the divisions between multiple groups from Europe and beyond, - to address and advise societies/governments on this issue and attempt to come to a consensus on best mechanisms to move forward in order to help future directions on recommendations/guidelines. There needs to be an ELSI workshop or working consultation which can debate these issues for High and LMICs for HIV individuals and couples from either high or low burden HIV countries or settings within Europe and beyond, the key ELSI issues that need to be addressed and the identification of key implementation and integration research gaps to ensure a future of zero transmission in adults, children and neonates, by starting from the beginning - innovative methods to achieve a safe start to pregnancy.

Overview:

HIV positive individuals are living longer, healthier and more productive lives with the advent of anti-retroviral therapies that are becoming more affordable worldwide. Those individuals who are healthy, and establishing stable relationships, are desiring children, desiring a family. This is especially true within cultures where great emphasis, as well as social and cultural identity is placed on childbearing. Most interestingly, HIV-serodiscordant couples knowingly risk HIV transmission to their uninfected partner in order to achieve pregnancy. This can be a contributing factor in the HIV epidemic, particularly in HIV-high burden countries – and within settings where pharmaceutical product integrity, and management of their usage are less reliable. Current recommendations and guidelines developed through societies and governmental agencies for example, in Europe, North America (US and Canada), UK and South Africa, consider that pre-exposure prophylaxis (PrEP) with timed unprotected intercourse should be offered to the HIV negative partner in HIV-serodiscordant couples who are planning a pregnancy. Although assisted reproductive services may be considered for HIV-serodiscordant couples, these innovative technologies are often dismissed in some settings due to barriers (cost, social) to access within the health sectors in either High or in Low & Middle Income Countries (LMICs.)  If one uses an ELSI perspective, should these innovative interventions be assumed to be only for those found to be infertile/subfertile, and thus dismissed or considered as a last resort for use in HIV+ or HIV sero-discordant couples? Is there an assumption that most couples are capable of natural pregnancy?

Recent WHO prevalence data on infertility, has found that the burden of infertility remains high in LMICs, and within settings of high HIV prevalence. Thus, is an assumption of fertility without a reproductive evaluation, and simply providing PrEP, a concern?  What are the risks associated with long term, but intermittent, use of PrEP over long periods of time by the HIV negative partner on fertilization, implantation and on the growing embryo?  

The objective of the workshop would be to look at the divisions between multiple groups from Europe and beyond, - to address and advise societies/governments on this issue and attempt to come to a consensus on best mechanisms to move forward in order to help future directions on recommendations/guidelines. There needs to be an ELSI workshop or working consultation which can debate these issues for High and LMICs for HIV individuals and couples from either high or low burden HIV countries or settings within Europe and beyond, the key ELSI issues that need to be addressed and the identification of key implementation and integration research gaps to ensure a future of zero transmission in adults, children and neonates, by starting from the beginning - innovative methods to achieve a safe start to pregnancy.

 

Goals

This workshop will help to work with a multi-disciplinary group, which includes an active groups/socieites such as CREAThE, ESHRE, ASRM, IFFS, and other fertility and HIV/AIDS societies, and NGOs that would debate with WHO and other entities, to find a method to reach consensus on a systematic process that could be used by nations/other entities and communities to debate the current ELSI controversies surrounding HIV+ and HIV-serodiscordant couples within the context of their own HIV epidemic and access to both HIV and Reproductive Health care. (article) To develop and clarify the situation of HIV effected individuals and couples on their fertility status, their decision-making processes associated with use of ARVs, PrEP and assisted reproductive innovations to achieve zero transmission AND a pregnancy. (commentary) To address the difference between evidence collected in High versus Low and Middle Income Countries - between countries of high and low burden of HIV - between countries with high and low burden of infertility/sub-fertility. (investment case to funders to fill knowledge/evidence gaps) These outcomes will be in the form of peer-reviewed publications for minimally the WHO Bulletin and others.

Not in….

- safely achieve pregnancy in their desire to form a family - ethical, social and cultural aspects of this desire;  

- the use of pre-exposure prophylaxis (PrEP) in the HIV-negative partners during times of unprotected intercourse - risk of HIV if prolonged use, ethical use of antiretrovirals when others in the community with HIV, who are not receiving treatment

- their different needs depending upon the setting they are living - high burden HIV or poverty or poor education in or access to reproductive health - ethical, legal and social issues which may alter the guidance depending on the setting

- also to address the negative effects of HIV infection/ anti-retrovirals / and co-morbidities (infectious disease, etc) on the fertility and reproductive health of these men and women and offspring. (for example, women with HIV have 25% to 40% lower fertility than non-infected women; HIV/ARV effects on semen parameters)

Specific Goals

This workshop will help to work with a multi-disciplinary group, which includes an active and powerful group, CREAThE, fertility and HIV/AIDS societies, and NGOs that would debate with WHO and other entities, to find a method to reach consensus on a systematic process that could be used by nations/other entities and communities to debate the current ELSI controversies surrounding HIV+ and HIV-serodiscordant couples within the context of their own HIV epidemic and access to both HIV and Reproductive Health care. To develop and clarify the situation of HIV effected individuals and couples on their fertility status, their decision-making processes associated with use of ARVs, PrEP and assisted reproductive innovations to achieve zero transmission AND a pregnancy. To address the difference between evidence collected in High versus Low and Middle Income Countries - between countries of high and low burden of HIV - between countries with high and low burden of infertility/sub-fertility.  These outcomes will be in the form of peer-reviewed publications for minimally the WHO Bulletin.

This workshop will help to work with a multi-disciplinary group, which includes an active groups/ societies such as CREAThE, ESHRE, ASRM, IFFS, and other fertility and HIV/AIDS societies, and NGOs that would debate with WHO and other entities, to find a method to reach consensus on a systematic process that could be used by nations/other entities and communities to debate the current ELSI controversies surrounding HIV+ and HIV-serodiscordant couples within the context of their own HIV epidemic and access to both HIV and Reproductive Health care. (article) To develop and clarify the situation of HIV effected individuals and couples on their fertility status, their decision-making processes associated with use of ARVs, PrEP and assisted reproductive innovations to achieve zero transmission AND a pregnancy. (commentary) To address the difference between evidence collected in High versus Low and Middle Income Countries - between countries of high and low burden of HIV - between countries with high and low burden of infertility/sub-fertility. (investment case to funders to fill knowledge/evidence gaps) These outcomes will be in the form of peer-reviewed publications for minimally the WHO Bulletin and others.