TY - JOUR
T1 - The role of male partners in women's participation in research during pregnancy
T2 - A case study from the partners demonstration project
AU - Ngure, Kenneth
AU - Trinidad, Susan Brown
AU - Beima-Sofie, Kristin
AU - Baeten, Jared M.
AU - Mugo, Nelly R.
AU - Bukusi, Elizabeth A.
AU - Heffron, Renee
AU - John-Stewart, Grace
AU - Kelley, Maureen C.
N1 - Funding Information:
Bill & Melinda Gates Foundation (grants OPP47674, OPP1056051). The Partners Demonstration Project was funded by the National Institute of Mental Health of the US National Institutes of Health (grant R01 MH095507), the Bill & Melinda Gates Foundation (grant OPP1056051), and through the generous support of the American people through the US Agency for International Development (cooperative agreement AID-OAA-A-12-00023). Gilead Sciences donated the PrEP medication but had no role in data collection or analysis. Maureen Kelley’s efforts were supported by funding from Wellcome Trust Strategic Award (grant 096527) and Wellcome Trust and MRC Newton Fund Collaborative Award (grant 200,344/Z/15/Z). The results and interpretation presented here do not necessarily reflect the views of the study funders. The publication cost of this article was funded by the Wellcome Trust.
Publisher Copyright:
© 2017 The Author(s).
PY - 2017/12/14
Y1 - 2017/12/14
N2 - The exclusion of pregnant women from health research remains a significant challenge globally. In settings where cultural traditions and gender norms support a more restricted decision-making role for women in general, little is known about the attitudes of male partners toward the inclusion of women in research during pregnancy. Understanding the expectations of both men and women in such cultural settings offers an opportunity to engage and address local ethical concerns to improve women's access to research during pregnancy and enhance intervention development. In this paper, we present a qualitative research ethics case study, drawn from the Partners Demonstration Project of pre-exposure prophylaxis (PrEP) in Kenya, regarding the role of male partners in decision-making to continue PrEP during pregnancy. PrEP is an effective HIV prevention tool; however, since pregnant women were excluded from early PrEP clinical trials, safety and efficacy data during pregnancy are limited. Given continued high rates of HIV infection for women, some pregnant women are now being provided with PrEP or are involved in PrEP research. Men and women in our study were equally concerned about the health risks of PrEP to the fetus and depended on healthcare provider guidance to understand these risks. Because the demonstration project enrolled couples, an implicit social expectation for many women's continuation of PrEP during pregnancy was consultation with male partners. Some women reported that consenting to participate was exclusively a woman's decision; however, many reported that they deferred to their male partner's opinion and support during the decision-making process. Most male partners believed women should not participate in research studies without their partner's permission, while a few men believed participation was ultimately a woman's decision. We suggest that relational autonomy can support a middle ground for informed consent that promotes women's autonomy while accommodating partner engagement.
AB - The exclusion of pregnant women from health research remains a significant challenge globally. In settings where cultural traditions and gender norms support a more restricted decision-making role for women in general, little is known about the attitudes of male partners toward the inclusion of women in research during pregnancy. Understanding the expectations of both men and women in such cultural settings offers an opportunity to engage and address local ethical concerns to improve women's access to research during pregnancy and enhance intervention development. In this paper, we present a qualitative research ethics case study, drawn from the Partners Demonstration Project of pre-exposure prophylaxis (PrEP) in Kenya, regarding the role of male partners in decision-making to continue PrEP during pregnancy. PrEP is an effective HIV prevention tool; however, since pregnant women were excluded from early PrEP clinical trials, safety and efficacy data during pregnancy are limited. Given continued high rates of HIV infection for women, some pregnant women are now being provided with PrEP or are involved in PrEP research. Men and women in our study were equally concerned about the health risks of PrEP to the fetus and depended on healthcare provider guidance to understand these risks. Because the demonstration project enrolled couples, an implicit social expectation for many women's continuation of PrEP during pregnancy was consultation with male partners. Some women reported that consenting to participate was exclusively a woman's decision; however, many reported that they deferred to their male partner's opinion and support during the decision-making process. Most male partners believed women should not participate in research studies without their partner's permission, while a few men believed participation was ultimately a woman's decision. We suggest that relational autonomy can support a middle ground for informed consent that promotes women's autonomy while accommodating partner engagement.
KW - Autonomy
KW - Consent
KW - HIV prevention
KW - Male partners
KW - Pre-exposure prophylaxis (PrEP)
KW - Pregnancy
UR - http://www.scopus.com/inward/record.url?scp=85041185266&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85041185266&partnerID=8YFLogxK
U2 - 10.1186/s12978-017-0424-0
DO - 10.1186/s12978-017-0424-0
M3 - Article
C2 - 29297375
AN - SCOPUS:85041185266
VL - 14
JO - Reproductive Health
JF - Reproductive Health
SN - 1742-4755
M1 - 160
ER -