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Implementation of PrEP in pregnancy has potential to avert HIV infections in HIV-exposed pregnant women. However, during the transition from clinical trials to implementation questions remain about drug safety during pregnancy and social and cultural acceptability. In many countries with a high HIV burden, men play an important role in the health decisions of their female partners, particularly during pregnancy. Understanding men and women’s perspectives on the role of partners when considering prevention decisions for use of PrEP has important practical and ethical implications for designing implementation programs and moving to clinical use. We conducted a qualitative study linked to the PrEP Demonstration Project in Kenya, relying on focus groups and individual interviews with women, partners, and clinicians to characterize the social, biologic, and ethical considerations surrounding treatment decisions during pregnancy for investigational interventions, focusing particularly on experiences surrounding PrEP use. Here we report the findings related to the role of partners in decision-making during pregnancy.

Overall, our study found that both women and men in this socio-cultural context viewed the role of male partners as important but varied on the reasons and degree of involvement. Women’s views about the need to involve male partners in investigational prevention decisions during pregnancy varied, ranging from pragmatic deference to partners, willing shared decision-making, to strong views about a woman’s right to make independent decisions. Whereas most men believed that they should be consulted before women participate in biomedical research during pregnancy–with a few male partners taking the strong position that their female partners should not participate without the husband’s direct consent to have her participate.

These findings raised challenging ethical questions about how to reconcile respect for women’s autonomy while planning implementation programs that are culturally sensitive. Reflecting on this data, we consider ways to reconcile ethical requirements for individual consent of pregnant women in treatment or research decisions with sociocultural norms that ranged from strongly paternalistic to supporting shared decision-making between partners. Understanding and addressing partner concerns and clarifying the role of partners in decisions to participate in implementation of new interventions during pregnancy are important factors for expanding the interventions available to women during pregnancy.