Human Immunodeficiency Virus Transmission Risk in Analytical Treatment Interruption Studies: Relational Factors and Moral Responsibility.

Abstract

Analytical treatment interruption (ATI) is becoming common in human immunodeficiency virus (HIV) cure-related research, but its use is controversial. ATI raises concerns about risks of HIV transmission to sexual partners of study participants. Researchers may have difficulty addressing these risks, given that study participants' private behavior is implicated, the partners are not enrolled in the research, and behavioral HIV risk mitigation strategies usually fall outside the study objectives. This analysis argues that researchers should assume some responsibility for partners' risks, based on the importance of partner relationships for the study participants themselves, and out of concern for the partners' welfare. Adding this responsibility is reasonable since the risk is created in part by research procedures, and since concern for third parties is often part of professional standards for healthcare providers. Study participants and their partners also bear some responsibility. Specific recommendations for measures to address risk are discussed.