A MULTI-YEAR PROJECT FUNDED BY THE U.S. NATIONAL INSTITUTES OF HEALTH

PREPARE (PRomoting Equity for Pregnant Adolescents in REsearch) aims to develop empirically informed guidance for conducting ethically responsible HIV and co-infections research with adolescents who are pregnant.

INTRODUCTION

PRomoting Equity for Pregnant Adolescents in REsearch (PREPARE) is an international, research-driven project funded through the U.S. National Institute of Allergy and Infectious Diseases of the National Institutes of Health (2R01AI108368).  

PREPARE is led by Dr. Anne Drapkin Lyerly, MD, MA, (Principal Investigator) and, Dr. Suzanne Day, PhD, MA (Principal Investigator) at the University of North Carolina at Chapel Hill, in collaboration with research partners at UNC Project Malawi, Botswana Harvard AIDS Institute Partnership, Botswana Baylor Children’s Clinical Centre of Excellence, and Children’s National Hospital.

The PREPARE Youth Advisory Boards (YABs) will support the meaningful, ongoing involvement of adolescents throughout the project, elevating the viewpoints and experiences of those most affected by the broad exclusion of this population from clinical HIV and coinfections research. YAB members will provide input and recommendations on specific aspects of the research approach, products and dissemination throughout the course of the project. There will be a YAB convened at research sites in Malawi, Botswana, and the United States. Members will elect a Chair at each site that will act as a group representative on the PREPARE Working Group.

The PREPARE Working Group will be composed of international members from diverse fields and backgrounds. Together with the PREPARE research team, the Working Group will develop recommendations for advancing timely, ethically responsible HIV and co-infections research with pregnant adolescents

GOALS

Building on the work of the PHASES (Pregnancy and HIV/AIDS, Seeking Equitable Study) Project which focused on the responsible inclusion of adult pregnant women in HIV and co-infections research, the PREPARE study aims to understand the views and experiences of a broad range of HIV research stakeholders around the inclusion of pregnant adolescents. These findings, along with scholarly ethical and regulatory analyses, will inform the development of ethics guidance for the HIV research community about responsibly expanding the HIV and co-infections evidence base for this important population.

OBJECTIVES

The project’s objectives are to:

  • Identify scientific priorities in, perceived barriers and enablers to conducting HIV and co-infections prevention and treatment research with pregnant adolescents.

  • Characterize reasoning around participation in HIV and co-infections prevention and treatment research during pregnancy from the viewpoints of affected adolescents.

  • Identify ethical conditions for responsible HIV and co-infections research with pregnant adolescents.

  • Develop an adolescence-specific framework delineating when and under what circumstances pregnant adolescents can and should be included in HIV and co-infections research.

APPROACH

  • Interviews with adolescents: PREPARE seeks to elevate the views of pregnant adolescents affected by HIV throughout the project. In addition to deep engagement with the Youth Advisory Boards at our research sites, we are conducting in-depth interviews with pregnant adolescents living with or at risk of HIV in the US, Malawi and Botswana.

  • Interviews with stakeholders: Developing guidance requires a well-informed understanding of the needs and experiences of stakeholders in the research, advocacy, policy, and regulatory communities. To this end, we will conduct interviews and focus group discussions with investigators, community advisory board members, IRB/REC members, policy makers, regulators, ethicists and others in the US, Malawi, Botswana, and South Africa.

  • Scholarly ethical analysis: We will analyze key ethical considerations critical to informing the conceptual framework of the guidance for this morally complex population.

  • Guidance development: The PREPARE Working Group will develop an adolescence-specific framework for advancing HIV research in pregnancy, whose utility and acceptability will be vetted by a range of stakeholders in the HIV research and advocacy communities, and those involved in the ethical and regulatory oversight of research.