Principal Investigator: Chelsea Morroni, MPH, MPhil, PhD, MBChB, DTM&H, DFSRH

Study Objectives:


  1. To identify scientific priorities in, perceived barriers and enablers to conducting HIV/co-infections prevention and treatment research with pregnant adolescents through interviews and engagement with key stakeholders in HIV research, advocacy, research ethics and regulation communities in Botswana - and through other sites in the US, Malawi, and South Africa.
  2. To characterize reasoning around participation in HIV/co-infections prevention and treatment research from the viewpoints of affected adolescents through interviews with pregnant adolescents with or at risk for HIV in Botswana, and through other sites in the US and Malawi.
  3. To develop, engage, and evaluate a Youth Advisory Board throughout this project, to create mutually beneficial partnerships that enhance adolescents’ knowledge and abilities to advocate for their needs regarding HIV and research, while also ensuring the researchers understand community priorities and utilize qualitative research materials and approaches appropriate for the population and local context.
  4. Informed by the findings from objectives 1-3 at all study sites, to evaluate the PHASES Ethics Guidance and articulate ways in which it does or does not apply to pregnant adolescents. An adapted framework will be developed and disseminated, whose utility and acceptability will be vetted by a series of HIV youth advocates and Working Groups, delineating when and under what circumstances pregnant adolescents can and should be included in HIV/co-infections research.

Study Design:

The goal of the PREPARE Project is to advance the health interests of pregnant adolescents living with or at risk of HIV through building on the work of PHASES to develop an empirically informed Ethics Guidance to facilitate timely, responsible research with pregnant adolescents. It will be built on robust qualitative data collection with diverse stakeholders in Botswana, as well as in the US, Malawi, and South Africa; qualitative research with affected adolescents in Botswana, US, and Malawi; feedback and input from the Youth Advisory Board comprised of affected adolescents; and scholarly ethical and regulatory analysis.  The Ethics Guidance will be iteratively vetted and refined, and actively disseminated.

Stakeholder Interviews

Developing practical, actionable guidance suitable to the distinctive context of HIV/co-infections and adolescent pregnancy requires a well-informed understanding of the needs and experiences of stakeholders in the research and advocacy communities, including: investigators, research community advisory board (CAB) members, and advocacy leaders, regulatory and policy experts, and research ethics committee chairs and members. We will conduct interviews and focus group discussions (FGDs) and engage a minimum of 15-20 stakeholders in Botswana. Other project sites will conduct stakeholder interviews in the US, Malawi, and South Africa. Interviews will last approximately one hour.

Adolescent Interviews

We will conduct in-depth interviews (IDIs) with ever pregnant adolescents, ages 15-19 years old, living with (n=20) or at risk of HIV (n=20) who would be eligible to participate in HIV research, to understand what matters the most to them, what research questions they would prioritize, whether or under what conditions they would participate, what would make risks acceptable, the role of parents and partners, and how they would assess risks and benefits of participation, overall.

Youth Advisory Board

The PREPARE Botswana Youth Advisory Board (YAB) will have 5 adolescent members, who will participate in an initial 2-day training with the YAB facilitator on HIV research, research ethics, being a research advocate, and team building. YAB members will then meet regularly to provide input on the study.  The YAB meetings will be evaluated with a brief, 10-item questionnaire following each meeting.  Additionally, individual interviews with YAB members will be conducted once a year to explore their experiences and perceptions of strengths of the YAB and areas needing improvement.

Study Population

Interviews with stakeholders: We will recruit stakeholders from the following groups: HIV and co-infections investigators, community advisory board members, HIV advocates, research regulatory and policy experts, and IRB/REC members. Stakeholder participants will be both males and females, and all will be adults 18 years of age and older who are willing and able to provide consent. 

Interviews with adolescents: Across sites, participants will be female adolescents, ages 15-19 who are currently or have been pregnant before the age of 18, living with or at risk for HIV (at risk for HIV defined as having a pregnancy during adolescence and living in an area with elevated HIV risk for AGYW), who are willing and able to provide consent to the study (if 18-19 years old) or assent along with verbal parental consent (if 15-17 years old).

Youth Advisory Board (YAB) members: Across sites, participants will be female adolescents, ages 15-17 at the time of recruitment, who are currently or have been pregnant, are living with or at risk for HIV, are interested in learning more about HIV research and serving as a youth advocate on the project, and who are willing and able to provide assent along with verbal parental consent. Participants may serve on the YAB for up to 3 years.

Sample size:

Stakeholder interviews: We will conduct interviews and FGDs with approximately 15-20 stakeholders in Botswana.  We will identify potential participants through review of the literature and engage research collaborators, PHASES Working Group members and our broader network of allies.

Interviews with adolescents: We will conduct interviews with a total of 40 adolescents, ages 15-19, who are or have ever been pregnant, including 20 living with HIV and 20 at-risk of HIV. We will identify adolescents through clinic appointments at participating sites, participants in the Botswana Baylor COE Teen Club, and social media. 

Youth Advisory Board members:  We will recruit 5 members for the Botswana PREPARE YAB through the Botswana Baylor COE Teen Club. Teen Club members are known to study staff and will be approached based on an assessment of their potential interest in HIV research and being a youth advocate.

Study duration: 3 years

Study Results: Study is on-going and no results yet.

Sponsor: Sub-award through University of North Carolina at Chapel Hill; funding through the US National Institute of Allergies and Infectious Disease

Study Findings

Study is on-going and no data analyses have been done yet

Contact Details