# Addressing HIV drug resistance research gaps in a cohort of perinatally infected Kenyan children and adolescents

> **NIH NIH R01** · MIRIAM HOSPITAL · 2020 · $166,607

## Abstract

PROJECT SUMMARY/ABSTRACT
Young people aged 10 to 24 years and living with HIV (YPLWH) have high rates of HIV-related morbidity and
mortality, particularly in sub-Saharan Africa. Additional research with YPLWH is urgently needed to inform HIV
programs and policies, however, there are insufficient ethical guidelines on research with YPLWH in diverse
cultural and socioeconomic contexts. The long-term goal of our research is to provide evidence to inform and
improve the care of children and YPLWH in Kenya and other resource-limited settings. This proposal will
investigate bioethical research gaps in research with YPLWH and provide recommendations to inform ethical
guidelines and policies. This work will take place through a long-standing academic partnership between
Kenyan and North American universities called the Academic Model Providing Access to Healthcare
(AMPATH), where we also maintain community and governmental partnerships. The specific aims for this
study are: Aim 1: Explore ethical issues in longitudinal clinical research with YPLWH in Kenya from the
perspective of YPLWH, caregivers, and other key informants. Aim 2: Analyze key bioethics guidelines and
policies relevant to research with YPLWH in Kenya. To achieve Aim 1, we will conduct in-depth interviews with
YPLWH (research experienced and not), caregivers of YPLWH, and a diverse range of stakeholders:
community leaders, youth and community advisory boards, healthcare providers, IRB members, researchers,
laboratory heads, and government representatives. Interviews will examine ethical issues related to adolescent
and young adult participation, as well as the collection, storage and future use of biological samples. To enroll
YPLWH and caregivers experienced in research, we will leverage an ongoing parent R01 (R01AI14733301,
MPIs: Kantor and Vreeman) that is longitudinally examining viral and drug resistance outcomes for a well-
characterized cohort of 499 Kenyan YPLWH for 4 years, including biannual blood specimens. To achieve Aim
2, we will identify global, regional, and Kenyan ethical guidelines and policies relevant to research across key
areas: children and YPLWH, people living with HIV, biological sampling and biobanking, and research in
resource-limited settings. Qualitative data will be analyzed using a content analysis and framework approach,
with an initial coding guide informed deductively by the themes described above and refined inductively.
Triangulation will be used to explore convergence, complementarity, and dissonance across data sources and
methods. The outcomes of our proposed supplement will guide the ethical conduct of the parent R01 and lead
to novel insights on critical ethical issues for research with YPLWH in Kenya and other settings. After
completing the aims of this supplement, we will integrate our findings from interviews with YPLWH, caregivers,
and key stakeholders and the document analysis to generate concrete recommendations. We will disseminate
our findin...

## Key facts

- **NIH application ID:** 10131379
- **Project number:** 3R01AI147333-02S1
- **Recipient organization:** MIRIAM HOSPITAL
- **Principal Investigator:** Rami Kantor
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $166,607
- **Award type:** 3
- **Project period:** 2019-06-27 → 2025-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10131379

## Citation

> US National Institutes of Health, RePORTER application 10131379, Addressing HIV drug resistance research gaps in a cohort of perinatally infected Kenyan children and adolescents (3R01AI147333-02S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10131379. Licensed CC0.

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