# Comparative effectiveness of tailored HIV treatment plans and mortality

> **NIH NIH K01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $131,606

## Abstract

PROJECT SUMMARY
The overall goal of this K01 application is to optimize clinical care decisions for people living with HIV.
Specifically, this project will explore how cause-specific mortality among people with HIV has changed as
treatment has become more effective and how the choice of antiretroviral therapy (ART) regimen can be
tailored or personalized based on patient characteristics to improve survival. Since 2012, many patients have
initiated regimens containing integrase inhibitors, but overall and cause-specific mortality for patients on these
regimens is uncertain. In addition, the comparative effectiveness of the recommended integrase inhibitor
containing regimens for patients with disparate characteristics and treatment histories has yet to be explored.
Standard epidemiologic methods are insufficient to optimize HIV treatment plans because treatment plans and
tailoring strategies are high dimensional, resulting in sparse data and unstable inference in many data sources,
particularly when treatment plans can change over time. The goal of this career development project is to train
the recipient to perform comparative effective research in settings with many exposure plans and outcomes.
Research aims of this project are to 1) Compare the cause-specific mortality risks among patients with HIV in
the US across three time periods representing the triple drug therapy era, the single tablet era, and the
integrase inhibitor era (i.e., 2000 – 2005, 2006 – 2012, 2013 – 2018); and 2) Estimate all-cause mortality risks
under strategies to optimize selection of an integrase inhibitor containing regimen based on treatment history
and patient characteristics. To address these aims in cohort data, the training component of this grant focuses
on building expertise in semi-Bayesian semiparametric inference in the context of HIV research. Specifically,
training aims include 1) Instruction in statistical techniques to improve inference for tailored treatment plans in
high dimensional settings; 2) Training in applied HIV epidemiology; and 3) Experience and preliminary results
necessary to prepare an R01 application in the fourth year of this award. The training aims will be achieved
through rigorous coursework in advanced biostatistics, mentored and collaborative research, and conference
participation. Research aims will be conducted using data from the Centers for AIDS Research Network of
Integrated Clinical Systems, which includes over 30,000 HIV-seropositive adults engaged in clinical care from
January 1, 1995 to the present at 8 US sites. The project will use semiparametric methods to account for
missing causes of death and will estimate all parameters describing cause-specific mortality accounting for
competing causes of death. Aim 2 will use Bayesian penalization techniques to estimate the causal effects of
tailored treatment plans using marginal structural models and the parametric g-formula. This project will
address an urgent need to optimize treat...

## Key facts

- **NIH application ID:** 9823829
- **Project number:** 5K01AI125087-04
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Jessie Edwards
- **Activity code:** K01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $131,606
- **Award type:** 5
- **Project period:** 2016-12-15 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9823829

## Citation

> US National Institutes of Health, RePORTER application 9823829, Comparative effectiveness of tailored HIV treatment plans and mortality (5K01AI125087-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9823829. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*