# Combining sources of information to improve HIV pre-exposure prophylaxis

> **NIH NIH K01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2024 · $136,327

## Abstract

PROJECT SUMMARY
HIV prevention requires improvements in effectiveness, reduction of side-effects, and removing barriers
to adherence for antiretroviral pre-exposure prophylaxis (PrEP). Evaluation of these improvements
through randomized trials remains difficult due to sample size requirements, strict eligibility criteria, and
assessments limited to active comparators. Addressing these challenges has made novel analytical
approaches increasingly necessary. The proposed research will use cutting-edge quantitative methods
to evaluate new PrEP combinations by combining diverse sources of information. Data from the HIV
Prevention Trials Network 083 and iPrEx (Preexposure Prophylaxis Initiative) trials will be used to
compare long-acting injectable cabotegravir PrEP to placebo among men who have sex with men and
transgender women. Results will provide a reliable estimate of the efficacy of long-acting injectable
cabotegravir in lieu of direct randomized comparisons, which are not forthcoming. Next, data from the
VOICE (Vaginal and Oral Interventions to Control the Epidemic) trial will be integrated with subject-
matter expert knowledge through statistical and mechanistic modeling to evaluate the expected efficacy
of tenofovir alafenamide and emtricitabine daily oral PrEP among cisgender women. Results from this
second analysis can aid in the planning of randomized trials of tenofovir alafenamide in cisgender
women (e.g., assess whether a planned trial would likely fail to demonstrate efficacy under previously
observed adherence patterns). Finally, flexible analytic tools to apply the quantitative methods used in
the proposed research will be developed and made freely available through open-source software.
Provision of these tools will decrease barriers to future applications. Scientific results from this proposal
will accelerate and strengthen how we can learn from randomized trials and make strides in the
prevention of HIV. The candidate will benefit from strong mentorship and additional training in HIV
epidemiology, mechanistic modeling, semiparametric theory, and guided development as an
independent scientist. Through additional quantitative methods training, the candidate will be uniquely
prepared to jointly use statistical and mechanistic modeling to bring field-specific strengths to address
deficiencies that neither field can easily address on its own. Completion of the training and research
aims of this mentored developmental award will situate the candidate at the forefront of HIV
epidemiology and methodological research and prepare the candidate to become to an independent
researcher.

## Key facts

- **NIH application ID:** 10895580
- **Project number:** 5K01AI177102-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Paul Nicholas Zivich
- **Activity code:** K01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $136,327
- **Award type:** 5
- **Project period:** 2023-07-28 → 2028-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10895580

## Citation

> US National Institutes of Health, RePORTER application 10895580, Combining sources of information to improve HIV pre-exposure prophylaxis (5K01AI177102-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10895580. Licensed CC0.

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