# Risks, Benefits, and Stakeholder Perspectives of Molecular Epidemiology for HIV Prevention (HIV-ME)

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2021 · $737,669

## Abstract

ABSTRACT
The recently proposed Ending the HIV Epidemic (EHE) Initiative includes four pillars: Diagnose, Treat, Protect,
and Respond. Research that involves the “Respond” pillar of the EHE Initiative may be associated with barriers
not observed with the other three EHE pillars, due to a set of associated scientific, ethical, legal and social
challenges. The success of EHE research applications will be contingent upon carefully addressing the
implementation challenges of this prevention strategy. This proposal will take the innovative leap of addressing
the Ethical, Legal and Social Implications (ELSI) of an array of potential ME-informed HIV prevention efforts
developed by simulations, parameterized using real-world data, and incorporating current and emerging
technological and analytic approaches. These quantitative estimates will inform our efforts to understand the
ethical, legal, and social issues related to ME, as well as guide policy development to attenuate concerns related
to them. The proposed study, “Perspectives Among Key Populations of the Risks and Benefits of Molecular
Epidemiology for HIV Prevention (HIV-ME)” will engage a national population of persons living with HIV (PLWH)
and persons at risk without HIV (PWoH) in a multi-method examination of the ELSI of ME-informed inferences
(i.e., identification of individuals with genetically linked HIV sequences) to facilitate successful implementation of
ME-guided HIV prevention research. Key populations, including men who have sex with men, transgender
women, and persons who inject drugs in geographic areas prioritized by the EHE initiative will be included.
Quantitative and qualitative methods will be informed by well-characterized estimates of benefit (e.g., improved
risk stratification by molecular surveillance) and risk (e.g., inferred directionality of transmission and false
identification) derived from simulations of a well characterized U.S. HIV epidemic. To date, there has not been a
comprehensive effort to provide quantitative estimates of the actual risks and benefits associated with ME-
informed HIV prevention interventions among PLWH and PWoH in the U.S. and there has been no large-scale
engagement of key populations to determine how these risks and benefits are perceived. Furthermore, no
previous studies focus on high HIV burden jurisdictions.
Our overarching goal is to gauge the acceptability of ME approaches for HIV prevention research among key
populations of PLWH and PWoH across the US, informed by well-characterized estimates of the risks and
benefits. We will identify the facilitators and barriers that may impact those most affected by HIV-ME and develop
guidance to improve acceptability of ME guided HIV prevention research. To do so we will address the following
Specific Aims: 1) AIM 1 - Identify the perceived ethical, legal and social risks of molecular epidemiology for HIV
prevention; 2) AIM 2 - Estimate the measurable scientific benefits and risks of molecular epid...

## Key facts

- **NIH application ID:** 10212958
- **Project number:** 5R01MH124590-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** SUSAN JANET LITTLE
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $737,669
- **Award type:** 5
- **Project period:** 2020-07-08 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10212958

## Citation

> US National Institutes of Health, RePORTER application 10212958, Risks, Benefits, and Stakeholder Perspectives of Molecular Epidemiology for HIV Prevention (HIV-ME) (5R01MH124590-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10212958. Licensed CC0.

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