# Pilot Integration of Participant-Centered Outcomes in HIV Cure Research in the United States: Implications for Ethical Conduct

> **NIH NIH R21** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $221,971

## Abstract

Program Director/Principal Investigator (Last, First, Middle): Dubé, Karine
Project Abstract:
 HIV cure research is a strategic priority of the National Institutes of Health (NIH), the International AIDS
Society (IAS), and the pharmaceutical industry. While there have been over 240 biomedical studies related to
HIV cure conducted around the world, and this field of research continues to grow and innovate, there has been
limited work dedicated to understanding the motivations and experiences of people living with HIV (PLWHIV)
who consider, enter, and participate in these clinical investigations. While preliminary research found a number
of factors influence hypothetical participation in HIV cure-related research beyond personal clinical risks,
including psychosocial, mental, emotional, logistical, ethical, societal and economic factors, we know little about
how PLWHIV understand and experience actual HIV cure research participation, including factors that affect
their decision to join, defer, continue or exit these high-risk/low-benefit HIV cure studies. Very little data exist as
to participant experiences within HIV cure trials, and how they view these trials after participating. Our
multidisciplinary team of social scientists, biomedical HIV cure researchers, and HIV patient advocates proposes
to capture participant-centered outcomes longitudinally at critical time points in HIV cure clinical studies being
conducted in the U.S. that include diverse populations with respect to sex/gender, health status and
chronic/acute HIV status, and transmission groups (e.g. MSM, people who inject drugs (PWIDs). While patient-
centered outcomes have been used extensively in HIV treatment, Hepatitis C and oncology, they have yet to be
applied to participants of HIV cure research trials. We will integrate novel, longitudinal, mixed-methods
assessments into at least three ongoing HIV cure clinical studies at AIDS Clinical Trials Group (ACTG)-affiliated
sites: 1) “Last Gift” cohort involving PLWHIV at the end-of-life (EOL) who will interrupt HIV treatment (n=30); 2)
ACTG 5345/A5347s (study involving intensively monitored antiretroviral pauses (IMAPs) and extensive tissue
biopsies; n=66); 3) ACTG 5366 (latency-reversing study in women; n=30). Studies were selected because
biomedical teams sought out this socio-behavioral research and expertise.
 We propose three specific aims: 1) Quantitatively and qualitatively assess PLWHIV experiences with
enrollment into HIV cure clinical studies, including their decision-making processes (e.g., entry vs. non-entry),
perceptions of risks and benefits, and understanding of the study; 2) Quantitatively and qualitatively assess how
PLWHIV experience prospective participation in HIV cure studies using robust participant-centered outcomes;
3) Develop general and study-specific ethical, practical and tactical recommendations from key stakeholders to
inform the design and conduct of future HIV cure studies. We anticipate that particip...

## Key facts

- **NIH application ID:** 9905559
- **Project number:** 5R21MH118120-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Karine Dube
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $221,971
- **Award type:** 5
- **Project period:** 2019-05-01 → 2022-10-01

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9905559

## Citation

> US National Institutes of Health, RePORTER application 9905559, Pilot Integration of Participant-Centered Outcomes in HIV Cure Research in the United States: Implications for Ethical Conduct (5R21MH118120-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9905559. Licensed CC0.

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