# Investigating Psychosocial Experiences of HIV Cure Trial Participants Undergoing Extended HIV Treatment Interruptions: Implications for Ethical Conduct

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2023 · $694,568

## Abstract

7. PROJECT SUMMARY/ABSTRACT
HIV cure research is a high-priority for the National Institutes of Health and is targeting a strategy that can lead
to sustained antiretroviral treatment (ART)-free suppression. However, because there are no clear biomarkers
for an HIV cure – unlike CD4+ count and viral load as markers of ART efficacy – the only way to evaluate the
efficacy of a strategy is to require otherwise healthy people living with HIV (PLWH) who have achieved viral
suppression to pause their ART. This pausing is called an analytical treatment interruption (ATI) and is the most
controversial aspect of HIV cure research. Further, to advance HIV cure research, participants are required to
tolerate extended ATIs, which are long periods of high levels of uncontrolled viremia. The goals of the proposed
research are to investigate the informed consent process and participants' understanding and experiences with
extended ATIs, and use a robust consensus-building technique to resolve the most pressing ethical challenges
in HIV cure research. Aims 1 – 2 are nested within four entirely unique trials across the U.S. with a combined
total of 120 participants. The studies are taking place through the AIDS Clinical Trials Group Network (ACTG)
and the University of California, San Francisco (UCSF). Aim 1 will evaluate the quality of informed consent in 30
participants going through an ATI study, and survey data will be collected measuring perceived benefits, risks,
understanding of study procedures, expectations, and relevant psychosocial domains (e.g., HIV stigma,
resilience). Aims 2 will prospectively evaluate the psychosocial experiences, quantitatively and qualitatively, of
HIV cure research participants before, during and after ATIs. This involves the analysis of strategically placed,
and fully integrated prospective psychosocial survey assessments and interviews from study entry to exit.
Surveys include measures of anxiety-related outcomes to monitor potential for psychological harm and stress
levels during the ATI (among other domains). In addition, Aim 3 involves the use of a hybrid Delphi process to
build consensus for strategies to address evolving ethical challenges in HIV cure research. A panel of experts
are selected from across the U.S. to engage in four rounds of surveys, with community partners providing input
on survey results in between rounds. The goal is to hone in on consensus around how to address racial and
ethnic differences and medical mistrust as a barrier to engagement in HIV cure research (including women living
with HIV), how to implement ATIs safely, how to address psychosocial harms, and how to protect sexual partners
during ATIs. The proposed aims will show how people living with HIV understand and experience cutting-edge
HIV cure strategies that can only be evaluated through extended ATIs. The potential impact of this research will
result in concrete sets of recommendations and actionable items to enhance the informed consent p...

## Key facts

- **NIH application ID:** 10647752
- **Project number:** 5R01MH126768-03
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Karine Dube
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $694,568
- **Award type:** 5
- **Project period:** 2021-09-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10647752

## Citation

> US National Institutes of Health, RePORTER application 10647752, Investigating Psychosocial Experiences of HIV Cure Trial Participants Undergoing Extended HIV Treatment Interruptions: Implications for Ethical Conduct (5R01MH126768-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10647752. Licensed CC0.

---

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