# Decision Support for Early-Phase HIV Remission Trials

> **NIH NIH R34** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2021 · $387,417

## Abstract

PROJECT SUMMARY/ABSTRACT
Early phase HIV remission (“cure”) research has features that challenge good decision making. The goal of
this proposal is to develop a customizable decision aid (DA), with empirically and normatively-informed
content, for early phase HIV remission trials. It will address elements of informed choice that investigators and
PLHIV find most problematic, starting with expectations for personal benefit, type and magnitude of
foreseeable trial risks, and the potential for unanticipated harms. The long-term aim of “cure” trials can
engender unreasonable expectations and the cutting-edge, technical aspects of study procedures and
proposed interventions are often difficult to understand. Furthermore, trials require participants to understand,
evaluate, and weigh uncertain risks to their own health, risks to sexual partners when trials involve analytic
treatment interruption, potential benefits to HIV science, and whatever other values and considerations they
may find important in reaching their decisions. Standard consent processes typically used for these studies
have been empirically shown to have significant shortcomings. DAs are a promising approach to enhance the
quality of research informed consent, improve decision satisfaction, and ultimately improve the psychological
wellbeing of participants enrolled in trials. We propose to use RTI's Adaptable Decision Aid Platform for Trials
(ADAPT) to develop and test a customizable DA to augment informed consent in the challenging case of early-
phase HIV remission research. The resulting DA will be developed based on our prior research; ethical
principles and frameworks; standards, systematic reviews, and best practices in DA development; and input
from investigators at the trial sites and our multidisciplinary advisors. To accomplish this, we have four aims.
Aim 1: We will collect information from 50 HIV investigators about unmet decision-making needs for remission
trials, and attitudes about DA acceptability, utility, and impact. Aim 2: We will develop and assess a phase 1
DA in remission trials to be conducted by the AIDS Clinical Trials Group (ACTG). We will collect longitudinal
data from 30 individuals invited to the trials and interview ACTG investigators about conducting informed
consent after participants use the DA. Aim 3: We will conduct two deliberative engagement stakeholder
meetings that use data from Aims 1 and 2 to develop evidence-based recommendations for refining and
expanding to the phase 2 DA. In Aim 4, we will conduct user test interviews of the phase 2 DA with 30 PLHIV
and 8 HIV researchers. Interviews will be used to make iterative refinements to the DA content and user
experience (based on feedback from PLHIV and researchers) and to the customization capabilities of the tool
(based on feedback from researchers). Thus, we propose an evidence-based and user-centered approach to
DA development. The resulting decision aid will be evaluated in a subsequent randomi...

## Key facts

- **NIH application ID:** 10160205
- **Project number:** 1R34MH123328-01A1
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Gail E HENDERSON
- **Activity code:** R34 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $387,417
- **Award type:** 1
- **Project period:** 2021-04-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10160205

## Citation

> US National Institutes of Health, RePORTER application 10160205, Decision Support for Early-Phase HIV Remission Trials (1R34MH123328-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10160205. Licensed CC0.

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