# DOSE DETERMINATION TRIAL FOR IMPLEMENTING EVIDENCE-BASEDBEHAVIORAL INTERVENTIONS

> **NIH NIH R01** · UNIVERSITY OF CONNECTICUT STORRS · 2021 · $590,419

## Abstract

The proposed research will conduct the first ever dose-determination trial of a behavioral intervention to
improve engagement in HIV care, antiretroviral therapy (ART) adherence and HIV viral suppression. The
trial is designed to inform the implementation of behavioral interventions, including several in CDC’s
Compendium of Evidence-Based Interventions. Behavioral counseling has the flexibility and reach to
overcome numerous challenges to HIV care, including social, emotional, and structural barriers. However,
basic questions of how to best implement and scale-up interventions remain unanswered, such as “how much
intervention is needed to achieve HIV suppression in subgroups of patients facing individual and social
challenges?” There are currently no dose-determination trials in the HIV behavioral intervention
literature to guide implementation decisions and health service policy. In the proposed research we
specifically aim to: (a) determine the minimum effective dose of an evidence-based HIV treatment
engagement and adherence intervention, (b) identify subgroups of patients requiring greater and fewer
intervention resources to achieve and sustain viral suppression, and (c) the costs associated with
intervention dose-response. Participants who are receiving ART and confirmed HIV unsuppressed (>200
copies/mL) will be randomized to either: (a) the dose determination condition of weekly evidence-based
behavioral self-regulation counseling until achieving HIV suppression (<200 copies/mL), or (b) fixed dose
5-weekly sessions of evidence-based behavioral self-regulation counseling sessions. The dose
determination condition adjusts to patient needs and determines the dose to achieve HIV suppression, in
contrast to the fixed dose condition that does not adjust to patient response. The trial is therefore designed
to determine the number of behavioral counseling intervention sessions needed to achieve and sustain
HIV suppression. Once viral suppressed, counseling in the dose-determination condition is suspended. In
contrast, the fixed-dose condition is delivered in five prescribed sessions as disseminated by the CDC.
Follow-up assessments commence for 12-months from baseline with the primary endpoint of 12-month
blood plasma HIV viral load and secondary outcome of ART adherence. Response to counseling is
defined by achieving viral suppression (<200 copies/mL) and non-response is defined by not achieving
viral suppression (>200 copies/mL). Participants in both the dose-determination and fixed-session
conditions who initially respond and rebound to unsuppressed viral load will receive additional counseling
with redose-response monitored and analyzed. Longitudinal analyses will examine intervention dose for
key patient subgroups and dose-response cost-effectiveness analyses to guide resource allocation and
implementation decisions. This research is aimed at informing health policy makers and programmatic
decisions regarding intervention implementation to inc...

## Key facts

- **NIH application ID:** 10089484
- **Project number:** 5R01MH121129-02
- **Recipient organization:** UNIVERSITY OF CONNECTICUT STORRS
- **Principal Investigator:** SETH C KALICHMAN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $590,419
- **Award type:** 5
- **Project period:** 2020-02-01 → 2024-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10089484

## Citation

> US National Institutes of Health, RePORTER application 10089484, DOSE DETERMINATION TRIAL FOR IMPLEMENTING EVIDENCE-BASEDBEHAVIORAL INTERVENTIONS (5R01MH121129-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10089484. Licensed CC0.

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