HIV Treatment Adherence Dose Determination Trial

DOSE DETERMINATION TRIAL: The Start/Persist Studies

The proposed research will conduct the first dose-determination trial to find the optimal number of behavioral counseling sessions (dose) needed to achieve and sustain optimal HIV treatment adherence. The results of this study will determine how much intervention is needed for whom and at what cost to guide health policy and implementation of behavioral interventions designed to improve durable viral suppression.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Behavioral Self-Regulation Adherence Counseling

Detailed Description

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 the investigators 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 with empirically determined low-adherence will be randomized to either: (a) the dose determination condition of weekly evidence-based behavioral self-regulation counseling until achieving HIV suppression 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 optimal adherence / 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 meeting criteria for adherence / 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 and non-response is defined by not achieving optimal adherence / viral suppression. 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 increase the likelihood of sustained HIV suppression.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seth Kalichman, PhD; Phone Number: 860 208 3706; Email: seth.k@uconn.edu

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • Recruiting
      • University of Connecticut
      • Contact: Seth Kalichman, PhD; Phone Number: 860-208-3706; Email: seth.k@uconn.edu
      • Principal Investigator: Seth Kalichman, PhD
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • University of Connecticut Field Site
      • Contact: Seth Kalichman, PhD; Phone Number: 860-208-3706; Email: seth.k@uconn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed HIV positive
• Confirmed prescribed antiretroviral therapy
• Confirmed non-adherent to anti-retroviral therapy

Exclusion Criteria:

• Does not have access to a phone
• Does not have access to the internet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous Counseling; Receives up to 16 weekly behavioral counseling sessions over the phone to achieve optimal medication adherence. Counseling adjusts to patient needs and determines the dose to achieve optimal adherence / HIV suppression, in contrast to the fixed dose condition that does not adjust to patient response.	Behavioral: Behavioral Self-Regulation Adherence Counseling; Telephone-delivered counseling to focus on cognitive-behavioral skills to improve HIV treatment adherence.
Active Comparator: Fixed Counseling; Receives up to five weekly behavioral counseling sessions over the phone focused on improving HIV medication adherence / viral suppression.	Behavioral: Behavioral Self-Regulation Adherence Counseling; Telephone-delivered counseling to focus on cognitive-behavioral skills to improve HIV treatment adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Antiretroviral Therapy Adherence from Baseline to 12-Months	Medication adherence defined by percentage of medication doses taken as prescribed	12-Month
Change in HIV Viral Load from Baseline to 12-months	Blood plasma HIV RNA	12-months

Collaborators and Investigators

• Sponsor: University of Connecticut
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• Kalichman SC, Kalichman MO, Cherry C, Eaton LA, Cruess D, Schinazi RF. Randomized Factorial Trial of Phone-Delivered Support Counseling and Daily Text Message Reminders for HIV Treatment Adherence. J Acquir Immune Defic Syndr. 2016 Sep 1;73(1):47-54. doi: 10.1097/QAI.0000000000001020.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: September 23, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: H19-161; R01MH121129 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sets masked for all patient level identifying information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No