HIV Treatment Adherence Dose Determination Trial

NCT ID: NCT04577313

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2026-11-30

Brief Summary

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.

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Behavioral Self-Regulation Adherence Counseling

Intervention Type: BEHAVIORAL

Telephone-delivered counseling to focus on cognitive-behavioral skills to improve HIV treatment adherence.

Fixed Counseling

Receives up to five weekly behavioral counseling sessions over the phone focused on improving HIV medication adherence / viral suppression.

Group Type: ACTIVE_COMPARATOR

Behavioral Self-Regulation Adherence Counseling

Intervention Type: BEHAVIORAL

Telephone-delivered counseling to focus on cognitive-behavioral skills to improve HIV treatment adherence.

Interventions

Behavioral Self-Regulation Adherence Counseling

Telephone-delivered counseling to focus on cognitive-behavioral skills to improve HIV treatment adherence.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Connecticut

Storrs, Connecticut, United States

Site Status: RECRUITING

University of Connecticut Field Site

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Seth Kalichman, PhD

Role: CONTACT

seth.k@uconn.edu

860 208 3706

Facility Contacts

Seth Kalichman, PhD

Role: primary

seth.k@uconn.edu

860-208-3706

Seth Kalichman, PhD

Role: primary

seth.k@uconn.edu

860-208-3706

References

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.

Reference Type: BACKGROUND

PMID: 27105048 (View on PubMed)

Other Identifiers

R01MH121129

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H19-161

Identifier Type: -

Identifier Source: org_study_id