Recruiting

HIV Treatment

Sponsor:

University of Connecticut

Code:

NCT04577313

Conditions

HIV Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral Self-Regulation Adherence Counseling

Study Details

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.

Conditions

HIV Infections

Study ID

NCT04577313

Start date

Sep 1, 2020

Status verified date

Aug, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Fixed Counseling

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

Interventions

Behavioral Self-Regulation Adherence Counseling

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

Primary outcome measure

  • Change in Antiretroviral Therapy Adherence from Baseline to 12-Months [ Time Frame: 12-Month ]
  • Change in HIV Viral Load from Baseline to 12-months [ Time Frame: 12-months ]

Central Contacts and Locations

Central contacts

Seth Kalichman, PhD

860 208 3706seth.k@uconn.edu

Locations

University of Connecticut

Recruiting

Storrs, Connecticut, United States, 06269

Contacts

Seth Kalichman, PhD

860-208-3706seth.k@uconn.edu

Principal Investigator:

Seth Kalichman, PhD

University of Connecticut Field Site

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Seth Kalichman, PhD

860-208-3706seth.k@uconn.edu

More Information

Sponsor

University of Connecticut

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Connecticut on 2025-08-29.