HIV Clinic-Based Intervention to Improve ART Adherence and Prevent HIV Transmission (APTcare)

March 18, 2025 updated by: Centers for Disease Control and Prevention
This research, co-sponsored by the Centers for Disease Control and Prevention and the National Institute of Mental health, is conducted at six HIV clinics in the U.S. The research examines the effect of a clinic-based multi-component intervention delivered to HIV patients when they attend clinic for primary care. The study tests the hypothesis that the intervention will improve the viral load status of patients and improve attendance for HIV primary care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study examines the effect of an HIV clinic-based multi-component intervention on HIV patients' subsequent viral load status and attendance for HIV primary care. The intervention has clinic-wide and targeted components. The clinic-wide components are given to all HIV patients when they attend clinic for primary care and include: (1) patient behavioral screening used by providers in the clinical care of patients and (2) dissemination of palm cards which contain messages about the importance of adhering to antiretroviral therapy (ART), coming to clinic regularly, and safer sex. The targeted components focus on patients whose viral loads exceed 1000 copies/mL. Targeted components include: (1) an interactive computer-based intervention (CBI) completed twice (separated by 2-4 months) by patients at the clinic and (2) referral for one-on-one counseling from trained project Health Coaches if the patient's viral load does not show a 1-log reduction after the first CBI or remains above 200 copies/mL after two administrations of the CBI.

Patients are not individually randomly assigned to arms. The multi-component intervention is evaluated using a group-randomized design. Clinics were randomized to either Panel A or Panel B with the intent of equating the two panels on the percentage of patients with suppressed viral load prior to implementing the intervention. Three clinics (Panel A) begin intervention activities, and the other three clinics (Panel B) delay onset of all intervention activities for 16 months and thus serve as a concurrent control group during that 16-month period. This enables between-panel comparisons of the outcomes during this time interval.

The primary analytic cohort for the group-randomized analysis will be all patients in Panel A and Panel B whose viral load exceeds 1000 copies/mL who have a scheduled primary care appointment during a 7-month enrollment period. Viral load eligible patients in Panel A will be part of the analytic cohort regardless of whether they enroll in the CBI or not. These viral load eligible patients represent the group of patients who are targeted for the main intervention components (CBI and counseling) and, accordingly, will comprise the denominator (estimated to be 2,794) for the primary analysis of the viral load and clinic attendance outcomes. Each cohort member in Panel A is followed for 9 months for purpose of delivering the intervention and assessing the outcomes. Each cohort member in Panel B is followed for 9 months for purpose of assessing the outcomes.

Two secondary levels of analysis will also be performed. First, analysis will be performed focusing on all patients in Panel A clinics who have a viral load over 1000 copies/mL and received at least one administration of the CBI ("as-treated" approach). Outcomes of these patients will be compared to patients in Panel B whose viral load exceeds 1000 copies/mL during the recruitment period. Second, an analysis will be performed at the clinic-wide level including all patients in Panel A clinics regardless of viral load level who are scheduled for primary care during the recruitment period. Outcomes of these patients will be compared to all patients in Panel B scheduled for primary care visits during the recruitment period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2794

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • 1917 Clinic
    • California
      • San Diego, California, United States, 92103
        • Owen Clinic
    • Florida
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
    • Texas
      • Houston, Texas, United States, 77009
        • Thomas Street Health Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients are eligible to receive behavioral screening and palm cards
  • Patients with viral load exceeding 1000 copies/mL are eligible for the computer-based intervention and referral to counseling

Exclusion Criteria:

  • Patients under the age of 18 (under 19 in Alabama) are not eligible for the computer-based intervention or referral to counseling because they cannot provide legal informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Multi-component intervention

Computer-based intervention (CBI) completed twice (separated by 2-4 months) among patients whose viral load exceeds 1000 copies/mL at time of enrollment.

One-on-one counseling from a project Health Coach (three 1-hour sessions at the clinic and two follow-up phone calls at 1 and 3 months after last session). The counseling is offered to patients who do not show a 1-log reduction in their viral load after the first CBI or whose viral load remains above 200 copies/mL after two administrations of the CBI.

Behavioral screening of patients at HIV primary care visits.

Dissemination of palm cards with empowering messages at HIV primary care visits.
Behavioral: Multi-component intervention

The computer-based intervention (CBI) is offered to patients whose viral load exceeds 1000 copies/mL at enrollment.

Counseling is offered to patients whose viral load does not drop 1-log after the first CBI or remains above 200 copies/mL after completing two CBIs.

The behavioral screener will be conducted of all patients at primary care visits. The patient completes the screener before seeing the provider. Responses are given to their provider who can use it in clinical care of the patient.

At primary care visits, all patients are given a palm card containing 1 of 15 empowering messages before they leave the clinic. Messages cover three domains: adhering to antiretroviral therapy, regular care, and safer sex.
No Intervention: Standard of care control
HIV patients will continue to receive existing standard of care practices at the clinic without receiving the multi-component intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of patients with suppressed HIV (≤ 200 copies/mL)
Time Frame: At 9-month time point
At 9-month time point
Percentage of patients without a gap in HIV primary care (without a gap > 6 months)
Time Frame: From baseline to 9-month time point
From baseline to 9-month time point

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change across time in log10 viral load values
Time Frame: From baseline to 9-month time point
From baseline to 9-month time point
HIV primary care appointment adherence
Time Frame: From baseline to 9-month time point
Proportion of scheduled HIV primary care appointments kept (omitting prior cancellations) per patient
From baseline to 9-month time point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thomas P Giordano, MD, Baylor College of Medicine
  • Principal Investigator: Margaret Sullivan, MD, Boston University
  • Principal Investigator: Matthew Golden, MD, University of Washington
  • Principal Investigator: Edward Cachay, MD, University of California, San Diego
  • Principal Investigator: Michael J Mugavero, MD, University of Alabama at Birmingham
  • Principal Investigator: Allan E Rodriguez, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDC-NCHHSTP-2468
  • CDC (CDC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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