Trial record 18 of 36 for:    " January 13, 2014":" February 12, 2014"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Centers for Disease Control and Prevention
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT02044484
First received: January 22, 2014
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
HIV
Behavioral: Multi-component intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV Clinic-Based Intervention to Improve ART Adherence and Prevent HIV Transmission

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Percentage of patients with suppressed HIV (≤ 200 copies/mL) [ Time Frame: At 9-month time point ] [ Designated as safety issue: No ]
  • Percentage of patients without a gap in HIV primary care (without a gap > 6 months) [ Time Frame: From baseline to 9-month time point ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change across time in log10 viral load values [ Time Frame: From baseline to 9-month time point ] [ Designated as safety issue: No ]
  • HIV primary care appointment adherence [ Time Frame: From baseline to 9-month time point ] [ Designated as safety issue: No ]
    Proportion of scheduled HIV primary care appointments kept (omitting prior cancellations) per patient


Estimated Enrollment: 2794
Study Start Date: January 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02044484

Locations
United States, Alabama
1917 Clinic Not yet recruiting
Brimingham, Alabama, United States, 35294
Contact: Michael J Mugavero, MD    205-996-5822    mmugavero@uab.edu   
Principal Investigator: Michael J Mugavero, MD         
United States, California
Owen Clinic Not yet recruiting
San Diego, California, United States, 92103
Contact: Edward Cachay, MD    619-543-3995    ecachay@ucsd.edu   
Principal Investigator: Edward Cachay, MD         
United States, Florida
Jackson Memorial Hospital Not yet recruiting
Miami, Florida, United States, 33136
Contact: Allan E Rodriguez, MD    305-243-3011    ARodriguez2@med.miami.edu   
Principal Investigator: Allan E Rodriguez, MD         
United States, Massachusetts
Boston Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Margaret Sullivan, MD    617-414-3574    meg.sullivan@bmc.org   
Principal Investigator: Margaret Sullivan, MD         
United States, Texas
Thomas Street Health Center Recruiting
Houston, Texas, United States, 77009
Contact: Thomas P Giordano, MD    713-794-8682    tpg@bcm.edu   
Principal Investigator: Thomas P Giordano, MD         
United States, Washington
Harborview Medical Center Not yet recruiting
Seattle, Washington, United States, 98104
Contact: Shireesha Dhanireddy, MD    206-744-5103    sdanir@u.washington.edu   
Sub-Investigator: Shireesha Dhanireddy, MD         
Sponsors and Collaborators
Investigators
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
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02044484     History of Changes
Other Study ID Numbers: CDC-NCHHSTP-2468, CDC
Study First Received: January 22, 2014
Last Updated: January 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
HIV
AIDS
Viral load
Primary care

ClinicalTrials.gov processed this record on August 21, 2014