HIV Clinic-Based Intervention to Improve ART Adherence and Prevent HIV Transmission (APTcare)
|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|
- 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 ]
- 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
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02044484
|United States, Alabama|
|Brimingham, Alabama, United States, 35294|
|Contact: Michael J Mugavero, MD 205-996-5822 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Thomas P Giordano, MD|
|United States, Washington|
|Harborview Medical Center||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: Shireesha Dhanireddy, MD 206-744-5103 email@example.com|
|Sub-Investigator: Shireesha Dhanireddy, MD|
|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|