Clinical trial NCT02044484: HIV Clinic-Based Intervention to Improve ART Adherence and Prevent HIV Transmission
Official title: HIV Clinic-Based Intervention to Improve ART Adherence and Prevent HIV Transmission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
AIDS
Viral load
Primary care
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2014-01-24
Enrollment: 2794
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: Percentage of patients with suppressed HIV (≤ 200 copies/mL)
timeFrame: At 9-month time point
measure: Percentage of patients without a gap in HIV primary care (without a gap > 6 months)
timeFrame: From baseline to 9-month time point
Secondary outcomes:
measure: Change across time in log10 viral load values
timeFrame: From baseline to 9-month time point
measure: HIV primary care appointment adherence
timeFrame: From baseline to 9-month time point
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1917 Clinic
state: Alabama
city: San Diego
country: United States
facility: Owen Clinic
state: California
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Houston
country: United States
facility: Thomas Street Health Center
state: Texas
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: Baylor College of Medicine
name: Thomas P Giordano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Margaret Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Matthew Golden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Edward Cachay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Michael J Mugavero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Allan E Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stirratt MJ, Marks G, O'Daniels C, Cachay ER, Sullivan M, Mugavero MJ, Dhanireddy S, Rodriguez AE, Giordano TP. Characterising HIV transmission risk among US patients with HIV in care: a cross-sectional study of sexual risk behaviour among individuals with viral load above 1500 copies/mL. Sex Transm Infect. 2018 May;94(3):206-211. doi: 10.1136/sextrans-2017-053178. Epub 2017 Nov 2.