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

HIV Clinical Trial

— APTcare  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02044484
• Other study ID #: CDC-NCHHSTP-2468
• Secondary ID: CDC
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2014
• Last updated: February 11, 2015
• Start date: January 2014
• Est. completion date: October 2016

Study information

• Verified date: February 2015
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2794
• Est. completion date: October 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	1917 Clinic	Brimingham	Alabama
United States	Thomas Street Health Center	Houston	Texas
United States	Jackson Memorial Hospital	Miami	Florida
United States	Owen Clinic	San Diego	California
United States	Harborview Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with suppressed HIV (= 200 copies/mL)		At 9-month time point	No
Primary	Percentage of patients without a gap in HIV primary care (without a gap > 6 months)		From baseline to 9-month time point	No
Secondary	Change across time in log10 viral load values		From baseline to 9-month time point	No
Secondary	HIV primary care appointment adherence	Proportion of scheduled HIV primary care appointments kept (omitting prior cancellations) per patient	From baseline to 9-month time point	No