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

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.

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.