Telephone Support to Improve Adherence to Anti-HIV Medications

Antiretroviral therapy (ART) is only successful in treating HIV when people take all the
medications prescribed to them when and how they are instructed. However, a third or more of
patients on ART are not able to adhere to their medication regimens. Therefore, making sure
that these patients stay healthy involves making sure they are motivated and informed about
the importance of adhering to their ART. Nurses can deliver interventions to motivate and
inform patients through regularly scheduled phone calls. These calls allow nurses to check
in between clinic visits, are convenient to patients, and are cost efficient. This study
will test an enhanced telephone support intervention provided by nurses that aims to improve
ART adherence and treatment outcomes.

Participation in this study will last 48 weeks, with follow-up lasting 72 weeks.
Participants will be randomly assigned to receive either care as usual or the enhanced
telephone support intervention plus care as usual. The telephone support intervention will
involve phone calls made weekly for the first 8 weeks of the study and then every 2 weeks
for the next 40 weeks. Nurses will make these calls at a time and place participants choose.
During the calls, nurses will provide information, motivational enhancement, and
problem-solving skills.

Study assessments will take place at study entry and after 12, 24, 48, and 72 weeks.
Assessments will measure CD4 cell count, HIV viral load, adherence, and illness events.
Adherence will be measured through questionnaires and an electronic pill cap.

Inclusion Criteria:

- Enrollment in an AIDS Clinical Trials Group (ACTG) treatment study that is an
approved A5251 parent or coenrolling partner study

- Virologic failure on combination antiretroviral therapy (ART), with an HIV-1 genotype
conducted on or soon after the failure, within 16 weeks prior to entry. HIV-1
genotype results must be available at entry.

- History of prior nonadherence to ART during the past year documented either by
patient self-report or recorded in the patient's medical record

- Most recent HIV-1 RNA value of at least 400 copies/mL, obtained within 90 days prior
to study entry and measured using any FDA-approved test for quantifying HIV-1 RNA

- Initiating a new ART regimen within 3 days after randomization with two or more new
antiretroviral (ARV) medications to which the participant is expected to be
susceptible based on HIV-1 genotype, as specified in the parent or coenrolling
partner study or determined by the site investigator. The regimen must be selected
for the participant prior to the time of randomization for A5251.

- Ability to have CD4+ cell count and plasma HIV-1 RNA assays as a component of the
parent or coenrolling partner study or per other mechanism. Only HIV-1 RNA at week 48
and confirmation of virologic failure will be collected by A5251, unless collected by
the parent or coenrolling partner study per exact A5251 specifications.

Exclusion Criteria:

- No regular access to a phone. Candidates without phones may elect to participate by
calling the HIV nurse specialists using an 800 number, rather than being called by
the HIV nurse specialist.

- Coenrollment in another adherence trial, unless approved by the A5251 study chair

- Current incarceration

- Any condition that, in the opinion of the site investigator, would compromise the
candidate's ability to participate in the study