Telephone Support to Improve Adherence to Anti-HIV Medications
Telephone Support to Improve Adherence to Anti-HIV Medications
This study tested a system of nursing telephone support to determine if it improves adherence
 to antiretroviral therapy (ART) in at-risk, treatment-experienced people.
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 tested
 an enhanced telephone support intervention provided by nurses that aimed to improve ART
 adherence and treatment outcomes.

 Follow-up for this study lasted 72 weeks. Participants were randomly assigned to receive
 either care as usual or the enhanced telephone support intervention plus care as usual. The
 telephone support intervention involved phone calls made weekly for the first 8 weeks of the
 study and then every 2 weeks for the next 40 weeks. Nurses made these calls at a time and
 place participants chose. During the calls, nurses provided information, motivational
 enhancement, and problem-solving skills.

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

 This study was closed early to both accrual and follow-up due to low recruitment. The study
 aimed to enroll 296 participants. The actual study accrual at the time of early closing was
 59 participants.
Inclusion Criteria:

 -  Enrollment in an AIDS Clinical Trials Group (ACTG) treatment study that is an approved
 A5251 parent or coenrolling partner study ("ACTG parent study participant") or not
 enrolled in one of the ACTG parent studies, but receiving routine HIV patient care at
 an institution that was also an ACTG-funded site ("ACTG clinic patient participant").

 -  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. Availability
 of HIV-1 genotype results 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 200 copies/mL, obtained within 90 days prior
 to study entry and measured using any FDA-approved test for quantifying HIV-1 RNA

 -  Initiating or restarting an ART regimen with 2 or more active ARV medications within 3
 days after randomization. The regimen must have been selected for the participant
 prior to the time of randomization for A5251. An active ARV medication was defined as
 a medication to which the participant was expected to be susceptible based on HIV-1
 resistance testing, as specified in the ACTG parent study, or determined by the
 participant's health care provider per standard of care.

 Exclusion Criteria:

 -  No regular access to a phone. Candidates without phones may have elected 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 have compromised
 the candidate's ability to participate in the study