Telephone Support to Improve Adherence to Anti-HIV Medications
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Enhanced nursing telephone support; Standard care
Intervention description: Weekly phone calls by study nurses for 8 weeks and then calls every 2 weeks for 40 weeks; nurses could schedule more frequent calls at their discretion. Calls provided information, motivational enhancement, problem-solving skills, and affective support.; Usual ACTG site care.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adherence; Treatment; Adherence Intervention; Telephone Intervention; treatment experienced

Summary:

      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.
    

Eligibility criteria:

        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