A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Enrollment
- 59
- Locations
- 16
- Primary Endpoint
- Number of Participants With Virologic Suppression
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
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 A
- •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
Outcomes
Primary Outcomes
Number of Participants With Virologic Suppression
Time Frame: Week 48
Number of participants with virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL at week 48.
Secondary Outcomes
- Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation(From study entry to Week 72)
- Change in CD4 Cell Count at Week 48(Baseline and Week 48)
- Confirmed Virologic Failure(Week 24 through Week 72)
- Cost of the Adherence Telephone Interventions(Week 48)
- Number of Participants With Illness Events or Mortality(Measured from entry to Week 72 or premature study discontinuation)
- Number of Participants With Virological Suppression(Measured from entry to Week 72 or premature study discontinuation)
- Number of Participants Who Received Last Telephone Call if Prior to the End of Defined Intervention Period(Measured from entry to Week 72 or premature study discontinuation)
- Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered)(Measured at Week 12)
- Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls)(Week 12)
- Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12(Week 12)
- Change in CD4 Cell Count at Week 12(Baseline and Week 12)
- Change in CD4 Cell Count at Week 24(Baseline and Week 24)
- Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire(Week 12)
- Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24.(Week 24)
- Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12(Week 12)
- Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24(Week 24)
- Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48(Measured at Week 48)
- Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire(Week 24)
- Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall(Week 12)
- Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall(Week 24)
- Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale(Week 12)
- Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale(Week 24)
- Quality of Life Measured by Euro-QoL - Mobility(Week 24)
- Quality of Life Measured by Euro-QoL - Self-Care(Week 24)
- Quality of Life Measured by Euro-QoL - Usual Activities(Week 24)
- Quality of Life Measured by Euro-QoL - Pain/Discomfort(Week 24)
- Quality of Life Measured by Euro-QoL - Anxiety/Depression(Week 24)