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A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Alabama Therapeutics CRS
Birmingham, Alabama, United States
Ucsd, Avrc Crs
San Diego, California, United States
Northwestern University CRS (2701)
Chicago, Illinois, United States
Rush University Medical Center ACTG
Chicago, Illinois, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States
Bmc Actg Crs (104)
Boston, Massachusetts, United States
Cooper Univ. Hosp. CRS (31476)
Camden, New Jersey, United States
New Jersey Medical School-Adult Clinical Research Ctr. CRS
Newark, New Jersey, United States
Cornell CRS
New York, New York, United States
HIV Prevention & Treatment CRS
New York, New York, United States
Start Date
October 1, 2010
Primary Completion Date
February 1, 2013
Completion Date
February 1, 2013
Last Updated
July 17, 2017
59
ACTUAL participants
Enhanced nursing telephone support
BEHAVIORAL
Standard care
BEHAVIORAL
Lead Sponsor
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Collaborators
NCT04142047
NCT06694805
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
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