HIV Infections Clinical Trial
Official title:
A Randomized Trial of Enhanced Nursing Telephone Support to Improve Medication Self-Management and Viral Outcomes of Antiretroviral Therapy-Experienced Patients
This study will test a system of nursing telephone support to see 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
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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