Telephone Support to Improve Adherence to Anti-HIV Medications

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Enhanced nursing telephone support
* Behavioral: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced nursing telephone support with standard care<br>Participants received enhanced nursing telephone support plus care as usual. | Behavioral: Enhanced nursing telephone support<br>* 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.<br>Behavioral: Standard care<br>* Usual ACTG site care.<br>|
| Active Comparator: Standard care<br>Participants received care as usual. | Behavioral: Standard care<br>* Usual ACTG site care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Virologic Suppression | Number of participants with virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL at week 48. | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation | Number of premature ART regimen discontinuations, defined as the first substitution, subtraction, or addition of one or more ARVs made to the initial study regimen. | From study entry to Week 72 | 
| Change in CD4 Cell Count at Week 12 | Change in CD4 cell count from baseline at week 12, calculated as Week 12 CD4 minus baseline CD4. | Baseline and Week 12 | 
| Change in CD4 Cell Count at Week 24 | Change in CD4 cell count from baseline at Week 24, calculated as Week 24 CD4 minus baseline CD4. | Baseline and Week 24 | 
| Change in CD4 Cell Count at Week 48 | Change in CD4 cell count from baseline at Week 48, calculated as Week 48 CD4 minus baseline CD4. | Baseline and Week 48 | 
| Confirmed Virologic Failure | Number of participants with confirmed virologic failure. Virologic failure is defined as confirmed HIV-1 RNA ≥200 copies/mL at or after the week 24 HIV-1 RNA evaluation (obtained at least 20 weeks after the date of randomization). | Week 24 through Week 72 | 
| Cost of the Adherence Telephone Interventions | This outcome was planned to be analyzed if the intervention was found to be successful. However, the intervention was not determined to be successful. | Week 48 | 
| Number of Participants With Illness Events or Mortality | Number of participants who had acute illnesses and mortality during follow-up. The categories of illness events and mortality are not mutually exclusive. | Measured from entry to Week 72 or premature study discontinuation | 
| Number of Participants With Virological Suppression | Number of participants with virological suppression, defined as HIV-1 RNA less than 200 copies/mL. | 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 | Number of participants whose last telephone call received occurred prior to the end of the 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) | Intervention dosage score for enhanced nursing telephone support. This is the 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) | Intervention dosage score for enhanced nursing telephone support. This is the total amount of time spent in calls overall. | Week 12 | 
| Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12 | Number of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL, at week 12. | Week 12 | 
| Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24. | 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 | 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 | 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 | 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 12 Using ACTG Adherence Questionnaire | ARV medication adherence at week 12, as measured by the ACTG adherence questionnaire index. This questionnaire index is on a 0-100 scale, with higher scores indicating higher adherence. | Week 12 | 
| Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire | ARV medication adherence at week 24, as measured by the ACTG adherence questionnaire index. The ACTG adherence questionnaire index is on a 0-100 scale where higher scores indicate better adherence. | Week 24 | 
| Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall | ARV medication adherence at week 12, as measured by four day recall, i.e. Missed doses in last 4 days. | Week 12 | 
| Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall | ARV medication adherence, as measured by four day recall, i.e. Missed doses in last 4 days. | Week 24 | 
| Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale | ARV medication adherence at week 12, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month. | Week 12 | 
| Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale | ARV medication adherence at Week 24, as measured by the visual analog scale. The visual analog scale is a 0-100% scale that measures the percentage of HIV medication taken in the past month. | Week 24 | 
| Quality of Life Measured by Euro-QoL - Mobility | Quality of life measured by Euro-QoL - Question 1: Mobility. | Week 24 | 
| Quality of Life Measured by Euro-QoL - Self-Care | Quality of Life Measured by Euro-QoL - Question 2: Self-Care. | Week 24 | 
| Quality of Life Measured by Euro-QoL - Usual Activities | Quality of Life Measured by Euro-QoL - Question 3: Usual activities. | Week 24 | 
| Quality of Life Measured by Euro-QoL - Pain/Discomfort | Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort. | Week 24 | 
| Quality of Life Measured by Euro-QoL - Anxiety/Depression | Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression. | Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adherence, Treatment, Adherence Intervention, Telephone Intervention, treatment experienced