Telephone Support to Improve Adherence to Anti-HIV Medications

Phase 2TerminatedNCT00988442

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

HIV Infections

Interventions

Enhanced nursing telephone supportBEHAVIORAL

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.

Standard careBEHAVIORAL

Usual ACTG site care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Alabama Therapeutics CRS

Birmingham, Alabama, United States

Ucsd, Avrc Crs

San Diego, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 48

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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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

...and 6 more locations

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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".

Time frame: 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".

Time frame: 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.

Time frame: 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.

Time frame: Week 24

Quality of Life Measured by Euro-QoL - Mobility

Quality of life measured by Euro-QoL - Question 1: Mobility.

Time frame: Week 24

Quality of Life Measured by Euro-QoL - Self-Care

Quality of Life Measured by Euro-QoL - Question 2: Self-Care.

Time frame: Week 24

Quality of Life Measured by Euro-QoL - Usual Activities

Quality of Life Measured by Euro-QoL - Question 3: Usual activities.

Time frame: Week 24

Quality of Life Measured by Euro-QoL - Pain/Discomfort

Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort.

Time frame: Week 24

Quality of Life Measured by Euro-QoL - Anxiety/Depression

Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression.

Time frame: Week 24