HIV Infections
Conditions
Keywords
Adherence, Treatment, Adherence Intervention, Telephone Intervention, treatment experienced
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.
Interventions
BEHAVIORALEnhanced nursing telephone support
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.
BEHAVIORALStandard care
Usual ACTG site care.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Virologic Suppression | Week 48 | Number of participants with virologic suppression, defined as HIV-1 RNA at less than 200 copies/mL at week 48. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CD4 Cell Count at Week 12 | Baseline and Week 12 | Change in CD4 cell count from baseline at week 12, calculated as Week 12 CD4 minus baseline CD4. |
| Change in CD4 Cell Count at Week 24 | Baseline and Week 24 | Change in CD4 cell count from baseline at Week 24, calculated as Week 24 CD4 minus baseline CD4. |
| Change in CD4 Cell Count at Week 48 | Baseline and Week 48 | Change in CD4 cell count from baseline at Week 48, calculated as Week 48 CD4 minus baseline CD4. |
| Confirmed Virologic Failure | Week 24 through Week 72 | 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). |
| Cost of the Adherence Telephone Interventions | Week 48 | This outcome was planned to be analyzed if the intervention was found to be successful. However, the intervention was not determined to be successful. |
| Number of Participants With Illness Events or Mortality | Measured from entry to Week 72 or premature study discontinuation | Number of participants who had acute illnesses and mortality during follow-up. The categories of illness events and mortality are not mutually exclusive. |
| Number of Participants With Virological Suppression | Measured from entry to Week 72 or premature study discontinuation | Number of participants with virological suppression, defined as HIV-1 RNA less than 200 copies/mL. |
| 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 | Number of participants whose last telephone call received occurred prior to the end of the defined intervention period. |
| 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. This is the total percentage of scheduled calls successfully delivered. |
| Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls) | Week 12 | Intervention dosage score for enhanced nursing telephone support. This is the total amount of time spent in calls overall. |
| 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 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 200 copies/mL, at 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 12. |
| Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation | From study entry to Week 72 | 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. |
| Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48 | Measured at Week 48 | Number of participants with virologic suppression, defined as HIV-1 RNA less than 1,000 copies/mL, at week 48. |
| Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire | Week 12 | 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. |
| Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire | Week 24 | 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. |
| Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall | Week 12 | ARV medication adherence at week 12, as measured by four day recall, i.e. Missed doses in last 4 days. |
| Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall | Week 24 | ARV medication adherence, as measured by four day recall, i.e. Missed doses in last 4 days. |
| Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale | Week 12 | 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. |
| Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale | Week 24 | 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. |
| Quality of Life Measured by Euro-QoL - Mobility | Week 24 | Quality of life measured by Euro-QoL - Question 1: Mobility. |
| Quality of Life Measured by Euro-QoL - Self-Care | Week 24 | Quality of Life Measured by Euro-QoL - Question 2: Self-Care. |
| Quality of Life Measured by Euro-QoL - Usual Activities | Week 24 | Quality of Life Measured by Euro-QoL - Question 3: Usual activities. |
| Quality of Life Measured by Euro-QoL - Pain/Discomfort | Week 24 | Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort. |
| Quality of Life Measured by Euro-QoL - Anxiety/Depression | Week 24 | Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression. |
| 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 24. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between April 21, 2011 (first participant enrolled) and October 18, 2012 (last participant enrolled).
Pre-assignment details
59 participants were randomized 1:1 to standard care and enhanced nursing telephone support with standard care arms.
Participants by arm
| Arm | Count |
|---|---|
| Enhanced Nursing Telephone Support With Standard Care Participants received enhanced nursing telephone support plus care as usual.
Enhanced nursing telephone support: 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 care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site. | 30 |
| Standard Care Participants received care as usual.
Standard care: Care as usual for participants initiating or restarting an ART regimen; this could vary by study site. | 29 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Early Study Closure | 29 | 25 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Standard Care | Total | Enhanced Nursing Telephone Support With Standard Care |
|---|---|---|---|
| Age, Continuous | 46.6 years STANDARD_DEVIATION 10.8 | 45.5 years STANDARD_DEVIATION 11.5 | 44.5 years STANDARD_DEVIATION 12.2 |
| CD4+ Count | 157 cells/mm^3 | 180 cells/mm^3 | 180 cells/mm^3 |
| HIV-1 RNA | 4.5 log10 copies/mL | 4.0 log10 copies/mL | 4.0 log10 copies/mL |
| Intravenous (IV) Drug History Never | 25 Participants | 51 Participants | 26 Participants |
| Intravenous (IV) Drug History Previously | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Black Non-Hispanic | 20 Participants | 43 Participants | 23 Participants |
| Race/Ethnicity, Customized Hispanic (Regardless of Race) | 3 Participants | 7 Participants | 4 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 6 Participants | 9 Participants | 3 Participants |
| Region of Enrollment United States | 29 Participants | 59 Participants | 30 Participants |
| Sex: Female, Male Female | 13 Participants | 23 Participants | 10 Participants |
| Sex: Female, Male Male | 16 Participants | 36 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 30 | 2 / 29 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Population: All participants enrolled who had Week 48 HIV-1 RNA results available were included in this intent-to-treat-analysis. At the time of early study closure, 14 participants had reached week 48.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Virologic Suppression | 4 Participants |
| Standard Care | Number of Participants With Virologic Suppression | 5 Participants |
Comparison: A Fisher's exact test was used to compare the proportion of participants with virologic suppression, defined as HIV-1 RNA less than 200 copies/mL at week 48 between the standard of care and standard of care + enhanced telephone support groups.p-value: 1Fisher Exact
Secondary
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
Population: Due to early study closure, only 30 participants had complete adherence data for this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire | 97 units on a scale |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using ACTG Adherence Questionnaire | 93 units on a scale |
Secondary
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
Population: Due to early study closure, only 42 participants had adherence data at week 12 for this outcome.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall | Missed Doses: 0 | 17 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall | Missed Doses: 1-2 | 0 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall | Missed Doses: 3-4 | 3 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall | Missed Doses: 5+ | 3 Participants |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall | Missed Doses: 5+ | 1 Participants |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall | Missed Doses: 0 | 16 Participants |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall | Missed Doses: 3-4 | 1 Participants |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using Four Day Recall | Missed Doses: 1-2 | 1 Participants |
Secondary
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
Population: Due to early study closure, only 44 participants had adherence data available at week 12 for this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale | 95 percentage of HIV meds taken last month |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 12 Using Visual Analog Scale | 95 percentage of HIV meds taken last month |
Secondary
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
Population: Due to early study closure, 31 participants had complete adherence data for this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire | 91 units on a scale |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using ACTG Adherence Questionnaire | 95 units on a scale |
Secondary
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
Population: Due to early study closure, only 39 participants had adherence data at week 24.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall | Missed Doses: 0 | 12 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall | Missed Doses: 1-2 | 1 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall | Missed Doses: 3-4 | 2 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall | Missed Doses: 5+ | 6 Participants |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall | Missed Doses: 5+ | 3 Participants |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall | Missed Doses: 0 | 11 Participants |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall | Missed Doses: 3-4 | 3 Participants |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using Four Day Recall | Missed Doses: 1-2 | 1 Participants |
Secondary
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
Population: Due to early study closure, only 40 participants had adherence data available at week 24 for this outcome.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale | 95 percentage of HIV meds taken last month |
| Standard Care | Antiretroviral (ARV) Medication Adherence at Week 24 Using Visual Analog Scale | 95 percentage of HIV meds taken last month |
Secondary
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
Population: Due to early study closure, only 44 participants had week 12 CD4 observations to be included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Change in CD4 Cell Count at Week 12 | 11 cells/mm^3 |
| Standard Care | Change in CD4 Cell Count at Week 12 | 27 cells/mm^3 |
Secondary
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
Population: Due to early study closure, only 42 participants had week 24 CD4 observations to be included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Change in CD4 Cell Count at Week 24 | 37 cells/mm^3 |
| Standard Care | Change in CD4 Cell Count at Week 24 | 9 cells/mm^3 |
Secondary
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
Population: Only 16 participants had week 48 CD4 observations to be included in this analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Change in CD4 Cell Count at Week 48 | 63 cells/mm^3 |
| Standard Care | Change in CD4 Cell Count at Week 48 | 80 cells/mm^3 |
Secondary
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
Population: The analysis population was all participants randomized to a treatment arm in this trial.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Confirmed Virologic Failure | Virologic Failure | 8 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Confirmed Virologic Failure | Virologic Non-failure | 6 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Confirmed Virologic Failure | Insufficient Follow Up | 16 Participants |
| Standard Care | Confirmed Virologic Failure | Virologic Failure | 7 Participants |
| Standard Care | Confirmed Virologic Failure | Virologic Non-failure | 6 Participants |
| Standard Care | Confirmed Virologic Failure | Insufficient Follow Up | 16 Participants |
Secondary
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.
Time frame: Week 48
Population: This outcome was not analyzed, since the intervention was not determined to be successful.
| Arm | Measure | Value |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Cost of the Adherence Telephone Interventions | 0 |
| Standard Care | Cost of the Adherence Telephone Interventions | 0 |
Secondary
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
Population: Only participants in the telephone support group were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Amount of Time Spent in Calls) | 19 minutes |
Secondary
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
Population: Only participants in the telephone support group were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Intervention Dosage Score for Enhanced Nursing Telephone Support (Total Percentage of Scheduled Calls Successfully Delivered) | 34.6 percent of scheduled calls delivered | Standard Deviation 34.3 |
Secondary
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
Population: Only participants in the telephone support group were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants Who Received Last Telephone Call if Prior to the End of Defined Intervention Period | 21 participants |
Secondary
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
Population: Due to early study closure, only 59 participants were accrued and followed on study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Pulmonary | 4 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Neoplastic diseases | 1 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Gastrointestinal | 5 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Bacterial/Mycobacterial infections | 5 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Neuropsychiatric | 4 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Cardiovascular diseases | 5 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Musculoskeletal | 1 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Fungal infections | 2 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Dermatologic | 3 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - General Diagnoses | 6 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - STD | 0 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Viral infections | 1 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Other HIV Associated Diseases | 0 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Metabolic/Endocrine | 3 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Deaths | 1 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Genitourinary | 1 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Deaths | 2 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Fungal infections | 5 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Bacterial/Mycobacterial infections | 3 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Viral infections | 4 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Neoplastic diseases | 1 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Cardiovascular diseases | 2 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - General Diagnoses | 4 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Metabolic/Endocrine | 0 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Pulmonary | 2 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Genitourinary | 2 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Neuropsychiatric | 2 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Musculoskeletal | 0 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Dermatologic | 0 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - STD | 1 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Other HIV Associated Diseases | 2 Participants |
| Standard Care | Number of Participants With Illness Events or Mortality | Other Disease - Gastrointestinal | 4 Participants |
Secondary
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
Population: All participants with available ART data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation | 4 participants |
| Standard Care | Number of Participants With Premature Antiretroviral Therapy (ART) Regimen Discontinuation | 7 participants |
Secondary
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
Population: All participants with scheduled post baseline HIV-1 RNA measurements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Virological Suppression | 14 participants |
| Standard Care | Number of Participants With Virological Suppression | 15 participants |
Secondary
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
Population: Due to early study closure, only the 43 participants who reached week 12 with available data were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12 | 12 Participants |
| Standard Care | Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 12 | 13 Participants |
Secondary
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
Population: Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24 | 11 Participants |
| Standard Care | Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 24 | 8 Participants |
Secondary
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
Population: Due to early study closure, only the 14 participants that reached week 48 with available data were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48 | 5 Participants |
| Standard Care | Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 1,000 Copies/mL at Week 48 | 5 Participants |
Secondary
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
Population: Due to early study closure, only the 43 participants who reached week 12 with available virologic data were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12 | 10 Participants |
| Standard Care | Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 12 | 12 Participants |
Secondary
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
Population: Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24. | 10 Participants |
| Standard Care | Number of Participants With Virologic Suppression, Defined as HIV-1 RNA Less Than 200 Copies/mL at Week 24. | 7 Participants |
Secondary
Quality of Life Measured by Euro-QoL - Anxiety/Depression
Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression.
Time frame: Week 24
Population: Available data from participants who made it to week 24 are summarized.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Anxiety/Depression | Not anxious or depressed | 17 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Anxiety/Depression | Moderately anxious or depressed | 3 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Anxiety/Depression | Extremely anxious or depressed | 2 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Anxiety/Depression | Not anxious or depressed | 10 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Anxiety/Depression | Moderately anxious or depressed | 8 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Anxiety/Depression | Extremely anxious or depressed | 1 Participants |
Secondary
Quality of Life Measured by Euro-QoL - Mobility
Quality of life measured by Euro-QoL - Question 1: Mobility.
Time frame: Week 24
Population: Available data for participants that reached week 24 are summarized.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Mobility | No problems walking | 18 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Mobility | Some problems walking | 4 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Mobility | No problems walking | 11 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Mobility | Some problems walking | 8 Participants |
Secondary
Quality of Life Measured by Euro-QoL - Pain/Discomfort
Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort.
Time frame: Week 24
Population: Available data from participants who reached week 24 are summarized.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Pain/Discomfort | No pain or discomfort | 14 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Pain/Discomfort | Moderate pain or discomfort | 6 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Pain/Discomfort | Extreme pain or discomfort | 2 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Pain/Discomfort | No pain or discomfort | 9 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Pain/Discomfort | Moderate pain or discomfort | 5 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Pain/Discomfort | Extreme pain or discomfort | 5 Participants |
Secondary
Quality of Life Measured by Euro-QoL - Self-Care
Quality of Life Measured by Euro-QoL - Question 2: Self-Care.
Time frame: Week 24
Population: All available data from participants that reached week 24 are summarized.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Self-Care | No problems with self-care | 21 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Self-Care | Some problems washing or dressing | 1 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Self-Care | No problems with self-care | 18 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Self-Care | Some problems washing or dressing | 1 Participants |
Secondary
Quality of Life Measured by Euro-QoL - Usual Activities
Quality of Life Measured by Euro-QoL - Question 3: Usual activities.
Time frame: Week 24
Population: All available data from participants that reached week 24 are summarized.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Usual Activities | No problems performing usual activities | 20 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Usual Activities | Some probs performing usual activities | 1 Participants |
| Enhanced Nursing Telephone Support With Standard Care | Quality of Life Measured by Euro-QoL - Usual Activities | Unable to perform usual activities | 1 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Usual Activities | No problems performing usual activities | 16 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Usual Activities | Some probs performing usual activities | 3 Participants |
| Standard Care | Quality of Life Measured by Euro-QoL - Usual Activities | Unable to perform usual activities | 0 Participants |