| 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. | 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. | Posted | | Count of Participants | | Participants | | Week 48 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | Fisher Exact | | 1.000 | Two-sided 5% significance level. | | | | | | | | | | | | | Superiority or Other | | |
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| 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. | All participants with available ART data. | Posted | | Number | | participants | | From study entry to Week 72 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Due to early study closure, only 44 participants had week 12 CD4 observations to be included in this analysis. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Baseline and Week 12 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Due to early study closure, only 42 participants had week 24 CD4 observations to be included in this analysis. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Only 16 participants had week 48 CD4 observations to be included in this analysis. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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). | The analysis population was all participants randomized to a treatment arm in this trial. | Posted | | Count of Participants | | Participants | | Week 24 through Week 72 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | This outcome was not analyzed, since the intervention was not determined to be successful. | Posted | | | | | | Week 48 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Due to early study closure, only 59 participants were accrued and followed on study. | Posted | | Count of Participants | | Participants | | Measured from entry to Week 72 or premature study discontinuation | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Number of Participants With Virological Suppression | Number of participants with virological suppression, defined as HIV-1 RNA less than 200 copies/mL. | All participants with scheduled post baseline HIV-1 RNA measurements. | Posted | | Number | | participants | | Measured from entry to Week 72 or premature study discontinuation | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Only participants in the telephone support group were analyzed. | Posted | | Number | | participants | | Measured from entry to Week 72 or premature study discontinuation | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Only participants in the telephone support group were analyzed. | Posted | | Mean | Standard Deviation | percent of scheduled calls delivered | | Measured at Week 12 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Only participants in the telephone support group were analyzed. | Posted | | Median | Inter-Quartile Range | minutes | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Due to early study closure, only the 43 participants who reached week 12 with available virologic data were included in this analysis. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Due to early study closure, only the 43 participants who reached week 12 with available data were included in this analysis. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Standard Care | Participants received care as usual. Standard care: Care as usual for participants initiating or restarting an ART regimen; this may vary by study site. |
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| 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. | Due to early study closure, only the 41 participants who reached week 24 with available data were included in this analysis. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Due to early study closure, only the 14 participants that reached week 48 with available data were included in this analysis. | Posted | | Count of Participants | | Participants | | Measured at Week 48 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Due to early study closure, only 30 participants had complete adherence data for this outcome. | Posted | | Median | Inter-Quartile Range | units on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Due to early study closure, 31 participants had complete adherence data for this outcome. | Posted | | Median | Inter-Quartile Range | units on a scale | | Week 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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". | Due to early study closure, only 42 participants had adherence data at week 12 for this outcome. | Posted | | Count of Participants | | Participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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". | Due to early study closure, only 39 participants had adherence data at week 24. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Due to early study closure, only 44 participants had adherence data available at week 12 for this outcome. | Posted | | Median | Inter-Quartile Range | percentage of HIV meds taken last month | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Due to early study closure, only 40 participants had adherence data available at week 24 for this outcome. | Posted | | Median | Inter-Quartile Range | percentage of HIV meds taken last month | | Week 24 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Quality of Life Measured by Euro-QoL - Mobility | Quality of life measured by Euro-QoL - Question 1: Mobility. | Available data for participants that reached week 24 are summarized. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Quality of Life Measured by Euro-QoL - Self-Care | Quality of Life Measured by Euro-QoL - Question 2: Self-Care. | All available data from participants that reached week 24 are summarized. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Quality of Life Measured by Euro-QoL - Usual Activities | Quality of Life Measured by Euro-QoL - Question 3: Usual activities. | All available data from participants that reached week 24 are summarized. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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: Usual ACTG site care. | | OG001 | Standard Care | Participants received care as usual. Standard care: Usual ACTG site care. |
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| Secondary | Quality of Life Measured by Euro-QoL - Pain/Discomfort | Quality of Life Measured by Euro-QoL - Question 4: Pain/Discomfort. | Available data from participants who reached week 24 are summarized. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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: Usual ACTG site care. | | OG001 | Standard Care | Participants received care as usual. Standard care: Usual ACTG site care. |
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| Secondary | Quality of Life Measured by Euro-QoL - Anxiety/Depression | Quality of Life Measured by Euro-QoL - Question 5: Anxiety/Depression. | Available data from participants who made it to week 24 are summarized. | Posted | | Count of Participants | | Participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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: Usual ACTG site care. | | OG001 | Standard Care | Participants received care as usual. Standard care: Usual ACTG site care. |
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