Aids, Hiv
Conditions
Keywords
Rwanda, Treat All, Antiretroviral therapy
Brief summary
The objectives of this study are to pilot test the effect of reducing time to spaced-out appointments from 18 to 6 months for newly-diagnosed people living with HIV (PLWH) in Rwanda who have initiated antiretroviral therapy (ART). PLWH are currently required to visit the health center monthly for ART and clinical appointments for the first 18 months on ART, after which they can attend quarterly. Reducing the time to spaced-out appointments from 18 to 6 months has the potential to reduce the burden on patients and the health system, but may lead to suboptimal treatment outcomes. To better understand the effects of early spaced-out appointments as well as the degree of viral load monitoring needed to determine stability on ART, the investigators will conduct a 3-arm pilot intervention study. The investigators will randomize participants to 1) 6-month advancement to spaced-out appointments after 1 viral load measurement; 2) 6-month advancement to spaced-out appointments after 2 viral load measurements; or 3) usual care. The investigators will compare the study arms with respect to viral suppression at 12 months after enrollment in ART care (primary outcome) and appointment/ pharmacy adherence (secondary outcome).
Detailed description
Most countries in sub-Saharan Africa have adopted differentiated care models for people living with HIV (PLWH), including Rwanda. Current Rwandan HIV guidelines classify newly-diagnosed PLWH as unstable, requiring monthly visits to the health facility. Before they can advance to being stable patients, with spaced-out appointments that allow them to visit the health facility every three months, they must be on antiretroviral therapy (ART) for 18 months and virally suppressed on two consecutive measurements. Patients face multiple barriers to attending frequent appointments including structural issues (such as distance to the health facility, transportation cost, long waiting times) and facing stigma while traveling to and while at the health facility. Reducing the time newly-diagnosed PLWH spend in the unstable category could potentially decrease the burden on patients and the health facility and potentially decrease the costs of frequent appointments. The investigators therefore propose a pilot study to examine the effect of reducing the time from ART initiation to advancement to the stable category from 18 to 6 months. The investigators will enroll 90 patients: 30 will be randomized to 6-month advancement to spaced out appointments after 1 viral load is measured (at 5 months after enrollment in ART care) (Early 1); 30 will be randomized to 6-month advancement to spaced-out appointments after 2 viral loads are measured (at 3- and 5-months after enrollment in ART care) (Early 2); and 30 will be randomized to continue in usual care with monthly visits (Usual care). The investigators will compare study arms with respect to viral suppression at 12 months (primary outcome) and appointment/pharmacy adherence (secondary outcome). The investigators hypothesize that reducing the time to the stable category with spaced out appointments will be feasible, acceptable, not inferior to 18 months with respect to viral suppression or adherence, and will be cost-effective.
Interventions
OTHEREarly spaced-out appointments
Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits.
Sponsors
National Institute of Mental Health (NIMH)
Albert Einstein College of Medicine
Rwanda Military Hospital
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ≥15 years; 2. newly-diagnosed with HIV (within 6 months); 3. enrolled in care at study health facility; 4. initiated ART.
Exclusion criteria
1. planning on moving away from health center/Kigali in the next 12 months; 2. unable to provide informed consent; 3. enrolled in care while pregnant; 4. co-infected with tuberculosis; 5. concurrent known mental health or substance use disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression | Measured at 12 months after enrollment into ART care | Percentage of participants with suppressed viral load (less than 200 copies/ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appointment Adherence | Measured at 12 months after enrollment into ART care | Proportion of participants that attended all pharmacy and clinical appointments |
| Participant Acceptability of Reduced Time to Spaced-out Appointments | Measured at 12 months after enrollment into ART care | The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied \[1\], not satisfied \[2\], no opinion \[3\], satisfied \[4\], very satisfied \[5\]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction. |
| Provider Acceptability of Reduced Time to Spaced-out Appointments | Measured at 12 months after enrollment into ART care | Acceptability of reduced time to spaced-out appointments, as measured by the number of instances when providers overrode the study assignment. Override could only occur a maximum of one time for each participant. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Care | Measured at 6 months after enrollment in ART care | The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied \[1\], not satisfied \[2\], no opinion \[3\], satisfied \[4\], very satisfied \[5\]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction. |
| Enacted and Internalized Stigmas | Measured at 6 months after enrollment in ART care | As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma). |
| Anticipated Stigma | Measured at 6 months after enrollment in ART care | As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely \[1\] to Very Likely \[5\]), with higher scores indicating greater stigma. Items are averaged to create a composite score. |
| Participant Health-related Costs | 12-months | Repeated measures analysis of participant direct and indirect costs. While we initially planned to report measurements at 1-, 6- and 12-months after enrollment in ART care, we ultimately reported direct and indirect average costs at 12 months by adding the reported costs at each of the 3 time points to calculate the cost over the entire study period, and then dividing by the number of visits to the health center. |
| ART Adherence | Measured at 12-months after enrollment in ART care | Repeated measures analysis of patient self-reported ART adherence |
| Perceived Quality of Life | Measured at 6 months after enrollment in ART care | Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health. |
Countries
Rwanda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early 1 Advance to spaced-out appointments at month 6 after a single viral load is measured.
Early spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 5-month viral load are suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits. | 31 |
| Early 2 Advance to spaced-out appointments at month 6 after two viral loads are measured.
Early spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In this arm, starting at 6 months after ART initiation, participants whose 3- and 5-month viral loads are both suppressed attend health centers quarterly for ART pick-up and semi-annually for clinical visits. | 31 |
| Usual Care Do not advance to spaced-out appointments during study period | 28 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 2 |
| Overall Study | Withdrawal by investigative team (participants did not meet eligibility criteria) | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Early 2 | Usual Care | Total | Early 1 |
|---|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 13 | 29 years STANDARD_DEVIATION 6 | 31 years STANDARD_DEVIATION 10 | 30 years STANDARD_DEVIATION 10 |
| Anticipated stigma | 2.40 units on a scale STANDARD_DEVIATION 0.72 | 2.43 units on a scale STANDARD_DEVIATION 0.85 | 2.40 units on a scale STANDARD_DEVIATION 0.7 | 2.40 units on a scale STANDARD_DEVIATION 0.074 |
| ART Adherence | 0.03 Days of ART missed in last 30 days STANDARD_DEVIATION 0.18 | 0.04 Days of ART missed in last 30 days STANDARD_DEVIATION 0.19 | 0.06 Days of ART missed in last 30 days STANDARD_DEVIATION 0.44 | 0.1 Days of ART missed in last 30 days STANDARD_DEVIATION 0.72 |
| Enacted and Internalized Stigma Enacted | 1.03 units on a scale STANDARD_DEVIATION 0.09 | 1.00 units on a scale STANDARD_DEVIATION 0.01 | 1.00 units on a scale STANDARD_DEVIATION 0.11 | 1.04 units on a scale STANDARD_DEVIATION 0.2 |
| Enacted and Internalized Stigma Internalized | 1.62 units on a scale STANDARD_DEVIATION 0.72 | 2.08 units on a scale STANDARD_DEVIATION 0.97 | 1.90 units on a scale STANDARD_DEVIATION 0.8 | 2.02 units on a scale STANDARD_DEVIATION 0.77 |
| Quality of life | 45.5 units on a scale STANDARD_DEVIATION 17.7 | 37.9 units on a scale STANDARD_DEVIATION 16.2 | 42.9 units on a scale STANDARD_DEVIATION 16.2 | 45.0 units on a scale STANDARD_DEVIATION 14 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment Rwanda | 31 participants | 28 participants | 90 participants | 31 participants |
| Satisfaction with care Clinical | 3.84 units on a scale STANDARD_DEVIATION 0.21 | 3.85 units on a scale STANDARD_DEVIATION 0.24 | 3.83 units on a scale STANDARD_DEVIATION 0.24 | 3.81 units on a scale STANDARD_DEVIATION 0.28 |
| Satisfaction with care Non-clinical | 4.12 units on a scale STANDARD_DEVIATION 0.34 | 4.11 units on a scale STANDARD_DEVIATION 0.49 | 4.13 units on a scale STANDARD_DEVIATION 0.4 | 4.15 units on a scale STANDARD_DEVIATION 0.34 |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 60 Participants | 20 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 30 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 | 2 / 28 |
| other Total, other adverse events | 3 / 31 | 1 / 31 | 2 / 28 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 0 / 28 |
Outcome results
Primary
Viral Suppression
Percentage of participants with suppressed viral load (less than 200 copies/ml)
Time frame: Measured at 12 months after enrollment into ART care
Population: Note: as the primary, intention to treat outcome, persons who did not complete the study were treated as being not virally suppressed. 3 enrolled participants were assigned to groups (one participant to the 'Early 1' group and two participants to the 'Usual Care' group), but subsequently withdrawn from the study when it became clear that they did not meet eligibility criteria. Their data were not included in the analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early 1 | Viral Suppression | 25 Participants |
| Early 2 | Viral Suppression | 25 Participants |
| Usual Care | Viral Suppression | 19 Participants |
Secondary
Appointment Adherence
Proportion of participants that attended all pharmacy and clinical appointments
Time frame: Measured at 12 months after enrollment into ART care
Population: Appointment adherence was defined in the protocol as the proportion of participants in each arm who attended all scheduled clinical appointments and ART pick-ups during the study. We planned to ascertain appointment adherence through review of participants' medical files at the conclusion of the study. During medical file review, it became apparent that scheduled appointments (i.e. next planned) were inconsistently documented. We therefore were unable to accurately ascertain this outcome.
Secondary
Participant Acceptability of Reduced Time to Spaced-out Appointments
The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied \[1\], not satisfied \[2\], no opinion \[3\], satisfied \[4\], very satisfied \[5\]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction.
Time frame: Measured at 12 months after enrollment into ART care
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early 1 | Participant Acceptability of Reduced Time to Spaced-out Appointments | Non-clinical | 4.2 score on a scale (Likert) | Standard Deviation 0.5 |
| Early 1 | Participant Acceptability of Reduced Time to Spaced-out Appointments | Clinical aspects of care | 3.9 score on a scale (Likert) | Standard Deviation 0.3 |
| Early 2 | Participant Acceptability of Reduced Time to Spaced-out Appointments | Non-clinical | 4.3 score on a scale (Likert) | Standard Deviation 0.5 |
| Early 2 | Participant Acceptability of Reduced Time to Spaced-out Appointments | Clinical aspects of care | 4.0 score on a scale (Likert) | Standard Deviation 0.3 |
| Usual Care | Participant Acceptability of Reduced Time to Spaced-out Appointments | Non-clinical | 4.2 score on a scale (Likert) | Standard Deviation 0.6 |
| Usual Care | Participant Acceptability of Reduced Time to Spaced-out Appointments | Clinical aspects of care | 3.9 score on a scale (Likert) | Standard Deviation 0.3 |
Secondary
Provider Acceptability of Reduced Time to Spaced-out Appointments
Acceptability of reduced time to spaced-out appointments, as measured by the number of instances when providers overrode the study assignment. Override could only occur a maximum of one time for each participant.
Time frame: Measured at 12 months after enrollment into ART care
Population: Overriding of study assignment was only examined for participants in intervention arms (Early 1 and Early 2). 3 enrolled participants were assigned to groups (one participant to the 'Early 1' group and two participants to the 'Usual Care' group), but subsequently withdrawn from the study when it became clear that they did not meet eligibility criteria. As such, data for one 'Early 1' group participant was not included in the analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early 1 | Provider Acceptability of Reduced Time to Spaced-out Appointments | 7 Participants |
| Early 2 | Provider Acceptability of Reduced Time to Spaced-out Appointments | 6 Participants |
| Usual Care | Provider Acceptability of Reduced Time to Spaced-out Appointments | 0 Participants |
Other Pre-specified
Anticipated Stigma
As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely \[1\] to Very Likely \[5\]), with higher scores indicating greater stigma. Items are averaged to create a composite score.
Time frame: Measured at 12 months after enrollment in ART care
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early 1 | Anticipated Stigma | 2.41 score on a scale | Standard Deviation 0.77 |
| Early 2 | Anticipated Stigma | 2.37 score on a scale | Standard Deviation 0.52 |
| Usual Care | Anticipated Stigma | 2.45 score on a scale | Standard Deviation 0.56 |
Other Pre-specified
Anticipated Stigma
As measured by an adapted version of the HIV stigma scale (anticipated stigma). Anticipated stigma is rated on a 5-point Likert-type scale (Very Unlikely \[1\] to Very Likely \[5\]), with higher scores indicating greater stigma. Items are averaged to create a composite score.
Time frame: Measured at 6 months after enrollment in ART care
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early 1 | Anticipated Stigma | 2.43 score on a scale | Standard Deviation 0.57 |
| Early 2 | Anticipated Stigma | 2.37 score on a scale | Standard Deviation 0.59 |
| Usual Care | Anticipated Stigma | 2.73 score on a scale | Standard Deviation 0.66 |
Other Pre-specified
ART Adherence
Repeated measures analysis of patient self-reported ART adherence
Time frame: Measured at 6 months after enrollment in ART care
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early 1 | ART Adherence | 0.9 Days of ART missed in last 30 days | Standard Deviation 2 |
| Early 2 | ART Adherence | 1.6 Days of ART missed in last 30 days | Standard Deviation 5.5 |
| Usual Care | ART Adherence | 0.6 Days of ART missed in last 30 days | Standard Deviation 1.1 |
Other Pre-specified
ART Adherence
Repeated measures analysis of patient self-reported ART adherence
Time frame: Measured at 12-months after enrollment in ART care
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early 1 | ART Adherence | 0.8 Days of ART missed in last 30 days | Standard Deviation 1.2 |
| Early 2 | ART Adherence | 1.1 Days of ART missed in last 30 days | Standard Deviation 5.4 |
| Usual Care | ART Adherence | 0.6 Days of ART missed in last 30 days | Standard Deviation 1.1 |
Other Pre-specified
Enacted and Internalized Stigmas
As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma).
Time frame: Measured at 6 months after enrollment in ART care
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early 1 | Enacted and Internalized Stigmas | Enacted stigma | 1.00 score on a scale | Standard Deviation 0.01 |
| Early 1 | Enacted and Internalized Stigmas | Internalized stigma | 1.35 score on a scale | Standard Deviation 0.66 |
| Early 2 | Enacted and Internalized Stigmas | Enacted stigma | 1.00 score on a scale | Standard Deviation 0 |
| Early 2 | Enacted and Internalized Stigmas | Internalized stigma | 1.39 score on a scale | Standard Deviation 0.8 |
| Usual Care | Enacted and Internalized Stigmas | Enacted stigma | 1.02 score on a scale | Standard Deviation 0.1 |
| Usual Care | Enacted and Internalized Stigmas | Internalized stigma | 1.27 score on a scale | Standard Deviation 0.54 |
Other Pre-specified
Enacted and Internalized Stigmas
As measured by the HIV/AIDS Stigma Instrument-PLWA (HASI-P) Scale. The HASI-P is a 33-item scale that contains questions in 6 different stigma-related domains or factors. For each item, participants are asked to describe the frequency of experienced stigmatizing events in the past 3 months on a 4-point Likert scale (0- Never, 1- Once or twice, 2- Several times, or 3- Most of the time), with higher scores indicating greater stigma. The instrument is scored by summing the scores (0-3) for each item and then dividing by the number of items within each factor (enacted or internalized stigma).
Time frame: Measured at 12 months after enrollment in ART care
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early 1 | Enacted and Internalized Stigmas | Enacted stigma | 1.00 score on a scale | Standard Deviation 0 |
| Early 1 | Enacted and Internalized Stigmas | Internalized stigma | 1.11 score on a scale | Standard Deviation 0.4 |
| Early 2 | Enacted and Internalized Stigmas | Enacted stigma | 1.04 score on a scale | Standard Deviation 0.2 |
| Early 2 | Enacted and Internalized Stigmas | Internalized stigma | 1.21 score on a scale | Standard Deviation 0.58 |
| Usual Care | Enacted and Internalized Stigmas | Enacted stigma | 1.05 score on a scale | Standard Deviation 0.018 |
| Usual Care | Enacted and Internalized Stigmas | Internalized stigma | 1.10 score on a scale | Standard Deviation 0.27 |
Other Pre-specified
Participant Health-related Costs
Repeated measures analysis of participant direct and indirect costs. While we initially planned to report measurements at 1-, 6- and 12-months after enrollment in ART care, we ultimately reported direct and indirect average costs at 12 months by adding the reported costs at each of the 3 time points to calculate the cost over the entire study period, and then dividing by the number of visits to the health center.
Time frame: 12-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early 1 | Participant Health-related Costs | 4562 Rwandan Francs (currency) | Standard Deviation 4034 |
| Early 2 | Participant Health-related Costs | 4817 Rwandan Francs (currency) | Standard Deviation 3716 |
| Usual Care | Participant Health-related Costs | 4842 Rwandan Francs (currency) | Standard Deviation 3948 |
Other Pre-specified
Perceived Quality of Life
Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health.
Time frame: Measured at 6 months after enrollment in ART care
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early 1 | Perceived Quality of Life | 52.2 score on a scale | Standard Deviation 11.5 |
| Early 2 | Perceived Quality of Life | 53.6 score on a scale | Standard Deviation 13.8 |
| Usual Care | Perceived Quality of Life | 50.4 score on a scale | Standard Deviation 14.6 |
Other Pre-specified
Perceived Quality of Life
Repeated measures analysis of participant quality of life as measured by the EuroQOL-5 Dimension-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS). The EQ-5D-5L is a 5-level scale that measures self-rated problems (no problems, slight problems, moderate problems, severe problems and extreme problems) in 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) as well as self-rated health. For this measure, we chose to use only the VAS, which asks respondents to rate their overall health from 0-100, with higher scores indicating greater self-rated health.
Time frame: Measured at 12 months after enrollment in ART care
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early 1 | Perceived Quality of Life | 52.2 score on a scale | Standard Deviation 10.3 |
| Early 2 | Perceived Quality of Life | 54.5 score on a scale | Standard Deviation 11.4 |
| Usual Care | Perceived Quality of Life | 54.4 score on a scale | Standard Deviation 10.1 |
Other Pre-specified
Satisfaction With Care
The Satisfaction With Care scale is a 9-item scale containing questions about satisfaction with clinical (n=6) and non-clinical elements (n=3) of health care. Participants describe satisfaction with each element on a 5-point Likert scale (very unsatisfied \[1\], not satisfied \[2\], no opinion \[3\], satisfied \[4\], very satisfied \[5\]). Satisfaction with clinical and non-clinical care elements are reported separately, by summing scores (1-5) for each item and then dividing by the number of items within each subscale. Subscale scores range from 1 to 5; higher scores indicate greater satisfaction.
Time frame: Measured at 6 months after enrollment in ART care
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Early 1 | Satisfaction With Care | Non-clinical | 3.96 score on a scale | Standard Deviation 0.46 |
| Early 1 | Satisfaction With Care | Clinical | 3.74 score on a scale | Standard Deviation 0.18 |
| Early 2 | Satisfaction With Care | Non-clinical | 3.98 score on a scale | Standard Deviation 0.26 |
| Early 2 | Satisfaction With Care | Clinical | 3.72 score on a scale | Standard Deviation 0.19 |
| Usual Care | Satisfaction With Care | Non-clinical | 4.04 score on a scale | Standard Deviation 0.33 |
| Usual Care | Satisfaction With Care | Clinical | 3.72 score on a scale | Standard Deviation 0.21 |