Trial Outcomes & Findings for Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV (NCT NCT04567693)
NCT ID: NCT04567693
Last Updated: 2023-10-25
Results Overview
Percentage of participants with suppressed viral load (less than 200 copies/ml)
COMPLETED
NA
93 participants
Measured at 12 months after enrollment into ART care
2023-10-25
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
Usual Care
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
30
|
|
Overall Study
COMPLETED
|
30
|
31
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Usual Care
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
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
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Early 1
n=31 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=28 Participants
Do not advance to spaced-out appointments during study period
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 10 • n=31 Participants
|
33 years
STANDARD_DEVIATION 13 • n=31 Participants
|
29 years
STANDARD_DEVIATION 6 • n=28 Participants
|
31 years
STANDARD_DEVIATION 10 • n=90 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=31 Participants
|
20 Participants
n=31 Participants
|
20 Participants
n=28 Participants
|
60 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=31 Participants
|
11 Participants
n=31 Participants
|
8 Participants
n=28 Participants
|
30 Participants
n=90 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Rwanda
|
31 participants
n=31 Participants
|
31 participants
n=31 Participants
|
28 participants
n=28 Participants
|
90 participants
n=90 Participants
|
|
ART Adherence
|
0.1 Days of ART missed in last 30 days
STANDARD_DEVIATION 0.72 • n=31 Participants
|
0.03 Days of ART missed in last 30 days
STANDARD_DEVIATION 0.18 • n=31 Participants
|
0.04 Days of ART missed in last 30 days
STANDARD_DEVIATION 0.19 • n=28 Participants
|
0.06 Days of ART missed in last 30 days
STANDARD_DEVIATION 0.44 • n=90 Participants
|
|
Satisfaction with care
Non-clinical
|
4.15 units on a scale
STANDARD_DEVIATION 0.34 • n=31 Participants
|
4.12 units on a scale
STANDARD_DEVIATION 0.34 • n=31 Participants
|
4.11 units on a scale
STANDARD_DEVIATION 0.49 • n=28 Participants
|
4.13 units on a scale
STANDARD_DEVIATION 0.40 • n=90 Participants
|
|
Satisfaction with care
Clinical
|
3.81 units on a scale
STANDARD_DEVIATION 0.28 • n=31 Participants
|
3.84 units on a scale
STANDARD_DEVIATION 0.21 • n=31 Participants
|
3.85 units on a scale
STANDARD_DEVIATION 0.24 • n=28 Participants
|
3.83 units on a scale
STANDARD_DEVIATION 0.24 • n=90 Participants
|
|
Enacted and Internalized Stigma
Enacted
|
1.04 units on a scale
STANDARD_DEVIATION 0.20 • n=31 Participants
|
1.03 units on a scale
STANDARD_DEVIATION 0.09 • n=31 Participants
|
1.00 units on a scale
STANDARD_DEVIATION 0.01 • n=28 Participants
|
1.00 units on a scale
STANDARD_DEVIATION 0.11 • n=90 Participants
|
|
Enacted and Internalized Stigma
Internalized
|
2.02 units on a scale
STANDARD_DEVIATION 0.77 • n=31 Participants
|
1.62 units on a scale
STANDARD_DEVIATION 0.72 • n=31 Participants
|
2.08 units on a scale
STANDARD_DEVIATION 0.97 • n=28 Participants
|
1.90 units on a scale
STANDARD_DEVIATION 0.80 • n=90 Participants
|
|
Quality of life
|
45.0 units on a scale
STANDARD_DEVIATION 14.0 • n=31 Participants
|
45.5 units on a scale
STANDARD_DEVIATION 17.7 • n=31 Participants
|
37.9 units on a scale
STANDARD_DEVIATION 16.2 • n=28 Participants
|
42.9 units on a scale
STANDARD_DEVIATION 16.2 • n=90 Participants
|
|
Anticipated stigma
|
2.40 units on a scale
STANDARD_DEVIATION .074 • n=31 Participants
|
2.40 units on a scale
STANDARD_DEVIATION 0.72 • n=31 Participants
|
2.43 units on a scale
STANDARD_DEVIATION 0.85 • n=28 Participants
|
2.40 units on a scale
STANDARD_DEVIATION 0.70 • n=90 Participants
|
PRIMARY outcome
Timeframe: Measured at 12 months after enrollment into ART carePopulation: 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.
Percentage of participants with suppressed viral load (less than 200 copies/ml)
Outcome measures
| Measure |
Early 1
n=31 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=28 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Viral Suppression
|
25 Participants
|
25 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Measured at 12 months after enrollment into ART carePopulation: 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.
Proportion of participants that attended all pharmacy and clinical appointments
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at 12 months after enrollment into ART careThe 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.
Outcome measures
| Measure |
Early 1
n=30 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=24 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Participant Acceptability of Reduced Time to Spaced-out Appointments
Non-clinical
|
4.2 score on a scale (Likert)
Standard Deviation 0.5
|
4.3 score on a scale (Likert)
Standard Deviation 0.5
|
4.2 score on a scale (Likert)
Standard Deviation 0.6
|
|
Participant Acceptability of Reduced Time to Spaced-out Appointments
Clinical aspects of care
|
3.9 score on a scale (Likert)
Standard Deviation 0.3
|
4.0 score on a scale (Likert)
Standard Deviation 0.3
|
3.9 score on a scale (Likert)
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Measured at 12 months after enrollment into ART carePopulation: 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.
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.
Outcome measures
| Measure |
Early 1
n=31 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Provider Acceptability of Reduced Time to Spaced-out Appointments
|
7 Participants
|
6 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at 6 months after enrollment in ART careAs 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).
Outcome measures
| Measure |
Early 1
n=30 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=24 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Enacted and Internalized Stigmas
Enacted stigma
|
1.00 score on a scale
Standard Deviation 0.01
|
1.00 score on a scale
Standard Deviation 0.00
|
1.02 score on a scale
Standard Deviation 0.10
|
|
Enacted and Internalized Stigmas
Internalized stigma
|
1.35 score on a scale
Standard Deviation 0.66
|
1.39 score on a scale
Standard Deviation 0.80
|
1.27 score on a scale
Standard Deviation 0.54
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12-monthsRepeated 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.
Outcome measures
| Measure |
Early 1
n=30 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=24 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Participant Health-related Costs
|
4562 Rwandan Francs (currency)
Standard Deviation 4034
|
4817 Rwandan Francs (currency)
Standard Deviation 3716
|
4842 Rwandan Francs (currency)
Standard Deviation 3948
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at 12-months after enrollment in ART careRepeated measures analysis of patient self-reported ART adherence
Outcome measures
| Measure |
Early 1
n=30 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=24 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
ART Adherence
|
0.8 Days of ART missed in last 30 days
Standard Deviation 1.2
|
1.1 Days of ART missed in last 30 days
Standard Deviation 5.4
|
0.6 Days of ART missed in last 30 days
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at 6 months after enrollment in ART careRepeated measures analysis of patient self-reported ART adherence
Outcome measures
| Measure |
Early 1
n=30 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=24 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
ART Adherence
|
0.9 Days of ART missed in last 30 days
Standard Deviation 2.0
|
1.6 Days of ART missed in last 30 days
Standard Deviation 5.5
|
0.6 Days of ART missed in last 30 days
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at 6 months after enrollment in ART careRepeated 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.
Outcome measures
| Measure |
Early 1
n=30 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=24 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Perceived Quality of Life
|
52.2 score on a scale
Standard Deviation 11.5
|
53.6 score on a scale
Standard Deviation 13.8
|
50.4 score on a scale
Standard Deviation 14.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at 12 months after enrollment in ART careRepeated 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.
Outcome measures
| Measure |
Early 1
n=30 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=24 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Perceived Quality of Life
|
52.2 score on a scale
Standard Deviation 10.3
|
54.5 score on a scale
Standard Deviation 11.4
|
54.4 score on a scale
Standard Deviation 10.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at 6 months after enrollment in ART careThe 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.
Outcome measures
| Measure |
Early 1
n=30 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=24 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Satisfaction With Care
Non-clinical
|
3.96 score on a scale
Standard Deviation 0.46
|
3.98 score on a scale
Standard Deviation 0.26
|
4.04 score on a scale
Standard Deviation 0.33
|
|
Satisfaction With Care
Clinical
|
3.74 score on a scale
Standard Deviation 0.18
|
3.72 score on a scale
Standard Deviation 0.19
|
3.72 score on a scale
Standard Deviation 0.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at 6 months after enrollment in ART careAs 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.
Outcome measures
| Measure |
Early 1
n=30 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=24 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Anticipated Stigma
|
2.43 score on a scale
Standard Deviation 0.57
|
2.37 score on a scale
Standard Deviation 0.59
|
2.73 score on a scale
Standard Deviation 0.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at 12 months after enrollment in ART careAs 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.
Outcome measures
| Measure |
Early 1
n=30 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=24 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Anticipated Stigma
|
2.41 score on a scale
Standard Deviation 0.77
|
2.37 score on a scale
Standard Deviation 0.52
|
2.45 score on a scale
Standard Deviation 0.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Measured at 12 months after enrollment in ART careAs 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).
Outcome measures
| Measure |
Early 1
n=30 Participants
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.
|
Early 2
n=31 Participants
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.
|
Usual Care
n=24 Participants
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Enacted and Internalized Stigmas
Enacted stigma
|
1.00 score on a scale
Standard Deviation 0.00
|
1.04 score on a scale
Standard Deviation 0.20
|
1.05 score on a scale
Standard Deviation .018
|
|
Enacted and Internalized Stigmas
Internalized stigma
|
1.11 score on a scale
Standard Deviation 0.40
|
1.21 score on a scale
Standard Deviation 0.58
|
1.10 score on a scale
Standard Deviation 0.27
|
Adverse Events
Early 1
Early 2
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Early 1
n=31 participants at risk
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 the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits.
|
Early 2
n=31 participants at risk
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 the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits.
|
Usual Care
n=28 participants at risk
Do not advance to spaced-out appointments during study period
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Became pregnant during study
|
6.5%
2/31 • Number of events 2 • Adverse event data were collected on participants during their participation in the study (12 months)
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected on participants during their participation in the study (12 months)
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected on participants during their participation in the study (12 months)
|
|
Social circumstances
Incarcerated during study
|
0.00%
0/31 • Adverse event data were collected on participants during their participation in the study (12 months)
|
0.00%
0/31 • Adverse event data were collected on participants during their participation in the study (12 months)
|
3.6%
1/28 • Number of events 1 • Adverse event data were collected on participants during their participation in the study (12 months)
|
|
Infections and infestations
Developed tuberculosis during study
|
3.2%
1/31 • Number of events 1 • Adverse event data were collected on participants during their participation in the study (12 months)
|
0.00%
0/31 • Adverse event data were collected on participants during their participation in the study (12 months)
|
0.00%
0/28 • Adverse event data were collected on participants during their participation in the study (12 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place