Trial Outcomes & Findings for INTERVAL: Varying Intervals of ART to Improve Outcomes in HIV (NCT NCT03101592)
NCT ID: NCT03101592
Last Updated: 2020-10-27
Results Overview
The primary outcome to be studied is whether scripting/dispensing of ART for intervals of six months is non-inferior to three months with respect to retention in care.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9118 participants
Primary outcome timeframe
12 months
Results posted on
2020-10-27
Participant Flow
Recruitment relied on active identification and referral of stable patients by clinic staff. Clinics were randomized to a study arm, and enrolled individuals initiated the study drug dispensing interval to which the clinic had been randomly assigned. A total of 14,430 individuals were screened from May 2017- April 2018 across 30 study sites.
Unit of analysis: clinics
Participant milestones
| Measure |
Standard of Care ART Dispensing
The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study.
|
Three-month ART Dispensing
Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.
Three-month ART dispensing: Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study.
|
Six-month ART Dispensing
Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.
Six-month ART dispensing: Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3123 10
|
2896 10
|
3099 10
|
|
Overall Study
COMPLETED
|
3012 10
|
2726 10
|
2981 10
|
|
Overall Study
NOT COMPLETED
|
111 0
|
170 0
|
118 0
|
Reasons for withdrawal
| Measure |
Standard of Care ART Dispensing
The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study.
|
Three-month ART Dispensing
Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.
Three-month ART dispensing: Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study.
|
Six-month ART Dispensing
Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.
Six-month ART dispensing: Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study.
|
|---|---|---|---|
|
Overall Study
participant files could not be located
|
111
|
170
|
118
|
Baseline Characteristics
For each demographic variable analyzed, some responses were missing, so could not be included.
Baseline characteristics by cohort
| Measure |
Standard of Care ART Dispensing (SOC)
n=10 clinics
The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study.
|
Three-month ART Dispensing (3MD)
n=10 clinics
Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.
Three-month ART dispensing: Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study.
|
Six-month ART Dispensing (6MD)
n=10 clinics
Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.
Six-month ART dispensing: Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study.
|
Total
n=30 clinics
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.9 years
n=2965 Participants • For each demographic variable analyzed, some responses were missing, so could not be included.
|
42.7 years
n=2669 Participants • For each demographic variable analyzed, some responses were missing, so could not be included.
|
42.6 years
n=2956 Participants • For each demographic variable analyzed, some responses were missing, so could not be included.
|
42.6 years
n=8590 Participants • For each demographic variable analyzed, some responses were missing, so could not be included.
|
|
Sex: Female, Male
Female
|
2020 Participants
n=3011 Participants • In the SOC arm, there was 1 missing data point for sex.
|
1841 Participants
n=2726 Participants • In the SOC arm, there was 1 missing data point for sex.
|
1913 Participants
n=2981 Participants • In the SOC arm, there was 1 missing data point for sex.
|
5774 Participants
n=8718 Participants • In the SOC arm, there was 1 missing data point for sex.
|
|
Sex: Female, Male
Male
|
991 Participants
n=3011 Participants • In the SOC arm, there was 1 missing data point for sex.
|
885 Participants
n=2726 Participants • In the SOC arm, there was 1 missing data point for sex.
|
1068 Participants
n=2981 Participants • In the SOC arm, there was 1 missing data point for sex.
|
2944 Participants
n=8718 Participants • In the SOC arm, there was 1 missing data point for sex.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Malawi
|
1532 participants
n=3012 Participants
|
1430 participants
n=2726 Participants
|
1588 participants
n=2981 Participants
|
4550 participants
n=8719 Participants
|
|
Region of Enrollment
Zambia
|
1480 participants
n=3012 Participants
|
1296 participants
n=2726 Participants
|
1393 participants
n=2981 Participants
|
4169 participants
n=8719 Participants
|
|
Disclosure of HIV status to primary partner
Yes
|
2054 Participants
n=2215 Participants • The number that disclosed HIV status was among those who reported having a primary partner. Additionally, there were missing/not answered data for each arm: in the standard of care arm, 3 were missing; in 3MD 3 were missing; and in 6MD, 1 was missing.
|
1819 Participants
n=2043 Participants • The number that disclosed HIV status was among those who reported having a primary partner. Additionally, there were missing/not answered data for each arm: in the standard of care arm, 3 were missing; in 3MD 3 were missing; and in 6MD, 1 was missing.
|
2100 Participants
n=2266 Participants • The number that disclosed HIV status was among those who reported having a primary partner. Additionally, there were missing/not answered data for each arm: in the standard of care arm, 3 were missing; in 3MD 3 were missing; and in 6MD, 1 was missing.
|
5973 Participants
n=6524 Participants • The number that disclosed HIV status was among those who reported having a primary partner. Additionally, there were missing/not answered data for each arm: in the standard of care arm, 3 were missing; in 3MD 3 were missing; and in 6MD, 1 was missing.
|
|
Disclosure of HIV status to primary partner
No
|
161 Participants
n=2215 Participants • The number that disclosed HIV status was among those who reported having a primary partner. Additionally, there were missing/not answered data for each arm: in the standard of care arm, 3 were missing; in 3MD 3 were missing; and in 6MD, 1 was missing.
|
224 Participants
n=2043 Participants • The number that disclosed HIV status was among those who reported having a primary partner. Additionally, there were missing/not answered data for each arm: in the standard of care arm, 3 were missing; in 3MD 3 were missing; and in 6MD, 1 was missing.
|
166 Participants
n=2266 Participants • The number that disclosed HIV status was among those who reported having a primary partner. Additionally, there were missing/not answered data for each arm: in the standard of care arm, 3 were missing; in 3MD 3 were missing; and in 6MD, 1 was missing.
|
551 Participants
n=6524 Participants • The number that disclosed HIV status was among those who reported having a primary partner. Additionally, there were missing/not answered data for each arm: in the standard of care arm, 3 were missing; in 3MD 3 were missing; and in 6MD, 1 was missing.
|
|
Median years on ART
|
4.9 years
n=2030 Participants • Medians calculated among those with data available
|
5.4 years
n=1666 Participants • Medians calculated among those with data available
|
4.9 years
n=1885 Participants • Medians calculated among those with data available
|
5.0 years
n=5581 Participants • Medians calculated among those with data available
|
|
Marital status
Married or long-term partner
|
1889 Participants
n=3012 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
1650 Participants
n=2725 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
1977 Participants
n=2980 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
5516 Participants
n=8717 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
|
Marital status
Single or no long-term partner
|
247 Participants
n=3012 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
248 Participants
n=2725 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
267 Participants
n=2980 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
762 Participants
n=8717 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
|
Marital status
Widowed, divorced, or separated
|
876 Participants
n=3012 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
827 Participants
n=2725 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
736 Participants
n=2980 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
2439 Participants
n=8717 Participants • In the 3MD arm and 6MD arm, there was 1 missing from each.
|
|
Median household size
|
4 People in household
n=3012 Participants • Calculated by arm and overall
|
5 People in household
n=2726 Participants • Calculated by arm and overall
|
5 People in household
n=2981 Participants • Calculated by arm and overall
|
4 People in household
n=8719 Participants • Calculated by arm and overall
|
|
School (highest level completed)
No education or less than primary school
|
574 Participants
n=3005 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
480 Participants
n=2722 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
347 Participants
n=2964 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
1401 Participants
n=8691 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
|
School (highest level completed)
Primary school
|
1453 Participants
n=3005 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
1293 Participants
n=2722 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
1372 Participants
n=2964 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
4118 Participants
n=8691 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
|
School (highest level completed)
Secondary school
|
841 Participants
n=3005 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
811 Participants
n=2722 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
978 Participants
n=2964 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
2630 Participants
n=8691 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
|
School (highest level completed)
University/Graduate
|
137 Participants
n=3005 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
138 Participants
n=2722 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
267 Participants
n=2964 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
542 Participants
n=8691 Participants • Missing/not answered: SOC arm- 7; 3MD arm- 4; 6MD arm- 17
|
|
Work status
Formal employment
|
450 Participants
n=3006 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
398 Participants
n=2722 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
629 Participants
n=2977 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
1477 Participants
n=8705 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
|
Work status
Informal employment
|
1435 Participants
n=3006 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
1027 Participants
n=2722 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
1545 Participants
n=2977 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
4007 Participants
n=8705 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
|
Work status
Not working
|
1121 Participants
n=3006 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
1297 Participants
n=2722 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
803 Participants
n=2977 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
3221 Participants
n=8705 Participants • 6 missing/not answered from the SOC arm, 4 from the 3MD arm, and 4 from the 6MD arm
|
|
Missed work to attend current ART clinic visit
|
1490 Participants
n=3004 Participants • Missing/Unanswered for SOC arm = 8, 3MD arm = 6, 6MD arm =4.
|
1101 Participants
n=2720 Participants • Missing/Unanswered for SOC arm = 8, 3MD arm = 6, 6MD arm =4.
|
1600 Participants
n=2977 Participants • Missing/Unanswered for SOC arm = 8, 3MD arm = 6, 6MD arm =4.
|
4191 Participants
n=8701 Participants • Missing/Unanswered for SOC arm = 8, 3MD arm = 6, 6MD arm =4.
|
|
Average monthly earnings
|
48.02 USD
n=1861 Participants • Average monthly earnings among those who reported working in US dollars
|
66.24 USD
n=1418 Participants • Average monthly earnings among those who reported working in US dollars
|
72.45 USD
n=2158 Participants • Average monthly earnings among those who reported working in US dollars
|
60.00 USD
n=5437 Participants • Average monthly earnings among those who reported working in US dollars
|
|
Transport method to ART clinic
Walk
|
1786 Participants
n=3012 Participants
|
1618 Participants
n=2726 Participants
|
1306 Participants
n=2981 Participants
|
4710 Participants
n=8719 Participants
|
|
Transport method to ART clinic
Bicycle
|
339 Participants
n=3012 Participants
|
304 Participants
n=2726 Participants
|
385 Participants
n=2981 Participants
|
1028 Participants
n=8719 Participants
|
|
Transport method to ART clinic
Bus or minibus
|
770 Participants
n=3012 Participants
|
634 Participants
n=2726 Participants
|
925 Participants
n=2981 Participants
|
2329 Participants
n=8719 Participants
|
|
Transport method to ART clinic
Bicycle taxi
|
65 Participants
n=3012 Participants
|
96 Participants
n=2726 Participants
|
237 Participants
n=2981 Participants
|
398 Participants
n=8719 Participants
|
|
Transport method to ART clinic
Personal or friend's vehicle
|
42 Participants
n=3012 Participants
|
55 Participants
n=2726 Participants
|
119 Participants
n=2981 Participants
|
216 Participants
n=8719 Participants
|
|
Transport method to ART clinic
Other
|
10 Participants
n=3012 Participants
|
19 Participants
n=2726 Participants
|
9 Participants
n=2981 Participants
|
38 Participants
n=8719 Participants
|
|
Median one-way travel time to clinic
|
40.2 minutes
n=3012 Participants • Medians overall and by arm among those for whom data were reported.
|
45.0 minutes
n=2726 Participants • Medians overall and by arm among those for whom data were reported.
|
40.2 minutes
n=2981 Participants • Medians overall and by arm among those for whom data were reported.
|
40.3 minutes
n=8719 Participants • Medians overall and by arm among those for whom data were reported.
|
|
Proportion of patients incurring transport costs to clinic
|
917 Participants
n=3012 Participants
|
812 Participants
n=2726 Participants
|
1265 Participants
n=2981 Participants
|
2994 Participants
n=8719 Participants
|
|
For those incurring transport costs, median one-way cost
|
0.69 USD
n=917 Participants • For those who did incur transport costs.
|
0.55 USD
n=812 Participants • For those who did incur transport costs.
|
0.69 USD
n=1265 Participants • For those who did incur transport costs.
|
0.69 USD
n=2994 Participants • For those who did incur transport costs.
|
|
Median time spent at ART clinic
|
120.0 minutes
n=3012 Participants • Medians by arm and overall.
|
180.0 minutes
n=2726 Participants • Medians by arm and overall.
|
180.0 minutes
n=2981 Participants • Medians by arm and overall.
|
150.0 minutes
n=8719 Participants • Medians by arm and overall.
|
|
Median ART dispensing interval in year prior
|
60.0 days
n=2208 Participants • Medians by arm and overall
|
80.0 days
n=2084 Participants • Medians by arm and overall
|
78.0 days
n=2197 Participants • Medians by arm and overall
|
75.0 days
n=6489 Participants • Medians by arm and overall
|
|
Among reproductive age women, received contraception in last three months
|
139 Participants
n=1001 Participants • This variable was just among women of reproductive age. In each arm, there were missing/unanswered among this group: in the SOC arm= 204, 3MD arm = 212, 6MD arm = 220.
|
155 Participants
n=962 Participants • This variable was just among women of reproductive age. In each arm, there were missing/unanswered among this group: in the SOC arm= 204, 3MD arm = 212, 6MD arm = 220.
|
214 Participants
n=1035 Participants • This variable was just among women of reproductive age. In each arm, there were missing/unanswered among this group: in the SOC arm= 204, 3MD arm = 212, 6MD arm = 220.
|
508 Participants
n=2998 Participants • This variable was just among women of reproductive age. In each arm, there were missing/unanswered among this group: in the SOC arm= 204, 3MD arm = 212, 6MD arm = 220.
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The sample includes only those participants for whom outcome data was available (n=8719). As described in the participant flow, 399 participant files could not be located to analyze final outcome data at the endpoint.
The primary outcome to be studied is whether scripting/dispensing of ART for intervals of six months is non-inferior to three months with respect to retention in care.
Outcome measures
| Measure |
Standard of Care ART Dispensing (SOC)
n=3012 Participants
The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study.
|
Three-month ART Dispensing (3MD)
n=2726 Participants
Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.
Three-month ART dispensing: Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study.
|
Six-month ART Dispensing (6MD)
n=2981 Participants
Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.
Six-month ART dispensing: Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study.
|
Zambia: Standard of Care (SOC)
Patients in the standard of care arm in Zambia.
|
Zambia: 3 Month Dispensing (3MD)
Patients in the 3 month dispensing arm in Zambia.
|
Zambia: 6 Month Dispensing (6MD)
Patients in the 6 month dispensing arm in Zambia.
|
|---|---|---|---|---|---|---|
|
Retention in Care at 12 Months
Death
|
11 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Retention in Care at 12 Months
Retention
|
2478 Participants
|
2356 Participants
|
2729 Participants
|
—
|
—
|
—
|
|
Retention in Care at 12 Months
Transfer
|
60 Participants
|
66 Participants
|
58 Participants
|
—
|
—
|
—
|
|
Retention in Care at 12 Months
Lost to follow-up
|
463 Participants
|
296 Participants
|
186 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Viral load was originally listed as a secondary outcome. However, given the nature of this implementation science project, and under real world conditions, Viral Load testing was not done due to the early state of viral load scale-up in both Malawi and Zambia.
The secondary outcome to be studied is whether scripting/dispensing of ART for intervals of six months is non-inferior to three months with respect to a viral load outcome of \<1,000 copies/ml (undetectable) at 12 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: For the cost analysis, we excluded 179 participants whose visit data were unclear, leaving an analytic sample of 8,540 patients.
The secondary outcome to be studied is the cost-effectiveness of scripting/dispensing of ART for intervals of six months compared to three months and SOC. Cost-effectiveness will be estimated as the average cost per successful outcome (patient retained at 12 months).
Outcome measures
| Measure |
Standard of Care ART Dispensing (SOC)
n=1328 Participants
The standard of care arm will allow ART dispensing based on usual practice at the clinic. Standard of care is anticipated to have variability in how ART is dispensed, although the approach should be consistent with applicable country guidelines at the time of study.
|
Three-month ART Dispensing (3MD)
n=1224 Participants
Providers at facilities randomized to three-month ART dispensing will be expected to provide all enrolled patients with a 90-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.
Three-month ART dispensing: Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study.
|
Six-month ART Dispensing (6MD)
n=1465 Participants
Providers at facilities randomized to six-month ART dispensing will be expected to provide all enrolled patients with a 180-day supply of ART and associated HIV medications (cotrimoxazole and isoniazid if part of country guidelines). All other aspects of care will be as per standard of care for the enrolling clinic.
Six-month ART dispensing: Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study.
|
Zambia: Standard of Care (SOC)
n=1101 Participants
Patients in the standard of care arm in Zambia.
|
Zambia: 3 Month Dispensing (3MD)
n=1056 Participants
Patients in the 3 month dispensing arm in Zambia.
|
Zambia: 6 Month Dispensing (6MD)
n=1241 Participants
Patients in the 6 month dispensing arm in Zambia.
|
|---|---|---|---|---|---|---|
|
Provider Cost Per Patient by Outcome (USD) (Mean, 95% CI)
Achieved primary outcome
|
89.00 US Dollars
Interval 87.9 to 91.9
|
88.40 US Dollars
Interval 86.44 to 90.36
|
85.92 US Dollars
Interval 83.97 to 87.89
|
143.60 US Dollars
Interval 141.68 to 145.6
|
141.60 US Dollars
Interval 139.64 to 143.56
|
131.13 US Dollars
Interval 129.2 to 133.12
|
|
Provider Cost Per Patient by Outcome (USD) (Mean, 95% CI)
Did not achieve primary outcome
|
63.40 US Dollars
Interval 61.42 to 65.37
|
62.30 US Dollars
Interval 60.35 to 64.3
|
66.10 US Dollars
Interval 64.12 to 68.09
|
99.00 US Dollars
Interval 97.04 to 100.98
|
99.00 US Dollars
Interval 97.04 to 100.98
|
99.00 US Dollars
Interval 96.98 to 100.92
|
|
Provider Cost Per Patient by Outcome (USD) (Mean, 95% CI)
All patients
|
86.50 US Dollars
Interval 84.5 to 88.42
|
86.00 US Dollars
Interval 83.99 to 87.91
|
84.60 US Dollars
Interval 82.62 to 86.54
|
132.00 US Dollars
Interval 130.43 to 134.35
|
134.00 US Dollars
Interval 132.09 to 136.02
|
128.00 US Dollars
Interval 125.64 to 129.57
|
Adverse Events
Standard of Care ART Dispensing (SOC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 deaths
Three-month ART Dispensing (3MD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Six-month ART Dispensing (6MD)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Risa Hoffman, MD, MPH; Director of GHP; Associate Professor of Clinical Medicine
David Geffen School of Medicine at UCLA
Phone: 310 825-7225
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place