Trial Outcomes & Findings for Drinkers' Intervention to Prevent Tuberculosis (DIPT Study) (NCT NCT03492216)
NCT ID: NCT03492216
Last Updated: 2025-01-13
Results Overview
Non-hazardous drinking is a composite outcome, measured at both 3 and 6 months. An individual must meet criteria for non-hazardous drinking (Alcohol Use Disorders Identification Test - Consumption \[AUDIT-C\], prior 3 months, negative) and phosphatidylethanol (PEth) \<35 ng/mL) at both time-points (3- and 6-months) in order to achieve the outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
680 participants
Primary outcome timeframe
Both 3 months and 6 months (composite measure)
Results posted on
2025-01-13
Participant Flow
Study recruitment occurred from April 2018 through July 2021. 5,508 persons were screened and 680 persons were enrolled and randomized.
Participant milestones
| Measure |
Control
All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines.
|
Escalating Incentives (Ethyl Glucuronide [EtG] Tests)
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
|
Escalating Incentives (IsoScreen Tests)
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Incentives for positive IsoScreen test: Economic incentives contingent on point-of-care IsoScreen (Isoniazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
Escalating incentives for ethyl glucuronide (EtG) negative tests and for IsoScreen positive urine tests, with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine ethyl glucuronide (EtG) \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
Incentives for positive IsoScreen test: Economic incentives contingent on POC (IsoScreen) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
169
|
169
|
170
|
172
|
|
Overall Study
3 Month Visit
|
158
|
162
|
166
|
168
|
|
Overall Study
6 Month Visit
|
154
|
164
|
162
|
165
|
|
Overall Study
COMPLETED
|
149
|
160
|
153
|
158
|
|
Overall Study
NOT COMPLETED
|
20
|
9
|
17
|
14
|
Reasons for withdrawal
| Measure |
Control
All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines.
|
Escalating Incentives (Ethyl Glucuronide [EtG] Tests)
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
|
Escalating Incentives (IsoScreen Tests)
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Incentives for positive IsoScreen test: Economic incentives contingent on point-of-care IsoScreen (Isoniazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
Escalating incentives for ethyl glucuronide (EtG) negative tests and for IsoScreen positive urine tests, with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine ethyl glucuronide (EtG) \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
Incentives for positive IsoScreen test: Economic incentives contingent on POC (IsoScreen) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
9
|
2
|
7
|
8
|
|
Overall Study
Moved
|
5
|
3
|
3
|
5
|
|
Overall Study
Too ill
|
0
|
1
|
0
|
0
|
|
Overall Study
Incarcerated
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=169 Participants
All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines.
|
Escalating Incentives (Ethyl Glucuronide [EtG] Tests)
n=169 Participants
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
|
Escalating Incentives (IsoScreen Tests)
n=170 Participants
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Incentives for positive IsoScreen test: Economic incentives contingent on point-of-care IsoScreen (Isnoiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
n=172 Participants
Escalating incentives for ethyl glucuronide (EtG) negative tests and for IsoScreen positive urine tests with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
Incentives for positive IsoScreen test: Economic incentives contingent on POC (IsoScreen) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Total
n=680 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=169 Participants
|
0 Participants
n=169 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=172 Participants
|
0 Participants
n=680 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
167 Participants
n=169 Participants
|
164 Participants
n=169 Participants
|
167 Participants
n=170 Participants
|
169 Participants
n=172 Participants
|
667 Participants
n=680 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=169 Participants
|
5 Participants
n=169 Participants
|
3 Participants
n=170 Participants
|
3 Participants
n=172 Participants
|
13 Participants
n=680 Participants
|
|
Age, Continuous
|
40 years
n=169 Participants
|
38 years
n=169 Participants
|
40 years
n=170 Participants
|
39 years
n=172 Participants
|
39 years
n=680 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=169 Participants
|
53 Participants
n=169 Participants
|
53 Participants
n=170 Participants
|
53 Participants
n=172 Participants
|
210 Participants
n=680 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=169 Participants
|
116 Participants
n=169 Participants
|
117 Participants
n=170 Participants
|
119 Participants
n=172 Participants
|
470 Participants
n=680 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Uganda
|
169 participants
n=169 Participants
|
169 participants
n=169 Participants
|
170 participants
n=170 Participants
|
172 participants
n=172 Participants
|
680 participants
n=680 Participants
|
PRIMARY outcome
Timeframe: Both 3 months and 6 months (composite measure)Population: As pre-specified in the Study Protocol, participants in the EtG incentive arms (2 + 4) were compared to those in the no EtG incentive arms (1 + 3). EtG incentives (arms 2 + 4): 323/341 participants included; 18/341 participants excluded. No EtG incentives (arms 1 + 3): 313/339 participants included; 26/339 participants excluded.
Non-hazardous drinking is a composite outcome, measured at both 3 and 6 months. An individual must meet criteria for non-hazardous drinking (Alcohol Use Disorders Identification Test - Consumption \[AUDIT-C\], prior 3 months, negative) and phosphatidylethanol (PEth) \<35 ng/mL) at both time-points (3- and 6-months) in order to achieve the outcome.
Outcome measures
| Measure |
Alcohol Incentives
n=323 Participants
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test). (Arms 2 + 4)
|
No Alcohol Incentives
n=313 Participants
No ethylglucuronide (EtG) testing; no incentives for EtG negative urine test. (Arms 1 + 3)
|
Escalating Incentives (IsoScreen Tests)
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Incentives for positive IsoScreen test: Economic incentives contingent on point-of-care IsoScreen (Isnoiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
Escalating incentives for ethyl glucuronide (EtG) negative tests and for IsoScreen positive urine tests with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
Incentives for positive IsoScreen test: Economic incentives contingent on POC IsoScreen (Inosiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
|---|---|---|---|---|
|
Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months.
Non-hazardous alcohol use at 3 and 6 months = yes
|
57 Participants
|
31 Participants
|
—
|
—
|
|
Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months.
Non-hazardous alcohol use at 3 and 6 months = no
|
266 Participants
|
282 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: As pre-specified in the Study Protocol, participants in the INH incentive arms (3 + 4) were compared to those in the no INH incentive arms (1 + 2). INH incentive group (arms 3 + 4): 335/342 participants are included; 7 are excluded. No INH incentive group (arms 1 + 2): 321/338 participants are included; 17 are excluded.
Isoniazid (INH) adherence percentage is defined as the number of days with \>0 pill bottle openings divided by the number of prescribed doses, times 100. Pill bottle openings are captured by the Medication Event Monitoring System (MEMS) pill cap, with no more than 1 opening per day counted. The INH adherence outcome is INH adherence percentage, dichotomized as \>90% versus \<= 90%.
Outcome measures
| Measure |
Alcohol Incentives
n=335 Participants
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test). (Arms 2 + 4)
|
No Alcohol Incentives
n=321 Participants
No ethylglucuronide (EtG) testing; no incentives for EtG negative urine test. (Arms 1 + 3)
|
Escalating Incentives (IsoScreen Tests)
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Incentives for positive IsoScreen test: Economic incentives contingent on point-of-care IsoScreen (Isnoiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
Escalating incentives for ethyl glucuronide (EtG) negative tests and for IsoScreen positive urine tests with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
Incentives for positive IsoScreen test: Economic incentives contingent on POC IsoScreen (Inosiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
|---|---|---|---|---|
|
Number of Participants With >90% Isoniazid (INH) Adherence During Prescribed Course of INH
<=90% INH adherence
|
91 Participants
|
87 Participants
|
—
|
—
|
|
Number of Participants With >90% Isoniazid (INH) Adherence During Prescribed Course of INH
>90% INH adherence
|
244 Participants
|
234 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 9 monthsIsoniazid (INH) treatment discontinuation due to a Grade 3+ hepatotoxicity at any time during the treatment period. Grade 3 hepatoxicity is defined by lab and/or clinical criteria as alanine transaminase (ALT) or aspartate transaminase (AST) elevation ≥5 (but \<10) times the upper limit of normal and/or symptoms consistent with hepatotoxicity; and Grade 4 as ALT or AST elevation ≥10 times the upper limit of normal or potentially life-threatening symptoms.
Outcome measures
| Measure |
Alcohol Incentives
n=169 Participants
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test). (Arms 2 + 4)
|
No Alcohol Incentives
n=169 Participants
No ethylglucuronide (EtG) testing; no incentives for EtG negative urine test. (Arms 1 + 3)
|
Escalating Incentives (IsoScreen Tests)
n=170 Participants
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Incentives for positive IsoScreen test: Economic incentives contingent on point-of-care IsoScreen (Isnoiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
n=172 Participants
Escalating incentives for ethyl glucuronide (EtG) negative tests and for IsoScreen positive urine tests with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
Incentives for positive IsoScreen test: Economic incentives contingent on POC IsoScreen (Inosiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
|---|---|---|---|---|
|
Number of Participants With Hepatotoxicity Resulting in Isoniazid (INH) Discontinuation.
|
13 Participants
|
10 Participants
|
15 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 3 and 6 monthsPopulation: Only participants in the INH adherence incentive arms had INH concentration in hair analyzed.
Secondary Outcome. INH concentration in hair captures INH adherence over a period of weeks to months. Hair samples collected at the 3- and 6-month study visits will be analyzed for INH concentration.
Outcome measures
| Measure |
Alcohol Incentives
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test). (Arms 2 + 4)
|
No Alcohol Incentives
No ethylglucuronide (EtG) testing; no incentives for EtG negative urine test. (Arms 1 + 3)
|
Escalating Incentives (IsoScreen Tests)
n=150 Participants
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Incentives for positive IsoScreen test: Economic incentives contingent on point-of-care IsoScreen (Isnoiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
n=153 Participants
Escalating incentives for ethyl glucuronide (EtG) negative tests and for IsoScreen positive urine tests with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
Incentives for positive IsoScreen test: Economic incentives contingent on POC IsoScreen (Inosiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
|---|---|---|---|---|
|
INH Concentration in Hair
at 3 months
|
—
|
—
|
49.4 pmol INH + AcINH / mg hair
Interval 26.8 to 81.3
|
49.1 pmol INH + AcINH / mg hair
Interval 28.0 to 81.1
|
|
INH Concentration in Hair
at 6 months
|
—
|
—
|
49.3 pmol INH + AcINH / mg hair
Interval 27.4 to 78.8
|
57.1 pmol INH + AcINH / mg hair
Interval 31.9 to 84.0
|
SECONDARY outcome
Timeframe: 12 monthsThe percentage of study participants with HIV viral load suppression (defined as \<200 copies/ml) at 12 months post-enrollment.
Outcome measures
| Measure |
Alcohol Incentives
n=148 Participants
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test). (Arms 2 + 4)
|
No Alcohol Incentives
n=155 Participants
No ethylglucuronide (EtG) testing; no incentives for EtG negative urine test. (Arms 1 + 3)
|
Escalating Incentives (IsoScreen Tests)
n=149 Participants
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Incentives for positive IsoScreen test: Economic incentives contingent on point-of-care IsoScreen (Isnoiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
n=148 Participants
Escalating incentives for ethyl glucuronide (EtG) negative tests and for IsoScreen positive urine tests with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
Incentives for positive IsoScreen test: Economic incentives contingent on POC IsoScreen (Inosiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
|---|---|---|---|---|
|
Number of Participants With and Without HIV Viral Suppression at 12 Months
HIV viral suppression = yes
|
144 Participants
|
147 Participants
|
146 Participants
|
146 Participants
|
|
Number of Participants With and Without HIV Viral Suppression at 12 Months
HIV viral suppression = no
|
4 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsSecondary Outcome. Number of participants diagnosed with active TB, within the 12 months of study follow-up.
Outcome measures
| Measure |
Alcohol Incentives
n=169 Participants
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test). (Arms 2 + 4)
|
No Alcohol Incentives
n=169 Participants
No ethylglucuronide (EtG) testing; no incentives for EtG negative urine test. (Arms 1 + 3)
|
Escalating Incentives (IsoScreen Tests)
n=170 Participants
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Incentives for positive IsoScreen test: Economic incentives contingent on point-of-care IsoScreen (Isnoiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
n=172 Participants
Escalating incentives for ethyl glucuronide (EtG) negative tests and for IsoScreen positive urine tests with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
Incentives for positive IsoScreen test: Economic incentives contingent on POC IsoScreen (Inosiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
|---|---|---|---|---|
|
Number of Participants With Active Tuberculosis (TB).
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Control
Serious events: 5 serious events
Other events: 64 other events
Deaths: 1 deaths
Escalating Incentives (Ethyl Glucuronide [EtG] Tests)
Serious events: 5 serious events
Other events: 50 other events
Deaths: 0 deaths
Escalating Incentives (IsoScreen Tests)
Serious events: 8 serious events
Other events: 55 other events
Deaths: 4 deaths
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=169 participants at risk
All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines.
|
Escalating Incentives (Ethyl Glucuronide [EtG] Tests)
n=169 participants at risk
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
|
Escalating Incentives (IsoScreen Tests)
n=170 participants at risk
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Incentives for positive IsoScreen test: Economic incentives contingent on point-of-care IsoScreen (Isnoiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
n=172 participants at risk
Escalating incentives for ethyl glucuronide (EtG) negative tests and for IsoScreen positive urine tests with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
Incentives for positive IsoScreen test: Economic incentives contingent on POC (IsoScreen) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Physical assault; hospitalization
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
1.2%
2/169 • Number of events 2 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Hepatobiliary disorders
Elevated ALT or AST
|
1.8%
3/169 • Number of events 3 • Adverse event data were collected over the course of the study follow-up (1 year).
|
1.2%
2/169 • Number of events 2 • Adverse event data were collected over the course of the study follow-up (1 year).
|
1.8%
3/170 • Number of events 3 • Adverse event data were collected over the course of the study follow-up (1 year).
|
1.7%
3/172 • Number of events 3 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.59%
1/169 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Nervous system disorders
Alcohol withdrawal
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/169 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Injury, poisoning and procedural complications
Road traffic accident; hospitalization
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/170 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumonia
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/170 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Pregnancy, puerperium and perinatal conditions
Hospitalization
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.58%
1/172 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
General disorders
Death
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/170 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
0.59%
1/169 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Infections and infestations
Death
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/170 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
Other adverse events
| Measure |
Control
n=169 participants at risk
All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines.
|
Escalating Incentives (Ethyl Glucuronide [EtG] Tests)
n=169 participants at risk
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
|
Escalating Incentives (IsoScreen Tests)
n=170 participants at risk
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Incentives for positive IsoScreen test: Economic incentives contingent on point-of-care IsoScreen (Isnoiazid, INH) urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen)
n=172 participants at risk
Escalating incentives for ethyl glucuronide (EtG) negative tests and for IsoScreen positive urine tests with the incentives rewarded separately (Interventions: Incentives for negative EtG test and Incentives for positive IsoScreen test).
Incentives for negative EtG test: Economic incentives are given to the study participant contingent on point-of-care (POC) urine EtG \<300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
Incentives for positive IsoScreen test: Economic incentives contingent on POC (IsoScreen) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
|
|---|---|---|---|---|
|
Cardiac disorders
Hypertension
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/169 • Number of events 2 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/170 • Number of events 2 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Eye disorders
Blurry vision
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/169 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.59%
1/169 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Hepatobiliary disorders
Grade 3: elevated AST or ALT
|
7.1%
12/169 • Number of events 12 • Adverse event data were collected over the course of the study follow-up (1 year).
|
4.1%
7/169 • Number of events 8 • Adverse event data were collected over the course of the study follow-up (1 year).
|
8.2%
14/170 • Number of events 14 • Adverse event data were collected over the course of the study follow-up (1 year).
|
5.2%
9/172 • Number of events 9 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Hepatobiliary disorders
Grade 2: elevated AST or ALT
|
30.8%
52/169 • Number of events 66 • Adverse event data were collected over the course of the study follow-up (1 year).
|
24.9%
42/169 • Number of events 66 • Adverse event data were collected over the course of the study follow-up (1 year).
|
23.5%
40/170 • Number of events 51 • Adverse event data were collected over the course of the study follow-up (1 year).
|
18.0%
31/172 • Number of events 43 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Musculoskeletal and connective tissue disorders
Myalgia of thighs
|
0.59%
1/169 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Gastrointestinal disorders
Epigastric pain
|
0.59%
1/169 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia of knees
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/170 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Immune system disorders
Drug-induced lupus
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/170 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Infections and infestations
Active TB
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/169 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Nervous system disorders
Peripheral neuropathy
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
1.2%
2/170 • Number of events 2 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Renal and urinary disorders
Elevated creatinine
|
0.59%
1/169 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/170 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
|
Blood and lymphatic system disorders
Low platelets
|
0.00%
0/169 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.59%
1/169 • Number of events 1 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/170 • Adverse event data were collected over the course of the study follow-up (1 year).
|
0.00%
0/172 • Adverse event data were collected over the course of the study follow-up (1 year).
|
Additional Information
Dr. Gabriel Chamie
University of California, San Francisco (UCSF)
Phone: 415-476-4082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place