An interventional study of Incentives for negative EtG test and Incentives for positive IsoScreen test in HIV/AIDS and Tuberculosis, sponsored by University of California, San Francisco. Completed at 2 sites in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
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Among 77 studies in Acquired Immunodeficiency Syndrome by University of California, San Francisco — 7 open to participants now, 14 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · University of California, San Francisco.
Among the 77 studies in Acquired Immunodeficiency Syndrome by University of California, San Francisco, this one is the 8th largest by enrollment of the 68 interventional ones that give a count, is one of 5 that started in 2018, is one of 53 with no phase, and was the 42nd registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →7 of the 77 studies in Acquired Immunodeficiency Syndrome by University of California, San Francisco are open now, in 4 countries. Recruiting first, the newest first:
University of California, San Francisco · Sites in Uganda
Ages 15+ · Women only · Healthy volunteers
University of California, San Francisco · Sites in Malawi
Ages 18+ · Healthy volunteers
University of California, San Francisco · Sites in United States
Ages 40+
University of California, San Francisco · Sites in United States
Ages 18+
University of California, San Francisco · Sites in United States
Ages 30+
By country, each count listing its studies:
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
77 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 6 · Phase 3 2 · Phase 4 6
First in 2000; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 680 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 143 across the 68 interventional studies, 309 across the 6 observational. Of the 63 that completed or were terminated, 24 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of California, San Francisco is the lead sponsor of 2,171 studies on the registry; 370 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 203 (76%) have results posted.
2 of the studies in Acquired Immunodeficiency Syndrome by University of California, San Francisco that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07115901University of California, San FranciscoGuaranteed Income to Boost HIV Care Continuity and Suppression Post-Jail Release | 2027-02-25 |
| NCT07064928University of California, San FranciscoIntervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women | 2027-07-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 77 studies in Acquired Immunodeficiency Syndrome by University of California, San Francisco, from their registry updates:
This tab as a report to print or save as PDF → With an account.
There is an urgent global need to decrease the high mortality of tuberculosis (TB) in persons with HIV as TB is the leading cause of death among persons with HIV worldwide. The DIPT (Drinkers' Intervention to Prevent TB) study is a randomized, 2x2 factorial trial among HIV/TB co-infected adults in Uganda with heavy alcohol use (n=680 persons, 340 each U01). The goal of the study is to determine whether economic incentive interventions can promote both reduced alcohol use and isoniazid (INH) pill taking among HIV/TB co-infected adult heavy drinkers, during isoniazid preventive therapy (IPT: a six-month course of INH) at HIV clinics in southwestern Uganda. Participants will be randomized to one of four arms: Arm 1: no incentives (control); Arm 2: economic incentives for decreasing alcohol use only; Arm 3: economic incentives for IPT adherence only; Arm 4: economic incentives for decreasing alcohol use and for IPT adherence (rewarded independently).
TB is the leading cause of death among persons with HIV worldwide, and HIV-infected drinkers are at very high risk for TB disease and mortality. Globally, an estimated 25% of persons with HIV are heavy drinkers, and the risk of TB disease is 3-fold higher among heavy drinkers compared to non-drinkers. Six months of isoniazid (INH) preventive therapy (IPT) reduces TB morbidity and mortality by 30-50% above the benefit of antiretroviral therapy (ART). However, INH can be toxic to the liver, and as a result in many high TB/HIV prevalence settings, such as east Africa, heavy drinkers are not offered IPT. Thus interventions to reduce alcohol use are needed to decrease INH toxicity during IPT among HIV/TB infected drinkers. It is also well established that heavy drinkers have poorer ART adherence, and there is growing evidence of reduced IPT adherence in drinkers. However, interventions to reduce drinking have had limited impact on ART adherence, and further interventions to increase IPT adherence among HIV/TB infected drinkers are likely needed.
The use of incentives to promote healthy behavior is a highly effective approach for reducing substance use and for improving adherence to HIV and TB regimens in resource-rich settings. Economic incentives to reduce alcohol use may create a window for safe and effective IPT use over six months by decreasing hepatotoxicity. Decreases in alcohol use may also improve IPT adherence, or additional incentives for IPT adherence may be needed. Such strategies to reduce alcohol use have not been studied in low-income countries and the effectiveness of incentives to optimize IPT in HIV/TB co-infected drinkers is unknown.
OBJECTIVES
Aim 1: Alcohol Reduction Intervention: Determine the effectiveness of economic incentives contingent on point-of-care (POC) urine ethyl glucuronide (EtG) \<300 ng/mL (Arms 2 \& 4) versus no alcohol incentives (Arms 1 \& 3) to reduce heavy drinking over 6 months, among HIV/TB co-infected adult drinkers receiving IPT. The investigators will randomize participants to low-cost escalating prize incentives for EtG negative urine tests at IPT refill visits (Arms 2+4), versus no incentives (Arms 1+3).
Aim 2: INH Adherence Intervention: Determine the effectiveness of economic incentives contingent on POC (IsoScreen) INH urine positive tests (Arms 3 \& 4) versus no INH incentives (Arms 1 \& 2) on INH adherence among HIV/TB co-infected adult drinkers. The investigators will randomize participants to low-cost escalating prize incentives for INH positive urine tests at IPT refill visits (Arms 3+4), versus no incentives (Arms 1+2).
Aim 3: Impact Assessment of Intervention: Assess the impact of economic incentives on HIV virologic suppression and explore their mechanisms of action, six months after trial completion. The investigators will follow all study participants for six months after trial completion.
This study will leverage new low-cost POC tests for alcohol use and INH pill-taking for the first study of incentive-based alcohol and adherence interventions in low-resource settings; these interventions may improve the safety and effectiveness of life-saving medications for heavy alcohol users in many settings.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines.
Escalating incentives for EtG negative urine test (Intervention: Incentives for negative EtG test).
Behavioral: Incentives for negative EtG test
Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test).
Behavioral: Incentives for positive IsoScreen test
Escalating incentives for 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).
Behavioral: Incentives for negative EtG test · Behavioral: Incentives for positive IsoScreen 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.
Economic incentives contingent on POC (IsoScreen) 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 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.
Time frame: Both 3 months and 6 months (composite measure)
Number of Participants With >90% Isoniazid (INH) Adherence During Prescribed Course of INH
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%.
Time frame: 6 months
Number of Participants With Hepatotoxicity Resulting in Isoniazid (INH) Discontinuation.
Isoniazid (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.
Time frame: up to 9 months
INH Concentration in Hair
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.
Time frame: 3 and 6 months
Number of Participants With and Without HIV Viral Suppression at 12 Months
The percentage of study participants with HIV viral load suppression (defined as \<200 copies/ml) at 12 months post-enrollment.
Time frame: 12 months
Number of Participants With Active Tuberculosis (TB).
Secondary Outcome. Number of participants diagnosed with active TB, within the 12 months of study follow-up.
Time frame: 12 months
Study recruitment occurred from April 2018 through July 2021. 5,508 persons were screened and 680 persons were enrolled and randomized.
| Milestone | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) |
|---|---|---|---|---|
| Started | 169 | 169 | 170 | 172 |
| 3 month visit | 158 | 162 | 166 | 168 |
| 6 month visit | 154 | 164 | 162 | 165 |
| Completed | 149 | 160 | 153 | 158 |
| Not completed | 20 | 9 | 17 | 14 |
| Withdrew: Death | 1 | 0 | 4 | 0 |
| Withdrew: Withdrawal by subject | 5 | 3 | 1 | 1 |
| Withdrew: Lost to follow-up | 9 | 2 | 7 | 8 |
| Withdrew: Moved | 5 | 3 | 3 | 5 |
| Withdrew: Too ill | 0 | 1 | 0 | 0 |
| Withdrew: Incarcerated | 0 | 0 | 2 | 0 |
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.
| Participants | Alcohol Incentives | No Alcohol Incentives |
|---|---|---|
| Non-hazardous alcohol use at 3 and 6 months = yes | 57 | 31 |
| Non-hazardous alcohol use at 3 and 6 months = no | 266 | 282 |
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%.
| Participants | Isoniazid (INH) Adherence Incentives | No Incentives for Isoniazid (INH) Adherence |
|---|---|---|
| >90% INH adherence | 244 | 234 |
| <=90% INH adherence | 91 | 87 |
Isoniazid (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.
| Participants | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) |
|---|---|---|---|---|
| Number of Participants With Hepatotoxicity Resulting in Isoniazid (INH) Discontinuation. | 13 | 10 | 15 | 9 |
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.
| pmol INH + AcINH / mg hair | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) |
|---|---|---|---|---|
| at 3 months | — | — | 49.4 (26.8 to 81.3) | 49.1 (28.0 to 81.1) |
| at 6 months | — | — | 49.3 (27.4 to 78.8) | 57.1 (31.9 to 84.0) |
The percentage of study participants with HIV viral load suppression (defined as \<200 copies/ml) at 12 months post-enrollment.
| Participants | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) |
|---|---|---|---|---|
| HIV viral suppression = yes | 144 | 147 | 146 | 146 |
| HIV viral suppression = no | 4 | 8 | 3 | 2 |
Secondary Outcome. Number of participants diagnosed with active TB, within the 12 months of study follow-up.
| Participants | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) |
|---|---|---|---|---|
| Number of Participants With Active Tuberculosis (TB). | 0 | 1 | 2 | 1 |
Collected over Adverse event data were collected over the course of the study follow-up (1 year).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 1/169 (0.6%) | 5/169 (3%) | 64/169 (37.9%) |
| Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | 0/169 (0%) | 5/169 (3%) | 50/169 (29.6%) |
| Escalating Incentives (IsoScreen Tests) | 4/170 (2.4%) | 8/170 (4.7%) | 55/170 (32.4%) |
| Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) | 0/172 (0%) | 4/172 (2.3%) | 39/172 (22.7%) |
| Event | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) |
|---|---|---|---|---|
| Elevated ALT or ASTHepatobiliary disorders | 3/169 | 2/169 | 3/170 | 3/172 |
| Physical assault; hospitalizationInjury, poisoning and procedural complications | 0/169 | 2/169 | 0/170 | 0/172 |
| Intestinal obstructionGastrointestinal disorders | 1/169 | 0/169 | 0/170 | 0/172 |
| Alcohol withdrawalNervous system disorders | 0/169 | 1/169 | 0/170 | 0/172 |
| DeathNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/169 | 0/169 | 0/170 | 0/172 |
| Road traffic accident; hospitalizationInjury, poisoning and procedural complications | 0/169 | 0/169 | 1/170 | 0/172 |
| BronchopneumoniaRespiratory, thoracic and mediastinal disorders | 0/169 | 0/169 | 1/170 | 0/172 |
| DeathGeneral disorders | 0/169 | 0/169 | 1/170 | 0/172 |
| DeathInfections and infestations | 0/169 | 0/169 | 1/170 | 0/172 |
| DeathInfections and infestations | 0/169 | 0/169 | 1/170 | 0/172 |
| Event | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) |
|---|---|---|---|---|
| Grade 2: elevated AST or ALTHepatobiliary disorders | 52/169 | 42/169 | 40/170 | 31/172 |
| Grade 3: elevated AST or ALTHepatobiliary disorders | 12/169 | 7/169 | 14/170 | 9/172 |
| Peripheral neuropathyNervous system disorders | 0/169 | 0/169 | 2/170 | 0/172 |
| Myalgia of thighsMusculoskeletal and connective tissue disorders | 1/169 | 0/169 | 0/170 | 0/172 |
| Epigastric painGastrointestinal disorders | 1/169 | 0/169 | 0/170 | 0/172 |
| Active TBInfections and infestations | 0/169 | 1/169 | 0/170 | 0/172 |
| HypertensionCardiac disorders | 0/169 | 1/169 | 1/170 | 0/172 |
| Blurry visionEye disorders | 0/169 | 1/169 | 0/170 | 0/172 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/169 | 0/169 | 0/170 | 0/172 |
| Elevated creatinineRenal and urinary disorders | 1/169 | 0/169 | 0/170 | 0/172 |
| Age, Categorical(Participants) | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 167 | 164 | 167 | 169 | 667 |
| >=65 years | 2 | 5 | 3 | 3 | 13 |
| Age, Continuous(years) | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) | Total |
|---|---|---|---|---|---|
| Median | 40 (33 to 46) | 38 (32 to 46) | 40 (32 to 48) | 39 (31 to 46) | 39 (32 to 47) |
| Sex: Female, Male(Participants) | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) | Total |
|---|---|---|---|---|---|
| Female | 51 | 53 | 53 | 53 | 210 |
| Male | 118 | 116 | 117 | 119 | 470 |
| Race and Ethnicity Not Collected(Participants) | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(participants) | Control | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) | Escalating Incentives (IsoScreen Tests) | Escalating Incentives (Ethyl Glucuronide [EtG] + IsoScreen) | Total |
|---|---|---|---|---|---|
| Uganda | 169 | 169 | 170 | 172 | 680 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Feb 2022, 45 months.
Results were first posted in Jan 2025, 2 years 11 months after primary completion.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 45 months is above that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
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