HIV/AIDSDIPTNCT03492216
Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)
A study testing Incentives for negative EtG test and Incentives for positive IsoScreen test in people with HIV/AIDS and Tuberculosis, run by University of California, San Francisco at 2 sites in Uganda.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Tuberculosis
- What is being tested?
- Incentives for negative EtG test and Incentives for positive IsoScreen test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 2 sitesUganda
- Study dates
- 16 Apr 2018to 2 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected adult (≥18 years) prescribed antiretroviral therapy (ART) for at least 6 months;
- Current heavy alcohol use (AUDIT-C positive for prior 3 month drinking and positive EtG urine test);
- Positive tuberculin skin test (TST) (≥5 mm induration);
- AST and ALT <2x the upper limit of normal (ULN);
- Fluent in Runyankole or English;
- No history of active TB, TB treatment, or TB preventive therapy;
- Lives within 2-hour travel time or 60 km of the study site.
Who cannot join
- Prescribed nevirapine (NVP, an ART drug that is declining in usage due to high risk for hepatotoxicity);
- Plans to move out of the catchment area within 6 months;
- Prescribed anti-convulsion medications or history of recurring seizures;
- ALT or AST elevations (>2X ULN);
- Suspected or confirmed active TB as determined by symptom screening and followed by chest X-ray and sputum testing;
- History of prior active TB treatment or prior IPT.
- Pregnant at time of screening
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
Infectious Disease Research Collaboration (IDRC)
Mbarara
Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV
Mbarara
About this study
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).
Read the detailed description
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.
- Assess the impact of the 3 separate incentive interventions (Arms 2, 3, 4) vs. no incentives (Arm 1) on HIV virologic suppression.
- Explore the mechanisms that may drive the economic incentives to increase virologic suppression. Potential mediators will be reductions in alcohol use and level of IPT adherence.
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.
- Conditions
- HIV/AIDS, Tuberculosis
- Being tested
- Incentives for negative EtG test, Incentives for positive IsoScreen test
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentives for negative EtG testBehavioural
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 testBehavioural
Economic incentives contingent on POC (IsoScreen) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines. |
| Escalating incentives (EtG tests) | Experimental | Escalating incentives for EtG negative urine test (Intervention: Incentives for negative EtG test). Receives: Behavioral: Incentives for negative EtG test |
| Escalating incentives (IsoScreen tests) | Experimental | Escalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test). Receives: Behavioral: Incentives for positive IsoScreen test |
| Escalating incentives (EtG + IsoScreen) | Experimental | 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). Receives: Behavioral: Incentives for negative EtG test; Behavioral: Incentives for positive IsoScreen test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 6 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start16 Apr 2018
- Primary completion1 Feb 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Research Collaboration, Uganda, Mbarara University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Judith A Hahn, PhD, Principal investigator, University of California, San FranciscoGabriel Chamie, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492216
- Sponsor's protocol ID
- 17-22727
- Acronym
- DIPT
- Status last verified
- Jan 2025
- First submitted
- 20 Feb 2018
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muyindike WR, Fatch R, Lodi S, Emenyonu NI, Kekibiina A, Adong J, Beesiga B, Marson K, Thirumurthy H, McDonell MG, Kamya MR, Chamie G, Hahn JA. Alcohol use and HIV suppression after completion of financial incentives for alcohol abstinence and isoniazid adherence: a randomized controlled trial. EClinicalMedicine. 2025 Jan 8;80:103045. doi: 10.1016/j.eclinm.2024.103045. eCollection 2025 Feb.
PubMed 39867970Chamie G, Hahn JA, Kekibiina A, Emenyonu NI, Beesiga B, Marson K, Fatch R, Lodi S, Adong J, Thirumurthy H, McDonell MG, Gandhi M, Bryant K, Havlir DV, Kamya MR, Muyindike WR. Financial incentives for reduced alcohol use and increased isoniazid adherence during tuberculosis preventive therapy among people with HIV in Uganda: an open-label, factorial randomised controlled trial. Lancet Glob Health. 2023 Dec;11(12):e1899-e1910. doi: 10.1016/S2214-109X(23)00436-9.
PubMed 37973340Lodi S, Emenyonu NI, Marson K, Kwarisiima D, Fatch R, McDonell MG, Cheng DM, Thirumurthy H, Gandhi M, Camlin CS, Muyindike WR, Hahn JA, Chamie G. The Drinkers' Intervention to Prevent Tuberculosis (DIPT) trial among heavy drinkers living with HIV in Uganda: study protocol of a 2x2 factorial trial. Trials. 2021 May 20;22(1):355. doi: 10.1186/s13063-021-05304-7.
PubMed 34016158
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drinkers' Intervention to Prevent Tuberculosis (DIPT Study)
- ClinicalTrials.gov ID
- NCT03492216
- Acronym / sponsor ID
- DIPT / 17-22727
- Conditions
- HIV/AIDS, Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Infectious Diseases Research Collaboration, Uganda, Mbarara University of Science and Technology
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
- Assess the impact of the 3 separate incentive interventions (Arms 2, 3, 4) vs. no incentives (Arm 1) on HIV virologic suppression.
- Explore the mechanisms that may drive the economic incentives to increase virologic suppression. Potential mediators will be reductions in alcohol use and level of IPT adherence.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines. |
| Escalating incentives (EtG tests) | Experimental | Behavioral: Incentives for negative EtG testEscalating incentives for EtG negative urine test (Intervention: Incentives for negative EtG test). |
| Escalating incentives (IsoScreen tests) | Experimental | Behavioral: Incentives for positive IsoScreen testEscalating incentives for IsoScreen positive urine tests (Intervention: Incentives for positive IsoScreen test). |
| Escalating incentives (EtG + IsoScreen) | Experimental | Behavioral: Incentives for negative EtG test, Behavioral: Incentives for positive IsoScreen testEscalating 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- HIV-infected adult (≥18 years) prescribed antiretroviral therapy (ART) for at least 6 months;
- Current heavy alcohol use (AUDIT-C positive for prior 3 month drinking and positive EtG urine test);
- Positive tuberculin skin test (TST) (≥5 mm induration);
- AST and ALT <2x the upper limit of normal (ULN);
- Fluent in Runyankole or English;
Key exclusion criteria (7 listed)
- Prescribed nevirapine (NVP, an ART drug that is declining in usage due to high risk for hepatotoxicity);
- Plans to move out of the catchment area within 6 months;
- Prescribed anti-convulsion medications or history of recurring seizures;
- ALT or AST elevations (>2X ULN);
- Suspected or confirmed active TB as determined by symptom screening and followed by chest X-ray and sputum testing;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentives for negative EtG testEconomic 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. | Behavioural | Escalating incentives (EtG + IsoScreen), Escalating incentives (EtG tests) |
| Incentives for positive IsoScreen testEconomic incentives contingent on POC (IsoScreen) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test. | Behavioural | Escalating incentives (EtG + IsoScreen), Escalating incentives (IsoScreen tests) |
Primary outcome
Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months.
Time frame: Both 3 months and 6 months (composite measure)
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.
Number of Participants With >90% Isoniazid (INH) Adherence During Prescribed Course of INH
Time frame: 6 months
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%.
4 secondary outcomes
Number of Participants With Hepatotoxicity Resulting in Isoniazid (INH) Discontinuation.
Time frame: up to 9 months
INH Concentration in Hair
Time frame: 3 and 6 months
Number of Participants With and Without HIV Viral Suppression at 12 Months
Time frame: 12 months
Number of Participants With Active Tuberculosis (TB).
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39867970Muyindike WR, Fatch R, Lodi S, Emenyonu NI, Kekibiina A, Adong J, Beesiga B, Marson K, Thirumurthy H, McDonell MG, Kamya MR, Chamie G, Hahn JA. Alcohol use and HIV suppression after completion of financial incentives for alcohol abstinence and isoniazid adherence: a randomized controlled trial. EClinicalMedicine. 2025 Jan 8;80:103045. doi: 10.1016/j.eclinm.2024.103045. eCollection 2025 Feb.
- Derived from this study: PubMed 37973340Chamie G, Hahn JA, Kekibiina A, Emenyonu NI, Beesiga B, Marson K, Fatch R, Lodi S, Adong J, Thirumurthy H, McDonell MG, Gandhi M, Bryant K, Havlir DV, Kamya MR, Muyindike WR. Financial incentives for reduced alcohol use and increased isoniazid adherence during tuberculosis preventive therapy among people with HIV in Uganda: an open-label, factorial randomised controlled trial. Lancet Glob Health. 2023 Dec;11(12):e1899-e1910. doi: 10.1016/S2214-109X(23)00436-9.
- Derived from this study: PubMed 34016158Lodi S, Emenyonu NI, Marson K, Kwarisiima D, Fatch R, McDonell MG, Cheng DM, Thirumurthy H, Gandhi M, Camlin CS, Muyindike WR, Hahn JA, Chamie G. The Drinkers' Intervention to Prevent Tuberculosis (DIPT) trial among heavy drinkers living with HIV in Uganda: study protocol of a 2x2 factorial trial. Trials. 2021 May 20;22(1):355. doi: 10.1186/s13063-021-05304-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith A Hahn, PhD principal investigator
University of California, San Francisco
Gabriel Chamie, MD, MPH principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incentives for negative EtG test and Incentives for positive IsoScreen test in people with HIV/AIDS and Tuberculosis, run by University of California, San Francisco at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months. (time frame: Both 3 months and 6 months (composite measure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03492216, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025; AzTrials last refreshed its copy on 30 Oct 2026.