Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Infectious Diseases Research Collaboration, Uganda | OTHER |
| Mbarara University of Science and Technology | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Escalating incentives (IsoScreen tests) | Experimental | Escalating incentives for IsoScreen positive urine tests (Intervention: 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incentives for negative EtG test | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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%. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Judith A Hahn, PhD | University of California, San Francisco | Principal Investigator |
| Gabriel Chamie, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infectious Disease Research Collaboration (IDRC) | Mbarara | Uganda | ||||
| Mbarara Regional Referral Hospital (MRRH): Immune Suppression Syndrome HIV |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39867970 | Derived | 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. | |
| 37973340 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study recruitment occurred from April 2018 through July 2021. 5,508 persons were screened and 680 persons were enrolled and randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines. |
| BG001 | Escalating Incentives (Ethyl Glucuronide [EtG] Tests) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Participants | Participants | Both 3 months and 6 months (composite measure) |
|
Adverse event data were collected over the course of the study follow-up (1 year).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | All participants will receive brief alcohol and adherence counseling according to Uganda Ministry of Health guidelines. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Physical assault; hospitalization | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3: elevated AST or ALT | Hepatobiliary disorders | Systematic Assessment | Grade 3 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT >=5 to < 10 times the upper limit of normal (ULN). |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gabriel Chamie | University of California, San Francisco (UCSF) | 415-476-4082 | 445 | gabriel.chamie@ucsf.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 31, 2020 | Dec 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2022 | Dec 18, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Incentives for positive IsoScreen test | Behavioral | Economic incentives contingent on POC (IsoScreen) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test. |
|
| 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. | 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. | 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. | 12 months |
| Mbarara |
| Uganda |
| Derived |
| Chamie 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. |
| 34016158 | Derived | Lodi 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. |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Moved |
|
| Too ill |
|
| Incarcerated |
|
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.
| BG002 | 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. |
| BG003 | 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) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Escalating incentives for ethyl glucuronide (EtG) negative urine test (Intervention: Incentives for negative EtG test). (Arms 2 + 4) |
| OG001 | No Alcohol Incentives | No ethylglucuronide (EtG) testing; no incentives for EtG negative urine test. (Arms 1 + 3) |
|
|
|
| Primary | 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%. | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 9 months |
|
|
|
| Secondary | 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. | Only participants in the INH adherence incentive arms had INH concentration in hair analyzed. | Posted | Median | Inter-Quartile Range | pmol INH + AcINH / mg hair | 3 and 6 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | Number of Participants With Active Tuberculosis (TB). | Secondary Outcome. Number of participants diagnosed with active TB, within the 12 months of study follow-up. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 1 |
| 169 |
| 5 |
| 169 |
| 64 |
| 169 |
| EG001 | 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 urine EtG <300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test. | 0 | 169 | 5 | 169 | 50 | 169 |
| EG002 | 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. | 4 | 170 | 8 | 170 | 55 | 170 |
| EG003 | 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) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test. | 0 | 172 | 4 | 172 | 39 | 172 |
| Elevated ALT or AST | Hepatobiliary disorders | Systematic Assessment | Grade 4 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT >=10 times the upper limit of normal (ULN). |
|
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment | Hospitalization; surgery for intestinal obstruction |
|
| Alcohol withdrawal | Nervous system disorders | Systematic Assessment | Alcohol withdrawal delirium and alcohol induced psychosis |
|
| Road traffic accident; hospitalization | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bronchopneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Bronchopneumonia resulting in hospitalization |
|
| Hospitalization | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Hospitalization secondary to prior spontaneous abortion |
|
| Death | General disorders | Systematic Assessment | cause unknown |
|
| Death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | esophageal tumor/regurgitation of food |
|
| Death | Infections and infestations | Systematic Assessment | developed active tuberculosis |
|
| Death | Infections and infestations | Systematic Assessment | sepsis |
|
| Death | General disorders | Systematic Assessment | Per post-mortem report, had bronchopneumonia and haemorrhagic pancreatitis |
|
|
| Grade 2: elevated AST or ALT | Hepatobiliary disorders | Systematic Assessment | Grade 2 aspartate transaminase (AST) or alanine transaminase (ALT) elevation defined as AST or ALT >2 to < 5 times the upper limit of normal (ULN). |
|
| Myalgia of thighs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | Systematic Assessment |
|
| Arthralgia of knees | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Drug-induced lupus | Immune system disorders | Systematic Assessment |
|
| Active TB | Infections and infestations | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Blurry vision | Eye disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Peripheral neuropathy | Nervous system disorders | Systematic Assessment |
|
| Elevated creatinine | Renal and urinary disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Low platelets | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
| at 6 months |
|
|
| HIV viral suppression = no |
|
| Regression, Logistic |
| 0.70 |
| Risk Difference (RD) |
| 0.7 |
| 2-Sided |
| 95 |
| -2.8 |
| 4.1 |
adjusted risk different for HIV viral suppression at 12 months, Arm 3 (escalating incentives; IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site. |
| Superiority |
| Regression, Logistic | 0.42 | Risk Difference (RD) | 1.3 | 2-Sided | 95 | -1.9 | 4.5 | adjusted risk different for HIV viral suppression at 12 months, Arm 4 (escalating incentives; EtG and IsoScreen tests) compared to Arm 1 (control); logistic regression model adjusted for randomization arm, participant sex, and study site. | Superiority |