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| Name | Class |
|---|---|
| Boston University | OTHER |
| Boston Medical Center | OTHER |
| Mbarara University of Science and Technology | OTHER |
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The Alcohol Drinkers' Exposure to Preventive Therapy for TB (ADEPTT) will examine the safety and tolerability of, and adherence to, 6 months of daily INH (6H) in 300 TB and HIV-infected persons (200 drinkers and 100 non-drinkers) in Uganda. The first aim is to evaluate the safety and tolerability of 6H overall and by level of alcohol use. The second aim is to estimate adherence and compare adherence by level of alcohol use and at 3 and 6 months. Self-reported measures of alcohol use will be augmented by phosphatidylethanol (PEth), an established biomarker of alcohol use. Objective measures of adherence will include electronic pill bottle monitoring and a novel measure of INH exposure, INH concentration in hair. The study will actively monitor for hepatotoxicity using the U.S. standard of care for TB preventive therapy for heavy drinkers and discontinue if any Grade 3/4 toxicities are detected. The investigators will use the safety, tolerability, and adherence results, together with the known efficacy and mortality benefit of TB preventive therapy in HIV-infected persons in SSA, and an established decision analytic model of TB preventive therapy to conduct the third aim: to determine whether the benefits of TB preventive therapy outweigh the toxicity risks for HIV-infected drinkers in resource limited settings. The study will additionally follow the cohort every 6 months after completing INH to monitor drinking and the development of active TB.
Tuberculosis (TB) is the leading cause of mortality in persons with HIV worldwide, accounting for 20-33% of HIV-related deaths, and is a high-priority area of research in HIV/AIDS by the NIH. TB preventive therapy decreases both all-cause mortality and active TB in persons with HIV by 30-50% above and beyond the benefits of antiretroviral therapy (ART) alone. Based on these findings, the World Health Organization (WHO) recommends isoniazid (INH) preventive therapy (IPT) for all persons with HIV in resource constrained settings. However, the WHO warns against the use of IPT in persons with "regular and heavy alcohol use." This exclusion stems from concern for increased hepatotoxicity in heavy drinkers in settings where liver enzymes are not routinely monitored. Heavy drinking in persons with HIV is very common, approximately 25%, in sub-Saharan Africa (SSA). Heavy drinking increases the risk for active TB at least threefold; thus, HIV-infected alcohol users should be prioritized for TB prevention. However, no studies have systematically assessed the safety of TB preventive therapy in heavy drinkers with or without HIV infection. It is critical to examine the safety and tolerability of TB preventive therapy for HIV-infected drinkers, given the high rates of HIV, TB infection, and alcohol comorbidities worldwide. While the risk of toxicity exists, the risk of TB disease could outweigh the toxicity harms. Thus, it is also crucial to determine whether the mortality benefits outweigh the toxicity risks for this significant portion of the HIV-infected population.
In addition, TB preventive therapy is only effective if taken consistently for the full course. Alcohol use is an established risk factor for decreased ART pill taking and active TB treatment discontinuation. Whether HIV-infected drinkers on ART can be adherent to TB preventive therapy is not known. Therefore it is essential to determine the level of adherence to TB preventive therapy by HIV-infected drinkers on ART, thus this study aims to examine adherence to TB preventative therapy as well.
This is a study to examine 6 months of daily INH (6H) among N=300 persons co-infected with HIV and TB. The aims of the study are:
Aim 1: To examine the safety and tolerability of 6H in HIV/TB co-infected drinkers, measured by hepatotoxicity and treatment discontinuation rates. The main aim is to estimate safety and tolerability overall among drinkers (primary) and by level of drinking (secondary).
Aim 2: To determine the level of TB preventive therapy adherence overall among drinkers and by level of drinking, and at 3 and 6 months. The main goal of this aim is to estimate adherence overall among drinkers (primary). Secondarily the investigators will estimate adherence by level of drinking (heavy, current but not heavy drinkers, and non-drinkers) and compare adherence across drinking levels. The investigators hypothesize that adherence will be highest among the non-drinkers.
Aim 3: To determine whether the benefits of providing TB preventive therapy to HIV-infected drinkers in resource-limited settings outweigh the risks compared to no treatment. The investigators hypothesize that providing TB preventive therapy will result in longer life expectancy and quality-adjusted life expectancy than not providing TB preventive therapy (current standard of care).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isoniazid & pyridoxine | Experimental | Isoniazid 300 mg oral tablet: 300 mg daily by mouth for 6 months. Pyridoxine 25 mg oral tablet: 25mg daily by mouth for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoniazid 300 Mg ORAL TABLET | Drug | The study intervention will include a single arm given (1) 6H: 300 mg INH daily by mouth for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Incidence of Participants Experiencing a Grade 3/4 Hepatotoxicity | Safety will be assessed by the occurrence of a Grade 3/4 hepatotoxicity at any time during the assigned treatment period. | Hepatotoxicity occurring during the six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Discontinued Treatment | Lack of tolerability will be defined as any isoniazid (INH) treatment discontinuation prior to completion of the prescribed course (6 months of INH taken over a maximum period of 9 months) due to side effects or alanine transaminase (ALT)/aspartate transaminase (AST) elevations. | Six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months. |
| Measure | Description | Time Frame |
|---|---|---|
| INH Concentration in Hair: (INH Pmol + Acetyl INH Pmol) Per mg of Hair | INH concentration in hair (pmol/mg) will be measured at 3- and 6- months during INH therapy. | Measured at 3- and 6- months after INH initiation |
| Number of Participants With Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Elevations at Study Screening |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith A Hahn, PhD, MA | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mbarara University of Science and Technology/Mbarara Regional Referral Hospital | Mbarara | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20091503 | Background | Akolo C, Adetifa I, Shepperd S, Volmink J. Treatment of latent tuberculosis infection in HIV infected persons. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD000171. doi: 10.1002/14651858.CD000171.pub3. | |
| 26348618 | Background | Edessa D, Likisa J. A Description of Mortality Associated with IPT plus ART Compared to ART Alone among HIV-Infected Individuals in Addis Ababa, Ethiopia: A Cohort Study. PLoS One. 2015 Sep 8;10(9):e0137492. doi: 10.1371/journal.pone.0137492. eCollection 2015. |
| Label | URL |
|---|---|
| Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. | View source |
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The investigators will make de-identified data available to investigators with relevant and well-articulated research plans, after the main study analyses have been conducted. No personal identifiers will be shared, and nor identifiers that could be linked back to the original study ID. In addition, some journals require de-identified data to be posted for public access.
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Participants were recruited from an HIV clinic from April 2017 through December 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | INH and Vitamin B6 | This was a single arm trial with a recruitment goal of 200 participants who reported current (prior 3 months) alcohol use, and 100 prior year abstinence from alcohol use. All participants were given 300 mg INH daily by mouth for 6 months, and 25 mg pyridoxine (vitamin B-6) daily by mouth for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 of 302 persons originally enrolled in the study was found to be ineligible during their baseline interview. They were disenrolled immediately and are excluded from all analyses, leaving 301 participants for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | INH and Vitamin B6 | This was a single arm trial; participants were given 300 mg INH daily by mouth for 6 months, and 25 mg pyridoxine (vitamin B-6) daily by mouth for 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Cumulative Incidence of Participants Experiencing a Grade 3/4 Hepatotoxicity | Safety will be assessed by the occurrence of a Grade 3/4 hepatotoxicity at any time during the assigned treatment period. | Posted | Number | 95% Confidence Interval | percent | Hepatotoxicity occurring during the six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months. |
|
|
Data were collected over the course of study participation, for a maximum of 42 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INH and Vitamin B6 | This was a single arm trial; participants were given 300 mg INH daily by mouth for 6 months, and 25 mg pyridoxine (vitamin B-6) daily by mouth for 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated AST or ALT | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3: AST or ALT elevation | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Judy Hahn | University of California San Francisco | 415-476-5815 | judy.hahn@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2017 | Sep 21, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D000163 | Acquired Immunodeficiency Syndrome |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D007538 | Isoniazid |
| D013607 | Tablets |
| D011736 | Pyridoxine |
| D025101 | Vitamin B 6 |
| ID | Term |
|---|---|
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
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| Pyridoxine 25 Mg Oral Tablet | Drug | All participants will also receive 25 mg pyridoxine (vitamin B-6) daily by mouth for 6 months for the treatment duration to reduce the risk of INH-induced peripheral neuropathy. |
|
|
| Percentage of Participants With Suboptimal INH Medication Adherence | Suboptimal INH adherence was defined as <90% of days with at least 1 electronic medication management (EMM) pill cap opening in the previous 90 days, at 3- and 6-months. | Adherence will be measured over the 6 months on INH or until INH discontinuation (whichever is shorter) |
| Self-reported INH Medication Adherence: Number of Days Taking INH in the Past 30 Days | Participants were asked "In the past 30 days, how many days in total have you not taken your pill?" and were presented with a visual analog scale (VAS) to indicate the percentage of INH taken in the past 30 days. We converted the VAS percentage into number of days out of 30 to match the first question. Our final self-report measure was the minimum number of the 2 self-reported measurements. | Self-reported INH medication adherence via VAS will be measured 3- and 6- months after starting INH |
| Self-reported INH Medication Adherence by the Self Rating Single Item (SRSI) Scale | The Self Rating Single Item (SRSI) adherence scale asks participants to rate their ability to take their medications as prescribed over the past 30 days. Participants reporting INH use in the prior 30 days at the 3- or 6-month interview are included here, and reported their INH adherence in the prior 30 days as excellent, very good, good, fair, poor, or very poor. | Self-reported INH medication adherence via SRSI will be measured 3- and 6- months after starting INH |
Alanine transaminase (ALT) or aspartate transaminase (AST) elevations (>2x the upper limit of normal) at study screening |
| Study screening visit |
| Number of Participants With Latent Tuberculosis at Study Screening. | Latent tuberculosis assessed at screening via tuberculin skin testing (TST). A TST induration >=5mm was considered positive for latent tuberculosis. | Study screening visit |
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| 19222624 | Background | Bounthavong M, Hsu DI, Okamoto MP. Cost-effectiveness analysis of linezolid vs. vancomycin in treating methicillin-resistant Staphylococcus aureus complicated skin and soft tissue infections using a decision analytic model. Int J Clin Pract. 2009 Mar;63(3):376-86. doi: 10.1111/j.1742-1241.2008.01958.x. |
| 12088234 | Background | Frey HC, Patil SR. Identification and review of sensitivity analysis methods. Risk Anal. 2002 Jun;22(3):553-78. |
| 36044285 | Derived | Muyindike WR, Fatch R, Cheng DM, Emenyonu NI, Forman L, Ngabirano C, Adong J, Linas B, Jacobson KR, Hahn JA. Unhealthy Alcohol Use Is Associated With Suboptimal Adherence to Isoniazid Preventive Therapy in Persons With HIV in Southwestern Uganda. J Acquir Immune Defic Syndr. 2022 Dec 15;91(5):460-468. doi: 10.1097/QAI.0000000000003082. |
| UNAIDS Country Report, Uganda. 2014 | View source |
| Global Status Report on Alcohol and Health. Geneva: World Health Organization;2014 | View source |
| year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Number of Participants Who Discontinued Treatment | Lack of tolerability will be defined as any isoniazid (INH) treatment discontinuation prior to completion of the prescribed course (6 months of INH taken over a maximum period of 9 months) due to side effects or alanine transaminase (ALT)/aspartate transaminase (AST) elevations. | Posted | Count of Participants | Participants | Six month course (180 pills) of isoniazid (INH), which may be taken over a maximum of 9 months. |
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| Secondary | Percentage of Participants With Suboptimal INH Medication Adherence | Suboptimal INH adherence was defined as <90% of days with at least 1 electronic medication management (EMM) pill cap opening in the previous 90 days, at 3- and 6-months. | 279/301 participants completed at least 1 study visit at either 3 or 6 months while on INH and are included here. 275 participants were included at 3 months; 264 participants were included at 6 months. | Posted | Number | percentage of participants | Adherence will be measured over the 6 months on INH or until INH discontinuation (whichever is shorter) |
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| Secondary | Self-reported INH Medication Adherence: Number of Days Taking INH in the Past 30 Days | Participants were asked "In the past 30 days, how many days in total have you not taken your pill?" and were presented with a visual analog scale (VAS) to indicate the percentage of INH taken in the past 30 days. We converted the VAS percentage into number of days out of 30 to match the first question. Our final self-report measure was the minimum number of the 2 self-reported measurements. | 290 unique participants are included here. 285 individuals are included at 3 months; 268 individuals are included at 6 months. Participants with missed visits or who were not taking INH (ie. due to either a temporary pause due to the COVID lockdown in Uganda, or because they were discontinued) were excluded. | Posted | Median | Inter-Quartile Range | days | Self-reported INH medication adherence via VAS will be measured 3- and 6- months after starting INH |
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| Secondary | Self-reported INH Medication Adherence by the Self Rating Single Item (SRSI) Scale | The Self Rating Single Item (SRSI) adherence scale asks participants to rate their ability to take their medications as prescribed over the past 30 days. Participants reporting INH use in the prior 30 days at the 3- or 6-month interview are included here, and reported their INH adherence in the prior 30 days as excellent, very good, good, fair, poor, or very poor. | 280 unique participants are included here. 279 individuals are included at 3 months; 260 individuals are included at 6 months. Participants who reported no INH use in the prior 30 days were excluded. | Posted | Count of Participants | Participants | Self-reported INH medication adherence via SRSI will be measured 3- and 6- months after starting INH |
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| Other Pre-specified | INH Concentration in Hair: (INH Pmol + Acetyl INH Pmol) Per mg of Hair | INH concentration in hair (pmol/mg) will be measured at 3- and 6- months during INH therapy. | We had funding to analyze the first shipped batch of hair (n=161 total visits, representing 97 unique participants) for INH. | Posted | Median | Inter-Quartile Range | pmol/mg | Measured at 3- and 6- months after INH initiation |
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| Other Pre-specified | Number of Participants With Alanine Transaminase (ALT) or Aspartate Transaminase (AST) Elevations at Study Screening | Alanine transaminase (ALT) or aspartate transaminase (AST) elevations (>2x the upper limit of normal) at study screening | People who completed liver transaminase testing as part of the screening for this study. | Posted | Count of Participants | Participants | Study screening visit |
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| Other Pre-specified | Number of Participants With Latent Tuberculosis at Study Screening. | Latent tuberculosis assessed at screening via tuberculin skin testing (TST). A TST induration >=5mm was considered positive for latent tuberculosis. | People who completed tuberculin skin testing (TST) as part of the study screening. People who did not return for the TST reading within the required window of 48-72 hours are excluded here. | Posted | Count of Participants | Participants | Study screening visit |
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|
|
| 2 |
| 301 |
| 11 |
| 301 |
| 88 |
| 301 |
|
| Accident | Injury, poisoning and procedural complications | Systematic Assessment | Injury from accident, resulting in hospitalization |
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| Death | General disorders | Systematic Assessment | Death - cause unknown |
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| Septicemia | Infections and infestations | Systematic Assessment | Septicemia causing hospitalization |
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| Low hemoglobin | Blood and lymphatic system disorders | Systematic Assessment | Low hemoglobin, likely caused by persistent vaginal bleeding. Hospitalization |
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| High blood pressure | Cardiac disorders | Systematic Assessment | High blood pressure. Hospitalization. |
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| Hospitalization | General disorders | Systematic Assessment | Hospitalization due to dizziness, loss of appetite, nausea, paresthesia. |
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| Grade 2: AST or ALT elevation | 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). |
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| PPD hypersensitivity | Immune system disorders | Systematic Assessment | Hypersensitivity reaction to the tuberculin purified protein derivative (PPD) test. The total number at risk includes all people who received the PPD test as part of study screening. |
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| Paresthesias | Nervous system disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Vomiting | General disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Angioedema | Immune system disorders | Systematic Assessment |
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| Allergic conjuctivitis | Eye disorders | Systematic Assessment |
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| Shooting pains | Nervous system disorders | Systematic Assessment |
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| Visual changes (blurring) | General disorders | Systematic Assessment |
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| Hypotension | General disorders | Systematic Assessment |
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| Poor appetite | General disorders | Systematic Assessment |
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| Physically assaulted | Injury, poisoning and procedural complications | Systematic Assessment | Physically assaulted by partner (grade 2 injury). |
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| Soft tissue injury | Injury, poisoning and procedural complications | Systematic Assessment | Road traffic accident (grade 2 injury) |
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| Hypertension | Cardiac disorders | Systematic Assessment |
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Not provided
Not provided
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| 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 |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D010847 | Picolines |
|
| Regression, Logistic |
| <0.01 |
global p-value for 3-category alcohol use variable in a multivariable generalized estimating equation logistic regression model of sub-optimal INH adherence. |
| Odds Ratio (OR) |
| 2.78 |
| 2-Sided |
| 95 |
| 1.62 |
| 4.76 |
OR is for participants with unhealthy alcohol use in the prior 3 months, compared to those with no alcohol use in the prior 3 months. |
| Superiority |
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| Good |
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| Fair |
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| Poor |
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| Very poor |
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| At 6 months |
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