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Alcohol Reduction Among People With TB and HIV in India (HATHI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230395
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The highest incidence of tuberculosis disease (TB) in the world is in India, accounting for 27% of all new cases globally, with approximately 86,000 among persons with HIV (PWH). Unhealthy alcohol use can worsen the health of people who have Tuberculosis (TB) and people who have both TB and HIV. Behavioral interventions that 1) target alcohol use and 2) are integrated into TB and TB/HIV care may lead to better outcomes. The goal of this study is to test if a behavioral alcohol reduction intervention integrated into TB treatment can reduce alcohol use and improve TB and HIV health outcomes among people with unhealthy alcohol use. The aims of the HATHI study are: Aim 1: To test if a 4 session behavioral alcohol reduction intervention, called CAP (Counseling on Alcohol Problems), integrated into TB and TB/HIV Care can decrease unhealthy alcohol use among persons with TB and TB and HIV. Aim 2: To test if the CAP intervention, integrated into TB and TB/HIV care can improve TB and HIV clinical outcomes; Aim 3: To evaluate barriers and facilitators to integrating CAP into TB and TB/HIV care, and to determine the incremental costs of delivering CAP in TB and HIV clinical settings. Investigators hypothesize that CAP intervention will reduce alcohol use among persons with TB and TB with HIV, and that it delivery in the TB and TB/HIV setting will be acceptable to patient and providers and feasible.

Condition or disease Intervention/treatment Phase
Tuberculosis Hiv Behavioral: CAP Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hybrid Trial for Alcohol Reduction Among People With TB and HIV in India (HATHI)
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CAP (Counseling on Alcohol Problems)
The CAP intervention is an up to 4-session alcohol reduction intervention that uses a combination of Motivational Enhancement Therapy and Cognitive Behavioral Therapy. The intervention will also include 3 booster sessions.
Behavioral: CAP
4-session combination Motivational Enhancement Therapy and Cognitive Behavioral Therapy alcohol reduction intervention. The intervention will also include 3 booster sessions.

Usual Care
Provider advice to reduce alcohol use per recommended standard of clinical care, and referral to treatment as indicated
Other: Usual Care
Provider advice to reduce alcohol use per recommended standard of clinical care, and referral to treatment as indicated




Primary Outcome Measures :
  1. Alcohol Use: Drinking days [ Time Frame: 6 months ]
    Self reported number of drinking days on the 30-day Time Line Follow Back Interview (TLFB)

  2. Alcohol Use: Heavy drinking days [ Time Frame: 6 months ]
    Self reported heavy drinking days on the 30-day Time Line Follow Back Interview (TLFB)

  3. Alcohol Use: Standard drinks per drinking day [ Time Frame: 6 months ]
    Self reported standard drinks per drinking day the 30-day Time Line Follow Back Interview (TLFB)


Secondary Outcome Measures :
  1. Change in Alcohol Use as assessed by change in Drinking days [ Time Frame: 3 months and 12 months ]
    Change in Self reported number of drinking days on the 30-day Time Line Follow Back Interview (TLFB)

  2. Change in Alcohol Use as assessed by change in heavy Drinking days [ Time Frame: 3 months and 12 months ]
    Change in Self reported heavy drinking days on the 30-day Time Line Follow Back Interview (TLFB)

  3. Change in Alcohol Use as assessed by change in standard drinks per drinking days [ Time Frame: 3 months and 12 months ]
    Change in Self reported standard drinks per drinking day on the 30-day Time Line Follow Back Interview

  4. TB treatment failure, TB treatment default, or all-cause mortality [ Time Frame: 12 months ]
    Composite outcome: TB treatment failure, TB treatment default, or all-cause mortality (defined as a binary outcome i.e. 0=none of these outcomes and 1= one or more of these outcomes)

  5. HIV-RNA Non-Suppression [ Time Frame: 6 months ]
    This will be assessed as HIV-RNA >200 copies

  6. HIV-RNA Non-Suppression [ Time Frame: 12 months ]
    This will be assessed as HIV-RNA >200 copies


Other Outcome Measures:
  1. Change in Phosphatidyl Ethanol [ Time Frame: 3, 6, 12 months ]
    We will assess change in blood levels of Phosphatidyl Ethanol as an Alcohol Biomarker



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active TB defined as either a) microbiologically confirmed TB (sputum AFB smear positive by microscopy or +GeneXpert at entry) or b) clinical TB that is subsequently confirmed by Acid-Fast Bacilli (AFB) culture;
  • with or without concurrent HIV infection)
  • initiating TB therapy;
  • age ≥ 18 years of age;
  • AUDIT Score ≥ 8 in men /≥4 in women.

Exclusion Criteria:

  • already in treatment for unhealthy alcohol use;
  • unable to participate in intervention sessions either due to severity of medical illness, cognitive dysfunction or active psychosis;
  • pregnant (will refer directly to alcohol treatment);
  • household member of current study participant;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230395


Contacts
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Contact: Geetanjali Chander 443-287-2030 gchande1@jhmi.edu
Contact: Alison Pack 410-502-2653 apack@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Geetanjali Chander, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04230395    
Other Study ID Numbers: R01 AA027974
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per NOT-AA-19-020, we will share/upload data to the NIAAA Data Archive (NIAAADA).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Alcohol Use
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs