Ignite Creation Date:
2024-05-06 @ 2:09 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04230395
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2020-01-14
Brief Title:
Alcohol Reduction Among People With TB and HIV in India
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Hybrid Trial for Alcohol Reduction Among People With TB and HIV in India HATHI
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HATHI
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 86000 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 TBHIV 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 TBHIV 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 TBHIV care can improve TB and HIV clinical outcomes Aim 3 To evaluate barriers and facilitators to integrating CAP into TB and TBHIV 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 TBHIV setting will be acceptable to patient and providers and feasible
Detailed Description:
In 2017 over 10 million people worldwide developed tuberculosis disease TB with 9 of cases among people with HIV PWH In that same year there were 16 million deaths from TB with 300000 among PWH The highest incidence of TB is in India accounting for 27 of all new cases globally with approximately 86000 among PWH Unhealthy alcohol use triples the risk of TB in the general population increasing susceptibility to primary infection and reactivation Among PWH unhealthy alcohol use is associated with decreased use of and adherence to antiretroviral therapy ART lower viral suppression and increased mortality Treatment for TB presents a unique opportunity to address unhealthy alcohol use among people with TB and HIVTB given the frequent contact participants have with healthcare providers and the deleterious effects of unhealthy use on both HIV and TB clinical outcomes Although combined cognitive behavioral therapy CBT and motivational enhancement therapy MET can be effective in reducing alcohol use access to and implementation of such interventions is limited in high-need under-resourced low and middle income LMIC settings Even in settings where formal treatment is available alcohol-related stigma and cost of treatment may prevent individuals from seeking care Integrating treatment for unhealthy alcohol use into TB and HIVTB care may overcome barriers to alcohol treatment for such individuals at risk for poor health outcomes HATHI Hybrid trial for Alcohol reduction among people with TB and HIVTB in India is a 2-arm hybrid type 1 effectiveness-implementation randomized controlled trial RCT examining the effectiveness of a four-session combined CBTMET alcohol reduction intervention CAP-Counseling on Alcohol Problems followed by three intervention boosters integrated into TB and HIVTB care compared with usual care provider advice referral to treatment as needed There will be 3 phases In Phase 1 investigators will tailor the intervention tailoring based on results from a focus groups FG with patients with HIVTB medical and clinical staff and the intervention counselors IC and b individual intervention testing with a subgroup of HIVTB patients In Phase 2 investigators will conduct an RCT in which participants will be randomized to CAP intervention or to usual care Investigators will stratify by HIV status to ensure balance of HIV between the groups Effectiveness outcomes measured at 3 6 and 12 months will include 1 self-reported alcohol use primary and phosphatidyl ethanol PEth an alcohol biomarker secondary and 2 TB and HIV clinical outcomes In Phase 3 evaluating trial participants counselors clinical and organizational staff investigators will use the RE-AIM implementation framework using mixed methods to assess barriers and facilitators to alcohol treatment integration in TB and HIVTB clinical settings and to assess the incremental costs of this intervention strategy
Setting All phases of the study will take place at two sites in India the Byramjee Jeejeebhoy Government Medical College BJGMC and Dr DY Patil Medical College Pune DYPMC
ObjectivesAims
Aim 1 In a randomized controlled trial RCT to examine the effectiveness of CBTMET integrated into TB and HIVTB care compared to usual care on alcohol reduction
Aim 2 In a RCT to examine the effectiveness of CBTMET integrated into TB and HIVTB care compared to usual care on TB and HIV treatment outcomes
Aim 3 Guided by the RE-AIM implementation framework and using mixed methods to 3a evaluate patient provider and organizational barriers and facilitators to integrated alcohol treatment in TB and HIVTB settings and 3b measure incremental costs from health system and societal perspectives
Prior to RCT implementation investigators will tailor CAP and make final modifications to the CAP manual CAP will be enhanced with content specific to Pune such as local alcohol containing beverages and local or state drinking norms and alcohol impacts on TB and HIV progression and clinical outcomes Investigators will modify the manual and test in focus groups
Phase 2-Clinical Trial This phase involves collection of routinely used research assessments for individuals with TB and HIVTB at baseline 3 6 and 12 months and the launch of the RCT The study will include adults individuals with newly diagnosed TB unhealthy alcohol use initiating TB medication treatment Individuals will be recruited through both provider and self-referral Up to half of the sample will have both TB and HIV Eligible individuals will undergo baseline assessment which includes a medical history clinical exam questionnaires and a blood spot for the alcohol biomarker PEth
Assignments of Participants to the Study Intervention Eligible participants will be randomized in a 11 ratio upon completion of the baseline evaluation The study biostatistician independent of the trial will generate the randomization sequence in permuted blocks and randomization will be stratified by the presence of HIV infection A sealed envelope with study assignment will be used to conceal the study group assignment
Study Conditions
Control Individuals in the control arm will receive standard of care TB and HIV treatment and usual care from participants provider which includes advice to reduce alcohol use and referral to alcohol treatment services at participants providers discretion Participants will also receive a general guide on nutrition diabetes tobacco and alcohol
Intervention CAP is an up to 4-session manualized alcohol reduction treatment based on Cognitive Behavioral and Motivational Enhancement Therapy Each session lasts up to 45 minutes The 4 CAP sessions will be delivered by a counselor during an 8 week period closely aligned to regular TB treatment follow up visits After the 4 intervention sessions individuals will receive 3 scripted booster sessions one month apart corresponding to participants TB follow up visits
Research Data Ascertainment Assessments will occur at baseline prior to randomization 3 months end of 4 session intervention 6 and 12 months post-baseline Data collection will include self-report questionnaires staff interviews and biomarker and specimens and will encompass demographics a clinical assessment measurement of alcohol use its severity and consequences HIV measures including viral load medication adherence and HIV retention in care TB measures including TB clearance TB treatment default TB medication adherence and TB retention in care Other measures span mental health tobacco and other substance use quality of life diabetes mellitus motivation to change and self-efficacy
Investigators primary alcohol endpoint will occur at 6 months after baseline with investigators secondary endpoint at 12 months Sample size calculations are based on data from behavioral alcohol reduction interventions in low and middle income countries
Investigators trial will enroll a total of 450 participants with TB or TBHIV The study will be conducted at two sites and 2 counselors at each site will administer the intervention Power calculations assume a 10 loss to follow-up and intra-class correlation coefficient of 004 based on CAPPREMIUM RCT to account for 2 counselors per site 2 sites Analyses will also account for variation by counselor and by site
Phase 3 The Reach Effectiveness Adoption Implementation and Maintenance RE-AIM implementation framework will be used to collect quantitative and qualitative assessments from 3 levels of stakeholders Numbers approximate pending thematic saturation Investigators will evaluate barriers and facilitators to intervention reach effectiveness adoption implementation and maintenance focusing in implementation outcomes of feasibility acceptability appropriateness fidelity and sustainability Investigators will also calculate the incremental costs of the intervention
Setting All phases of the study will take place at two sites in India the Byramjee Jeejeebhoy Government Medical College BJGMC and Dr DY Patil Medical College Pune DYPMC
ObjectivesAims
Aim 1 In a randomized controlled trial RCT to examine the effectiveness of CBTMET integrated into TB and HIVTB care compared to usual care on alcohol reduction
Aim 2 In a RCT to examine the effectiveness of CBTMET integrated into TB and HIVTB care compared to usual care on TB and HIV treatment outcomes
Aim 3 Guided by the RE-AIM implementation framework and using mixed methods to 3a evaluate patient provider and organizational barriers and facilitators to integrated alcohol treatment in TB and HIVTB settings and 3b measure incremental costs from health system and societal perspectives
Prior to RCT implementation investigators will tailor CAP and make final modifications to the CAP manual CAP will be enhanced with content specific to Pune such as local alcohol containing beverages and local or state drinking norms and alcohol impacts on TB and HIV progression and clinical outcomes Investigators will modify the manual and test in focus groups
Phase 2-Clinical Trial This phase involves collection of routinely used research assessments for individuals with TB and HIVTB at baseline 3 6 and 12 months and the launch of the RCT The study will include adults individuals with newly diagnosed TB unhealthy alcohol use initiating TB medication treatment Individuals will be recruited through both provider and self-referral Up to half of the sample will have both TB and HIV Eligible individuals will undergo baseline assessment which includes a medical history clinical exam questionnaires and a blood spot for the alcohol biomarker PEth
Assignments of Participants to the Study Intervention Eligible participants will be randomized in a 11 ratio upon completion of the baseline evaluation The study biostatistician independent of the trial will generate the randomization sequence in permuted blocks and randomization will be stratified by the presence of HIV infection A sealed envelope with study assignment will be used to conceal the study group assignment
Study Conditions
Control Individuals in the control arm will receive standard of care TB and HIV treatment and usual care from participants provider which includes advice to reduce alcohol use and referral to alcohol treatment services at participants providers discretion Participants will also receive a general guide on nutrition diabetes tobacco and alcohol
Intervention CAP is an up to 4-session manualized alcohol reduction treatment based on Cognitive Behavioral and Motivational Enhancement Therapy Each session lasts up to 45 minutes The 4 CAP sessions will be delivered by a counselor during an 8 week period closely aligned to regular TB treatment follow up visits After the 4 intervention sessions individuals will receive 3 scripted booster sessions one month apart corresponding to participants TB follow up visits
Research Data Ascertainment Assessments will occur at baseline prior to randomization 3 months end of 4 session intervention 6 and 12 months post-baseline Data collection will include self-report questionnaires staff interviews and biomarker and specimens and will encompass demographics a clinical assessment measurement of alcohol use its severity and consequences HIV measures including viral load medication adherence and HIV retention in care TB measures including TB clearance TB treatment default TB medication adherence and TB retention in care Other measures span mental health tobacco and other substance use quality of life diabetes mellitus motivation to change and self-efficacy
Investigators primary alcohol endpoint will occur at 6 months after baseline with investigators secondary endpoint at 12 months Sample size calculations are based on data from behavioral alcohol reduction interventions in low and middle income countries
Investigators trial will enroll a total of 450 participants with TB or TBHIV The study will be conducted at two sites and 2 counselors at each site will administer the intervention Power calculations assume a 10 loss to follow-up and intra-class correlation coefficient of 004 based on CAPPREMIUM RCT to account for 2 counselors per site 2 sites Analyses will also account for variation by counselor and by site
Phase 3 The Reach Effectiveness Adoption Implementation and Maintenance RE-AIM implementation framework will be used to collect quantitative and qualitative assessments from 3 levels of stakeholders Numbers approximate pending thematic saturation Investigators will evaluate barriers and facilitators to intervention reach effectiveness adoption implementation and maintenance focusing in implementation outcomes of feasibility acceptability appropriateness fidelity and sustainability Investigators will also calculate the incremental costs of the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA027974 | NIH | None | httpsreporternihgovquickSearchR01AA027974 |