Lung DiseasesNCT00233168
Effectiveness of Public Health Model of Latent Tuberculosis Infection Control for High-Risk Adolescents
A study testing Adherence Program in people with Lung Diseases and Tuberculosis, run by San Diego State University at 1 site in United States.
Trial summary
This study will determine the differential cumulative mean number of isoniazid (INH) pills completed over 9 to 12 months for adolescents assigned to one of the following two groups: 1) peer adherence coaching, parent training, and self-esteem/life skills counseling; or 2) self-esteem/life skills counseling alone. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Lung Diseases, Tuberculosis
- What is being tested?
- Adherence Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 263 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- PPD positive
- San Diego County residents (without plans to relocate out of the county in the 12 months after study entry)
- Able to respond to the interview questions in English or Spanish
- Eligible for INH treatment
Who cannot join
- Receiving treatment in Mexico (due to differing medications and length of treatment)
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92123
About this study
Official title: Promoting Adherence to TB Regimens in High Risk Youth
This study will determine the differential cumulative mean number of isoniazid (INH) pills completed over 9 to 12 months for adolescents assigned to one of the following two groups: 1) peer adherence coaching, parent training, and self-esteem/life skills counseling; or 2) self-esteem/life skills counseling alone. The study will also estimate the costs and cost effectiveness of peer adherence coaching versus control procedures; this will be done from a provider and societal perspective.
Read the detailed description
BACKGROUND:
Tuberculosis (TB) was responsible for almost one billion deaths in the 20th century. It is epidemic in the developing world and immigrants introduce TB to developed nations. TB control requires treatment for latent TB infection (LTBI) and active disease, as well as adherence to medical regimens. This study will determine the effectiveness of a public health model of LTBI control among high-risk adolescents. The integration of behavioral science, medical services, parent instruction, and assistance from schools and clinics (coordinated by the county health department) is based on recommendations from the Centers for Disease Control and Prevention (CDC). The effectiveness of this system is dependent, in part, on patient adherence.
DESIGN NARRATIVE:
The primary outcome of this study is adherence to an INH treatment regimen. For a given participant, adherence is assessed every 30 days, with the final outcome determined 12 months after treatment start date. Adherence is assessed using participant recall, urine testing for INH metabolites, pill counts, and medication event monitoring system (MEMS) caps.
The key secondary outcomes are parent knowledge and practice of intervention support procedures, parent knowledge of TB, self-esteem effects and life skills acquisition, cost and cost effectiveness of the intervention, and knowledge and practice of LTBI care by providers at participating community clinics.
- Conditions
- Lung Diseases, Tuberculosis
- Being tested
- Adherence Program, Life Skills and Self-Esteem Training Program (Attention Control Arm)
- Medical subject headings
- Lung Diseases, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence ProgramBehavioural
14 counseling sessions focusing on INH adherence conducted over 6 months, starting once per week and decreasing in frequency to once a month.
Life Skills and Self-Esteem Training Program (Attention Control Arm)Behavioural
Peer counseling session covering life skills (e.g., communication skills, goal setting, self-esteem) training, 14 sessions over 6 months beginning once per week and decreasing in frequency over time to once per month.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Peer medication adherence counseling Receives: Behavioral: Adherence Program |
| 2 | Active comparator | Peer life skills counseling Receives: Behavioral: Life Skills and Self-Esteem Training Program (Attention Control Arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of INH pills taken
30-day recall of INH consumption measured monthly for up to 12 months
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 posted5 Oct 2005 (estimated)
- Study startSep 2003
- Primary completionAug 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Melbourne Hovell, San Diego State University
- Investigators
- Melbourne Hovell, Study chair, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233168
- Sponsor's protocol ID
- 323
- Other IDs
- R01HL068595
- Status last verified
- Jun 2014
- First submitted
- 3 Oct 2005
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hill LL, Hovell M, Blumberg E, Kelley N, Baird S, Sipan C, Schmitz K, Friedman L. Gaps between Adolescent Risk Behaviors and Disclosure during Outpatient Visits. Int J Family Med. 2013;2013:718568. doi: 10.1155/2013/718568. Epub 2013 Apr 24.
PubMed 23710357West JH, Blumberg EJ, Kelley NJ, Hill L, Sipan CL, Schmitz KE, Kolody B, Chambers CD, Friedman LS, Hovell MF. The Role of Parenting in Alcohol and Tobacco Use Among Latino Adolescents. J Child Adolesc Subst Abuse. 2013 Apr 1;22(2):120-132. doi: 10.1080/1067828X.2012.730359. Epub 2013 Feb 7.
PubMed 23439845West JH, Blumberg EJ, Kelley NJ, Hill L, Sipan CL, Schmitz KE, Ryan S, Clapp JD, Hovell MF. Does proximity to retailers influence alcohol and tobacco use among Latino adolescents? J Immigr Minor Health. 2010 Oct;12(5):626-33. doi: 10.1007/s10903-009-9303-2.
PubMed 19936923West JH, Blumberg EJ, Kelley NJ, Hill L, Sipan CL, Schmitz K, Kolody B, Madlensky L, Hovell MF. Latino parenting practices: a comparison of parent and child reports of parenting practices and the association with gateway drug use. J Ethn Subst Abuse. 2011;10(1):71-89. doi: 10.1080/15332640.2011.547800.
PubMed 21409705Hill L, Blumberg E, Sipan C, Schmitz K, West J, Kelley N, Hovell M. Multi-level barriers to LTBI treatment: a research note. J Immigr Minor Health. 2010 Aug;12(4):544-50. doi: 10.1007/s10903-008-9216-5. Epub 2008 Dec 16.
PubMed 19085104Schmitz KE, Hovell MF, Wong CA, Kelley NJ, Nilsen D, Blumberg EJ, Hill LL, Sipan CL, Kolody B, Chatfield DA. The reliability and practicality of the Arkansas method assay of isoniazid adherence. Clin Nurs Res. 2010 May;19(2):131-43. doi: 10.1177/1054773810363473.
PubMed 20435784Hovell MF, Schmitz KE, Blumberg EJ, Hill L, Sipan C, Friedman L. Lessons learned from two interventions designed to increase adherence to LTBI treatment in Latino youth. Contemp Clin Trials Commun. 2018 Aug 16;12:129-136. doi: 10.1016/j.conctc.2018.08.002. eCollection 2018 Dec.
PubMed 30456327
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adherence to TB Regimens in High Risk Youth
- ClinicalTrials.gov ID
- NCT00233168
- Acronym / sponsor ID
- 323
- Conditions
- Lung Diseases, Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2003
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 5 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the differential cumulative mean number of isoniazid (INH) pills completed over 9 to 12 months for adolescents assigned to one of the following two groups: 1) peer adherence coaching, parent training, and self-esteem/life skills counseling; or 2) self-esteem/life skills counseling alone. The study will also estimate the costs and cost effectiveness of peer adherence coaching versus control procedures; this will be done from a provider and societal perspective.
Detailed description
BACKGROUND:
Tuberculosis (TB) was responsible for almost one billion deaths in the 20th century. It is epidemic in the developing world and immigrants introduce TB to developed nations. TB control requires treatment for latent TB infection (LTBI) and active disease, as well as adherence to medical regimens. This study will determine the effectiveness of a public health model of LTBI control among high-risk adolescents. The integration of behavioral science, medical services, parent instruction, and assistance from schools and clinics (coordinated by the county health department) is based on recommendations from the Centers for Disease Control and Prevention (CDC). The effectiveness of this system is dependent, in part, on patient adherence.
DESIGN NARRATIVE:
The primary outcome of this study is adherence to an INH treatment regimen. For a given participant, adherence is assessed every 30 days, with the final outcome determined 12 months after treatment start date. Adherence is assessed using participant recall, urine testing for INH metabolites, pill counts, and medication event monitoring system (MEMS) caps.
The key secondary outcomes are parent knowledge and practice of intervention support procedures, parent knowledge of TB, self-esteem effects and life skills acquisition, cost and cost effectiveness of the intervention, and knowledge and practice of LTBI care by providers at participating community clinics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Adherence ProgramPeer medication adherence counseling |
| 2 | Active comparator | Behavioral: Life Skills and Self-Esteem Training Program (Attention Control Arm)Peer life skills counseling |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- PPD positive
- San Diego County residents (without plans to relocate out of the county in the 12 months after study entry)
- Able to respond to the interview questions in English or Spanish
- Eligible for INH treatment
Key exclusion criteria (1 listed)
- Receiving treatment in Mexico (due to differing medications and length of treatment)
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 |
|---|---|---|
| Adherence Program14 counseling sessions focusing on INH adherence conducted over 6 months, starting once per week and decreasing in frequency to once a month. | Behavioural | 1 |
| Life Skills and Self-Esteem Training Program (Attention Control Arm)Peer counseling session covering life skills (e.g., communication skills, goal setting, self-esteem) training, 14 sessions over 6 months beginning once per week and decreasing in frequency over time to once per month. | Behavioural | 2 |
Primary outcome
Number of INH pills taken
Time frame: 12 months
30-day recall of INH consumption measured monthly for up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- Results publication: PubMed 23710357Hill LL, Hovell M, Blumberg E, Kelley N, Baird S, Sipan C, Schmitz K, Friedman L. Gaps between Adolescent Risk Behaviors and Disclosure during Outpatient Visits. Int J Family Med. 2013;2013:718568. doi: 10.1155/2013/718568. Epub 2013 Apr 24.
- Results publication: PubMed 23439845West JH, Blumberg EJ, Kelley NJ, Hill L, Sipan CL, Schmitz KE, Kolody B, Chambers CD, Friedman LS, Hovell MF. The Role of Parenting in Alcohol and Tobacco Use Among Latino Adolescents. J Child Adolesc Subst Abuse. 2013 Apr 1;22(2):120-132. doi: 10.1080/1067828X.2012.730359. Epub 2013 Feb 7.
- Results publication: PubMed 19936923West JH, Blumberg EJ, Kelley NJ, Hill L, Sipan CL, Schmitz KE, Ryan S, Clapp JD, Hovell MF. Does proximity to retailers influence alcohol and tobacco use among Latino adolescents? J Immigr Minor Health. 2010 Oct;12(5):626-33. doi: 10.1007/s10903-009-9303-2.
- Results publication: PubMed 21409705West JH, Blumberg EJ, Kelley NJ, Hill L, Sipan CL, Schmitz K, Kolody B, Madlensky L, Hovell MF. Latino parenting practices: a comparison of parent and child reports of parenting practices and the association with gateway drug use. J Ethn Subst Abuse. 2011;10(1):71-89. doi: 10.1080/15332640.2011.547800.
- Results publication: PubMed 19085104Hill L, Blumberg E, Sipan C, Schmitz K, West J, Kelley N, Hovell M. Multi-level barriers to LTBI treatment: a research note. J Immigr Minor Health. 2010 Aug;12(4):544-50. doi: 10.1007/s10903-008-9216-5. Epub 2008 Dec 16.
- Results publication: PubMed 20435784Schmitz KE, Hovell MF, Wong CA, Kelley NJ, Nilsen D, Blumberg EJ, Hill LL, Sipan CL, Kolody B, Chatfield DA. The reliability and practicality of the Arkansas method assay of isoniazid adherence. Clin Nurs Res. 2010 May;19(2):131-43. doi: 10.1177/1054773810363473.
- Derived from this study: PubMed 30456327Hovell MF, Schmitz KE, Blumberg EJ, Hill L, Sipan C, Friedman L. Lessons learned from two interventions designed to increase adherence to LTBI treatment in Latino youth. Contemp Clin Trials Commun. 2018 Aug 16;12:129-136. doi: 10.1016/j.conctc.2018.08.002. eCollection 2018 Dec.
Related trials for Lung Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Melbourne Hovell study chair
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherence Program in people with Lung Diseases and Tuberculosis, run by San Diego State University at 1 site in United States.
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 4 inclusion and 1 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 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 INH pills taken (time frame: 12 months). 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 NCT00233168, which also lists 7 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 25 Jun 2014.