Tuberculosis Clinical Trial
Official title:
An Impact Evaluation of the Private Provider Interface Agency Program on Quality of Tuberculosis Care: A Standardized Patient Study in Mumbai, India
The purpose of this study is to evaluate the impact of the Private Provider Interface Agency (PPIA) program on quality of care. The PPIA is a tuberculosis pilot program implemented in the private health sector of Mumbai city, India.
By taking advantage of a randomized roll-out design of the PPIA program in Mumbai, this
evaluation aims to determine the causal effects of the program on quality of care among
private sector health providers. The evaluation is embedded in an existing quality of care
surveillance project that uses standardized patients to assess the quality of tuberculosis
(TB) care in Mumbai, India. Below is a description of (1) the TB intervention implemented by
the PPIA, (2) the quality of TB care (QuTUB) surveillance project, and (3) the randomized
roll-out of the PPIA program among a subset of providers in order to isolate the impact of
the program on quality of care.
The entire program and its implementation are external to the researchers. To better
understand the impact of the program using an already approved surveillance study, the
researchers use a stepped-wedge design that involves a sequential roll-out of the program to
a subset of providers over a period of time where the order of roll-out is randomized.
1. PPIA intervention: Between January 2014 and December 2016, the pilot PPIA program was
independently implemented by the non-governmental organization PATH (Program for
Appropriate Technology in Health as it is known formerly) in Mumbai city. In its role as
the PPIA in Mumbai, PATH's aim is to strengthen existing efforts to control TB through
engagement of the private health sector. Through this network, the objectives are to
facilitate early and accurate diagnosis with proper notification of cases and to ensure
appropriate treatment and treatment adherence to completion among TB patients in the
private sector. In order to achieve these objectives, the PPIA initiated and expanded a
private sector network based on a hub-and-spoke model. Hubs are generally private health
facilities ("hubs" with an MD Chest Physician and access to a pharmacy and digital X-ray
laboratory) and private clinics of MD and MD Chest Physicians. Spokes are generally
doctors with a Bachelor of Medicine, Bachelor of Surgery (MBBS) degree, practitioners of
alternative medicines (AYUSH practitioners who are trained Ayurveda, Yoga and
Naturopathy, Unani, Siddha, or Homeopathy), and informal providers with minimum or no
qualifications. The PPIA network also includes chemists/pharmacists and diagnostic
laboratories. The pilot in Mumbai will serve as a model for private health sector
involvement in national TB control and will be used to inform similar programs nearby
and in other urban Indian settings.
2. Quality of care surveillance: The QuTUB project is a part of the PPIA monitoring efforts
and runs in parallel to the programs' scale up and expansion. The objective of the QuTUB
project is to capture levels of quality of care through standardized patients ("mystery
shoppers" or "fake patients"), who are individuals recruited locally and trained to
portray four different TB cases. Developed by a Technical Advisory Group and benchmarked
against the Standards of TB Care of India, the cases were designed to reflect different
stages of TB disease progression, some with previous interactions with the health system
upon presentation to a health care provider. Outcomes captured by the standardized
patients through an exit questionnaire given to them within 2 hours of their interaction
with providers` include: history questions asked by the provider, laboratory tests
ordered, medicines dispensed or prescribed, and referrals made.
3. Randomized roll-out evaluation approach: In January 2015, PATH was interested in trying
to further understand the causal impact of their program on diagnostic processes, and
there was an opportunity to remove the selection bias and attribute differences in
quality of care solely to the program by taking advantage of a randomized roll-out
expansion plan of the PPIA program among a subset of providers. In collaboration with
the PPIA Mumbai team, this study takes an intention-to-treat and instrumental variables
evaluation approach through selective enrollment of a subset of providers in the second
round of program scale-up in Mumbai city. The researchers note that the subset of
providers are those who were not purposively selected in the earlier round of enrollment
and therefore may be those who see fewer TB patients, or those who were reluctant to
enroll into the program during the first rounds of program expansion. Therefore, the
impact of the program on this group may be different from among those who were enrolled
previously. Under this approach, it was agreed that for the evaluation eligible AYUSH
practitioners would be networked in two purposively selected high TB burden or high slum
population wards in Mumbai. For this, the researchers provided PATH with a list of 300
randomly selected practitioners among those who were not already networked into the
program. AYUSH practitioners on this list were randomly allocated to two groups: one
group (treatment) of 150 eligible AYUSH would be sensitized and networked, and the other
group (control) of 150 eligible AYUSH would not be approached for networking after a
year or more, when the QuTUB study team is able to complete end-line data collection in
2016. Selection into program roll-out groups was randomized. Standardized patients are
sent to both groups before any intervention for baseline measures of quality of care,
and the standardized patients would return again before the control group begins to
receive the intervention for an end-line measure. The entire intervention in Mumbai is
implemented by the PPIA and is separate from the team implementing the quality of care
surveillance and evaluation. Care is taken to ensure that the evaluation team will be in
the field independently of the implementation.
Analysis:
Intention-to-treat analysis and instrumental variables will be conducted after determining
(i) that the treatment assignment can serve as a good instrument by: a strong correlation to
the actual enrollment statuses of the providers regardless of treatment assignment, being
uncorrelated with the outcomes, and only being connected to the outcomes through actual
enrollment in the program, and (ii) balance at baseline between the treatment and control
groups.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05738681 -
Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial
|
Phase 2/Phase 3 | |
Recruiting |
NCT05526885 -
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
|
N/A | |
Completed |
NCT04369326 -
Community Initiated Preventive Therapy for TB
|
N/A | |
Recruiting |
NCT04568967 -
TB-CAPT EXULTANT - HIV
|
N/A | |
Completed |
NCT02337270 -
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
|
Phase 1 | |
Not yet recruiting |
NCT06253715 -
Shortened Regimen for Drug-susceptible TB in Children
|
Phase 3 | |
Recruiting |
NCT04271397 -
Immunological Biomarkers in Tuberculosis Management
|
N/A | |
Withdrawn |
NCT03639038 -
Tuberculosis Diagnosis by Flow Cytometry
|
||
Completed |
NCT03199313 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid
|
Phase 1 | |
Recruiting |
NCT04975178 -
Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
|
Phase 3 | |
Completed |
NCT04463680 -
Rifampin and the Contraceptive Implant
|
Phase 4 | |
Completed |
NCT03973970 -
Assessing the Ability of the T-SPOT®.TB Test (IQ)
|
||
Recruiting |
NCT04230395 -
Alcohol Reduction Among People With TB and HIV in India
|
N/A | |
Completed |
NCT04874948 -
Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment
|
Phase 1 | |
Active, not recruiting |
NCT02906007 -
Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05917210 -
Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda
|
N/A | |
Not yet recruiting |
NCT06017843 -
Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding
|
N/A | |
Not yet recruiting |
NCT05845112 -
Start Taking Action For TB Diagnosis
|
||
Active, not recruiting |
NCT02715271 -
Study of TB Lesions Obtained in Therapeutical Surgery
|
||
Completed |
NCT02781909 -
Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis
|
Phase 2 |