Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02234908
Other study ID # H-33047
Secondary ID M1405291U01AI100
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date December 2016

Study information

Verified date January 2021
Source Boston University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot project is an evaluation of the feasibility, acceptability, and cost of offering an economic reward, in the form of a shopping voucher, to the household contacts of index patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the study clinic for TB screening and optional HIV testing, providing a reward to the index patients for participating, and entering index patients whose contacts do present into a lottery to win a prize.The effectiveness of the intervention in screening a high proportion of contacts will be compared to existing published data from studies of active case-finding through home visits and of the status quo passive case finding. If successful, this pilot project will create a demand for screening among high risk patients, who will be rewarded for identifying themselves to the healthcare system, and could prove to be an affordable alternative to resource-intensive home visits. It will also shift responsibility for contact tracing from overburdened clinic staff to those who have the most to gain from early case detection-the patients and their families.


Description:

Despite the success of antiretroviral treatment (ART) programs in reaching > 10 million HIV-infected patients in resource-limited countries over the past decade, HIV and tuberculosis (TB), continue to take a heavy toll on survival and health in southern Africa. In South Africa, where 6.4 million people are estimated to be HIV-positive and up to 2.1 million are on ART, TB incidence is the second highest in the world (after Swaziland), 65% of TB patients are HIV-infected, and TB remains the leading natural cause of death. Drug-resistant TB (DR-TB) is even more concerning, with more than 15,000 South African patients diagnosed with multidrug-resistant TB (MDR-TB) in 2012, nearly a fifth of the global total, and very high mortality among those receiving standard MDR-TB treatment. Because of the high risk of both TB and HIV among the household contacts of TB patients and the importance of early case detection for both diseases and especially for DR-TB, improving TB case finding is a high priority. Recent studies have shown that having healthcare workers make multiple visits to the homes of TB patients in order to screen household contacts is a logistically challenging and resource- intensive strategy, and it is not routinely undertaken in most public sector settings in South Africa. One alternative to home visits that could prove effective and affordable is to offer small economic rewards to the household contacts of TB patients who voluntarily present at a healthcare facility for TB symptom screening and optional HIV testing. Economic incentives have been successful in increasing demand for healthcare in a variety of settings, but they have not been tried before as a way to increase uptake of services among patients' contacts, rather than among the diagnosed patients themselves. This pilot project is an evaluation of the feasibility and results of offering an economic reward, in the form of a shopping voucher, to the household contacts of index patients (outpatient drug-susceptible and drug-resistant TB patients) who present at the study clinic for TB screening and optional HIV testing, providing a reward to the index patients for participating, and entering index patients whose contacts do present into a lottery to win a prize. The effectiveness of the intervention in screening a high proportion of contacts will be compared to existing published data from studies of active case-finding through home visits and of the status quo passive case finding. If successful, this pilot project will create a demand for screening among high risk patients, who will be rewarded for identifying themselves to the healthcare system, and could prove to be an affordable alternative to resource-intensive home visits. It will also shift responsibility for contact tracing from overburdened clinic staff to those who have the most to gain from early case detection-the patients and their families.


Recruitment information / eligibility

Status Completed
Enrollment 301
Est. completion date December 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion criteria for index cases: - Adult patients (>18 years) - Newly diagnosed with pulmonary TB (drug-susceptible or drug-resistant) or initiating treatment for TB at one of the study sites Exclusion criteria for index cases: - Resident outside the site's permissible catchment area for service delivery - No household contacts (live alone) - Admitted for inpatient care immediately following their TB diagnosis, and thus not readily able to distribute the referral cards - Not physically, mentally, or emotionally able to participate in the study, in the view of study staff - Previously enrolled in the same study - Declines to provide written informed consent to participate - Unable to speak any of the languages for which consent documents are available and not accompanied by person who can Inclusion criteria for contacts: - Usually spend at least 4 nights per week in the same household as an index case - Can provide referral card given to contact by index patient Exclusion criteria for contacts: - Currently on any type of TB treatment - Not able to present any form of identification that matches the information on the referral card - Previously enrolled in the same study - Declines to provide written informed consent to participate - Unable to speak any of the languages for which consent documents are available and not accompanied by person who can Inclusion criteria for interview respondents: - Experience with the intervention as provider or patient - Written informed consent to be interviewed Exclusion criteria for contacts: • None

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Contacts
Household contacts who come to the study clinic, present a referral card, and complete TB symptom screening will receive a shopping voucher of $5-10 value.
Index
Index subjects will be entered in a prize lottery if any of their contacts complete TB symptom screening at the study clinic.

Locations

Country Name City State
South Africa Helen Joseph Hospital Johannesburg
South Africa OR Tambo Clinic Johannesburg

Sponsors (5)

Lead Sponsor Collaborator
Boston University City of Johannesburg, Helen Joseph Hospital, National Institute of Allergy and Infectious Diseases (NIAID), University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of household contacts volunteering for TB symptom screening The primary quantitative outcome is uptake of TB symptom screening, defined as the proportion of reported household contacts who complete TB symptom screening within 1 month of index subject enrollment. 30 days
See also
  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