Overview

This trial is active, not recruiting.

Conditions tuberculosis, drug-resistant tuberculosis
Treatments contacts, index
Sponsor Boston University
Collaborator University of Witwatersrand, South Africa
Start date October 2014
End date January 2016
Trial size 301 participants
Trial identifier NCT02234908, 1U01AI100015-01, H-33047, M140529

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 reward of R50-R100 ($5-$10) will be large enough to encourage voluntary presentation at the clinic, but not so large as to be perceived as coercive to patients or unaffordable to the health system. The effectiveness of the intervention in screening a high proportion of contacts and its cost per contact screen and TB case diagnosed will be compared to existing published and unpublished data from studies of active case-finding through home visits and of the status quo passive case finding.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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Contacts are the household contacts of confirmed TB and drug-resistant TB patients.
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.
(Other)
Index subjects are confirmed TB and drug-resistant TB patients who distribute referral cards to their household contacts.
index
Index subjects will be entered in a prize lottery if any of their contacts complete TB symptom screening at the study clinic.

Primary Outcomes

Measure
Proportion of household contacts volunteering for TB symptom screening
time frame: 30 days

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Rewards for Tuberculosis Contact Screening
Principal investigator Sydney Rosen
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, 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 reward of R50-R100 ($5-$10) will be large enough to encourage voluntary presentation at the clinic, but not so large as to be perceived as coercive to patients or unaffordable to the health system. The effectiveness of the intervention in screening a high proportion of contacts and its cost per contact screen and TB case diagnosed will be compared to existing published and unpublished 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Boston University.