Rewards for Tuberculosis Contact Screening (RECON)
Primary Purpose
Tuberculosis, Drug-resistant Tuberculosis
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Contacts
Index
Sponsored by
About this trial
This is an interventional diagnostic trial for Tuberculosis focused on measuring Tuberculosis, Drug-resistant tuberculosis, Incentives, Symptom screening
Eligibility Criteria
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
Sites / Locations
- Helen Joseph Hospital
- OR Tambo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Contacts
Index
Arm Description
Contacts are the household contacts of confirmed TB and drug-resistant TB patients.
Index subjects are confirmed TB and drug-resistant TB patients who distribute referral cards to their household contacts.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02234908
First Posted
September 5, 2014
Last Updated
January 7, 2021
Sponsor
Boston University
Collaborators
University of Witwatersrand, South Africa, City of Johannesburg, Helen Joseph Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT02234908
Brief Title
Rewards for Tuberculosis Contact Screening
Acronym
RECON
Official Title
Rewards for Tuberculosis Contact Screening
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
University of Witwatersrand, South Africa, City of Johannesburg, Helen Joseph Hospital, National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Drug-resistant Tuberculosis
Keywords
Tuberculosis, Drug-resistant tuberculosis, Incentives, Symptom screening
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
301 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Contacts
Arm Type
Experimental
Arm Description
Contacts are the household contacts of confirmed TB and drug-resistant TB patients.
Arm Title
Index
Arm Type
Other
Arm Description
Index subjects are confirmed TB and drug-resistant TB patients who distribute referral cards to their household contacts.
Intervention Type
Behavioral
Intervention Name(s)
Contacts
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Index
Intervention Description
Index subjects will be entered in a prize lottery if any of their contacts complete TB symptom screening at the study clinic.
Primary Outcome Measure Information:
Title
Proportion of household contacts volunteering for TB symptom screening
Description
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.
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sydney Rosen
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helen Joseph Hospital
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
OR Tambo Clinic
City
Johannesburg
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Rewards for Tuberculosis Contact Screening
We'll reach out to this number within 24 hrs