Rewards for Tuberculosis Contact Screening (RECON)
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|ClinicalTrials.gov Identifier: NCT02234908|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2014
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis Drug-resistant Tuberculosis||Behavioral: Contacts Behavioral: Index||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||301 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rewards for Tuberculosis Contact Screening|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||December 2019|
Contacts are the household contacts of confirmed TB and drug-resistant TB patients.
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 subjects are confirmed TB and drug-resistant TB patients who distribute referral cards to their household contacts.
Index subjects will be entered in a prize lottery if any of their contacts complete TB symptom screening at the study clinic.
- Proportion of household contacts volunteering for TB symptom screening [ Time Frame: 30 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234908
|Helen Joseph Hospital|
|Johannesburg, South Africa, 2193|
|OR Tambo Clinic|
|Johannesburg, South Africa|
|Principal Investigator:||Sydney Rosen||Boston University|