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.
