NCT02234908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

September 5, 2014

Last Update Submit

January 7, 2021

Conditions

TuberculosisDrug-resistant Tuberculosis

Keywords

TuberculosisDrug-resistant tuberculosisIncentivesSymptom screening

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Contacts

EXPERIMENTAL

Contacts are the household contacts of confirmed TB and drug-resistant TB patients.

Behavioral: Contacts

Index

OTHER

Index subjects are confirmed TB and drug-resistant TB patients who distribute referral cards to their household contacts.

Behavioral: Index

Interventions

ContactsBEHAVIORAL

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.

Contacts
IndexBEHAVIORAL

Index subjects will be entered in a prize lottery if any of their contacts complete TB symptom screening at the study clinic.

Index

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • 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
  • Experience with the intervention as provider or patient
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helen Joseph Hospital

Johannesburg, 2193, South Africa

Location

OR Tambo Clinic

Johannesburg, South Africa

Location

MeSH Terms

Conditions

TuberculosisTuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Sydney Rosen

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2014

First Posted

September 9, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2016

Study Completion

December 1, 2016

Last Updated

January 8, 2021

Record last verified: 2021-01

Locations

ZA(2)