Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201509000877140 Date of Approval: 27/08/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mobile Health for Implementation of Home-based TB Contact Investigation in Uganda
Official scientific title Mobile Health for Implementation of Home-based TB Contact Investigation in Uganda
Brief summary describing the background and objectives of the trial Contact investigation is a widely advocated strategy for extending tuberculosis (TB) case detection from clinics to communities through screening of household contacts of new TB patients and referral of at-risk patients for clinic-based confirmatory testing and treatment. Unfortunately, low rates of clinic follow-up among at-risk individuals represent a major barrier to implementing contact investigation in high-burden countries. In a formative evaluation, we have identified a lack of patient knowledge about TB and TB evaluation, and economic and geographic barriers, as the major determinants of this quality gap. The objective of this study is to determine if home sputum collection, supported by targeted, mobile-phone health (mHealth) messages, is an effective and scalable solution for overcoming these barriers to implementing contact investigation. The scientific approach will be to carry-out a household-randomized, controlled trial in six urban Ugandan communities comparing two approaches to evaluation of at-risk contacts: referral to clinics for TB testing (standard approach) vs. home sputum collection supported by mHealth interventions. We will assess the patient and public-health impact of these interventions, using pre-specified measures of their reach, effectiveness, adoption, implementation, and maintenance. Specifically, we will first determine if mHealth-facilitated home sputum collection increases rates of TB and HIV diagnosis and clinic follow-up (reach), TB-treatment initiation (effectiveness), and completion (maintenance), as compared to standard contact investigation. Second, we will use quantitative and qualitative methods to evaluate the internal effectiveness and fidelity of the component interventions across different sites (adoption). Third, we will employ economic and epidemic modeling to estimate the costs and epidemiological impact of this intervention (implementation).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) mHealthCI
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/09/2015
Actual trial start date 27/07/2016
Anticipated date of last follow up 27/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 774
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
DMID Protocol Number: 13-0052 National Institute of Allergy and Infectious Diseases
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation (HIV status, age (less than 5, 5-14, older than14), site/health worker) Sealed within electronic survey software Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group mHealth contact investigation N/A N/A Home-based, systematic symptom-screening, followed by home sputum collection for symptomatic and other at-risk individuals (HIV-infected patients) with SMS reporting of results; follow-up symptom screening by interactive SMS every 6 months for two years with home sputum collection and/or referral for clinic evaluation among household contacts who screen or test negative at baseline 389
Control Group Standard contact investigation N/A N/A One-time, home-based, systematic symptom-screening intervention, followed by a selective invitation of symptomatic and other at-risk individuals (HIV-infected patients, children <5 years of age) to travel to nearby clinics to undergo formal clinical evaluation 389 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Index TB patients: 1. Reported to the NTLP by appearing in the NTLP TB treatment register, as one of the following: a)New microbiologically confirmed pulmonary TB patient; b) AFB sputum smear-positive; c)GeneXpert-positive; d)Mtb culture-positive; e) Child under 5 with newly diagnosed TB of any form even without microbiologic confirmation 2. Residing with the political boundaries of Kampala 3. Any age (including children and emancipated minors) 4. Any gender Household contacts: 1. Sleeping under same roof as the index TB patient for >5 nights in the previous 3 months 2. Any age (including children and emancipated minors) 3. Any gender Index TB patients: 1. Unable to provide informed consent (e.g. lacking capacity) 2. Unwilling to provide informed consent 3. MDR-TB patient (will be referred to the NTLP MDR-TB program for contact investigation) 4. No contacts living in the household or homeless 5. Previously enrolled in the study as a household contact 6. No access to a mobile telephone in the household 7. Not conversant in Luganda or English 8. Unwilling to participate for any reason after first consenting to screening Household contacts: 1. Unable to provide informed consent (e.g. lacking capacity) 2. Unwilling to provide informed consent 3. Currently taking treatment for active TB 4. No access to a mobile telephone 5. Not conversant in Luganda or English 6. Unwilling to participate for any reason after first consenting to screening 0 Year(s) 200 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/04/2015 SOMREC- Makerere University School of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Deans Building, Makerere University School of Medicine Kampala 7072 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/09/2014 UNCST- Uganda National Council for Science and Technology
Ethics Committee Address
Street address City Postal code Country
Plot 6, Kimera Road Ntinda Kampala 6884 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/05/2016 SOMREC- Makerere University School of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Deans Building, Makerere University School of Medicine Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) Yield: Return defined as numerical count of contacts completing TB evaluation within 14 days of index patient diagnosis, divided by total number eligible household contacts equals yield of initial home visit. 14 days after index patient diagnosis
Primary Outcome Yield of serial SMS screening: for the 4 6-monthly interval SMS screenin interventions over 2 years, defined as added TB evaulations completed within 14 days of SMS over baseline Incremental 14 days after SMS Cumulative 24 months after index diagnosis
Primary Outcome (2) Yield for HIV diagnosis: Proportion of tested contacts diagnosed with HIV 24 months
Primary Outcome 3). Yield of home sputum collection (1) Proportion of screen-positive contacts successfully providing sputum, by risk group 24 months
Primary Outcome 3b). Yield of mHealth interventions, by risk group 24 months
Primary Outcome 3c).Time to impact of SMS 24 months
Primary Outcome 4a) Cost-effectiveness outcomes i) Primary Outcomes: Incremental Cost Effectiveness Ratio (1) mHealth CI compared to standard CI (2) mHealth CI compared to no CI (modeled using inputs from published literature) 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Naguru Hospital Naguru Hill Road Kampala Uganda
Kiswa Health Center Bugolobi Road Kampala 7010 Uganda
Kisenyi Health Center Kisenyi Kampala 7010 Uganda
Kisugu Namuwongo Road Kampala 7010 Uganda
Komamboga Health Center Komamboga Kampala 7010 Uganda
Kitebi Kitebi Kampala 7010 Uganda
Kawaala Health Center Kawala Kampala 7010 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
NIH - NIAID NIAID Office of Communicationa and Government Relations, 5601 Fishers Lane, MDSc 9806 Bethesda MD 20892-9806 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NIH-NIAID NIAID Office of Communictions and Government Relations, Fishers Lane, MSC 9806 Bethesda 20892-9806 MD United States of America Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Adithya Cattamanchi 1001 Potero Avenue San Francisco CA 94110 United States of America
Phil Hopewell 1001 Potero Avenue San Francisco CA 94110 United States of America
Elizabeth Fair 1001 Potero Avenue San Francisco CA 94110 United States of America
Margaret Handley Bldng 550, 15th Street, 2nd Floor San Francisco CA 94148 United States of America
Margaret Handley Bldng 550, 15th Street, 2nd Floor San Francisco CA 94148 United States of America
Sara Ackerman 3333 California Street, Room 455 San Francisco CA 94118 United States of America
Jessica Haberer 100 Cambridge Street, 15th Floor Boston MA 02114 United States of America
Achilles Katamba 301 Deans Bldg, Makerere College of Hewalth Sciences, Mulago Hospital Complex Kampala Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator J Lucian (Luke) Davis lucian.davis@yale.edu 2222
City Postal code Country Position/Affiliation
United States of America
Role Name Email Phone Street address
Principal Investigator J Lucian (Luke) Davis lucian.davis@yale.edu +1 203 785 3665 60 College Street, LEPH 620
City Postal code Country Position/Affiliation
New Haven CT 06520 United States of America Assoc Professor Epidemiology of Microbial Disease Yale School of Public Health
Role Name Email Phone Street address
Public Enquiries Irene Ayakaka ayakaka@gmail.com +256 772 868 838 c/o Deans Bldg Makeree Univeristy School of Medicine, Room 301
City Postal code Country Position/Affiliation
Kampala 7072 Uganda Project Manager
Role Name Email Phone Street address
Scientific Enquiries Achilles Katamba akatamba@yahoo.com +256 753 040 922 Deans Bldg, Makeree University School of Medicine, Room 301
City Postal code Country Position/Affiliation
Kampala Uganda Site Principal Investigator
REPORTING
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