Condition category
Infections and Infestations
Date applied
23/02/2018
Date assigned
13/04/2018
Last edited
13/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Tuberculosis (TB) is an infectious disease caused by a bacterium that spreads from person-to-person. However, compared to the general population, people who smoke tobacco and drink excess amounts of alcohol are more likely to catch TB and die from it. Furthermore, they are also less likely to take their TB and HIV (if co-infected) medicines, leading to treatment failure and death. Unfortunately, alcohol use and/or tobacco smoking are common among TB patients in South Africa. Therefore, addressing these major risk factors should be a key priority in TB treatment.
This study aims to develop and test a new approach, called the PROLIFE model, to change these behaviours and medication adherence in TB patients.

Who can participate?
Adults aged 18 years or older with drug-sensitive pulmonary TB (PTB) who are smokers or hazardous/harmful drinkers

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive the PROLIFE package. This consists of three counselling sessions covering medication adherence, smoking and drinking alcohol, in addition to usual TB care. The individual counselling sessions are re-enforced with short text message reminders regarding information supporting tobacco cessation, alcohol use and treatment adherence. Text messages are delivered twice a week over 12 weeks.
Participants in the second group receive usual care. They are seen by a TB nurse and receive the same medical investigations and treatment as those in the first group. This includes HIV testing with pre- and post-test counselling by a nurse or lay counsellor. Participants in this group do not receive the additional counselling and text messages.

What are the possible benefits and risks of participating?
Whilst there are no guaranteed benefits, participants may benefit from reduced tobacco smoking, reduced alcohol consumption and improved medication use (if appropriate). These factors may resultantly improve their recovery from TB.
There are no direct risks to participating in the study, however those in the intervention group attend follow up sessions which take up some time.

Where is the study run from?
Primary care clinics in the following areas:
1. Sedibeng district, Guteng province (South Africa)
2. Lejweleputswa district, Free State province (South Africa)
3. Bojanala district, North West province (South Africa)

When is the study starting and how long is it expected to run for?
May 2015 – June 2019

Who is funding the study?
South African Medical Research Council (South Africa)

Who is the main contact?
Prof Olalekan Ayo-Yusuf
lekan.ayo-yusuf@smu.ac.za

Trial website

Contact information

Type

Scientific

Primary contact

Prof Olalekan Ayo-Yusuf

ORCID ID

http://orcid.org/0000-0003-0689-7018

Contact details

Sefako Makgatho Health Sciences University
Main Campus
Research Office
Molotlegi Street
Ga-Rankuwa
Pretoria
0001
South Africa
+27 (0)12 521 4961
lekan.ayo-yusuf@smu.ac.za

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SMUREC/D/234/2017:IR

Study information

Scientific title

ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages: a randomised controlled trial

Acronym

PROLIFE

Study hypothesis

The PROLIFE package comprising motivational interviewing (MI) counselling and short text messaging is more effective and cost-effective than usual care in improving TB outcomes and modifying tobacco smoking, hazardous or harmful drinking and medication adherence among TB patients.

Ethics approval

1. Sefako Makgatho Health Sciences University, 07/09/2017, ref: SMUREC/D/234/2017:IR
2. University of Pretoria, 28/09/2017, ref: 434/2017
3. University of Free State, 27/09/2017, ref: HREC 71/2016
4. Health Sciences Research Governance Committee University of York, 15/01/2018, no ref number given
5. University of Witwatersrand, 08/11/2017, ref: M160455

Study design

Multi-centre open-label two-arm parallel individual randomised controlled superiority trial with concurrent economic evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tuberculosis

Intervention

Participants are randomised (stratified by clinic) using a randomised sequence generator performed by the trial statistician to one of two groups.
Those in the first group receive the PROLIFE package - three motivational interviewing (MI) counselling sessions, each one month apart, from a trained lay counsellor at their TB clinic. Each MI counselling session is expected to last not more than 20 minutes.
In the initial MI session at the start of TB treatment the counsellor establishes the participant’s tobacco smoking, problem drinking and other potential obstacles and facilitators for treatment adherence or initiation (both TB and ART treatment) are determined. This first session is concluded with agenda setting for the problem identified by the participant as the most salient. This could be a plan either to quit tobacco smoking, reduce or quit drinking or deal with other perceived obstacles relating to ART or TB treatment. As all TB patients are eligible for ART, for participants who are HIV-infected and not yet on ART, beliefs and attitudes regarding HIV-testing or ART are explored to facilitate ART initiation and adherence. The second session builds on the previous one and deal with challenges relating to the previous agenda setting, but then moves on to the next behavioural problem (T, A or TA) where applicable. The third session deals with the last identified problem.
The individual counselling sessions are re-enforced with short text message reminders regarding information supporting tobacco cessation, alcohol use and treatment adherence. Text messages are delivered twice a week over 12 weeks and pre-tested as outlined above. All participants first receive 10 TB-related messages. These messages are followed by seven alcohol or smoking-related messages depending on whether the participant smokes or drinks. Co-joint users receive all sets of messages (i.e. 24 in total).

Participants in the second group are the control and receive usual treatment, counselling and support offered to TB patients. Participants are seen by a TB nurse and receive the same biochemical investigations and medical treatments as the intervention arm. They do not receive the MI and short text message package of care as described above. The usual care consists of HIV testing with pre-and post-test counselling by a lay counsellor or a nurse (varies by district). Health education is given on:
• TB: nature of TB, treatment adherence (including DOTs), treatment side-effects / complications, drug interactions (especially ARVs), tobacco use, alcohol use and other substance abuse. This is mostly done by the TB nurses as part of usual care and is not intense – more of education than counselling.
• Healthy diet by a Dietician where possible
• Social problems and family support for treatment by a Social worker as needed and depending on the availability of social workers.
• Point of care blood glucose, Hb and pregnancy test are done. If co-infected with HIV, full blood count, liver function test and Creatinine are also done.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

TB treatment success rate measured according to treatment outcomes defined by the WHO and adopted in South Africa, at 6 months

Secondary outcome measures

1. Sputum conversion measured by negative culture or smears in the group of participants who had bacteriology confirmed PTB at baseline at the end of treatment
2. Sustained smoking abstinence measured using a self-report of not smoking more than 5 cigarettes from the start of the abstinence period, supported by a negative biochemical test (exhaled Carbon Monoxide <7) at 3 and 6 months
3. Reduction in harmful or hazardous drinking measured using the AUDIT questionnaire administered at baseline, 3 and 6 months
4. TB medication and ART adherence are measured using a modified version of the AIDS Clinical Trials Group (ACTG) Adherence Questionnaire (to include TB medication adherence) administered by field workers at baseline, 3 and 6 months
5. Proportion of HIV-positive participants on ART recorded as per the TB Treatment Record at baseline, 3 and 6 months. HIV positive participants will be asked about ART status at baseline, 3 months and 6 months using standardized questions on the CRF

Overall trial start date

02/05/2015

Overall trial end date

30/06/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (18 years or older) with drug-sensitive pulmonary TB (PTB)
2. Current smokers OR hazardous/harmful drinkers who are not alcohol dependent (AUDIT score ≥ 8 for men or ≥ 7 for women but <20)
3. Initiating TB treatment or on current TB treatment for less than 1 month (these include both “new” and “retreatment patients”)
4. Access to a functional cellphone
5. Understands one of the 4 languages used for the trial (Sesotho, Setswana, Zulu or English)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

689

Participant exclusion criteria

1. On TB treatment for more than one month
2. Alcohol dependent participants (AUDIT score more than or equal to 20) provided they are non-smokers
3. Extrapulmonary tuberculosis provided they don’t also have pulmonary tuberculosis
4. Drug resistance to one or more TB drugs at baseline.

Recruitment start date

01/03/2018

Recruitment end date

01/10/2018

Locations

Countries of recruitment

South Africa

Trial participating centre

Primary care clinics in Sedibeng district, Guteng province
0001
South Africa

Trial participating centre

Primary care clinics in Lejweleputswa district in the Free State province
0001
South Africa

Trial participating centre

Primary care clinics in Bojanala district in the North West province
0001
South Africa

Sponsor information

Organisation

South African Medical Research Council

Sponsor details

PO Box 19070
Tygerberg
Cape Town
7505
South Africa
+27 (0)21 938 0991
nondwe.zama@mrc.ac.za

Sponsor type

Research council

Website

www.samrc.ac.za

Funders

Funder type

Research council

Funder name

South African Medical Research Council

Alternative name(s)

SAMRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

South Africa

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal. The study protocol, including the statistical analysis plan, and results from the feasibility study will be submitted for publication in a peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes