Experiences and perceptions of lay counsellors and people with tuberculosis of a programme aimed at reducing alcohol drinking and tobacco smoking in South Africa
| ISRCTN | ISRCTN14213432 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14213432 |
- Submission date
- 14/12/2021
- Registration date
- 03/01/2022
- Last edited
- 12/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Tobacco smoking and excessive alcohol use are harmful to one's health, even more so for patients who have tuberculosis (further abbreviated as TB). If patients with TB continue to smoke during their treatment, drink too much alcohol or forget to take their treatment, they may not recover from TB. The ProLife study aims to test how best to get TB patients to stop smoking, reduce harmful or hazardous drinking and be adherent to their treatment (TB and/or HIV-treatment as applicable).
Who can participate?
Adult patients with lung tuberculosis who smoke tobacco or drink alcohol to a harmful or hazardous extent, will be enrolled at 9 clinics in 3 districts in South Africa over the course of 3.5 months.
What does the study involve?
The intervention will comprise three brief motivational interviewing (MI) sessions augmented with a Short-Message Service (SMS) programme, targeting as appropriate: tobacco smoking, harmful or hazardous drinking and medication adherence. Patients will receive SMS-messages twice a week. We will measure how many participants we can recruit in that time period and how many participants remain in the study. We will also study how well the lay counsellors apply the required counselling techniques. At the end of the programme, we will ask the lay counsellors and patients what they liked or disliked about the programme.
What are the possible benefits and risks of participating?
The counselling sessions and SMS messages may help you to quit smoking or reduce alcohol consumption and help you to take your medication better. This will help you to heal from your TB.
You may feel a bit uncomfortable disclosing personal issues relating to tobacco smoking or alcohol use or problems with taking your medication. However, we are here to help you to address any problem you may have with regards to those issues and we stress that all information will be kept confidential.
Where is the study run from?
Medical Research Council of South Africa
When is the study starting and how long is it expected to run for?
May 2016 to July 2017
Who is funding the study?
Newton Fund (UK)
Medical Research Council (UK)
Who is the main contact?
Prof Goedele Louwagie, goedele.louwagie@up.ac.za
Prof Olalekan Ayo-Yusuf, lekan.ayo-yusuf@smu.ac.za
Contact information
Scientific
Ganzendries, 106
Gent
9000
Belgium
 ORCID ID |
0000-0002-4384-2318 |
|---|---|
| Phone | +32 93115063 |
| goedele.louwagie@up.ac.za |
Scientific
Sefako Makgatho Health Sciences University
P.O.Box 222
Medunsa, Tshwane
0204
South Africa
| Phone | + 27 12 521 4611 |
|---|---|
| lekan.ayo-yusuf@smu.ac.za |
Study information
| Study design | Interventional mixed methods feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | See additional files |
| Scientific title | Addressing tobacco smoking and drinking to improve TB treatment outcomes, in South Africa: a feasibility study of the 'ProLife' programme |
| Study acronym | ProLife |
| Study objectives | We tested the feasibility of the ProLife intervention - consisting of a combination of 3 Motivational Interviewing (MI) Sessions combined with Short Message Service (SMS) messages aimed at reducing tobacco smoking or alcohol drinking and improving adherence in a group of tuberculosis (TB) patients who smoked tobacco or drank alcohol in harmful or hazardous amounts, in South Africa. The study aimed to provide answers to the following questions: 1. What are the enrolment and follow-up rates of TB patients in this study? 2. What is the fidelity to MI sessions and the proficiency of Lay Health Workers (LHWs) in facilitating the MI sessions? 3. What are the experiences of TB patients and LHWs with the interventions? |
| Ethics approval(s) | 1. Approved 21/04/2016, The University of Pretoria (31 Bophelo Road, HW Snyman South Building, Level 2, Room 2.33, Gezina, Pretoria, South Africa; +27 123541677; deepeka.behari@up.ac.za), ref: 119/2016 2. Approved 06/05/2021, The University of the Witswatersrand (Research Office, Faculty of Health Sciences, University of the Witswatersrand, Phillip Tobias Building, Offices 301-304, 3rd Floor, Cnr York Road and 29 Princess of Wales Terrace, Parktown, 2193, South Africa; +27 11 717 1252; Rhulani.Mkansi@wits.ac.za ), ref: MI60455 3. Approved 02/06/2016, The University of the Free State (PO Box 227, Bloemfotein, South Africa; +27 51 405 2812; ghpdbbh@ufs.ac.za), ref: HSREC-71/2016 4. Approved 29/06/2016, The South African Medical Research Council (Francie Van Zijl Drive, Parowvallei, 7505, Cape Town, Po Box 19070, Tygerberg, 7505, South Africa; +27 (0)21 938 0687; adri.labuschagne@mrc.ac.za), ref: EC010-4/2016 |
| Health condition(s) or problem(s) studied | Reduction of alcohol and tobacco smoking and improving adherence in patients with tuberculosis |
| Intervention | 3 Motivational Interviewing sessions and 10 adherence, 7 tobacco smoking and/or 7 alcohol related SMS-messages Participants will receive three counselling sessions of about 20 minutes’ duration - each one month apart- from a trained counsellor at the TB clinic. Participants will also receive Short Messages (SMS) via cell phone with helpful information. These messages will be sent to participants twice a week for 3 months. After the final counselling session, participants will also be asked a few short questions about what they liked and disliked about the counselling sessions and the SMS messages |
| Intervention type | Behavioural |
| Primary outcome measure | Recruitment and retention rates measured at the end of the 3rd MI session (approximately at 2 months follow-up) using patient records |
| Secondary outcome measures | 1. LHWs’ experiences and perceptions using semi-structured interviews at the end of the 3rd MI session 2. TB patients experiences and perceptions using semi-structured questionnaires at the end of the 3rd MI session 3. MI fidelity using recorded MI sessions measured at the end of study by expert review |
| Overall study start date | 01/05/2016 |
| Completion date | 30/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 45 |
| Total final enrolment | 45 |
| Key inclusion criteria | 1. Adults who were due to start TB treatment, or who had been on treatment for less than one month for the current TB episode for bacteriologically or clinically confirmed drug sensitive pulmonary TB (PTB) 2. Current smokers, defined as having smoked any tobacco in the past month or hazardous or harmful drinkers (Alcohol Use Disorders Identification Test [AUDIT] score ≥ 8 for men or ≥ 7 for women and < 16 for hazardous drinking and between 16 and 19 for harmful drinking). |
| Key exclusion criteria | 1. Did not possess a functioning cell phone 2. Too ill to be interviewed 3. Did not speak any of the languages used in the exit questionnaires (English, Isizulu, Sesotho, and Setswana) |
| Date of first enrolment | 15/11/2016 |
| Date of final enrolment | 30/03/2017 |
Locations
Countries of recruitment
- South Africa
Study participating centres
Matjhabeng Local Municipality
Free State
Welkom
9459
South Africa
Lejweleputswa District Municipality
Free State
Virginia
9431
South Africa
Bothaville
9660
South Africa
Evaton
1984
South Africa
Sebokeng
1984
South Africa
Sebokeng
1983
South Africa
Rustenburg
0300
South Africa
Boitekong
Rustenburg
0300
South Africa
Tlhabane
Rustenburg
0335
South Africa
Sponsor information
Research council
PO Box 19070
Tygerberg
7505
South Africa
| Phone | +27 21 938 0911 |
|---|---|
| info@mrc.ac.za | |
| Website | https://www.samrc.ac.za |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- The Newton Fund, NF
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication in a high impact journal, Tranlational Behavioural Medicine |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. goedele@louwagie.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Fieldworkers Training Manual | 16/12/2021 | No | No | |
| Protocol file | version 9 | 16/12/2021 | No | No | |
| Results article | 31/12/2020 | 12/04/2022 | Yes | No |
Additional files
- 40810 Fieldworkers Training Manual.pdf
- Fieldworkers Training Manual
- 40810 Protocol V09.pdf
Editorial Notes
12/04/2022: This is a feasibility study that preceded a randomised controlled trial of the same intervention, registered as ISRCTN62728852. Publication reference added.
16/12/2021: Trial's existence confirmed by University of Pretoria
