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.: PACTR202211868634078 Date of Approval: 24/11/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title HIV and tobacco use cessation
Official scientific title Integrating Tobacco use cessation into HIV Care and Treatment Clinics in Ministry of Health Facilities in Kisumu County, Kenya.
Brief summary describing the background and objectives of the trial Background: People Living with HIV (PLHIV) who use tobacco experience an excess of tobacco-attributable morbidity and mortality. An analysis of tobacco use among PLHIV in 28 LMIC found that HIV positive men were 40% more likely to use tobacco than HIV negative men. For women, the increase in risk of tobacco use was 36%. As the use of, and adherence to, anti-retroviral therapy (ART) increases, PLHIV who use tobacco become at higher risk for a range of diseases caused or aggravated by tobacco use, such as cancer, including lung, head and neck, cervical and anal cancers, hypertension and heart disease, diabetes, and lung diseases. In addition, PLHIV who use tobacco are at an increased risk of pneumonia, tuberculosis and other infections. There is paucity of studies on cessation in Africa and few cessation services in Kenya. This study will evaluate the implementation of cross cutting national recommendations on Tobacco use cessation among PLHIV. Broad Objectives: The primary objective is to compare the effectiveness of a tobacco use cessation intervention focusing on breadth (brief intervention) or depth (intensive intervention) in supporting Kenyans living with HIV to quit tobacco use.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Rehabilitation
Anticipated trial start date 01/12/2022
Actual trial start date
Anticipated date of last follow up 31/08/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 580
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Brief intervention 12 months Participants will be offered a one-time counseling plus access to a Quitline number 290 Uncontrolled
Experimental Group Intensive intervention 12 months The participants will be offered 12 counseling sessions in-person or telemedicine; provision of a Quitline number, Nicotine Replacement Therapy and bupropion 290
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Clinical Component (Randomized Control trial): - age ≥18 years - HIV-seropositive - on or initiating ART - not planning to move or travel within 12 weeks following entry in the study - Tobacco inclusion criteria: current tobacco users, i.e. used tobacco in the past 7 days; for smokers, smoked at least 100 cigarettes in lifetime, and at least 5 cigarettes per day, verified by expired Carbon Monoxide (CO)≥ 5-6 parts per million (ppm). - access to mobile phone for phone contact (and on intensive intervention also for text follow up visit) Additional inclusion criteria for intensive intervention only: - able to read or be read for the SMS messages Clinical Component: - age < 18 years - HIV-seronegative - unable to provide informed consent - unwilling to be contacted by clinic for follow up - Opioid users (who may be receiving Bupropion as part of their treatment) Additional exclusion criteria for intensive intervention only: - Myocardial Infarction in the 2 weeks prior to enrolling in the study - Pregnant (as NRT and Bupropion might be contraindicated). - We will also exclude patients for whom Bupropion is contraindicated (e.g. history of seizures, recent use of MAO inhibitors, breastfeeding, and whose ART protocol present, as per prescription guidance, contraindications). - For those who share phones, prior disclosure of HIV status to the phone owner will be required to prevent inadvertent disclosure Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 02/11/2022 KEMRI SERU
Ethics Committee Address
Street address City Postal code Country
Mbagathi Highway Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary objective is to compare the efficacy of a brief versus an intensive intervention in supporting PLHIV in quitting tobacco use. The time frame is 12 months. 12 months
Secondary Outcome The secondary objectives are to compare cessation status by brief versus intensive intervention at 1, 3 and 6 months. Other secondary objectives include: - Changes in providers self-reported tobacco dependence treatment interventions overtime and between groups - Assess cost-effectiveness of the brief versus intensive interventions 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenya Medical Research Institute RCTP Ondiek Highway Kisumu 40100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institites of Health 9000 Rockville Pike Bethesda, Maryland 20892 Bethesda 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of California San Francisco UCSF Medical Center at Parnassus 505 Parnassus Ave. San Francisco, CA 94143 San Francisci 94102 United States of America University
COLLABORATORS
Name Street address City Postal code Country
Kenya Medical Research Institute Mbagathi way Nairobi 00200 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Elizabeth Bukusi ebukus@kemri.go.ke +254733617503 Mbagathi way
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Principal investigator
Role Name Email Phone Street address
Public Enquiries Cirilus Ogolla cogollah@kemri-rctp.org +254724717472 Ondiek Highway
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Study coordinator
Role Name Email Phone Street address
Scientific Enquiries Francesca Odhiambo fodhiambo@kemri-rctp.org +254733617503 Ondiek highway
City Postal code Country Position/Affiliation
Kisumu 40100 Kenya Principal investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available.The Clinical study report will be available for researchers who provide a methodologically sound proposal immediately after study publication.This data shall only be used to achieve aims in the approved protocols Clinical Study Report 2 years controlled access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information