Clinical trial NCT05351606: Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya
Official title: Integrating Tobacco Use Cessation Into HIV Care and Treatment in Ministry of Health Facilities in Kisumu County, Kenya
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Tobacco Use Cessation
Tobacco Use
Keywords: Integrated Education
Behavioral Counselling
Nicotine Replacement therapy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: National Cancer Institute (NCI)
First posted: 2022-04-28
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: People living with HIV (PLHIV) have higher rates of tobacco use than the general population and higher rates of disease and death compared with PLHIV who do not use tobacco. This project will evaluate the impact of integrating an intensive tobacco use cessation intervention compared to a brief intervention within HIV care clinics in Kisumu County, Kenya.

There is evidence that PLHIV in Africa are more likely to use tobacco than the general population. Kenya is an example of a country coping with the dual epidemic of HIV and tobacco, with an estimated 1.5 million PLHIV and 2.5 million tobacco users. HIV remains one of the country's leading causes of morbidity and mortality, with an estimated 46,000 adults acquired HIV and 25,000 persons died of HIV in 2018. Tobacco use among the general population is estimated to be 11.6% (19.1% among men and 4.5% among women). The impact of tobacco use among PLHIV in Kenya has yet to be fully understood. There has been no research or initiatives in Kenya to support PLHIV to quit tobacco use in a primary care setting, a gap that this study seeks to address. In 2017, Kenya's Ministry of Health launched the National Guidelines for Tobacco Dependence Treatment and Cessation. This project will also examine the integration of the Guidelines' interventions into Ministry of Health HIV care clinics in Kisumu County.

Detailed description: PRIMARY OBJECTIVES:

I. To examine the success of the intensive versus a brief smoking cessation intervention after one year.

SECONDARY OBJECTIVES:

I. To examine the success of the intensive versus a brief smoking cessation intervention at 1 month, 3 months and 6 months.

II. To compare the HIV viral load with abstinence rates for each of the interventions.

STUDY OVERVIEW:

The investigator will conduct a cluster randomized controlled trial at 20 Ministry of Health HIV clinics in Kisumu Kenya, recruiting 580 patients who will be randomized to one of 2 conditions to investigate the effectiveness of an intensive versus a brief intervention aimed at smoking cessation.

Participants will be assessed at baseline, one month, three months, 6 months and 12 months.

Eligibility criteria: Inclusion Criteria:

* Human immunodeficiency virus (HIV)-seropositive,
* Age \>=18 years
* Currently taking or initiating antiretroviral therapy (ART)
* Access to mobile phone for phone or text follow up visit (intensive intervention only)
* Able to read or be read short message service (SMS) messages (intensive intervention only).

Tobacco inclusion criteria:

* Current tobacco users, who have used tobacco in the past 7 days;
* Must have smoked at least 100 cigarettes in lifetime, and at least 5 cigarettes per day biochemically verified by expired Carbon Monoxide (CO) \>= 5-6 parts per million (ppm).

Exclusion Criteria:

* Advanced HIV disease, age \< 18 years
* Unable to provide verbal informed consent
* Unwilling to be contacted by clinic for follow up

Additional exclusion criteria in the intensive intervention group:

* Myocardial Infarction (MI) in the 2 weeks prior to signing consent
* Pregnant (NRT and Bupropion may be contraindicated).
* Patients for whom Bupropion is contraindicated (e.g. history of seizures, recent use of Monoamine oxidase (MAO) inhibitors, breastfeeding, and whose ART protocol present, as per prescription guidance, contraindications).
* Prior disclosure of HIV status to the phone owner for those who use phones will be required to prevent inadvertent disclosure.

Primary outcomes:
measure: Proportion of participants who have abstained from tobacco use at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of participants who have abstained from tobacco use at 1 month
timeFrame: 1 month
measure: Proportion of participants who have abstained from tobacco use at 3 months
timeFrame: 3 months
measure: Proportion of participants who have abstained from tobacco use at 6 months
timeFrame: 6 months
measure: Median HIV Viral load by abstinence status
timeFrame: 12 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kenya Medical Research Institute (KEMRI)
Study officials:
affiliation: University of California, San Francisco
name: Stella Bialous, Dr PH
role: PRINCIPAL_INVESTIGATOR
References: