Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya

NCT05351606 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2025-07-02

No results posted yet for this study

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.

Conditions

  • Tobacco Use Cessation
  • Tobacco Use

Interventions

BEHAVIORAL

Tobacco Use Cessation Counselling Sessions

Counseling sessions will be given in person

DRUG

Bupropion

Given orally

DRUG

Nicotine patch

Given transdermally

DRUG

Nicotine lozenge

Given orally

Sponsors & Collaborators

Principal Investigators

  • Stella Bialous, Dr PH · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2025-01-07
Completion
2025-01-07
FDA Drug
Yes

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05351606 on ClinicalTrials.gov