Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT05351606
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2022-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Integrating Tobacco Use Cessation Into HIV Care and Treatment in Kisumu County, Kenya
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Integrating Tobacco Use Cessation Into HIV Care and Treatment in Ministry of Health Facilities in Kisumu County, Kenya
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U01CA261620-01 | NIH | None | https://reporter.nih.gov/quic… | View |