Integrating tobacco use cessation into HIV Care and Treatment in Ministry of Health Facilities in Kisumu County, Kenya

ABSTRACT
People living with HIV (PLHIV) are more likely to use tobacco than the general population. PLHIV who use
tobacco have higher mortality rates and risk for co-morbidities including diseases caused by tobacco, when
compared to PLHIV who do not use tobacco. Sub-Saharan African continues to be the epicenter of HIV
infection while experiencing an increase in tobacco consumption. 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 have been no research or initiatives in Kenya to support PLHIV to quit tobacco use
in a primary care setting, a gap that this proposal seeks to address. In 2017, Kenya's Ministry of Health
launched the National Guidelines for Tobacco Dependence Treatment and Cessation. This project will
evaluate integration of the Guidelines' interventions into HIV care clinics through the Family AIDS Care &
Education Services (FACES). FACES is a 16 years-partnership between the Kenya Medical Research
Institute, the University of California San Francisco and the Kisumu County Ministry of Health. FACES have
tested over 1.5 million people for HIV, diagnosing over 21,000 people, and currently serves over 51,000 PLHIV
on ART in 61 sites in Kisumu County. We will conduct a cluster randomized controlled trial at 20 FACES-
supported clinics, recruiting 580 patients to compare the effectiveness and cost-effectiveness of an intensive
(Nicotine Replacement Therapy and Bupropion, 12 sessions of behavioral counseling through in-person and
telemedicine approaches (telephone and texts), and provision of a quitline number) versus a brief (one-time
counseling plus the quitline number) intervention. We hypothesize that 15% of intensive intervention group
participants will achieve biochemically verified 7-day Point Prevalence Abstinence at 12 months compared to
the brief intervention group quit rate of 5%. We will offer the intensive intervention to brief intervention group
participants who continue to use tobacco at 12 months. Prior to the trial we will conduct a formative evaluation
to tailor the Guidelines to PLHIV and after the trail we will assess assessing barriers to and facilitators of
adoption, implementation, and factors associated with scalability/sustainability of the intervention. The
proposed study will determine the most cost-effective strategy to integrate tobacco use cessation within HIV
care in a community health setting. The project's results will inform policies to scale up tobacco dependence
treatment within HIV primary care centers across the country and serve as a model for the region.

Grant Number: 5U01CA261620-05
NIH Institute/Center: NIH
Principal Investigator: STELLA BIALOUS