| Protocol No: | ECCT/22/12/01 | Date of Protocol: | 05-08-2022 |
| Study Title: | Integrating Tobacco use cessation into HIV care and Treatment Clinics in Ministry of Health Facilities in Kisumu County, Kenya |
| Study Objectives: | Primary Objective 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. Secondary Objectives 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 |
| Laymans Summary: |
Tobacco use among people living with HIV (PLHIV) urgently needs to be addressed, particularly in low- and middle-income countries (LMIC) where the burden of double epidemics, tobacco and HIV, could overwhelm the health system, public health finances and be a barrier to reaching the Sustainable Development Goals (SDG)(1). Countries in sub- Saharan Africa remain the HIV epidemic epicenter (2) while experiencing significant growth in tobacco consumption (3-5). PLHIV who use tobacco experience an excess of tobacco- attributable morbidity and mortality. In high income countries, it is estimated that PLHIV are two or three times more likely to use tobacco than the general population (6-7). 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% (8). 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 (6). In addition, PLHIV who use tobacco are at an increased risk of pneumonia, tuberculosis and other infections (1). There is a paucity of studies on cessation in Africa (9) and few cessation services in Kenya. Approximately half of tobacco users made a quit attempt in the previous 12 months, and 80% were thinking about quitting, indicating that there might be a growing interest in cessation amongst Kenyans. However, only 34.1% of tobacco users who saw a healthcare provider received advice to quit. Most (70%) quit attempts in Kenya are without any support (10). In 2017 Kenya’s MOH launched the National Guidelines for Tobacco Dependence Treatment and Cessation (11) (hereafter, Guidelines). It supports the implementation of tobacco use cessation programs within health care services, based on the 5As approach (Ask, Advice, Assess, Assist and Arrange) and is a tool to reach the country’s goals of reducing non-communicable diseases burden.
The Ministry of Health in Kenya launched the National Guidelines for Tobacco Dependence Treatment and Cessation in 2017 that is mirrored on the World Health Organization guidelines and several systematic reviews demonstrating that pharmacotherapy supports tobacco use cessation and increase quit rates when compared with placebo or no intervention (or trying to quit without support). Evidence indicates that combination Nicotine Replacement Therapy (NRT) (a slow + a fast-acting agent, such as patch and lozenge), with Bupropion, and behavioral support to be the most effective (9,13). Evidence also support the use of Varenicline alone or in combination with NRT, this medication is not available in Kenya.
Therefore, there is a need to enhance support for tobacco cessation services in Kenya (10, 12) and to evaluate strategies to implement the Guidelines in routine clinical practice. This is the first study to implement the Guidelines in an HIV community healthcare setting. This project will evaluate the implementation of cross cutting national recommendations.
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| Abstract of Study: | 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. Implementation site(s): The project will be implemented in Kisumu County, within 20 HIV care and treatment clinics in Kisumu County-Kenya. Key Methods: The study will conduct a cluster randomized controlled trial at 20 HIV care and treatment clinics to compare the effectiveness of two levels of evidence-based tobacco use cessation strategies: 1) The intensive intervention (12 counseling sessions in-person or telemedicine; provision of a Quitline number, NRT and bupropion); 2) The brief intervention (one-time counseling plus the Quitline number). After 12 months the study will offer the intensive intervention to patients in the brief intervention group who continue to use tobacco. We will evaluate the cost of both interventions by biochemically verified abstinence at 12 months using standard costing methods and in the last year of the project, we will conduct qualitative studies to evaluate adopters at the clinic and health provider levels, assessing barriers to and facilitators of adoption, implementation, and factors associated with scalability/sustainability. Expected Application of findings: Results from this study will provide pivotal information to understand the needs for tobacco use cessation of PLHIV and the most effective strategies to integrate tobacco dependence treatment within HIV care. |