Protocol No: ECCT/19/10/03 Date of Protocol: 03-09-2019

Study Title:

Optimizing Smoking Cessation Interventions For People Living With Human Immunodeficiency Virus in Nairobi, Kenya

Study Objectives:
Primary objectives:
1. To compare bupropion therapy to placebo on rates of 7-day point prevalence abstinence (PPA) at 36 weeks in smokers with HIV/AIDS. We hypothesize that rates of smoking abstinence at week 36 will be higher in those treated with bupropion compared to placebo.
2. To compare Positively Smoke Free to low intensity, brief counseling on rates of 7-day PPA at 36 weeks in smokers with HIV/AIDS. We hypothesize that rates of smoking abstinence at week 36 will be higher in those treated with Positively Smoke Free compared to brief counseling.
3. To compare Positively Smoke Free + bupropion to the other two study conditions outlined above on rates of 7-day PPA in smokers with HIV/AIDS at 36 weeks. We hypothesize the effect of Positively Smoke Free with bupropion therapy is greater than the effect of Positively Smoke Free or bupropion therapy alone.
Major Secondary Objectives:
To estimate the organizational costs of implementing Positively Smoke Free, bupropion or both. All cost estimates will be appropriately time-discounted and inflation-adjusted. The planned assessment will yield rigorously obtained approximations of total implementation costs at a new site of care.
Other Secondary Objectives:
Other objectives of this study are to explore whether the effect of PSF compared to brief counseling with bupropion is greater than the effect of PSF without bupropion.
Laymans Summary:

This is a study that will investigate both pharmacological and behavorial interventions to smoking cessation among participants that are HIV positive and on ART and bothe ART and Methadone.

Abstract of Study:

Worldwide estimates suggest that people living with HIV/AIDS (PLWH) smoke at nearly three times the rate of the general population. Smoking among PLWH living in Sub-Saharan Africa is associated with gender (male>female), with living in an urban slum community, and perhaps most importantly with illicit substance use. Although precise prevalence estimates of tobacco use among PLWH in Kenya are lacking, recent data collected from a large, well established methadone maintenance program in Nairobi found the prevalence of smoking among PLWH with opiate use disorders was 100%. This compares to 7.7-9.1% Kenyan general population. Many interventions are effective in helping smokers in the general population quit. To what degree these data translate to PLWH in lower-middle income countries that may have greater challenges with health infrastructure, resources and medication access, is not clear. Our proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among PLWH who smoke. We propose to randomize 300 participants PLWH, who smoke and who are receiving care in a health care setting program in Nairobi, Kenya to one of the following 4 conditions: (1) bupropioin + Positively Smoke Free (an 8 session tailored behavioral intervention for PLWH smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care. We plan to use a factorial design as it is a highly efficient method of assessing multiple treatments in a single trial with the possibility of saving both time and resources. We plan to conduct the study in methadone maintenance clinics as well as in HIV clinics within Nairobi County. As Kenya has one of the strongest anti-tobacco legislations in sub-Saharan Africa, results of this study will provide policymakers, community leaders and clinicians with critical evidence of the most effective smoking cessation treatments for PLWH smokers in the methadone maintenance setting