Development, Implementation, and Evaluation of a Tobacco Cessation Intervention Tailored to Patients Living With HIV (PLWH) in Brazil: A Feasibility Study
Phase: NA
Conditions: HIV Infections, Tobacco Use Cessation
Sponsor: University of Alabama at Birmingham

Protocol Title 
 
Tobacco Cessation Tailored to Patients Living With HIV (PLWH) in Brazil 
 
 
Study Protocol & Statistical Analysis Plan 
 
NCT05560243 
 
Date of Last Protocol Approval by the UAB IRB (Last Progress 
Report) 
11/20/2023 approved through 11/19/2024 
 
 
Isabel C. Scarinci, PhD, MPH, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 
 
 
 

Feasibility Testing – Research Protocol 
We propose to develop and examine feasibility of a tobacco cessation intervention tailored 
to persons living with HIV in Brazil. We already conducted Phase I (development and pre-testing 
of the intervention) among 14 participants. Phase II (current amendment) consists of the first 
iteration of the feasibility testing of the intervention. We will pilot test the tobacco cessation 
program among 10 persons living with HIV and who meet the inclusion criteria. We anticipate 
additional changes and adaptations as we pilot test the intervention among 10 participants. We 
will make adaptations based on their feedback to move to Phase III. The specific components of 
the intervention, number of sessions, format, etc will be determined in the pretesting phase. 
However, we anticipate being a mix of in-person, telephone, and WhatsApp contacts. We also 
anticipate being a mix of cognitive behavior therapy strategies and pharmacological aids.  
Based on additional feedback obtained in Phase II, we will pilot test the final intervention among 
40 participants (Phase III). The specific components will be determined based on results of 
Phases I and II. If no changes are needed we will proceed enrolling the additional 40 
participants in Phase II and Phase III will not be needed.  
The primary outcome will be a 7-day point prevalence abstinence (defined as no tobacco 
use in the past 7 days and verified through measurement of salivary cotinine and exhaled 
carbon monoxide (CO) levels) at 7-month follow-up (from baseline).  
Feasibility Testing  
 
The intervention that was developed with input from the target audience during the 
pretesting phase consists of an initial comprehensive assessment (counseling + pharmacologic) 
since patients tend to come prepared to spend the day at the reference center to get all the 
needed services. If they are committed to quitting they will proceed with consenting, visits with 
the Clinical Psychologist and Pulmonologist. The four visits with the Clinical Psychologist can be 
in person, video or phone based on patient’s preferences. Each patient is different and some 
may require more visits. The Clinical Psychologist will also provide the participant with the 
opportunity to send and receive texts for support. We will deliver the active intervention following 
this pattern for three months given the high risk of relapse within the first three months. Then, 
participants will continue to be engaged for another three months and monthly “check-ins” with 
the Clinical Psychologist and Pulmonologist. Follow-up assessments will be implemented at 7 
months. The cognitive-behavioral component is based on evidence-based strategies but 
tailored to PLWH based on findings of the formative assessments. The tobacco cessation 
manual is available in Portuguese upon request. 
 
Pharmacological management will be consistent with the recommendations and aids 
available through the public health system in order to assure sustainability – nicotine 
replacement therapy (NRT) and bupropion (if needed). The optimal dose of NRT can be difficult 
to determine without evaluating tobacco use pattern, comorbidities, and context. Thus, the NRT 
dose will be determined based on this evaluation. For example, participants who smoke within 
30 minutes of awakening or smoke more than 10 cigarettes daily may be offered a higher dose 
NRT. (61) Others will receive a lower dose therapy with the option of increasing the dosage if 
physical withdrawal symptoms persist at 2 weeks. Patches will be initiated one week prior to the 
quit date, will be administered for 8 weeks total and the dose will be either 21 mg (high dose) or 
14 mg (low dose).  The dose will not be tapered. Those with skin sensitivities will be offered the 
alternative of scheduled nicotine gum at 4mg or 2mg doses (which is also offered through the 
public health system). The appropriate course of treatment will be decided as a collaborative 
discussion between the participant and the Pulmonologist and the medication will be provided 
free of charge.   
Recruitment and Retention Strategies  
The inclusion criteria are: (a) PLWH (that is, patients with a confirmed HIV diagnosis) 
receiving care at the reference center in Londrina; (b) 18 years of age and older; (c) smoke at 

least 5 cigarettes (industrialized or hand-rolled) per day; (d) smoked within the past seven days; 
and (e) no intent to move from the area served by reference center in Londrina within the next 
12 months. Exclusion criteria are a history of hypertension, angina, asthma, or medication for 
depression.  
Participants will be recruited at the reference center with the support from the nursing staff. 
That is, the nurse will approach the patient who are tobacco users during the visit and ask about 
their willingness to talk to the Clinical Psychologist to learn more about the program. If they 
agree, the Clinical Psychologist or Research Assistant will either talk to them that day or call 
them to explain the study, assure eligibility, and then enroll them the next time they come to the 
center. Additionally, the introduction brochure described above will also be available at the clinic 
with the Clinical Psychologist’s phone number. In our past studies, we have not provided 
incentives for participants in a tobacco cessation program since the trial must resemble the real 
world as much as possible. We will reimburse participants for their expenses associated with 
transportation and meals for completing assessments (baseline, post-test, 7-month f/u – total 
R$150/R$50 each).  
 
Assessments 
Participants will be interviewer-administered baseline, post-test, and 7-month f/u 
assessments by the Research Assistant since the Clinical Psychologist will be delivering the 
intervention. Baseline measures will include (those with an * will also be administered at post-
test and 7-month f/u): demographics (e.g., age, income, etc.), tobacco history (e.g., # cigarettes 
per day, previous attempts, etc.), nicotine dependence* (Fagerstrom Test for Nicotine 
Dependence), smoking self-efficacy* (Smoking Self-Efficacy Scale), depressive symptoms* 
(CES-D), and social support.* These measures have been translated into Portuguese. Exhaled 
CO levels will be recorded at baseline, post-test, and 7-month f/u. Salivary cotinine will only be 
assessed at 7-month follow-up. 
 
Sample Size and Statistical Analysis  
As this is a feasibility study, sample size is justified based on the measurement precision of 
parameters referable for larger study. We are estimating sample size based on the results of the 
meta-analysis of tobacco cessation among PLWH conducted by Pool et al. where cessation 
was 13% in the intervention group.  For the second phase of feasibility testing with 32 
participants, we will be 90% confident that true rate of 7-day point prevalence abstinence at 6-
months will be between 3.2% and 22.8%. For 90% confidence interval of true mean, we will be 
able to estimate 0.3 standard deviation as margin of error with sample size of 32. With 
conservative consideration of 8% attrition rate over 6 months, the study will recruit 40 
participants. Descriptive statistics will be presented for participants’ characteristics at each time 
of measures.