Study Locations: The study was carried out at the 16 Quit4Life+ sites in Uganda and Zambia

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Participants and Recruitment: Individuals were eligible for the study if they are HIV + , use tobacco according to the definition below, are aged 18 years or older, and are receiving continuous HIV care from a treatment facility. Individuals were ineligible for study participation if they: are currently pregnant or breastfeeding (or planning to do so in the next 6 months); have a physical or cognitive condition that would prevent them from study participation; or are illiterate in both English and the local language.

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Participants were recruited by health care professionals at HIV treatment centers where they were receiving care based on their HIV + status. Eligibility screening for the RCT included completion of a demographic questionnaire about current and past combustible and non-combustible tobacco use, intention to quit and/or past quit attempts.

 

Tobacco use status was biologically verified at baseline using urine cotinine dipsticks. The cotinine cut-off to detect current tobacco use was > 15 ng/mL, as validated among African populations. In addition to self-reported and biologically-verified daily tobacco use, we included a threshold level of nicotine dependence a score of 4 or above (the average score for a daily smoker) on the Fagerstrom Test for Nicotine Dependence (FTND) for both smoking and smokeless tobacco use to participate in the study.

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SMS Delivery: At enrollment, all participants received a project-provided mobile phone and a solar panel for charging the phone, as well as instruction on how to use the phone (including the use of security settings to alleviate privacy concerns). The phones were basic text-based phones with no study identifiers. Such phones are very prevalent throughout the study areas and previous research with similar basic mobile phones has shown that they are effective for text message delivery and user friendly.

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​The SMS text libraries differed across intervention conditions. Participants in the SOC and SOC + NRT arms received 22 text messages focused specifically on HIV education and importance of adhering to HIV treatment regimen selected from Uganda AIDS Commission (UAC) HIV messages library. Participants in the NRT arms received 11 additional text focused on use of the nicotine patch (i.e., 5 standard text messages, 5 prompted questions, and 1 possible requested information text). Participants in the Quit4Life+ arms received an additional 225 text messages focused on tobacco cessation: 164 standard text messages, 33 prompted questions (e.g., asking if they have quit), and 28 possible requested information texts. 

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Randomization and Blinding: EngageSpark implemented a randomization scheme/schedule using serial numbers from 1 through 400 for each country site using an appropriate STATA code; ii) randomly assigning enrolled participants to the study arms; and iii) sending the respective SMS messages per the assigned study arm to the participants. When a participant was enrolled at any of the study enrollment sites, they were assigned a serial number which corresponded to a telephone number. SMS messages were subsequently to the participants per the study arm assigned. 

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Data Management: Data was collected at enrollment and at follow up appointments by trained clinic staff through a mobile-based application, REDCap (Research Electronic Data Capture), loaded onto a password protected tablet. Data were uploaded to the cloud daily through secure internet connections at the clinic sites to a REDCap webserver guarded by multiple firewall and intrusion detection systems. All electronic connections to the REDCap environment were encrypted.

 

The data manager at the Center for Tobacco Control in Africa (CTCA) central coordination office was responsible for downloading the data off the cloud into a secure MySQL database server behind the Makerere University firewall. The data manager at the CTCA central coordination office was responsible for checking the accuracy and completeness of the data before entry into the database and following up with the relevant field team if any inconsistencies or problems are detected. Data was also received from EngageSpark also collected SMS-related data, including how often participants receive and respond to prompts. The application interface allows for outside applications to interact with the data to carry out additional analyses. All data was cleaned for final analysis by the CTCA data manager after it was received.

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Data Analysis: Analyses used standard intent-to-treat approach to examine the relative effects of the treatment arms on the outcomes of interest. Multilevel logistic regression analysis was used to assess differences in rates of tobacco use cessation between the study arms, and identification of the predictors of tobacco use cessation. Secondary outcomes that consider longitudinal data based on multiple follow ups and to adjust for the multi-level clustering per the study design, is still underway.

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Outcome Measures: The primary tobacco use outcome for this efficacy trial is the proportion of study participants that have prolonged abstinence 6 months post enrollment measured by self-report and biochemically-verified as recommended by the Society for Research on Nicotine and Tobacco.​​ Secondary outcomes include 7-day point-prevalence abstinence (self-reported and biochemically verified) at 4 weeks, 8 weeks, and 3 months; self-reported quit attempts and changes in tobacco use at those same timepoints; and NRT patch adherence among participants assigned to nicotine-patch arms. 

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Data Safety and Monitoring Board (DSMB): An independent DSMB composed of a clinician who is a specialist in HIV, a biostatistician, an expert in interventions studies and a community representative monitored the safety of the participants, but also ensure that the study was conducted according to the protocol. The Board met regularly throughout the study and had access to results on a regular basis. Specific functions of the DSMB incuded  research protocol review, review the plans for data safety and monitoring, evaluation of the intervention trial progress, reviews of data quality and timeliness as well as the accrual and retention, and review of participants’ risk versus benefit and the performance of the trial sites.