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Tobacco Cessation for People Living with HIV
Clinical Trial Protocol
Aims: This study will provide insight into the efficacy, feasibility, applicability, and affordability of delivering tobacco cessation interventions through health care professionals at HIV treatment centers in two countries with different tobacco use patterns, policy environments, and health care resources and provide needed information to providers and policymakers looking for cost-effective tobacco cessation interventions.
Sample size: 800 adult PLWH who use tobacco will be recruited by health care professionals at HIV treatment centers where they are receiving care.
Population: Adults (18+) in Uganda and Zambia who are living with HIV, use tobacco every day, and are receiving continuous HIV care from a treatment facility.
Recruitment: 800 PLWH who use tobacco will be recruited from HIV treatment centers in two districts in Uganda and Zambia each and randomized to one of the following four study arms (described in more detail below): (1) Standard of Care (SOC); (2) SOC + NRT; (3) SOC + SMS; and (4) SOC + NRT + SMS.
Data analysis: Multilevel logistic regression analysis will be used to assess differences in rates of tobacco use cessation between the study arms, and identification of the predictors of tobacco use cessation.
Link to Full Published Protocol
Trial registration: ClinicalTrials.gov Identifier NCT05487807.
NCI project page: https://reporter.nih.gov/project-details/11418603#description
Registered August 4, 2022, https://clinicaltrials.gov/ct2/show/record/NCT05487807
Consort diagram
Formative Research and Text Message Library Adaptation and Development
Text messaging-based interventions (TMIs) have demonstrated effectiveness in reducing tobacco use in many populations. However, such interventions have not been tailored to meet the complex medical and psychosocial factors confronting people living with HIV (PLWH) in sub-Saharan Africa (SSA). We describe the process of adapting the SmokefreeTXT message library so that it is applicable to all forms of tobacco use, addresses issues specifically facing PLWH who use tobacco, and is culturally appropriate for use in Uganda and Zambia.
Supplemental Studies
Stigma Supplement
Extensive research has been carried out on the impact of HIV stigma on the ability of PLWH to access essential services, including cancer prevention in the form of tobacco use cessation services. This research indicates that HIV stigma hinders the use of HIV-related medical infrastructure, including that for cancer prevention and screening services, such as tobacco use cessation interventions.
During the formative stage of the parent project, PLWH and health care providers identified HIV stigma in decreasing the motivation of PLWH to engage in tobacco use cessation programming offered through HIV health clinics due to concern that it would lead to community awareness of their HIV status. They also noted tobacco use stigma, especially for women, as a cause for failing to notify their physician of risky behaviors that increase cancer risk. Far less research has focused on intersecting cancer stigma, including our initial formative data collection which largely failed to collect perspectives on cancer within the PLWH communities in which we are working.
Cancer stigma often originates from cultural stereotypes that cancer is a fatal disease, is contagious, or is a punishment for immoral behavior. Further, stigma associated with cancer likely contributes to delays in biomedical treatment and social consequences of being labeled with a cancer diagnosis (e.g. shame) may deter the use of biomedical screening, resulting in treatment delays. Stigma research is essential for the development of culturally sensitive interventions that address the predominant cancer stigmas, enhance the reach of educational messages, and increase adherence to preventive and curative treatments.
Implementation Science Supplement
This supplement is an ideal mechanism to better assess these existing implementation challenges and build on growing cancer-related research infrastructure supported by multiple NIH-funded projects in Uganda, including the Quit4Life+ (5U01CA261624-03) parent project and the Building Independent Research Capacity in HIV-Associated Malignancies (HIVAM) (D43TW009759) consortium led by the Ugandan Cancer Institute in partnership with the Fred Hutchinson Cancer Research Center in Kampala. By fostering this collaboration between the Quit4Life+ and HIVAM programs, we seek to enhance cancer-related implementation science research capacity throughout SSA. Notably, while both projects are actively engaged in program implementation, neither uses implementation science theory or frameworks in training or outcomes evaluation. Specifically, the supplemental implementation science training and data collection activities proposed will leverage both projects’ research teams (e.g. research trainees, interviewers, field supervisors, data/records managers) and existing study partners (e.g. district officers, clinical supervisors, clinicians, nurses, counselors) to build implementation science capacity and better evaluate cancer-related interventions and services within local, regional, and national health systems.
IRB numbers
Makerere University School of Public Health Research Ethics Committee: 2021-178
Uganda National Council for Science and Technology: HS1762ES
University of Zambia Biomedical Research Ethics Committee: 2377-2021
Zambia National Health Research Authority: 2377-2021
University of Maryland: 2349242-1
University of Southern California: HS-22-00006
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