Highlights
- Proactive referral to a national Quitline achieved smoking abstinence rates comparable to more intensive nurse-led counseling and nicotine replacement therapy.
- Integration of tobacco cessation services into routine HIV outpatient clinics in Vietnam proved feasible and safe.
- The study highlights the potential for leveraging existing national Quitline infrastructure in 42 low- and middle-income countries to address the tobacco epidemic among people living with HIV.
The Clinical Context: Tobacco Use Among People Living with HIV
The success of antiretroviral therapy (ART) has transformed HIV into a manageable chronic condition. However, this longevity has shifted the burden of morbidity and mortality toward non-communicable diseases. Tobacco use remains a significant driver of this shift. Globally, people living with HIV (PLWH) are two to three times more likely to smoke than the general population. In countries like Vietnam, this disparity contributes to a disproportionate risk of cardiovascular disease, lung cancer, and respiratory infections, often overshadowing the risks posed by the virus itself.Despite the clear need, tobacco cessation services are rarely integrated into HIV care in low- and middle-income countries (LMICs). Resource constraints, including limited staff time and lack of access to pharmacotherapy, often hinder the implementation of intensive behavioral interventions. Identifying scalable, evidence-based strategies that can be integrated into existing healthcare systems is a global health priority.
Study Design: The Hanoi Pragmatic Trial
To address this gap, researchers conducted an open-label, three-arm pragmatic randomized controlled trial across 13 outpatient HIV clinics (OPCs) in Hanoi, Vietnam. The study, published in The Lancet Global Health, aimed to compare the effectiveness of three distinct cessation strategies.The trial enrolled 672 adults who smoked at least one cigarette daily and had regular access to a mobile phone. Participants were randomized into three groups:
1. Proactive Quitline Referral
Participants were referred to Vietnam’s national smokers’ Quitline. This represented a low-intensity, high-scalability model leveraging existing national resources.
2. Counseling + SMS
A more intensive arm involving six sessions of tailored counseling delivered by trained HIV clinic nurses, supplemented by support via text messages.
3. Counseling + SMS + Nicotine Replacement Therapy (NRT)
This arm combined the nurse-led counseling and SMS support with six weeks of nicotine gum (2 mg).The primary endpoint was 7-day point-prevalence smoking abstinence at six months, strictly confirmed by exhaled carbon monoxide (CO) concentrations of less than 8 ppm. The study utilized an intention-to-treat analysis, ensuring that the results reflected real-world clinical conditions.
Key Findings: Comparable Efficacy Across Interventions
The trial results provide a critical perspective on how tobacco treatment can be delivered in resource-limited settings. Between November 2021 and September 2023, the study successfully followed participants through the six-month mark.
Abstinence Rates
At the six-month follow-up, 109 patients (16% of the total cohort) achieved biochemically confirmed abstinence. The breakdown by group was as follows:
- Quitline Group: 13% (28/221)
- Counseling + SMS Group: 18% (40/225)
- Counseling + SMS + Gum Group: 18% (41/226)
Statistical Comparisons
While the point estimates for the counseling arms were slightly higher, the differences did not reach statistical significance:
- Counseling + SMS vs. Quitline: OR 1.48 (95% CI 0.78–2.81; p=0.33)
- Counseling + SMS + Gum vs. Quitline: OR 1.64 (95% CI 0.86–3.11; p=0.17)
- Counseling + SMS + Gum vs. Counseling + SMS: OR 1.11 (95% CI 0.61–2.00; p=0.91)
Notably, 50% of the participants reported dual use of cigarettes and traditional waterpipes, a common cultural practice in Vietnam that adds a layer of complexity to cessation efforts. Despite this, the interventions remained safe, with no serious adverse events linked to the study protocols.
Expert Commentary: Scaling What Works
The findings from the Hanoi trial are particularly significant for health policy experts and clinicians in LMICs. The lack of a statistically significant difference between the intensive nurse-led arms and the proactive Quitline referral suggests that the latter may be the most pragmatic choice for widespread implementation.
Feasibility and Resource Allocation
Integrating intensive counseling into a busy HIV clinic requires significant training and staff time. In contrast, proactive referral to a national Quitline shifts the counseling burden away from clinic staff while still providing patients with evidence-based behavioral support. Given that 42 LMICs already have national Quitline infrastructures, this model offers a ready-made pathway for integrating tobacco treatment into HIV care systems.
The Role of Pharmacotherapy
The addition of nicotine gum did not provide a statistically significant benefit over counseling alone in this specific population. This finding may be influenced by the relatively low dose of NRT used or the high prevalence of waterpipe use, which may require different pharmacological approaches. However, it also suggests that in environments where NRT is expensive or unavailable, behavioral support via Quitlines remains a powerful tool.
Conclusion: A Path Forward for Integrated Care
The Shelley et al. study demonstrates that tobacco cessation is achievable among PLWH in Vietnam using various intervention levels. The fact that a national Quitline performed comparably to more resource-intensive interventions provides a clear mandate for policy change. Integrating tobacco treatment into HIV care does not necessarily require the creation of new, expensive programs; rather, it requires better utilization of existing public health resources.As HIV care continues to evolve toward a comprehensive chronic disease management model, addressing tobacco use must become a standard of care. This trial provides the evidence needed to support the scale-up of Quitline referrals as a primary strategy for reducing tobacco-related health disparities in the global HIV population.
Funding and ClinicalTrials.gov
This study was funded by the US National Cancer Institute. The trial is registered at ClinicalTrials.gov under the identifier NCT05162911.
References
Shelley D, Armstrong-Hough M, Nguyen T, et al. Effectiveness of behavioural tobacco cessation interventions with and without pharmacotherapy among people living with HIV in Viet Nam: a three-arm pragmatic randomised controlled trial. Lancet Glob Health. 2026;14(3):e407-e416. doi:10.1016/S2214-109X(25)00451-6.