South Africa Smoking Cessation and Engagement in HIV/TB Care Care

HIV Infections Clinical Trial

Official title: Treatment Development for Smoking Cessation and Engagement in HIV/TB

Status Recruiting

Clinical Trial Summary

The purpose of this study is to integrate elements from existing interventions developed by our team into a single intervention (QUIT-AD), designed to improve smoking cessation and favorable HIV/TB treatment outcomes among individuals with HIV and/or TB in Cape Town, South Africa. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness/implementation testing. This program will has the potential to dramatically improve public health by increasing the smoking quit rate and facilitating favorable HIV/TB treatment outcomes among patients with HIV and/or TB in resource limited South African settings.

Clinical Trial Description

One of the greatest public health challenges facing South Africa (SA) is tobacco use, which fuels the overlapping epidemics of HIV and pulmonary tuberculosis (TB). Tobacco is the single most preventable cause of death globally, causing more than 7 million deaths per year, with 80% of individuals who use tobacco currently residing in low- and middle-income countries (LMICs). Smoking is an independent risk factor for HIV acquisition, higher viral load, and increased rate of progression to AIDS. Similarly, smoking exacerbates risk for TB and compromises TB treatment,12 increasing TB-related morbidity and mortality. Individuals who smoke are twice as likely to be infected with TB, to transition from latent to active TB, and to die from TB. The prevalence of smoking among people with HIV (PWH) in SA is disproportionately high, as is the prevalence of smoking among people with TB. Among men with HIV in SA, 52% are current smokers, significantly higher than in the general population, whereas 13% of women with HIV report current smoking. Similarly, 56% of patients in SA with active TB currently smoke tobacco, and the prevalence of smoking among individuals with suspected and confirmed TB in Cape Town (63% in men, 44% in women), is much higher than in the general population (35% in men, 10% in women). Together, smoking, HIV, and TB are fueling a dangerous increase in chronic obstructive pulmonary disease, which the World Health Organization (WHO) predicts will become the third most common cause of death globally by 2030, increasing the burden of lung disease in resource-limited settings. Given that the intersecting epidemics of smoking, HIV, and TB pose high risk for poor health outcomes, SA is in urgent need of a smoking cessation intervention that also improves engagement in HIV and TB treatment. This project will leverage components of our previous work to culturally adapt an intervention (QUIT-AD) that improves smoking cessation and HIV/TB treatment adherence specifically tailored for PWH and/or TB in SA. Individuals using tobacco who are (a) living with HIV or (b) initiating TB treatment or (c) living with HIV and initiating TB treatment will be recruited to participate. The study will take place in Khayelitsha, a peri-urban settlement in Cape Town.

Our aims are as follows:

Aim 1: To collect qualitative data that will inform the development of QUIT-AD. We will conduct semistructured interviews with PWH and/or TB who use tobacco (n=25-30) and a focus group with providers or other clinic staff (e.g., adherence counselors, pulmonologists; n=6-8). The patient interviews will identify (1) multi-level barriers (i.e., individual, interpersonal, structural) to smoking cessation and (2) the unique ways in which smoking affects engagement in HIV and TB care. The focus group will explore providers' perspectives on barriers to smoking cessation and treatment engagement and will inform the development of the QUIT-AD protocol.

Aim 2: Specify the QUIT-AD manual and conduct a small open trial (n=5) of the intervention. This open trial will enable us to iteratively refine the intervention, the treatment manual, and the study procedures.

Aim 3a: Assess the feasibility and acceptability of QUIT-AD in a pilot randomized controlled trial compared to enhanced (inclusive of basic adherence counseling and psychoeducation) treatment as usual (n=86, 43 per arm, to ensure 62 completers). Secondary outcomes will be biologically-verified point prevalence abstinence, number of cigarettes smoked, favorable HIV (defined as suppressed viral load), favorable TB treatment outcome (defined as absence of TB symptoms and a negative GeneXpert test or a negative sputum culture), or both at 6 months.

Aim 3b: Conduct individual interviews with providers and clinic administrators to inform future implementation (n=10-15). The provider interviews will explore issues that affected implementation of the intervention in the clinic, including intervention characteristics that will support sustainability. ;

Related Conditions & MeSH terms

• HIV Infections
• Smoking Cessation
• Tuberculosis

• NCT number: NCT05842161
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Conall O'Cleirigh, PhD
• Phone: 617-643-0385
• Email: cocleirigh@mgh.harvard.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Completion date: March 31, 2026