Clinical trial NCT05842161: South Africa Smoking Cessation and Engagement in HIV/TB Care Care
Official title: Treatment Development for Smoking Cessation and Engagement in HIV/TB
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Tuberculosis
Smoking Cessation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
name: University of Cape Town
First posted: 2023-05-03
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 or older
2. Willing and able to provide written informed consent
3. Living with HIV, confirmed via medical record, and on antiretroviral therapy (ART) AND/OR within 1 month of initiating or reinitiating TB treatment; positive GeneXpert test or sputum culture

(5) Daily smoker operationalized as \> 5 cigarettes per day, (6) Motivation (\> 5/10) to quit smoking or \> 24 hour quit past yr

Exclusion Criteria:

1. Habitual use of other tobacco products
2. Current interfering untreated/unstable mental health condition (e.g., psychosis, bipolar dx)
3. Current use of non-study pharmacotherapy for smoking cessation,
4. Cognitive Behavioral Therapy for smoking cessation initiated within the past year,
5. Diagnosed with extra-pulmonary or drug resistant (MDR or XDR) TB based upon chart review

Primary outcomes:
measure: Feasibility of intervention
timeFrame: At baseline
measure: Feasibility of intervention
timeFrame: At treatment sessions
measure: Feasibility of intervention
timeFrame: 2-Month Follow-Up (2 months post treatment initiation)
measure: Feasibility of intervention
timeFrame: 6-Month Follow-Up (6 months post treatment initiation)
measure: Acceptability of intervention
timeFrame: At baseline
measure: Acceptability of intervention
timeFrame: At treatment sessions
measure: Acceptability of intervention
timeFrame: 2-Month Follow-Up (2 months post treatment initiation)
measure: Acceptability of intervention
timeFrame: 6-Month Follow-Up (6 months post treatment initiation)
Secondary outcomes:
measure: Short-term point prevalence smoking abstinence
timeFrame: 2-Month Follow-Up (2 months post treatment initiation)
measure: Average number of cigarettes smoked over the past 7 days
timeFrame: At baseline
measure: Average number of cigarettes smoked over the past 7 days
timeFrame: At each treatment session
measure: Average number of cigarettes smoked over the past 7 days
timeFrame: 2-Month Follow-Up (2 months post treatment initiation)
measure: Average number of cigarettes smoked over the past 7 days
timeFrame: 6-Month Follow-Up (6 months post treatment initiation)
measure: Favorable HIV/TB treatment outcome
timeFrame: 6-Month Follow-Up (6 months post treatment initiation)
Other outcomes:
measure: Adherence to HIV/TB treatment
timeFrame: At baseline, six treatment sessions, and 2 follow-up visits - over 6 months
Locations:
city: Rondebosch
country: South Africa
facility: University of Cape Town
Study officials:
affiliation: Boston University
name: Amelia Stanton, PhD
role: PRINCIPAL_INVESTIGATOR
References: