HIV Infections, Smoking Cessation, Tuberculosis
Conditions
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 and/or semi-structured interviews will be conducted 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 and/or interviews with providers will explore their 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=40 completers, up to 50 randomized). 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 around 4 months. Aim 3b: Conduct individual interviews with participants, providers and clinic administrators to inform future implementation (n=40-50). The participant interviews will explore participants' experience with the QUIT-AD intervention in the clinic, including exploring the intervention characteristics that best affected their smoking habits and any barriers they had to care. The provider interviews will explore issues that affected implementation of the intervention in the clinic, including intervention characteristics that will support sustainability.
Interventions
BEHAVIORALQUIT-AD
An adapted, six-session cognitive behavioral therapy intervention for smoking cessation and treatment adherence
OTHEREnhanced Treatment as Usual
Standard treatment for HIV/TB with one session of psychoeducation.
Sponsors
Massachusetts General Hospital
Boston University
University of Cape Town
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 history of taking ART for at least three months (consecutively or non-consecutively) 4. Within 4 months of initiating or reinitiating TB treatment; positive GeneXpert test or sputum culture 5. Habitual smoker operationalized as smoking at least 4 days a week 6. Motivation (\> 5/10) to quit smoking or \> 24 hour quit past yr 7. Must be living in the catchment area for either the Town Two Clinic or the Michael Mapongwana Community Health Clinic in Khayelitsha
Exclusion criteria
1. Current interfering untreated/unstable mental health condition (e.g., psychosis, bipolar dx) 2. Current use of non-study pharmacotherapy for smoking cessation, 3. Cognitive Behavioral Therapy for smoking cessation initiated within the past year, 4. Diagnosed with extra-pulmonary or drug resistant (MDR or XDR) TB based upon chart review
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of intervention | At baseline | Feasibility of administering the QUIT-AD intervention. Will be will be assessed by (1) interventionist fidelity to the protocol (determined by a review of 20% of session audio recordings to document whether all key session themes were addressed), (2) session attendance, and (3) participant retention at the follow-up assessment |
| Acceptability of intervention | At baseline | How acceptable participants find the QUIT-AD intervention to be. Will be assessed via a brief questionnaire to be completed after every other treatment session; on a five-point Likert style scale, participants will rate the 7 component constructs of the acceptability of health care interventions framework: affective attitude (i.e., how an individual feels about the intervention), burden, ethicality (i.e., the extent to which the intervention aligns with one's value system), intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-term point prevalence smoking abstinence | 2-Month Follow-Up (2 months post treatment initiation) | Biologically verified 7-day point prevalence abstinence (PPA). Using the timeline follow-back method (TLFB), participants will self-report the last time they smoked. TLFB results will be biologically verified with saliva cotinine. |
| Average number of cigarettes smoked over the past 7 days | At baseline | Using the timeline follow-back method (TLFB), participants will self-report the number of cigarettes they smoked per day in the past 7 days. |
| Favorable HIV/TB treatment outcome | 4-Month Follow-Up (4 months post treatment initiation) | Favorable outcome defined differently based on a given participant's diagnoses. For participants with HIV alone, favorable treatment outcome will be defined as a VL \< 1000. For participants with TB alone, favorable treatment outcome will be defined by the following two criteria: absence of all three TB symptoms (productive cough, fever for more than two weeks, night sweats) determined by study nurse review; and a negative GeneXpert test or a negative sputum culture or smear. For participants with both HIV and TB, favorable treatment outcome will be a combined variable with three levels: failing to meet the definition for either favorable HIV or favorable TB outcome (coded as 0), meeting criteria for either favorable HIV or favorable TB treatment outcome (coded as 1), and meeting the definitions for both favorable HIV and TB treatment outcomes (coded as 2). |
Countries
South Africa
Contacts
CONTACTConall O'Cleirigh, PhD
CONTACTBrianna A Estrada, BS
PRINCIPAL_INVESTIGATORAmelia Stanton, PhD
Boston University
Outcome results
None listed