An interventional study of QUIT-AD and Enhanced Treatment as Usual in HIV Infections, Tuberculosis and Smoking Cessation, sponsored by Massachusetts General Hospital. Recruiting at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 83 is close to the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An six-session adapted cognitive-behavioral intervention for smoking cessation and treatment adherence. Intervention content will include psychoeducation related to cognitive-behavioral therapy, smoking, TB, and HIV; behavioral activation; distress tolerance; and relapse prevention.
Behavioral: QUIT-AD
After randomization, participants in the ETAU condition will receive one session of psychoeducation on the HIV- and TB-related health benefits of smoking cessation.
Other: Enhanced Treatment as Usual
An adapted, six-session cognitive behavioral therapy intervention for smoking cessation and treatment adherence
Standard treatment for HIV/TB with one session of psychoeducation.
Feasibility of intervention
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
Time frame: At baseline
Feasibility of intervention
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
Time frame: At treatment sessions
Feasibility of intervention
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
Time frame: 2-Month Follow-Up (2 months post treatment initiation)
Feasibility of intervention
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
Time frame: 4-Month Follow-Up (4 months post treatment initiation)
Acceptability of intervention
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.
Time frame: At baseline
Acceptability of intervention
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.
Time frame: At treatment sessions
Acceptability of intervention
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.
Time frame: 2-Month Follow-Up (2 months post treatment initiation)
Acceptability of intervention
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.
Time frame: 4-Month Follow-Up (4 months post treatment initiation)
Short-term point prevalence smoking abstinence
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.
Time frame: 2-Month Follow-Up (2 months post treatment initiation)
Average number of cigarettes smoked over the past 7 days
Using the timeline follow-back method (TLFB), participants will self-report the number of cigarettes they smoked per day in the past 7 days.
Time frame: At baseline
Average number of cigarettes smoked over the past 7 days
Using the timeline follow-back method (TLFB), participants will self-report the number of cigarettes they smoked per day in the past 7 days.
Time frame: At each treatment session
Average number of cigarettes smoked over the past 7 days
Using the timeline follow-back method (TLFB), participants will self-report the number of cigarettes they smoked per day in the past 7 days.
Time frame: 2-Month Follow-Up (2 months post treatment initiation)
Average number of cigarettes smoked over the past 7 days
Using the timeline follow-back method (TLFB), participants will self-report the number of cigarettes they smoked per day in the past 7 days.
Time frame: 4-Month Follow-Up (4 months post treatment initiation)
Favorable HIV/TB treatment outcome
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).
Time frame: 4-Month Follow-Up (4 months post treatment initiation)
Adherence to HIV/TB treatment
Adherence to HIV and TB treatment will be assessed via self-report and pharmacy refill count. The self-report measure will assess adherence over a 30-day period. For ART, participants will self-report on their adherence using a 3-item validated scale. For TB treatment, the measure will be informed by TB treatment adherence documentation on patients' adherence register/TB card and adapted from our previous work in HIV medication adherence. Pharmacy refill adherence will be calculated as the mean adherence of all drugs in the combination being prescribed at that time point; from this data, a binary measure will be created, and adherence will be defined as 90% or more of days covered in the specified time period.
Time frame: At baseline, six treatment sessions, and 2 follow-up visits - over 4 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital →