HIV InfectionsNCT05842161
South Africa Smoking Cessation and Engagement in HIV/TB Care Care
A study testing QUIT-AD and Enhanced Treatment as Usual in people with HIV Infections and Tuberculosis, run by Massachusetts General Hospital at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Tuberculosis, Smoking Cessation
- What is being tested?
- QUIT-AD and Enhanced Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSouth Africa
- Study dates
- 12 Mar 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or older
- Willing and able to provide written informed consent
- Living with HIV, confirmed via medical record, and history of taking ART for at least three months (consecutively or non-consecutively)
- Within 4 months of initiating or reinitiating TB treatment; positive GeneXpert test or sputum culture
- Habitual smoker operationalized as smoking at least 4 days a week
- Motivation (> 5/10) to quit smoking or > 24 hour quit past yr
- Must be living in the catchment area for either the Town Two Clinic or the Michael Mapongwana Community Health Clinic in Khayelitsha
Who cannot join
- Current interfering untreated/unstable mental health condition (e.g., psychosis, bipolar dx)
- Current use of non-study pharmacotherapy for smoking cessation,
- Cognitive Behavioral Therapy for smoking cessation initiated within the past year,
- Diagnosed with extra-pulmonary or drug resistant (MDR or XDR) TB based upon chart review
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
University of Cape Town
Rondebosch, 7700
John Joska, PhD
John Joska, PhD
About this study
Official title: Treatment Development for Smoking Cessation and Engagement in HIV/TB
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.
Read the 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.
- Conditions
- HIV Infections, Tuberculosis, Smoking Cessation
- Being tested
- QUIT-AD, Enhanced Treatment as Usual
- Medical subject headings
- HIV Infections, Tuberculosis, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUIT-ADBehavioural
An adapted, six-session cognitive behavioral therapy intervention for smoking cessation and treatment adherence
Enhanced Treatment as UsualOther
Standard treatment for HIV/TB with one session of psychoeducation.
| Study group | Role | What they receive |
|---|---|---|
| QUIT-AD | Experimental | 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. Receives: Behavioral: QUIT-AD |
| Enhanced Treatment as Usual (ETAU) | Active comparator | After randomization, participants in the ETAU condition will receive one session of psychoeducation on the HIV- and TB-related health benefits of smoking cessation. Receives: Other: Enhanced Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-Month Follow-Up (4 months post treatment initiation)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 4-Month Follow-Up (4 months post treatment initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start12 Mar 2024
- Primary completion1 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, University of Cape Town, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Conall O'Cleirigh, Massachusetts General Hospital
- Investigators
- Amelia Stanton, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842161
- Sponsor's protocol ID
- 2023P000792
- Other IDs
- 5R34DA057169-03
- Status last verified
- Mar 2026
- First submitted
- 12 Apr 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Development for Smoking Cessation and Engagement in HIV/TB
- ClinicalTrials.gov ID
- NCT05842161
- Acronym / sponsor ID
- 2023P000792
- Conditions
- HIV Infections, Tuberculosis, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston University, University of Cape Town, National Institute on Drug Abuse (NIDA)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QUIT-AD | Experimental | Behavioral: QUIT-ADAn 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. |
| Enhanced Treatment as Usual (ETAU) | Active comparator | Other: Enhanced Treatment as UsualAfter randomization, participants in the ETAU condition will receive one session of psychoeducation on the HIV- and TB-related health benefits of smoking cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 or older
- Willing and able to provide written informed consent
- Living with HIV, confirmed via medical record, and history of taking ART for at least three months (consecutively or non-consecutively)
- Within 4 months of initiating or reinitiating TB treatment; positive GeneXpert test or sputum culture
- Habitual smoker operationalized as smoking at least 4 days a week
Key exclusion criteria (4 listed)
- Current interfering untreated/unstable mental health condition (e.g., psychosis, bipolar dx)
- Current use of non-study pharmacotherapy for smoking cessation,
- Cognitive Behavioral Therapy for smoking cessation initiated within the past year,
- Diagnosed with extra-pulmonary or drug resistant (MDR or XDR) TB based upon chart review
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QUIT-ADAn adapted, six-session cognitive behavioral therapy intervention for smoking cessation and treatment adherence | Behavioural | QUIT-AD |
| Enhanced Treatment as UsualStandard treatment for HIV/TB with one session of psychoeducation. | Other | Enhanced Treatment as Usual (ETAU) |
Primary outcome
Feasibility of intervention
Time frame: 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
Feasibility of intervention
Time frame: At treatment sessions
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
Feasibility of intervention
Time frame: 2-Month Follow-Up (2 months post treatment initiation)
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
Feasibility of intervention
Time frame: 4-Month Follow-Up (4 months post treatment initiation)
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
Time frame: 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.
Acceptability of intervention
Time frame: At treatment sessions
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.
Acceptability of intervention
Time frame: 2-Month Follow-Up (2 months post treatment initiation)
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.
Acceptability of intervention
Time frame: 4-Month Follow-Up (4 months post treatment initiation)
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.
6 secondary outcomes
Short-term point prevalence smoking abstinence
Time frame: 2-Month Follow-Up (2 months post treatment initiation)
Average number of cigarettes smoked over the past 7 days
Time frame: At baseline
Average number of cigarettes smoked over the past 7 days
Time frame: At each treatment session
Average number of cigarettes smoked over 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
Time frame: 4-Month Follow-Up (4 months post treatment initiation)
Favorable HIV/TB treatment outcome
Time frame: 4-Month Follow-Up (4 months post treatment initiation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amelia Stanton, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QUIT-AD and Enhanced Treatment as Usual in people with HIV Infections and Tuberculosis, run by Massachusetts General Hospital at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Conall O'Cleirigh, PhD (617-643-0385, cocleirigh@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: At baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.