South Africa Smoking Cessation and Engagement in HIV/TB Care Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
QUIT-AD
BehavioralAn adapted, six-session cognitive behavioral therapy intervention for smoking cessation and treatment adherence
Enhanced Treatment as Usual
Other interventionStandard treatment for HIV/TB with one session of psychoeducation.
Treatment groups
83 Participants
are divided into 2 treatment groupsGroup A: QUIT-ADExperimental treatment 1 intervention
Group B: Enhanced Treatment as Usual (ETAU)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 baseline2
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 sessions3
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)4
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)Secondary outcomes
1
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)2
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 baseline3
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 session4
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)Other outcomes
1
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 monthsSponsors and contacts
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Massachusetts General Hospital
Lead sponsor
Boston University
Collaborator
University of Cape Town
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov