South Africa Smoking Cessation and Engagement in HIV/TB Care Care

NCT05842161 | Recruiting DMC

• 2 other identifiers: 2023P0007925R34DA057169-03
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Tuberculosis; Smoking Cessation

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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

  6-Month Follow-Up (6 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.

  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.

  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.

  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.

  6-Month Follow-Up (6 months post treatment initiation)

Secondary Outcomes (6)

• Short-term point prevalence smoking abstinence

  2-Month Follow-Up (2 months post treatment initiation)

• Average number of cigarettes smoked over the past 7 days

  At baseline

• Average number of cigarettes smoked over the past 7 days

  At each treatment session

• Average number of cigarettes smoked over the past 7 days

  2-Month Follow-Up (2 months post treatment initiation)

• Average number of cigarettes smoked over the past 7 days

  6-Month Follow-Up (6 months post treatment initiation)

Other Outcomes (1)

• Adherence to HIV/TB treatment

  At baseline, six treatment sessions, and 2 follow-up visits - over 6 months

Study Arms (2)

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.

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.

Other: Enhanced Treatment as Usual

Interventions

QUIT-AD BEHAVIORAL

An adapted, six-session cognitive behavioral therapy intervention for smoking cessation and treatment adherence

QUIT-AD

Enhanced Treatment as Usual OTHER

Standard treatment for HIV/TB with one session of psychoeducation.

Enhanced Treatment as Usual (ETAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or older
• Willing and able to provide written informed consent
• 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

You may not qualify if:

• Habitual use of other tobacco products
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Boston University: collaborator
• University of Cape Town: collaborator

Study Sites (1)

University of Cape Town

Rondebosch, 7700, South Africa

RECRUITING

MeSH Terms

Conditions

HIV Infections; Tuberculosis; Smoking Cessation

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Health Behavior; Behavior

Study Officials

• Amelia Stanton, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Conall O'Cleirigh, PhD

CONTACT

617-643-0385; cocleirigh@mgh.harvard.edu

Brianna A Estrada, BS

CONTACT

617-643-2147; bestrada@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Behavioral Medicine/Associate Professor

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 3, 2023
• Study Start: March 12, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)