Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842161
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-04-12
Brief Title:
South Africa Smoking Cessation and Engagement in HIVTB Care Care
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Treatment Development for Smoking Cessation and Engagement in HIVTB
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 HIVTB treatment outcomes among individuals with HIV andor TB in Cape Town South Africa If feasibility acceptability and preliminary efficacy are demonstrated the intervention will be ready for large-scale effectivenessimplementation testing This program will has the potential to dramatically improve public health by increasing the smoking quit rate and facilitating favorable HIVTB treatment outcomes among patients with HIV andor 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 treatment12 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 HIVTB treatment adherence specifically tailored for PWH andor 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 andor TB who use tobacco n25-30 and a focus group with providers or other clinic staff eg adherence counselors pulmonologists n6-8 The patient interviews will identify 1 multi-level barriers ie individual interpersonal structural to smoking cessation and 2 the unique ways in which smoking affects engagement in HIV and TB care The focus group will explore providers 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 n5 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 n86 43 per arm to ensure 62 completers 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 at 6 months
Aim 3b Conduct individual interviews with providers and clinic administrators to inform future implementation n10-15 The provider interviews will explore issues that affected implementation of the intervention in the clinic including intervention characteristics that will support sustainability
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 andor TB who use tobacco n25-30 and a focus group with providers or other clinic staff eg adherence counselors pulmonologists n6-8 The patient interviews will identify 1 multi-level barriers ie individual interpersonal structural to smoking cessation and 2 the unique ways in which smoking affects engagement in HIV and TB care The focus group will explore providers 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 n5 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 n86 43 per arm to ensure 62 completers 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 at 6 months
Aim 3b Conduct individual interviews with providers and clinic administrators to inform future implementation n10-15 The provider interviews will explore issues that affected implementation of the intervention in the clinic including intervention characteristics that will support sustainability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R34DA057169-02 | NIH | None | httpsreporternihgovquickSearch5R34DA057169-02 |