跳至主要内容
临床试验/NCT05162911
NCT05162911已完成不适用

Implementing Tobacco Use Treatment in HIV Clinics in Vietnam

New York University2 个研究点 分布在 1 个国家目标入组 672 人开始时间: 2021年11月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
672
试验地点
2
主要终点
Carbon test at 6-months of smoking abstinence

研究概览

简要总结

The primary objective of this study is to conduct a 3-arm randomized controlled trial (RCT) that compares the effectiveness of three multi-component interventions that are embedded in HIV outpatient clinics (OPCs): 1)3As+Referral to the national quitline: Ask about tobacco use, Advise to quit, Assist with brief counseling and Refer to Viet Nam's national Quitline; 2) AAA+ +Counsel (Counsel=6-session cessation counseling intervention adapted for patients living with HIV/AIDS (PLWH) and delivered by a trained, onsite nurse; and 3) AAA+Counsel+N (N=nicotine replacement therapy (NRT)). The main outcome is biochemically validated 6-months smoking abstinence. The investigators will recruit and randomize 672 patients across 13 outpatient clinics (OPCs) (48 per site, 16 per arm). The investigators will also recruit 75-nonsmokers to participate in a single survey to assess food safety. Therefore, the total sample = 747 patients.

详细描述

This research has three phases. For Aim 1 the investigators will conduct a formative assessment to inform further modifications to the intervention components. Participants in Aim 1 will be patients of the outpatient clinics (OPC) or health care providers who work there. Patients who use tobacco will be asked to participate in individual interviews (n=24 ). The investigators will conduct key informant interviews with health care providers from 3 OPCs (n=28) to adapt the intervention to the OPC clinical context. The investigators will then conduct a pilot test of ARM 1 and 3 in one OPC with 16 patients. The recruitment and enrollment process will be the same as described for Aim 2. For Aim 2 the investigators will conduct a three-arm randomized controlled trial (RCT) to compare the effectiveness of three interventions aimed at increasing tobacco cessation rates among people living with HIV/AIDS (PLWH). Patients (n=672) will be recruited and enrolled from the 13 OPCs. All enrolled patients will complete a baseline survey in person. This survey will be administered once eligibility is established and consent is obtained. The consent and survey will last 30 minutes. Follow up surveys will occur at 3-, -6 and 12-months after enrollment. Follow up surveys will be conducted by telephone. At 6-months follow up, patients who report smoking abstinence will be asked to come in person to the OPC and will complete a carbon monoxide test to validate self-report. The investigators will conduct baseline, 12 and 18 month surveys with all health care providers in the study sites in person (n=98). For Aim 3 the investigators will conduct a post intervention (12-month) assessment of factors associated with implementation effectiveness and potential for sustainability. This includes repeating the health care provider surveys and Key informant interviews. The investigators will conduct baseline, 12 and 18 month surveys with all health care providers in the study sites in person (n=98). For Aim 4 the investigators will enroll 75 more patients who are non-smokers for a total of (n=747) patients and assess the relationship between food insecurity and tobacco use among PLWH (75 smokers and 75 non-smokers), which includes administering the Household Food Insecurity Access Scale (HFIAS) survey to patients at baseline and 6-months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients in the HIV OPCs
  • current tobacco users
  • patients who live in Hanoi
  • patients reachable by phone

排除标准

  • patients for whom there is a need for precaution in using NRT will be excluded
  • patients with recent myocardial infarction (2 weeks)
  • patients serious underlying arrhythmias
  • patients who are pregnant or nursing
  • patients are unable to demonstrate capacity for consent
  • patients already enrolled in a tobacco use treatment program.

研究组 & 干预措施

Ask, Advise, Assist (AAA) and Refer.

Active Comparator

Patients will receive Ask, Advise, Assist (AAA) and refer to the quitline as the intervention.

干预措施: Ask, advise, Assist and refer to the Quitline (Behavioral)

AAA plus referral to onsite counselor (Counsel).

Active Comparator

Patients will receive Ask, Advise, Assist plus referral to onsite counselor.

干预措施: Ask, advise, Assist and referral to onsite counselor (Behavioral)

AAA+Counsel+N (Nicotine gum).

Active Comparator

Patients will receive Ask, Advise, Assist, plus referral to onsite counselor and nicotine gum.

干预措施: Ask, advise, Assist and referral to onsite counselor and NRT (Behavioral)

结局指标

主要结局

Carbon test at 6-months of smoking abstinence

时间窗: 6-months smoking abstinence

biochemically validated 6-months smoking abstinence will be measured using expired-air carbon monoxide reading equal to or less than 8 ppm (CO \< 8 ppm). The scale is 0-50ppm, where the lowest values represent less CO levels, which indicate a patient is not smoking, and the highest values represent higher CO levels indicating a patient is actively smoking.

次要结局

  • Factors that may influence tobacco cessation, and sustainability of the interventions tested(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验