Development of a Tailored Smoking Cessation Program for Individuals With HIV Infection in Washington, D.C.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Smoking Abstinence
研究概览
简要总结
Morbidity and mortality from smoking-related diseases among people living with HIV (PLWH) in the U.S. surpasses that due to HIV itself. Conventional smoking cessation treatments have not demonstrated strong efficacy among PLWH. The investigators conducted a pilot randomized controlled trial (RCT) to evaluate a tailored smoking cessation intervention based on the minority stress model, hypothesizing that behavioral counseling through this lens would enhance cessation. The investigators compared standard of care counseling (SOC) to a tailored intervention (TI) including one face-to-face counseling session incorporating cognitive behavioral therapy to build resilience, and 30 days of 2-way text messaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •≥18 years of age
- •report being HIV-infected
- •be a resident of the Washington, D.C. area
- •current, daily smokers of tobacco
- •have a confirmed smoking status of 6 parts per million (ppm) or more by using an exhaled carbon monoxide breath monitor
- •agree to participate
- •be willing to set a quit date within 7 days of baseline assessment.
排除标准
- •are currently using smokeless tobacco or electronic cigarettes at least every day
- •are currently using nicotine replacement therapy or other smoking cessation treatment
- •report being HIV-uninfected
- •report having heart disease or high blood pressure not controlled by medication
- •are currently in an alcohol treatment program
- •are pregnant (exclusion items 4-6 are contraindications of nicotine replacement therapy, which will be provided)
- •do not have a primary care provider or HIV care provider to refer to in the event of an adverse reaction to nicotine replacement therapy.
研究组 & 干预措施
Standard of Care
One-time standard of care in-person behavioral counseling lasting approximately one hour, plus a 30-day supply of nicotine replacement therapy consisting of nicotine patches and nicotine gum (dosage according to current smoking intensity according to manufacturers instructions). The standard of care behavioral counseling was adapted from the current U.S. clinical practice guidelines.
干预措施: Standard of Care (Behavioral)
Tailored Counseling
Participants in the intervention arm were provided a one-time tailored cognitive-behavioral therapy in-person cessation counseling intervention lasting approximately one hour, a 30-day supply of nicotine replacement therapy (consisting of nicotine patches and nicotine gum; dosage according to current smoking intensity according to manufacturers instructions), and a tailored bi-directional text messaging program delivering two messages per day for four weeks. The TI session was adapted from the clinical practice guidelines to include behavioral elements rooted in the minority stress model. The intervention used addressed issues of stress related to HIV stigma, minority status and socioeconomic condition.
干预措施: Tailored behavioral counseling (Behavioral)
结局指标
主要结局
Smoking Abstinence
时间窗: 30 day follow-up
7-day point prevalence plus exhaled breath carbon monoxide \< 7 parts per million (ppm)
次要结局
- Cigarettes per day(30 day follow-up)
- Self-efficacy(30 day follow-up)
- Exhaled breath carbon monoxide(30 day follow-up)
研究者
Jessica Elf
Assistant Professor
Colorado State University