Evaluating Smoking Cessation and Harm Reduction Approaches Among People Living With HIV/AIDS in South Africa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Follow-Up Rate at 6 Months
研究概览
简要总结
The purpose of this pilot randomized controlled trial study aims to address the unmet need for feasible and efficacious strategies for reducing combustible cigarette (CC) use among people living with HIV/AIDS (PLWHA) in South Africa, which has the potential to significantly improve the health and long-term survival of PLWHA CC smokers. Using the proposed intervention, based on the Information-Motivation-Behavioral Skills (IMB), and a simultaneous embedded mixed methods approach, the investigators will evaluate a telehealth program targeting CC harm reduction, comparing E-cigarettes (EC) to nicotine replacement therapy (NRT) that is enhanced by integrating ecological momentary intervention (EMI) texting. As such, this proposal will significantly build research capacity in South Africa to conduct telehealth tobacco treatment interventions using innovative EMI approaches enhancing participants' engagement, as well as state-of-the art evaluation approaches.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult PLWHA CC smokers;
- •Speaks Afrikaans, or Xhosa, or English;
- •reports daily CC smoking (≥ 5 CPD);
- •Owns any type of mobile phone;
- •interested in reducing CC smoking but not necessarily trying to quit;
- •Receives HIV/AIDS care in one of the eight selected clinics follow-up rates.
排除标准
- •are pregnant or breastfeeding;
- •unable to provide consent;
- •used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo);
- •currently engaged in an attempt to quit CC smoking;
- •current major depressive or manic episode, current psychotic disorder, past-year suicide attempt, or current suicidal ideation with plan or intent. plan or intent.
研究组 & 干预措施
Control (Quit-Line Referral)
Participants will receive referral to the existing South African Quitline. Participants will receive information to contact the Quitline if participants so choose, in addition to ecological momentary assessment (EMA) texting orientation.
干预措施: Counseling (Behavioral)
Nicotine Replacement Therapy (NRT)
In addition to phone counseling + ecological momentary intervention (EMI) texting, participants will receive combination NRT (daily patches and lozenges).
干预措施: Counseling (Behavioral)
Electronic Cigarette (EC)
In conjunction with phone counseling + EMI texting, participants will receive the VUSE "Solo" EC.
干预措施: E-Cigarette (EC) (Other)
Electronic Cigarette (EC)
In conjunction with phone counseling + EMI texting, participants will receive the VUSE "Solo" EC.
干预措施: Counseling (Behavioral)
结局指标
主要结局
Follow-Up Rate at 6 Months
时间窗: Month 6
Defined as the percent of participants who completed the 6-month follow-up.
Percent of Patients who Enroll in Counseling
时间窗: Up to Month 6
Defined as the percentage of participants who start the intervention counseling sessions.
Recruitment Rate
时间窗: Up to Month 6
Defined as the total number of participants recruited divided by the maximum number of recruiting sites, then divided by the total number of months that the trial recruited for.
Follow-Up Rate at 3 Months
时间窗: Month 3
Defined as the percent of participants who completed the 3-month follow-up.
Client Satisfaction Questionnaire (CSQ-8) Score
时间窗: Month 3
8-item assessment of satisfaction with the intervention. The total score is the sum of responses and ranges from 8 to 32, with higher numbers indicating greater satisfaction.
次要结局
- Percentage of Participants who Achieve 7-Day Point Prevalence Abstinence.(Month 3)
- Change in American Thoracic Society Questionnaire Score(Baseline, Month 6)
- Percentage of Participants who achieve 50% Reduction in Cigarettes Per Day (CPD), compared with Baseline(Up to Month 6)