Evaluating Smoking Cessation and Harm Reduction Approaches Among People Living With HIV/AIDS in South Africa
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Tobacco Smoking
- Sponsor
- NYU Langone Health
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Follow-Up Rate at 6 Months
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Follow-Up Rate at 6 Months
Time Frame: Month 6
Defined as the percent of participants who completed the 6-month follow-up.
Percent of Patients who Enroll in Counseling
Time Frame: Up to Month 6
Defined as the percentage of participants who start the intervention counseling sessions.
Recruitment Rate
Time Frame: 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
Time Frame: Month 3
Defined as the percent of participants who completed the 3-month follow-up.
Client Satisfaction Questionnaire (CSQ-8) Score
Time Frame: 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.
Secondary Outcomes
- 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)