Tobacco Cessation Clinical Trial
— M2Q2-HIVOfficial title:
mHealth Messaging to Motivate Quitline Use and Quitting Among Persons Living With HIV (PLWH) in Vietnam (M2Q2-HIV)
Verified date | June 2024 |
Source | University of Massachusetts, Worcester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The intersection of smoking and HIV/AIDS poses a serious public health threat in Vietnam. Vietnam is dealing with these two challenges with parallel rather than integrated plans. Using a computer-tailored texting intervention, study investigators seek to promote the use of an underused, available, government-funded resource (the Quitline) and Nicotine Replacement Therapy (NRT) that the quitline provides, thus, promoting cessation among PLWH.
Status | Enrolling by invitation |
Enrollment | 600 |
Est. completion date | August 31, 2026 |
Est. primary completion date | March 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Diagnosed HIV infection (prevalent and incident HIV). 2. At least 18 years old. 3. Current smoker. 4. Be able to receive texts and read text (literate). Exclusion Criteria: 1. Pregnant or planning to become pregnant during the next six months. 2. Unable or unwilling to provide informed consent. 3. Prior diagnosis of serious mental health illness. 4. Smoker who helped develop the motivational texts used in the intervention (participated in Aim 1). 5. Family member of another participant in the study. |
Country | Name | City | State |
---|---|---|---|
United States | UMass Chan Medical School | Worcester | Massachusetts |
Vietnam | Institute of Population, Health, and Development (PHAD) | Hanoi |
Lead Sponsor | Collaborator |
---|---|
University of Massachusetts, Worcester | Institute of Population, Health and Development, Vietnam, National Cancer Institute (NCI) |
United States, Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Smoking Cessation Rate | At six months, we will assess 7-day point prevalence cessation, based on the following question: "Do you currently smoke tobacco (smoked even 1 puff in the last 7 days)?" The Society of Nicotine and Tobacco Research has recommended this measure. | At 6 months post-randomization | |
Secondary | Self-Efficacy | Self-Efficacy, as measured by the Smoking Self-Efficacy Questionnaire (SEQ-12) questionnaire. The score for each question ranges on a 4-point Likert scale from 0-3. SEQ-12 score ranges from 0-36, with higher values indicating higher self-efficacy for smoking cessation. The aggregate score will only be computed if no more than 2 out of the 12 questionnaire items had missing or 'not applicable' responses. | 0-month (baseline) and 6-months post-randomization | |
Secondary | HIV-Related Stigma | HIV-related stigma, measured using a survey assessing five indicators of HIV/AIDS-related stigma according to USAID: (1) blame, judgment; (2) shame; (3) enacted stigma/discrimination; (4) disclosure; and (5) fear of casual transmission and refusal of contact. Survey response options include (1) Yes, (2) No, and (3) No answer. A response of "yes" to one or more survey questions will indicate the presence of HIV-related stigma. | 0-month (baseline) and 6-months post-randomization | |
Secondary | Quitline Use | The quitline staff will record details of intake assessment (time on call, readiness to quit, quit date, and goal-setting) and fidelity of follow-up call completion. | 6-months post-randomization | |
Secondary | NRT Use | The quitline staff will document the distribution of NRT lozenge and smoker use of NRT during follow-up. | 6-months post-randomization |
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