Health Trials

Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS

ConditionsSmoking CessationHIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) being aged ≥18 years

2) being HIV-positive

3) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes/day)

4) willing to set a date for a quit attempt within 2 weeks of study enrollment

Disqualifiers

1) history of a medical condition that precludes use of nicotine replacement therapy

2) physician/clinician deemed ineligible to participate based on medical or psychiatric condition

3) enrolled in another cessation program or use of other cessation medications.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Smartphone-delivered Automated Messaging

    Behavioral

    An interactive smartphone based intervention will provide weekly smoking-related assessments and personalized automated messages designed to increase motivation, self-efficacy, use of coping skills, social support and to reduce nicotine withdrawal symptoms and stress for a 26 week period.

  • Nicotine patch

    Drug

    Participants will be provided with a 8 week supply of nicotine patches

  • Brief Advice to Quit and Smoking Cessation Self Help Materials

    Behavioral

    Participants will receive self-help materials from Khmer Quit Now, a national smoking cessation campaign in Cambodia

  • Diet Assessment

    Behavioral

    Participants will be asked to complete brief weekly smartphone assessments about their diet for a 26-week period

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Standard Care GroupActive comparator 3 interventions
Group B: Automated Messaging Treatment GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Self Reported 7 Day Abstinence Smoking Status

Participants will self report 7-day abstinence smoking status

Time frame
12 Month Follow-Up
2

Smoking Status by Expired Carbon Monoxide

Investigators will use a CO monitor to verify smoking status biochemically

Time frame
12 Month Follow-up

Secondary outcomes

1

Self Reported 7 Day Abstinence Smoking Status at 3 Months

Participants will self report 7-day abstinence smoking status

Time frame
At 3 Months
2

Smoking Status by Expired Carbon Monoxide at 3 Months

Investigators will use a CO monitor to verify smoking status biochemically

Time frame
At 3 Months
3

Self Reported 7 Day Abstinence Smoking Status at 6 Months

Participants will self report 7-day abstinence smoking status

Time frame
At 6 Months
4

Smoking Status by Expired Carbon Monoxide at 6 Months

Investigators will use a CO monitor to verify smoking status biochemically

Time frame
At 6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator

University of Oklahoma

Collaborator

M.D. Anderson Cancer Center

Collaborator

Source ClinicalTrials.gov
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