Brief Summary

The goal of this research study is to learn about 2 different interactive methods that are designed to help people with HIV/AIDS stop smoking.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Jan 2015

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

November 21, 2014

Completed

6 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed

1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed

3.9 years until next milestone

Results Posted

Study results publicly available

January 27, 2020

Completed

Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

November 21, 2014

Results QC Date

March 29, 2017

Last Update Submit

January 23, 2020

Conditions

Tobacco Use Cessation

Keywords

Cancer PreventionTobacco Use CessationHIV-positiveNicotine patchNRTQuestionnaireSurveySmartphoneCounselingSaliva testSaliva cotinine testNicotine replacement therapySmoking abstinenceAids

Outcome Measures

Primary Outcomes (1)

Smoking Abstinence: 3-month Assessment Via Smart Phone
Smoking abstinence defined as number of participants with biochemically 7-day abstinence confirmed with weekly smart-phone assessments. Saliva cotinine levels, assessed with NicAlert test strips, used to biochemically verify abstinence. Participants will complete the NicAlert saliva cotinine test (supplies given at enrollment) and take a photograph of the test strip results. In primary abstinence analysis for difference in cessation rate between interventions, participants who do not complete follow-up assessments considered to be smokers.
3 months

Study Arms (2)

Standard Treatment (ST)

EXPERIMENTAL

Participants supplied with a 8-week supply of nicotine patches, a smart phone and brief advice to quit smoking. Participants also receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes. Participants receive weekly assessments to complete for the 8-week treatment period via smartphone. Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months after intervention. Participants complete saliva cotinine test 3 months after intervention.

Drug: Nicotine PatchBehavioral: QuestionnairesOther: PamphletBehavioral: Phone Counseling SessionsOther: Saliva TestDevice: Smart phone

Automated Treatment (AT)

EXPERIMENTAL

Participants supplied with a 8-week supply of nicotine patches and a smart phone. Participants also receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone. Participants receive weekly assessments to complete for the 8-week treatment period via smartphone, and again at 3 months. Participants complete saliva cotinine test 3 months after intervention.

Drug: Nicotine PatchBehavioral: QuestionnairesBehavioral: Phone Counseling SessionsOther: Saliva TestDevice: Smart phone