NCT02898597

Brief Summary

As people with HIV/AIDS live longer, the burden of non-AIDS-related health problems such as cardiovascular diseases and cancers on these people have consistently increased. Smoking is one of the major contributing factors to these health problems and rates of cigarette smoking in this group are substantially higher than those of the general population: 40-70% vs. 17-10%. Especially, women living with HIV/AIDS seem to be more susceptible to the negative consequence of smoking than their male counterparts. They are also less likely to see tobacco dependence treatment for dual stigma associated with both conditions: HIV infection and nicotine addiction. This is a pilot study to develop smoking cessation intervention for these women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 5, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

1.5 years

First QC Date

September 8, 2016

Results QC Date

October 9, 2018

Last Update Submit

August 2, 2019

Conditions

AIDS/HIV

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Abstinence

    Self-reported abstinence since the quit day, which will be verified with a salivary cotinine test at both 3-month and 6-month follow-ups

    6-month follow-up

Study Arms (2)

Video

EXPERIMENTAL

Video-call delivered cognitive behavioral therapy

Behavioral: Cognitive Behavioral Therapy

Voice

ACTIVE COMPARATOR

Voice-call delivered cognitive behavioral therapy

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Received 8 weekly individualized counseling sessions of cognitive behavioral therapy

VideoVoice

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • Diagnosis of HIV infection
  • Age 18 or older
  • Smoking at least 5 cigarettes a day
  • Having access to a mobile-phone with Internet connection
  • Willing to quit smoking within the next 4 weeks

You may not qualify if:

  • Inability to speak English
  • Involvement in another cessation program
  • Being pregnant or lactating
  • Having an active skin disease
  • History of serious mental illnesses (e.g., schizophrenia and bipolar disorder)
  • Serious alcohol use problem
  • Use of any illegal substances excluding marijuana

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Massachusetts Boston

Boston, Massachusetts, 02125, United States

Location

Related Publications (11)

  • Paudel V, Baral KP. Women living with HIV/AIDS (WLHA), battling stigma, discrimination and denial and the role of support groups as a coping strategy: a review of literature. Reprod Health. 2015 Jun 2;12:53. doi: 10.1186/s12978-015-0032-9.

    PMID: 26032304BACKGROUND

  • Bancroft A. Women, Families & HIV/AIDS: A Sociological Perspective on the Epidemic in America. J Health Psychol. 2001 May;6(3):356-8. doi: 10.1177/135910530100600309. No abstract available.

    PMID: 22049380BACKGROUND

  • Palella FJ Jr, Baker RK, Moorman AC, Chmiel JS, Wood KC, Brooks JT, Holmberg SD; HIV Outpatient Study Investigators. Mortality in the highly active antiretroviral therapy era: changing causes of death and disease in the HIV outpatient study. J Acquir Immune Defic Syndr. 2006 Sep;43(1):27-34. doi: 10.1097/01.qai.0000233310.90484.16.

    PMID: 16878047BACKGROUND

  • Lifson AR, Neuhaus J, Arribas JR, van den Berg-Wolf M, Labriola AM, Read TR; INSIGHT SMART Study Group. Smoking-related health risks among persons with HIV in the Strategies for Management of Antiretroviral Therapy clinical trial. Am J Public Health. 2010 Oct;100(10):1896-903. doi: 10.2105/AJPH.2009.188664. Epub 2010 Aug 19.

    PMID: 20724677BACKGROUND

  • Minkoff H, Feldman JG, Strickler HD, Watts DH, Bacon MC, Levine A, Palefsky JM, Burk R, Cohen MH, Anastos K. Relationship between smoking and human papillomavirus infections in HIV-infected and -uninfected women. J Infect Dis. 2004 May 15;189(10):1821-8. doi: 10.1086/383479. Epub 2004 Apr 27.

    PMID: 15122518BACKGROUND

  • Moscou-Jackson G, Commodore-Mensah Y, Farley J, DiGiacomo M. Smoking-cessation interventions in people living with HIV infection: a systematic review. J Assoc Nurses AIDS Care. 2014 Jan-Feb;25(1):32-45. doi: 10.1016/j.jana.2013.04.005. Epub 2013 Jul 20.

    PMID: 23876816BACKGROUND

  • Vidrine DJ, Marks RM, Arduino RC, Gritz ER. Efficacy of cell phone-delivered smoking cessation counseling for persons living with HIV/AIDS: 3-month outcomes. Nicotine Tob Res. 2012 Jan;14(1):106-10. doi: 10.1093/ntr/ntr121. Epub 2011 Jun 13.

    PMID: 21669958BACKGROUND

  • Mdege ND, Shah S, Dogar O, Pool ER, Weatherburn P, Siddiqi K, Zyambo C, Livingstone-Banks J. Interventions for tobacco use cessation in people living with HIV. Cochrane Database Syst Rev. 2024 Aug 5;8(8):CD011120. doi: 10.1002/14651858.CD011120.pub3.

    PMID: 39101506DERIVED

  • Kim SS, DeMarco RF. The Intersectionality of HIV-Related Stigma and Tobacco Smoking Stigma With Depressive and Anxiety Symptoms Among Women Living With HIV in the United States: A Cross-sectional Study. J Assoc Nurses AIDS Care. 2022 Sep-Oct 01;33(5):523-533. doi: 10.1097/JNC.0000000000000323. Epub 2022 Jan 7.

    PMID: 34999667DERIVED

  • Kim SS, Cooley ME, Lee SA, DeMarco RF. Prediction of Smoking Abstinence in Women Living With Human Immunodeficiency Virus Infection. Nurs Res. 2020 May/Jun;69(3):167-175. doi: 10.1097/NNR.0000000000000421.

    PMID: 31977840DERIVED

  • Kim SS, Darwish S, Lee SA, Sprague C, DeMarco RF. A randomized controlled pilot trial of a smoking cessation intervention for US women living with HIV: telephone-based video call vs voice call. Int J Womens Health. 2018 Sep 25;10:545-555. doi: 10.2147/IJWH.S172669. eCollection 2018.

    PMID: 30288127DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Sun Kim
Organization
University of Massachusetts Boston
sun.kim@umb.edu
617-287-6831

Study Officials

  • Sun S Kim, PhD

    University of Massachusetts, Boston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 8, 2016

First Posted

September 13, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2017

Study Completion

August 31, 2018

Last Updated

August 5, 2019

Results First Posted

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)