SoCIWHIV: Smoking Cessation Intervention for Women Living With HIV

• Sponsor: University of Massachusetts, Boston (Other)
• Overall Status: Completed
• CT.gov ID: NCT02898597
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Actual Duration (Months): 27
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AIDS/HIV	Behavioral: Cognitive Behavioral Therapy	N/A

Detailed Description

Women are at high risk of becoming HIV positive due to biological vulnerabilities, low socioeconomic status, dominant sexual practices of males and epidemiological factors. For example, the risk of being infected with HIV during unprotected sex is two to four times greater for women than for men. With the use of combined antiretroviral therapies, these women now live longer than ever before which now faces the healthcare community with the need for evolving understanding of HIV and aging. However, the burden of non-AIDS related health problems such as cardiovascular diseases and cancers on people living with HIV/AIDS while aging has considerably increased. Smoking is one of the major contributing factors to these health problems. Rates of current cigarette smoking are substantially higher among people living with HIV/AIDS than the general population: 40-75% versus 19%. Women smokers living with HIV have a 36% higher risk for developing AIDS and 53% higher mortality when compared to non-smoking women with HIV. This study is a pilot randomized controlled trial (RCT) testing the feasibility and acceptability of a videoconferencing smoking cessation intervention (video arm) for women with HIV in comparison with a telephone-based smoking cessation intervention (telephone arm). Both arms will receive 8, 30-minute weekly cessation counseling sessions plus 8-week nicotine replacement therapy. Participants will be followed up at 1, 3 and 6 months from the target quit day. Self-reported abstinence will be verified with a saliva cotinine test using an Nicotine Alert test strip and the testing process will be monitored via mobile-phone video call.

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Smoking Cessation Intervention for Women With HIV/AIDS
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Video Video-call delivered cognitive behavioral therapy	Behavioral: Cognitive Behavioral Therapy; Received 8 weekly individualized counseling sessions of cognitive behavioral therapy
Active Comparator: Voice Voice-call delivered cognitive behavioral therapy	Behavioral: Cognitive Behavioral Therapy; Received 8 weekly individualized counseling sessions of cognitive behavioral therapy

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Abstinence [6-month follow-up]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Massachusetts Boston	Boston	Massachusetts	United States	02125

Sponsors and Collaborators

• University of Massachusetts, Boston

Investigators

• Principal Investigator: Sun S Kim, PhD, University of Massachusetts, Boston

Study Documents (Full-Text)

• Informed Consent Form - Jan 31, 2017
• Study Protocol - Mar 31, 2018
• Statistical Analysis Plan - Jan 31, 2017

More Information

Publications

• 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.
• 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.
• 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. Epub 2004 Apr 27.
• 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. Review.
• 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.
• 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. Review.
• 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.

• Responsible Party: Sun S Kim, Associate Professor, University of Massachusetts, Boston
• ClinicalTrials.gov Identifier: NCT02898597
• Other Study ID Numbers: 2016059
• First Posted: Sep 13, 2016
• Last Update Posted: Aug 5, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Arm/Group Title	Video	Telephone
Arm/Group Description	Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling	Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling
Period Title: Overall Study
STARTED	25	24
COMPLETED	21	12
NOT COMPLETED	4	12

Baseline Characteristics

Arm/Group Title	Video	Voice	Total
Arm/Group Description	This is the group that received the cognitive behavioral therapy for smoking cessation via video calls.	This is the group that received the cognitive behavioral therapy for smoking cessation via voice calls.	Total of all reporting groups
Overall Participants	25	24	49
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	25 100%	22 91.7%	47 95.9%
>=65 years	0 0%	2 8.3%	2 4.1%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	48.76 (9.05)	53.25 (6.49)	50.96 (8.14)
Sex: Female, Male (Count of Participants)
Female	25 100%	24 100%	49 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	17 68%	18 75%	35 71.4%
White	2 8%	1 4.2%	3 6.1%
More than one race	4 16%	3 12.5%	7 14.3%
Unknown or Not Reported	2 8%	2 8.3%	4 8.2%
Region of Enrollment (participants) [Number]
United States	25 100%	24 100%	49 100%
Nicotine Dependence (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.88 (2.21)	5.16 (1.86)	5.51 (2.05)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Abstinence
Description	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
Time Frame	6-month follow-up

Outcome Measure Data

Analysis Population Description

Women living with HIV

Arm/Group Title	Video	Telephone
Arm/Group Description	Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling	Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling
Measure Participants	21	21
Count of Participants [Participants]	8 32%	1 4.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Video, Telephone
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.05
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	12.31
	Confidence Interval	(2-Sided) 95%; 1.37 to 110.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Video, Telephone
	Comments	Fisher Exact test was performed, comparing the proportion of participants whose abstinence was verified with salivary cotinine test between the two arms, which was significant (p = 0.02).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Time Frame	6 months
Arm/Group Title	Video		Telephone
Arm/Group Description	Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling		Cognitive behavioral therapy Nicotine replacement therapy (Habitrol Patch) Cognitive Behavioral Therapy: Receive cognitive behavioral cessation counseling
All Cause Mortality
	Video		Telephone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		1/24 (4.2%)
Serious Adverse Events
	Video		Telephone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		1/24 (4.2%)
Renal and urinary disorders
Kidney failure	0/25 (0%)	0	1/24 (4.2%)	1
Other (Not Including Serious) Adverse Events
	Video		Telephone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/24 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.