Smoking Cessation Intervention for Women Living With HIV

Not Applicable

Completed

Conditions: AIDS/HIV

Interventions: Behavioral: Cognitive Behavioral Therapy

Registration Number: NCT02898597

Lead Sponsor: University of Massachusetts, Boston

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 49

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video	Cognitive Behavioral Therapy	Video-call delivered cognitive behavioral therapy
Voice	Cognitive Behavioral Therapy	Voice-call delivered cognitive behavioral therapy

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures