AIDS/HIV
Conditions
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.
Interventions
BEHAVIORALCognitive Behavioral Therapy
Received 8 weekly individualized counseling sessions of cognitive behavioral therapy
Sponsors
University of Massachusetts, Boston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Video This is the group that received the cognitive behavioral therapy for smoking cessation via video calls. | 25 |
| Voice This is the group that received the cognitive behavioral therapy for smoking cessation via voice calls. | 24 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 9 |
| Overall Study | Protocol Violation | 4 | 2 |
Baseline characteristics
| Characteristic | Video | Voice | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 22 Participants | 47 Participants |
| Age, Continuous | 48.76 Years STANDARD_DEVIATION 9.05 | 53.25 Years STANDARD_DEVIATION 6.49 | 50.96 Years STANDARD_DEVIATION 8.14 |
| Nicotine Dependence | 5.88 units on a scale STANDARD_DEVIATION 2.21 | 5.16 units on a scale STANDARD_DEVIATION 1.86 | 5.51 units on a scale STANDARD_DEVIATION 2.05 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 18 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 25 participants | 24 participants | 49 participants |
| Sex: Female, Male Female | 25 Participants | 24 Participants | 49 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 1 / 24 |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 1 / 24 |
Outcome results
Primary
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
Time frame: 6-month follow-up
Population: Women living with HIV
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Video | Number of Participants With Abstinence | 8 Participants |
| Telephone | Number of Participants With Abstinence | 1 Participants |
p-value: <0.0595% CI: [1.37, 110.3]Regression, Logistic
Comparison: 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).p-value: <0.05Fisher Exact