- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00502827
Smoking Cessation for HIV/AIDS Patients
An Innovative Telephone Intervention for HIV-Positive Smokers
연구 개요
상세 설명
If you agree to take part in this study, researchers will first do a test to learn what the CO level of your blood is. To do this test, you will be asked to blow into a cardboard tube. If the test finds that you are ineligible, you will not be able to continue on this study.
If you are found to be eligible, you will be enrolled in this study and asked to complete an interview that should last about 1 hour. During this interview, you will be asked basic questions, such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and stress. You will then be asked to complete a short test that involves completing some basic tasks, such as remembering several words and drawing a simple shape. This test, which will take about 2-5 minutes to complete, is used to measure attention and concentration.
You will then be randomly assigned (as in the toss of a coin) to one of two treatment groups. There is an equal chance of being assigned to either group.
If you are assigned to Group 1, you will receive advice from your physician/provider to stop smoking and written materials designed to help you quit smoking.
If you are assigned to Group 2, you will receive the advice from your physician/provider to quit smoking and the written materials, but you also be given a cell phone and be called 11 times over the course of an 12 to 13 week period. During these calls, which will last about 10 minutes, you will be asked to talk about smoking and quitting smoking. Access to a hotline number that you can call to speak with a counselor about quitting smoking will also be given to you if you are assigned to group 2. Participants in Group 1 will not get the number to the hotline. There is a limited number of prepaid minutes on the phone, so participants who receive a cell phone should make an effort to save enough minutes to complete this study.
You will be asked to complete three more interviews about 3-, 6-, and 12-months after the first interview. During these interviews, you will again be asked questions about your smoking behavior, mood, quality of life, and stress. All three of these interviews will take about one hour to complete. Your participation in this study will be complete after the 12-month interview.
Lost, stolen, or broken cell phones will not be replaced, but participants will remain on study.
This is an investigational study. Up to 705 participants will take part in this research study. All participants will be enrolled at Thomas Street Clinic.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
Texas
-
Houston, Texas, 미국, 77030
- University of Texas MD Anderson Cancer Center
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Houston, Texas, 미국, 77009
- Thomas Street Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- HIV-positive
- 18 years of age or older
- Current, regular smoker (> 5 cigarettes per day for the past 30 days, breath CO of > 7ppm)
- English or Spanish speaking
- Able to provide written informed consent to participate
- Willing to set a quit date within 1 week of baseline assessment
Exclusion Criteria:
- Physician deemed ineligibility based on medical (HIV related or other condition) or psychiatric condition
- Current participation in another smoking cessation program
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Recommended Standard of Care
Recommended Standard of Care (RSOC) = Physician Advice + Written Materials
|
Advice from your physician to stop smoking and written materials designed to help you quit smoking.
다른 이름들:
|
|
다른: RSOC + Cell Phone Intervention
Recommended Standard of Care (RSOC) + Cell Phone Intervention
|
Advice from your physician to stop smoking and written materials designed to help you quit smoking.
다른 이름들:
Study participants called on a cell phone 11 times over course of a 12 - 13 week period, during 10 minute calls questions asked about smoking and quitting smoking.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Proportion of participants in the two intervention groups who are abstinent as measured by point prevalence
기간: 1 year after quit date
|
1 year after quit date
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Damon Vidrine, MS, DRPH, BA, M.D. Anderson Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2003-0784
- NCI-2012-02109 (레지스트리 식별자: NCI CTRP)
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