Smoking Cessation Medication And Rewards Using a Teamlet to Treat Tobacco Use Disorder (SMARTTT 2.0) Among Persons With HIV: A Multi-site Hybrid Type 2 Effectiveness-implementation Trial
Cigarette smoking is an important cause of illness and death among persons with HIV (PWH). This project will study the impact of adding contingency management (use of financial rewards) to receiving medications and counseling on promoting smoking abstinence and other health outcomes among PWH. As treatments will be provided by clinical pharmacists and other team members in HIV clinics, factors relevant for implementing this model to inform real-world practice will also be evaluated.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Cigarette smoking is a major threat to health among persons with HIV (PWH). Via direct effects and link with TUD-related conditions (behaviors and medical conditions that drive poor outcomes), smoking causes more lost life years than treated HIV. Cardiovascular disease, lung disease, and cancer are indeed leading causes of death among PWH. Guidelines recommend medications for TUD (MTUD) and behavioral interventions to promote smoking cessation. Data also support use of contingency management (CM) to target smoking cessation and treatment adherence. Yet, adoption of these approaches in HIV clinics has been suboptimal. Past projects have found that clinical pharmacist-prescribed TUD treatment involving MTUD with CM integrated in HIV clinics offers a feasible, acceptable, and practical solution to overcome multi-level challenges to adoption of such TUD treatments. Past projects have identified opportunities for enhanced patient-centeredness with: 1) creation of teamlets (little teams) to collaborate with clinical pharmacists to address challenges with MTUD access and implement CM; 2) use of multi-target CM to reward progress in addressing TUD-related care, HIV, and TUD-related conditions plus smoking abstinence; 3) promotion of patient choice in MTUD selection and flexibility for remote versus in-person services; and 4) focus on reducing health disparities. Grounded in the socioecological model and implementation science principles, this project will include a randomized trial to compare the effectiveness of teamlet-delivered CM as an adjunct to clinical pharmacist prescribed MTUD with teamlet telephone booster over 12 weeks among 794 PWH receiving care in one of six sites. This study will develop procedures directly informed by perspectives of PWH. The primary outcome is exhaled carbon monoxide-confirmed 7-day smoking abstinence at week 12 (Aim 1). This study will explore whether the effectiveness of the interventions differ based on access to basic needs (Aim 2). Consistent with a hybrid type 2 effectiveness-implementation approach, this study will include an implementation-focused evaluation incorporating perspectives of PWH, clinical pharmacists, and other teamlet members using qualitative and quantitative data; measures of intervention delivery; and economic viability via micro-costing and cost-effectiveness analyses (Aim 3). The research team brings together expertise in HIV, pharmacy, addiction medicine, smoking cessation, CM, clinical trials, health disparities, implementation science, and health economics. Innovative features of the proposal are: 1) clinical pharmacist delivered TUD treatment with teamlets integrated in HIV clinics; and 2) collaboratively created multi-target CM program to address smoking, HIV, and TUD-related conditions. The study has potential for high impact by generating data on and associated costs of a reproducible, scalable, sustainable strategy suitable for transforming TUD treatment in HIV clinics nationally.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 4단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: E. Jennifer Edelman, MD, MHS
- 전화번호: 203-737-7115
- 이메일: ejennifer.edelman@yale.edu
연구 연락처 백업
- 이름: June-Marie Weiss, MA, MEd
- 전화번호: 203-737-3347
- 이메일: junemarie.weiss@yale.edu
연구 장소
-
-
Connecticut
-
Bridgeport, Connecticut, 미국, 06610
- Bridgeport Hospital Primary Care Center Infectious Disease Clinic
-
연락하다:
- Manisha Gupta, MD
- 전화번호: (203) 384-3079
- 이메일: Manisha.Gupta@bpthosp.org
-
New Haven, Connecticut, 미국, 06511
- Yale Center for Infectious Diseases
-
연락하다:
- Erika Payne, PharmD
- 전화번호: (203) 200-6899
- 이메일: erika.payne@ynhh.org
-
-
New Jersey
-
Jersey City, New Jersey, 미국, 07305
- Center for Comprehensive Care at Jersey City Medical Center
-
연락하다:
- Nina Cooperman, PhD
- 전화번호: (201) 395-7600
- 이메일: cooperna@rwjms.rutgers.edu
-
Paterson, New Jersey, 미국, 07503
- Center for Comprehensive Care at St. Joseph's Health
-
연락하다:
- Nina Cooperman, PhD
- 전화번호: (973) 754-4701
- 이메일: cooperna@rwjms.rutgers.edu
-
-
New York
-
Brooklyn, New York, 미국, 11203
- Special Treatment And Research (STAR) at SUNY Downstate
-
연락하다:
- Jessica Yager, MD
- 전화번호: (718) 270-3745
- 이메일: jessica.yager@downstate.edu
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Have been diagnosed with HIV;
- Receive care at one of the participating sites;
- Are >18 years old;
- Have smoked >100 cigarettes lifetime;
- Smoke everyday or some days;
- Smoke, on average, >5 cigarettes per day; and
- Provide written informed consent.
Exclusion Criteria:
- Exclusive use of non-cigarette tobacco or nicotine products, including e-cigarettes;
- Self-report or urine testing confirming pregnancy, nursing, or trying to conceive;
- Life-threatening or unstable medical, surgical, or psychiatric condition;
- Anticipate being unable to return for follow-up for any reason, such as travel, planned procedure;
- Inability to provide >1 form of contact information;
- Inability to read or understand English or Spanish.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Clinical pharmacist-prescribed MTUD with teamlet booster
|
Clinical pharmacist prescribed MTUD, based on participant choice: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion. Participants on nicotine replacement may choose both a long acting (patch) and short acting (gum, lozenge) option to use at the same time. Participants will receive a booster call by a teamlet member after MTUD is prescribed to address any MTUD access issues and answer MTUD related questions. |
|
실험적: Clinical pharmacist-prescribed MTUD + teamlet delivered CM and booster
|
Clinical pharmacist prescribed MTUD, based on participant choice: nicotine patch, nicotine gum, nicotine lozenge, varenicline, bupropion. Participants on nicotine replacement may choose both a long acting (patch) and short acting (gum, lozenge) option to use at the same time. Participants will receive a booster call by a teamlet member after MTUD is prescribed to address any MTUD access issues and answer MTUD related questions. Participants will earn prizes for progress towards tobacco abstinence, achieving tobacco abstinence, and progress in improving HIV and other related health conditions. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
기간: 12 weeks
|
Self-reported tobacco abstinence over the past 7 days, confirmed by eCO of <6ppm |
12 weeks
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
7-day point-prevalence abstinence confirmed by exhaled carbon monoxide (eCO)
기간: 24 weeks
|
Self-reported tobacco abstinence over the past 7 days, confirmed by eCO <6ppm |
24 weeks
|
|
Self-reported 7 day point prevalence smoking abstinence
기간: Week 18
|
Week 18
|
|
|
Cigarettes per day
기간: Week 12
|
Self-reported reduction in mean number of cigarettes per day |
Week 12
|
|
Cigarettes per day
기간: Week 18
|
Self-reported reduction in mean number of cigarettes per day |
Week 18
|
|
Cigarettes per day
기간: Week 24
|
Self-reported reduction in mean number of cigarettes per day |
Week 24
|
|
HIV viral load, detectable
기간: Week 24
|
HIV viral load greater than 50 copies per milliliter of blood and detectable on standard lab test |
Week 24
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: E. Jennifer Edelman, MD, MHS, Yale University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2000043556
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
This project will generate data from patients with HIV and tobacco use disorder being seen for HIV primary care. Data generated will include responses to standardized ratings scales/questionnaires on tobacco use, alcohol, other substance use, depression, hypertension, physical activity, HIV symptoms, and lab data. Data will be collected at baseline, week 12, week 18, week 24. This study will also generate qualitative data and codebooks from in-depth interviews to inform revision and refinement of the intervention and post study participant experiences. Finally, this study will generate longitudinal mixed methods data on teamlet member implementation experiences from surveys and focus groups as well as cost data.
Data describing the patient sample, outcome measures, and cost analyses will be de-identified and shared. Interview/focus group guides and codebooks will also be shared. Recordings and transcripts will not be shared publicly since voice is PHI.
IPD 공유 기간
All de-identified data will be made available after completion of the project and publication of related work and will remain available indefinitely.
IPD 공유 액세스 기준
A Data Dictionary will be created, and the study Data Manager and the Program Manager will work with National Addiction & HIV Data Archive Program (NAHDAP), an NIH-funded repository, to define an appropriate data structure, if one does not already exist. Data will be formatted to align with NAHDAP standards to promote interoperability and data reuse.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .