- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00130273
Managed Problem Solving to Increase Treatment Adherence in Individuals With HIV (MAPS)
Managed Problem Solving: An HIV Adherence Trial
연구 개요
상세 설명
HAART is considered to be the most effective treatment for HIV. However, sustained and consistent adherence to HAART is necessary for long-term success. Issues such as memory problems, lack of social support, medication side effects, depression, and substance abuse can significantly reduce patient adherence to HAART. This study will evaluate the effectiveness of a managed problem solving strategy to increase HAART adherence in patients with HIV. Both treatment-naive and treatment-experienced participants will be recruited for this study.
The treatment part of this study will last 12 months. Participants will be randomly assigned to receive the managed problem solving intervention or standard of care for 12 months. Participants in the managed problem solving group will have 4 study visits and will receive 3 phone calls for the first 3 months of the study, and 1 phone call every month for the following 9 months. At each study visit, participants will identify barriers to adherence. During the phone calls, participants will be asked about any steps they have taken to improve their adherence. A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence. MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings. Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes. Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count. Follow-up phone interviews will be conducted every year for 3 years after the end of treatment.
Study hypothesis: Managed problem solving will result in better adherence to highly active antiretroviral therapy (HAART) and better virologic control and immunological outcomes at the end of 1 year compared with a control group receiving standard or care.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania School of Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for All Participants:
- HIV infected
- Infection likely to be susceptible to a specific treatment regimen
- Have access to a telephone
- Willing and able to comply with all study requirements
Exclusion Criteria for All Participants:
- Live in a care facility that provides medications on schedule
Inclusion Criteria for Treatment-Experienced Participants:
- Restarting HAART after a treatment interruption of at least 3 months OR after virologic failure with a viral load greater than 1,000 copies/ml
- On a treatment regimen for less than 2 weeks prior to study entry
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 1
Participants will receive managed problem solving for 12 months
|
Participants in the managed problem solving group will have four study visits and will receive three phone calls for the first 3 months of the study, and one phone call every month for the following 9 months.
At each study visit, participants will identify barriers to adherence.
During the phone calls, participants will be asked about any steps they have taken to improve their adherence.
A medication event monitoring system (MEMS) will be used to assess participants' treatment adherence.
MEMS uses microelectronic monitors on the caps of medication bottles to record the timing and frequency of bottle openings.
Participants whose adherence has decreased or remained the same at the end of 12 months will be evaluated for regimen changes.
Blood collection at the beginning and end of the study will be used to measure viral load and CD4 count.
|
활성 비교기: 2
Participants will receive standard of care for 12 months
|
Participants will receive standard of care for 12 months.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Improved adherence
기간: Measured at Year 4
|
Measured at Year 4
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Decrease in viral load
기간: Measured at Year 4
|
Measured at Year 4
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Increase in CD4 count
기간: Measured at Year 4
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Measured at Year 4
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Robert Gross, MD, MSCE, University of Pennsylvania
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 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. .
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