Test of an Intervention to Improve HIV Care
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- Ben Taub General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
1) Hospitalized at BTGH; 2) expected to be in the hospital for at least one more night at the time of enrollment; 3) at least 18 years of age at enrollment; 4) able to speak English or Spanish; 5) HIV infected, whether previously diagnosed or diagnosed this hospital stay; 6) cognitively aware enough to provide informed consent and participate in the study. Patients who are temporarily cognitively incapacitated (e.g., from an acute process) will be followed and approached for enrollment if and when they are cognitively and physically capable of participating in the study.
Exclusion Criteria:
1) Intending to use a source of HIV primary care other than TSHC after discharge from the hospital, because TSHC-specific mentoring is not relevant to them and the data on their appointments after discharge cannot be tracked; 2) in the opinion of the primary medical team, likely to be discharged to an institutional setting; 3) in the opinion of the primary medical team caring for the patient, likely to die in the hospital or be discharged to hospice; 4) cognitive impairment that in the opinion of the primary medical team caring for the patient is not expected to improve by discharge; 5) prisoner at admission and expected to be discharged back to prison or jail; 6) having had an HIV primary care visit in at least 3 of the 4 previous quarter-years AND having had at least 3 consecutive HIV VL<400 c/mL over at least 6 months, the most recent of which is within 3 months of enrollment; 7) enrolled in any other research project with prospective follow-up; 8) already enrolled in this study at any time.
For the purposes of this study, "prisoner" will be defined in accordance with Federal regulations, as "any individual involuntarily confined or detained in a penal institution...[including] individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing…Parolees who are detained in a treatment center as a condition of parole are prisoners; however, persons living in the community and sentenced to community-supervised monitoring, including parolees, are not prisoners." Parolees meeting the definition of prisoner will be ineligible for the study.
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 |
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실험적: Patient Mentor Intervention
The patient mentor intervention from TSHC has been adapted to the inpatient setting.
Participants randomized to that arm will receive 2 sessions with a patient mentor during their hospitalization, as well as 5 phone call sessions over the 10 weeks after discharge and a brief meeting between the subject and the mentor when the subject attends their first outpatient visit at TSHC after discharge.
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The first session includes an exploration of needs, barriers, and facilitators to HIV care.
HIV educational materials are introduced to identify areas of need.
Mentors will address concerns and possible barriers to care using their own experiences.
Mentors will encourage participants to set goals related to acquisition of care following discharge and how to address possible barriers to that goal.
The second session will reinforce the first session.
Mentors will call the patient 5 times over the 10 weeks after discharge.
These phone calls will be brief and goal centered, to either reinforce positive behavior if the patient is in care, or continue to help the patient re-engage in outpatient HIV care.
다른 이름들:
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위약 비교기: HIV transmission risk reduction
Participants randomized to the control arm will receive an attention control intervention delivered by a patient educator who is not an HIV patient mentor.
We will use a modified version of the RESPECT intervention for our attention control group.
Similar to the active intervention, these patients will receive 2 sessions in the hospital and 5 phone calls over 10 weeks after discharge.
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The control intervention is a modification of the project RESPECT intervention.
We will use material from sessions 1, 2, and 3 of the RESPECT enhanced counseling intervention.
These interactions will include a personalized assessment of risk behaviors and changing condom use self-efficacy.
The second interaction will build on material covered during the first interaction, with additional focus on condom use attitudes.
The counselors will call the patient 5 times in the 10 weeks after discharge.
These phone-based sessions will be brief and goal centered, to reinforce safe HIV transmission behaviors.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Engaged in outpatient HIV care
기간: 6 Months
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A composite of attending at least one HIV primary care visit within 30 days of discharge AND at least one between 31 and 180 days AND, for patient with an indication for ART, achieving a one log10 decrease in HIV VL or maintaining a VL <400 c/mL at 180 days after discharge.
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6 Months
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2차 결과 측정
결과 측정 |
기간 |
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Completion of at least one HIV primary care visit at TSHC within 30 days of discharge, health services use, changes in CD4 cell count and HIV VL, and quality of life.
기간: 6 Months
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6 Months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Thomas P Giordano, MD, MPH, Baylor College of Medicine
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. .