Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents
Cognitive, Behavioral, and Psychosocial Correlates of Medication Adherence in Children and Adolescents With HIV-1 Infection
연구 개요
상태
정황
상세 설명
Medication adherence is a critical issue for HIV infected children and adolescents because of drug resistance and the increased complexity of treatment regimens. Children and adolescents with HIV face depression, anxiety, denial, and rebellion that may interfere with their motivation to take medication. Depression and self-perceived social support have been found to predict regimen adherence in adults with HIV. Children with other chronic diseases are less likely to adhere to their medication regimens if they also have behavioral or emotional problems; assessing emotional and behavioral function in children and adolescents with HIV may help in predicting adherence and explaining adherence failure. This study will correlate cognitive, behavioral, and psychosocial functioning with measures of virologic suppression and immunological status, and it will compare self-report and pill count measures of adherence in a randomly selected subset of perinatally infected HIV participants of PACTG 219C.
Children and adolescents currently enrolled in PACTG 219C will be randomly selected for this study, which will last for 48 weeks. At entry, participants will undergo neuropsychological evaluation, including academic achievement, attention, memory, language comprehension, and behavior assessments, and complete a health beliefs questionnaire. Both the participants and their parents or primary caregivers will complete questionnaires at study entry and Weeks 24 and 48. Adherence will be evaluated from self-reported and pill count measures (Weeks 4 and 24) and the PACTG 219C Adherence Module (Weeks 24 and 48).
연구 유형
등록
연락처 및 위치
연구 장소
-
-
Alabama
-
Birmingham, Alabama, 미국, 35233
- UAB, Dept. of Ped., Div. of Infectious Diseases
-
-
Arizona
-
Phoenix, Arizona, 미국, 85006
- Phoenix Children's Hosp.
-
-
California
-
Long Beach, California, 미국, 90801
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
-
Los Angeles, California, 미국, 90033
- Usc La Nichd Crs
-
Oakland, California, 미국, 94609-1809
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
-
San Diego, California, 미국, 92103
- UCSD Mother-Child-Adolescent Program CRS
-
San Francisco, California, 미국, 94143-0105
- UCSF Pediatric AIDS CRS
-
-
Colorado
-
Denver, Colorado, 미국, 80218-1088
- Univ. of Colorado Denver NICHD CRS
-
-
Connecticut
-
New Haven, Connecticut, 미국, 06504
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
-
-
District of Columbia
-
Washington, District of Columbia, 미국, 20010
- Children's National Med. Ctr., ACTU
-
Washington, District of Columbia, 미국, 20060
- Howard Univ. Washington DC NICHD CRS
-
-
Florida
-
Fort Lauderdale, Florida, 미국, 33316
- South Florida CDTC Ft Lauderdale NICHD CRS
-
Miami, Florida, 미국, 33136
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
-
-
Georgia
-
Augusta, Georgia, 미국, 30912
- Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases
-
-
Illinois
-
Chicago, Illinois, 미국, 60614
- Chicago Children's CRS
-
-
Louisiana
-
New Orleans, Louisiana, 미국, 70112-2699
- Tulane/LSU Maternal/Child CRS
-
-
Maryland
-
Baltimore, Maryland, 미국, 21201
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
-
Baltimore, Maryland, 미국
- Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02115
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
-
Springfield, Massachusetts, 미국, 01199
- Baystate Medical Center, Springfield
-
-
New Jersey
-
Newark, New Jersey, 미국, 07101-1709
- NJ Med. School CRS
-
-
New York
-
Bronx, New York, 미국, 10457
- Bronx-Lebanon Hosp. IMPAACT CRS
-
Bronx, New York, 미국, 10461
- Jacobi Med. Ctr.
-
Brooklyn, New York, 미국, 11203-2098
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
-
New York, New York, 미국, 10016
- Nyu Ny Nichd Crs
-
New York, New York, 미국, 10037
- Harlem Hosp. Ctr. NY NICHD CRS
-
Stony Brook, New York, 미국, 11794-8111
- SUNY Stony Brook NICHD CRS
-
Syracuse, New York, 미국, 13210
- SUNY Upstate Med. Univ., Dept. of Peds.
-
-
North Carolina
-
Chapel Hill, North Carolina, 미국, 27599-7220
- UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
-
Durham, North Carolina, 미국, 27705
- DUMC Ped. CRS
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19134
- St. Christopher's Hosp. for Children
-
Philadelphia, Pennsylvania, 미국, 19104-4318
- The Children's Hosp. of Philadelphia IMPAACT CRS
-
-
Tennessee
-
Memphis, Tennessee, 미국, 38105-2794
- St. Jude/UTHSC CRS
-
-
Texas
-
Houston, Texas, 미국, 77030
- Texas Children's Hosp. CRS
-
-
-
-
-
San Juan, 푸에르토 리코
- San Juan City Hosp. PR NICHD CRS
-
San Juan, 푸에르토 리코, 00936-5067
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
- HIV-1 perinatal infection
- Already enrolled and in active follow-up in PACTG 219C
- Can communicate in English or Spanish
- On antiretroviral medication regimen at the time of enrollment, regardless of compliance with regimen, with no planned treatment interruptions
Exclusion Criteria
- Acquired HIV via routes other than perinatal transmission or source of HIV infection is unknown
- HIV-2 infection
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
공동 작업자 및 조사자
수사관
- 연구 의자: Sharon Nichols, PhD, Department of Neurosciences, University of California, San Diego
간행물 및 유용한 링크
일반 간행물
- Catz SL, Kelly JA, Bogart LM, Benotsch EG, McAuliffe TL. Patterns, correlates, and barriers to medication adherence among persons prescribed new treatments for HIV disease. Health Psychol. 2000 Mar;19(2):124-33.
- Gaughan DM, Hughes MD, Oleske JM, Malee K, Gore CA, Nachman S; Pediatric AIDS Clinical Trials Group 219C Team. Psychiatric hospitalizations among children and youths with human immunodeficiency virus infection. Pediatrics. 2004 Jun;113(6):e544-51. doi: 10.1542/peds.113.6.e544.
- Gordillo V, del Amo J, Soriano V, Gonzalez-Lahoz J. Sociodemographic and psychological variables influencing adherence to antiretroviral therapy. AIDS. 1999 Sep 10;13(13):1763-9. doi: 10.1097/00002030-199909100-00021.
- Rogers AS, Miller S, Murphy DA, Tanney M, Fortune T. The TREAT (Therapeutic Regimens Enhancing Adherence in Teens) program: theory and preliminary results. J Adolesc Health. 2001 Sep;29(3 Suppl):30-8. doi: 10.1016/s1054-139x(01)00289-0. No abstract available.
- Farley JJ, Montepiedra G, Storm D, Sirois PA, Malee K, Garvie P, Kammerer B, Naar-King S, Nichols S; PACTG P1042S Team. Assessment of adherence to antiretroviral therapy in perinatally HIV-infected children and youth using self-report measures and pill count. J Dev Behav Pediatr. 2008 Oct;29(5):377-84. doi: 10.1097/DBP.0b013e3181856d22.
- Naar-King S, Montepiedra G, Nichols S, Farley J, Garvie PA, Kammerer B, Malee K, Sirois PA, Storm D; PACTG P1042S Team. Allocation of family responsibility for illness management in pediatric HIV. J Pediatr Psychol. 2009 Mar;34(2):187-94. doi: 10.1093/jpepsy/jsn065. Epub 2008 Jun 27.
연구 기록 날짜
연구 주요 날짜
연구 시작
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. .