Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)

HIV/AIDS Clinical Trial

— AMP Up  

Official title:

Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02119702
• Other study ID #: HD052102 - PH300
• Secondary ID: PH300
• Status: Recruiting
• Start date: April 2014
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: Liz Salomon, EdM
• Phone: 617-432-6762
• Email: lsalomon[@]hsph.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection (YAPHIV) as they transition into adulthood. A group of of perinatally exposed but uninfected young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.

Description:

AMP Up aims to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition into adulthood. A group of uninfected perinatally-exposed young adults from a similar sociodemographic background and age distribution will be enrolled for comparison. The primary objectives of this study are: - To identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART, including disease progression, immune dysfunction, viral resistance, end-organ disease, and mortality. - To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults, including: - Metabolic abnormalities and risk factors for cardiovascular disease, including glucose and lipid metabolism, blood pressure, and body composition. - Sexually transmitted infections (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis, human papillomavirus (HPV), genital warts and HSV) among males and females, and cervical HPV-associated pre-cancers and cancers and Mycoplasma genitalium and other vaginal microbiota among females. - Reproductive health, fertility, and pregnancy outcomes including mother-to-child transmission of HIV. - To define the impact of perinatal HIV infection, its concomitant risk factors and ART on long-term neurocognitive and behavioral health outcomes, including: - Mental health and neurocognitive functioning. - Health care behaviors, including adherence to ART, participation in health care services, and transition to adult clinical care. - Risk behaviors, including sexual behavior and substance use. - Independent living skills, and vocational and education achievement necessary for successful transition to adult functioning and quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Perinatally HIV-Infected Cohort

Inclusion Criteria:

• Perinatal HIV infection as documented in the medical record
• At or beyond their 18th birthday at the time of informed consent with no upper age limit
• Willing to provide access to existing medical records
• Available medical record documentation since early childhood of:
• ART exposure history
• Opportunistic infection prophylaxis exposure history
• Viral load and CD4+ cell count history
• Major medical events history
• Willingness to participate and provide legal written consent

Exclusion Criteria:

• HIV acquired by other than maternal-child transmission (e.g., blood products, sexual contact, and IV drug use) as documented in the medical record Uninfected Cohort

Inclusion Criteria:

• Absence of perinatal HIV infection as indicated in the medical record; the Perinatally HIV-Exposed Uninfected (PHEU) participant may have horizontally-acquired HIV infection
• At or beyond their 18th birthday at the time of informed consent with no upper age limit
• Willingness to participate and provide legal written consent

Exclusion Criteria:

• Have confirmed perinatal HIV infection as documented in the medical record

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Locations

Country	Name	City	State
Puerto Rico	San Juan Research Hospital	San Juan
United States	University of Colorado Denver Health Sciences Center	Aurora	Colorado
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Bronx Lebanon Hospital Center	Bronx	New York
United States	Jacobi Medical Center	Bronx	New York
United States	Ann and Robert H. Lurie Children's Hospital	Chicago	Illinois
United States	Children's Diagnostic and Treatment Center	Fort Lauderdale	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	University of California San Diego	La Jolla	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Rutgers - New Jersey Medical School	Newark	New Jersey
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania

Sponsors (12)

Lead Sponsor

Collaborator

Harvard School of Public Health (HSPH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Drug Abuse (NIDA), NIH Office of AIDS Research (OAR), Tulane University School of Medicine

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (20)

Alperen J, Davidson J, Siminski S, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Utility of the National Death Index in Identifying Deaths in a Clinic-Based, Multisite Cohort: The Experience of the Pediatric HIV/AIDS Cohort Study. J Acquir Immune Defic S — View Citation

Berman CA, Kacanek D, Nichamin M, Wilson D, Davtyan M, Salomon L, Patel K, Reznick M, Tassiopoulos K, Lee S, Bauermeister J, Paul M, Aldape T, Seage Iii GR. Using Social Media and Technology to Communicate in Pediatric HIV Research: Qualitative Study With Young Adults Living With or Exposed to Perinatal HIV. JMIR Pediatr Parent. 2020 Jun 23;3(1):e20712. doi: 10.2196/20712. — View Citation

Cantos K, Franke MF, Tassiopoulos K, Williams PL, Moscicki AB, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Inconsistent Sexual Behavior Reporting Among Youth Affected by Perinatal HIV Exposure in the United States. AIDS Behav. 2021 Oct;25(10):3398-3412. doi: 10.1007/s10461-021-03268-y. Epub 2021 Apr 24. — View Citation

Goodenough CJ, Patel K, Van Dyke RB; Pediatric HIV/AIDS Cohort Study (PHACS). Is There a Higher Risk of Mother-to-child Transmission of HIV Among Pregnant Women With Perinatal HIV Infection? Pediatr Infect Dis J. 2018 Dec;37(12):1267-1270. doi: 10.1097/IN — View Citation

Innes S, Patel K. Noncommunicable diseases in adolescents with perinatally acquired HIV-1 infection in high-income and low-income settings. Curr Opin HIV AIDS. 2018 May;13(3):187-195. doi: 10.1097/COH.0000000000000458. — View Citation

Kacanek D, Huo Y, Malee K, Mellins CA, Smith R, Garvie PA, Tassiopoulos K, Lee S, Berman CA, Paul M, Puga A, Allison S; Pediatric HIV/AIDS Cohort Study. Nonadherence and unsuppressed viral load across adolescence among US youth with perinatally acquired H — View Citation

Lemon TL, Tassiopoulos K, Tsai AC, Cantos K, Escudero D, Quinn MK, Kacanek D, Berman C, Salomon L, Nichols S, Chadwick EG, Seage GR 3rd, Williams PL; Pediatric HIV/AIDS Cohort Study (PHACS). Health Insurance Coverage, Clinical Outcomes, and Health-Related Quality of Life Among Youth Born to Women Living With HIV. J Acquir Immune Defic Syndr. 2023 Jan 1;92(1):6-16. doi: 10.1097/QAI.0000000000003100. — View Citation

Moscicki AB, Karalius B, Tassiopoulos K, Yao TJ, Jacobson DL, Patel K, Purswani M, Seage GR; Pediatric HIV/AIDS Cohort Study. Human Papillomavirus Antibody Levels and Quadrivalent Vaccine Clinical Effectiveness in Perinatally Human Immunodeficiency Virus- — View Citation

Patel K, Karalius B, Powis K, Kacanek D, Berman C, Moscicki AB, Paul M, Tassiopoulos K, Seage GR 3rd; HIV/AIDS Cohort Study (PHACS). Trends in post-partum viral load among women living with perinatal HIV infection in the USA: a prospective cohort study. Lancet HIV. 2020 Mar;7(3):e184-e192. doi: 10.1016/S2352-3018(19)30339-X. Epub 2019 Dec 20. — View Citation

Patel K, Seage GR 3rd, Burchett SK, Hazra R, Van Dyke RB; Pediatric HIV/AIDS Cohort Study. Disparities in HIV Viral Suppression Among Adolescents and Young Adults by Perinatal Infection. Am J Public Health. 2019 Jul;109(7):e9. doi: 10.2105/AJPH.2019.30510 — View Citation

Sirois PA, Huo Y, Nozyce ML, Garvie PA, Harris LL, Malee K, McEvoy R, Mellins CA, Nichols SL, Smith R, Tassiopoulos K; Pediatric HIV/AIDS Cohort Study. Ageing with HIV: a longitudinal study of markers of resilience in young adults with perinatal exposure to HIV, with or without perinatally acquired HIV. J Int AIDS Soc. 2022 Sep;25 Suppl 4(Suppl 4):e25982. doi: 10.1002/jia2.25982. — View Citation

Smith R, Huo Y, Tassiopoulos K, Rutstein R, Kapetanovic S, Mellins C, Kacanek D, Malee K; Pediatric HIV/AIDS Cohort Study (PHACS). Mental Health Diagnoses, Symptoms, and Service Utilization in US Youth with Perinatal HIV Infection or HIV Exposure. AIDS Pa — View Citation

Tassiopoulos K, Huo Y, Kacanek D, Malee K, Nichols S, Mellins CA, Kohlhoff S, Van Dyke RB; Pediatric HIV/AIDS Cohort Study. Association of Perceived Social Support with Viral Suppression Among Young Adults with Perinatally-Acquired HIV in the US-based Pediatric HIV/AIDS Cohort Study (PHACS). Clin Epidemiol. 2023 May 9;15:601-611. doi: 10.2147/CLEP.S403570. eCollection 2023. — View Citation

Tassiopoulos K, Huo Y, Patel K, Kacanek D, Allison S, Siminski S, Nichols SL, Mellins CA; Pediatric HIV/AIDS Cohort Study (PHACS). Healthcare Transition Outcomes Among Young Adults With Perinatally Acquired Human Immunodeficiency Virus Infection in the United States. Clin Infect Dis. 2020 Jun 24;71(1):133-141. doi: 10.1093/cid/ciz747. — View Citation

Tassiopoulos K, Patel K, Alperen J, Kacanek D, Ellis A, Berman C, Allison SM, Hazra R, Barr E, Cantos K, Siminski S, Massagli M, Bauermeister J, Siddiqui DQ, Puga A, Van Dyke R, Seage GR 3rd; Pediatric HIV/AIDS Cohort Study. Following young people with pe — View Citation

Torre P 3rd, Russell JS, Smith R, Hoffman HJ, Lee S, Williams PL, Yao TJ; Pediatric HIV/AIDS Cohort Study (PHACS). Words-in-Noise Test Performance in Young Adults Perinatally HIV Infected and Exposed, Uninfected. Am J Audiol. 2020 Mar 5;29(1):68-78. doi: 10.1044/2019_AJA-19-00042. Epub 2020 Jan 31. — View Citation

Torre P 3rd, Zhang ZJ, Hoffman HJ, Frederick T, Purswani M, Williams PL, Yao TJ; Pediatric HIV/AIDS Cohort Study (PHACS). Auditory Function in the Pediatric HIV/AIDS Cohort Study Adolescent Master Protocol Up Young Adults: A Pilot Study. J Acquir Immune Defic Syndr. 2023 Apr 1;92(4):340-347. doi: 10.1097/QAI.0000000000003145. — View Citation

Wilkinson JD, Williams PL, Yu W, Colan SD, Mendez A, Zachariah JPV, Van Dyke RB, Shearer WT, Margossian RE, Lipshultz SE; Pediatric HIV/AIDS Cohort Study (PHACS). Cardiac and inflammatory biomarkers in perinatally HIV-infected and HIV-exposed uninfected c — View Citation

Williams PL, Jesson J. Growth and pubertal development in HIV-infected adolescents. Curr Opin HIV AIDS. 2018 May;13(3):179-186. doi: 10.1097/COH.0000000000000450. — View Citation

Yildirim C, Garvie PA, Chernoff M, Wilkins ML, Patton ED, Williams PL, Nichols SL; Memory and Executive Functioning Study of the Pediatric HIV/AIDS Cohort Study. The Role of Pharmacy Refill Measures in Assessing Adherence and Predicting HIV Disease Marker — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV disease progression	Factors of interest for this outcome include virologic suppression, immune impairment, immune activation, changes in ART, cumulative exposure to specific ART, viral resistance, co-infections, and host genetic polymorphisms. Data will be collected through chart abstraction and laboratory assessments and central laboratory testing.	Annually for 6 years
Primary	Metabolic abnormalities	Factors of interest include BMI, body composition, systolic and diastolic blood pressure, lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides). Data will be collected by chart review, physical assessments, and laboratory evaluations.	Annually for 6 years
Primary	Sexually transmitted infections (STI)	STI testing and chart review conducted annually.	Annually for 6 years
Primary	Pregnancies	Data collected annually through online surveys and chart abstraction.	Annually for 6 years
Primary	Mental health problems	Assessed at annually through the Patient Health Questionnaire (PHQ-9)) and General Anxiety Disorder-7 (GAD-7)	Annually for 6 years
Primary	ART adherence	Data collected annually through an online survey.	Annually for 6 years
Primary	Prevalence of risk behaviors including risky sexual behavior and licit and illicit substance use	Participants will complete an annual online survey.	Annually for 6 years
Primary	Transition to adult functioning	Every year participants will complete an online survey to collect data on educational attainment, employment, independent living and quality of life.	Every 3 years for 6 years
Primary	Hearing dysfunction	Assessed through the NIH Toolbox and a questionnaire to be completed at Entry, Year 3 and Year 6 visits.	Every 3 years for 6 years
Primary	Language development	The Clinical Evaluation of Language Fundamentals (CELF) IV assessment will be completed at the Entry or Year 3 visit.	Once, at the Entry or Year 3 visit
Primary	End-organ disease	Factors of interest for this outcome include virologic suppression, immune impairment, immune activation, changes in ART, cumulative exposure to specific ART, viral resistance, co-infections, and host genetic polymorphisms. Data will be collected through chart abstraction and laboratory assessments.	Annually for 6 years
Primary	Mortality	Factors of interest for this outcome include virologic suppression, immune impairment, immune activation, changes in ART, cumulative exposure to specific ART, viral resistance, co-infections, and host genetic polymorphisms. Data will be collected through chart abstraction and laboratory assessments.	Annually for 6 years
Primary	Risk factors for cardiovascular disease	Factors of interest include BMI, body composition, systolic and diastolic blood pressure, lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) and cumulative cardiometabolic risk. Data will be collected by chart review, physical assessments, and laboratory evaluations.	Annually for 6 years
Primary	Cervical HPV-associated pre-cancers and cancers (among female participants)	Data collected through annual chart review.	Annually for 6 years
Primary	Cognitive impairment	Assessed at Entry, Years 3, 6, 9, and 12 visits through the NIH Toolbox.	Every 3 years for 6 years
Primary	Maternal-to-child HIV transmission	Data collected through annual chart review.	Annually for 6 years

External Links

•   Pediatric HIV/AIDS Cohort Study