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Completed

NCT Number: NCT02119702

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

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Juan Research Hospital, San Juan, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. HIV disease progression

    Time frame: Annually for 6 years

    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.

  2. Metabolic abnormalities

    Time frame: Annually for 6 years

    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.

  3. Sexually transmitted infections (STI)

    Time frame: Annually for 6 years

    STI testing and chart review conducted annually.

  4. Pregnancies

    Time frame: Annually for 6 years

    Data collected annually through online surveys and chart abstraction.

  5. Mental health problems

    Time frame: Annually for 6 years

    Assessed at annually through the Patient Health Questionnaire (PHQ-9)) and General Anxiety Disorder-7 (GAD-7)

  6. ART adherence

    Time frame: Annually for 6 years

    Data collected annually through an online survey.

  7. Prevalence of risk behaviors including risky sexual behavior and licit and illicit substance use

    Time frame: Annually for 6 years

    Participants will complete an annual online survey.

  8. Transition to adult functioning

    Time frame: Every 3 years for 6 years

    Every year participants will complete an online survey to collect data on educational attainment, employment, independent living and quality of life.

  9. Hearing dysfunction

    Time frame: Every 3 years for 6 years

    Assessed through the NIH Toolbox and a questionnaire to be completed at Entry, Year 3 and Year 6 visits.

  10. Language development

    Time frame: Once, at the Entry or Year 3 visit

    The Clinical Evaluation of Language Fundamentals (CELF) IV assessment will be completed at the Entry or Year 3 visit.

  11. End-organ disease

    Time frame: Annually for 6 years

    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.

  12. Mortality

    Time frame: Annually for 6 years

    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.

  13. Risk factors for cardiovascular disease

    Time frame: Annually for 6 years

    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.

  14. Cervical HPV-associated pre-cancers and cancers (among female participants)

    Time frame: Annually for 6 years

    Data collected through annual chart review.

  15. Cognitive impairment

    Time frame: Every 3 years for 6 years

    Assessed at Entry, Years 3, 6, 9, and 12 visits through the NIH Toolbox.

  16. Maternal-to-child HIV transmission

    Time frame: Annually for 6 years

    Data collected through annual chart review.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • NIH Office of AIDS Research (OAR)
  • 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)
  • Tulane University School of Medicine

Registry information

Acronym: AMP Up

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2014
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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