HIV/AIDSAMP UpNCT02119702

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

An observational study of HIV/AIDS, run by Harvard School of Public Health (HSPH) at 14 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV/AIDS
How many people: 818 participants
Where: 14 sitesin 2 countries
Study dates: Apr 2014to 31 May 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Young adults 18 years of age or older at the time of enrollment with or without perinatal HIV-infection.

Who may be able to join

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

Show all 12Show fewer

Viral load and CD4+ cell count history
Major medical events history
Willingness to participate and provide legal written consent
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

Who cannot join

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
Have confirmed perinatal HIV infection as documented in the medical record

Trial locations and contacts

14 sites in 2 countries.

Country

City, postcode or hospital

14 sites in 2 countries

United States13 sites

University of Colorado Denver Health Sciences Center
Aurora, Colorado, 80045
Children's Hospital Boston
Boston, Massachusetts, 02115
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, 60614
Children's Diagnostic and Treatment Center
Fort Lauderdale, Florida, 33316
Baylor College of Medicine
Houston, Texas, 77030
University of California San Diego
La Jolla, California, 92093
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
University of Miami
Miami, Florida, 33316
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Rutgers - New Jersey Medical School
Newark, New Jersey, 07101
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Bronx Lebanon Hospital Center
The Bronx, New York, 10457
Jacobi Medical Center
The Bronx, New York, 10461

Other trials in United States

Puerto Rico1 site

San Juan Research Hospital
San Juan, 00936

Other trials in Puerto Rico

About this study

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.

Read the detailed 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.

Conditions: HIV/AIDS
Keywords: HIV/AIDS, perinatal HIV infection
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02119702
Study group	Role	What they receive
Infected Cohort - Closed to accrual		Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.
Uninfected Cohort		Perinatally HIV-exposed but uninfected participant at or beyond their 18th birthday at enrollment. May have horizontally-acquired HIV infection.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Annually for 6 years
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.
Measured: Annually for 6 years
Sexually transmitted infections (STI)
STI testing and chart review conducted annually.
Measured: Annually for 6 years
Pregnancies
Data collected annually through online surveys and chart abstraction.
Measured: Annually for 6 years
Mental health problems
Assessed at annually through the Patient Health Questionnaire (PHQ-9)) and General Anxiety Disorder-7 (GAD-7)
Measured: Annually for 6 years
ART adherence
Data collected annually through an online survey.
Measured: Annually for 6 years
Prevalence of risk behaviors including risky sexual behavior and licit and illicit substance use
Participants will complete an annual online survey.
Measured: Annually for 6 years
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.
Measured: Every 3 years for 6 years
Hearing dysfunction
Assessed through the NIH Toolbox and a questionnaire to be completed at Entry, Year 3 and Year 6 visits.
Measured: Every 3 years for 6 years
Language development
The Clinical Evaluation of Language Fundamentals (CELF) IV assessment will be completed at the Entry or Year 3 visit.
Measured: Once, at the Entry or Year 3 visit
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.
Measured: Annually for 6 years
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.
Measured: Annually for 6 years
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.
Measured: Annually for 6 years
Cervical HPV-associated pre-cancers and cancers (among female participants)
Data collected through annual chart review.
Measured: Annually for 6 years
Cognitive impairment
Assessed at Entry, Years 3, 6, 9, and 12 visits through the NIH Toolbox.
Measured: Every 3 years for 6 years
Maternal-to-child HIV transmission
Data collected through annual chart review.
Measured: Annually for 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201431 May 2025

First posted22 Apr 2014 (estimated)
Study startApr 2014
Primary completion31 May 2025
Study completion31 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 818 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02119702
Sponsor's protocol ID: 1P01HD103133 - PH300
Other IDs: PH300, 1P01HD103133
Acronym: AMP Up
Status last verified: Jun 2025
First submitted: 10 Apr 2014
Last updated: 27 Jun 2025
Results posted: No
Data monitoring committee: No

Publications

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 perinatal HIV infection from adolescence into adulthood: the protocol for PHACS AMP Up, a prospective cohort study. BMJ Open. 2016 Jun 9;6(6):e011396. doi: 10.1136/bmjopen-2016-011396.
PubMed 27288383
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.
PubMed 29432228
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.
PubMed 29432231
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/INF.0000000000002084.
PubMed 29742647
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 children. AIDS. 2018 Jun 19;32(10):1267-1277. doi: 10.1097/QAD.0000000000001810.
PubMed 29596110
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 Syndr. 2018 Sep 1;79(1):e37-e39. doi: 10.1097/QAI.0000000000001763. No abstract available.
PubMed 29847477
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 HIV. AIDS. 2019 Oct 1;33(12):1923-1934. doi: 10.1097/QAD.0000000000002301.
PubMed 31274538
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-infected and Exposed, Uninfected Youth. Clin Infect Dis. 2019 Sep 13;69(7):1183-1191. doi: 10.1093/cid/ciy1040.
PubMed 30927547
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 Markers in Youth with Perinatally-Acquired HIV (PHIV). AIDS Behav. 2019 Aug;23(8):2109-2120. doi: 10.1007/s10461-019-02468-x.
PubMed 30929147
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.2019.305108. No abstract available.
PubMed 31166735
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 Patient Care STDS. 2019 Jan;33(1):1-13. doi: 10.1089/apc.2018.0096.
PubMed 30601062
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.
PubMed 32004075
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.
PubMed 31870676
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.
PubMed 31584617
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.
PubMed 32540839

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
ClinicalTrials.gov ID: NCT02119702
Acronym / sponsor ID: AMP Up / 1P01HD103133 - PH300
Conditions: HIV/AIDS
Keywords: HIV/AIDS, perinatal HIV infection
Study type: Observational
Recruitment status: Completed
Enrolment: 818 participants (actual)
Lead sponsor: Harvard School of Public Health (HSPH)University, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute on Drug Abuse (NIDA), National Institute of Allergy and Infectious Diseases (NIAID), NIH Office of AIDS Research (OAR), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute on Deafness and Other Communication Disorders (NIDCD), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Dental and Craniofacial Research (NIDCR), National Institute on Alcohol Abuse and Alcoholism (NIAAA), Tulane University School of Medicine
Study start: Apr 2014 (actual)
Primary completion: 31 May 2025 (actual)
Study completion: 31 May 2025 (actual)
First posted: 22 Apr 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Infected Cohort - Closed to accrual	–	–Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.
Uninfected Cohort	–	–Perinatally HIV-exposed but uninfected participant at or beyond their 18th birthday at enrollment. May have horizontally-acquired HIV infection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Young adults 18 years of age or older at the time of enrollment with or without perinatal HIV-infection.

Key inclusion criteria (12 listed)

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
Willingness to participate and provide legal written consent
Absence of perinatal HIV infection as indicated in the medical record; the Perinatally HIV-Exposed Uninfected (PHEU) participant may have horizontally-acquired HIV infection

Key exclusion criteria (3 listed)

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
Have confirmed perinatal HIV infection as documented in the medical record

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.
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.
Sexually transmitted infections (STI)
Time frame: Annually for 6 years
STI testing and chart review conducted annually.
Pregnancies
Time frame: Annually for 6 years
Data collected annually through online surveys and chart abstraction.
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)
ART adherence
Time frame: Annually for 6 years
Data collected annually through an online survey.
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.
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.
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.
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.
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.
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.
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.
Cervical HPV-associated pre-cancers and cancers (among female participants)
Time frame: Annually for 6 years
Data collected through annual chart review.
Cognitive impairment
Time frame: Every 3 years for 6 years
Assessed at Entry, Years 3, 6, 9, and 12 visits through the NIH Toolbox.
Maternal-to-child HIV transmission
Time frame: Annually for 6 years
Data collected through annual chart review.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
Results publication: PubMed 27288383Tassiopoulos 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 perinatal HIV infection from adolescence into adulthood: the protocol for PHACS AMP Up, a prospective cohort study. BMJ Open. 2016 Jun 9;6(6):e011396. doi: 10.1136/bmjopen-2016-011396.
Results publication: PubMed 29432228Williams 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.
Results publication: PubMed 29432231Innes 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.
Results publication: PubMed 29742647Goodenough 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/INF.0000000000002084.
Results publication: PubMed 29596110Wilkinson 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 children. AIDS. 2018 Jun 19;32(10):1267-1277. doi: 10.1097/QAD.0000000000001810.
Results publication: PubMed 29847477Alperen 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 Syndr. 2018 Sep 1;79(1):e37-e39. doi: 10.1097/QAI.0000000000001763. No abstract available.
Results publication: PubMed 31274538Kacanek 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 HIV. AIDS. 2019 Oct 1;33(12):1923-1934. doi: 10.1097/QAD.0000000000002301.
Results publication: PubMed 30927547Moscicki 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-infected and Exposed, Uninfected Youth. Clin Infect Dis. 2019 Sep 13;69(7):1183-1191. doi: 10.1093/cid/ciy1040.
Results publication: PubMed 30929147Yildirim 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 Markers in Youth with Perinatally-Acquired HIV (PHIV). AIDS Behav. 2019 Aug;23(8):2109-2120. doi: 10.1007/s10461-019-02468-x.
Results publication: PubMed 31166735Patel 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.2019.305108. No abstract available.
Results publication: PubMed 30601062Smith 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 Patient Care STDS. 2019 Jan;33(1):1-13. doi: 10.1089/apc.2018.0096.
Results publication: PubMed 32004075Torre 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.
Pediatric HIV/AIDS Cohort StudyLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paige L Williams principal investigator

Harvard School of Public Health (HSPH)

Russell Van Dyke, MD principal investigator

Tulane University School of Medicine

Katherine Tassiopoulos, DSc, MPH principal investigator

Harvard School of Public Health (HSPH)

14 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV/AIDS, run by Harvard School of Public Health (HSPH) at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV disease progression (time frame: Annually for 6 years). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02119702, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.