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CompletedNCT03279185AMP Up LiteUpdated Jun 27, 2025

Adolescent Master Protocol for Participants 18 Years of Age or Older - Lite

An observational study in HIV/AIDS, sponsored by Harvard School of Public Health (HSPH). Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by Harvard School of Public Health (HSPH) · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
334
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies in Acquired Immunodeficiency Syndrome by Harvard School of Public Health (HSPH) — none open to participants now, none under way, none of them phase 3. Acquired Immunodeficiency Syndrome · Harvard School of Public Health (HSPH).

Started
2017
the only one that year
Observational
3 of 13
none open now
Registered
12th of 13
by date

Among the 13 studies in Acquired Immunodeficiency Syndrome by Harvard School of Public Health (HSPH), this one is the only one that started in 2017, is one of 3 observational ones, and was the 12th registered.

Acquired Immunodeficiency Syndrome

3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.

Browse Acquired Immunodeficiency Syndrome studies →

Open to participants now

None of the 13 studies in Acquired Immunodeficiency Syndrome by Harvard School of Public Health (HSPH) is open now. The open studies under Acquired Immunodeficiency Syndrome, anywhere →

Who these studies take

Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 13 studies in Acquired Immunodeficiency Syndrome by Harvard School of Public Health (HSPH) as a file.
02

Study 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 as they transition to adulthood.

Read the detailed description

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 as they transition to adulthood.

The primary objectives of this study are:

  1. To identify infectious and non-infectious complications of HIV disease and toxicities resulting from long-term ART, including disease progression, immune suppression, viral resistance, end-organ disease, and mortality.
  2. To define the impact of HIV infection and ART on the long-term clinical outcomes of young adults with perinatal HIV.
  3. To define the impact of perinatal HIV infection and ART on long-term mental and behavioral health outcomes.
03

Conditions studied

  • HIV/AIDS

Keywords

  • HIV/AIDS, perinatal HIV infection
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Perinatally HIV-infected (PHIV+) young adults 18 years of age or older at the time of enrollment born to HIV-infected mothers.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Perinatal infection as documented in the medical record;
  • At or beyond their 18th birthday at the time of with no upper age limit;
  • Willingness to provide access to existing medical records; and
  • Willingness to participate and provide legal consent

Exclusion criteria

Exclusion Criteria:

  • Prisoner status
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
334 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Infected Cohort - closed to accrual

    Perinatally HIV-infected participants at or beyond their 18th birthday at enrollment.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Annually for 6 years

  2. Metabolic Anomalies

    Data will be collected by chart review, physical assessments, and laboratory evaluations.

    Time frame: Annually for 6 years

  3. Sexually Transmitted Infections

    Data collected through chart abstraction.

    Time frame: Annually for 6 years

  4. Reproductive Health

    Data collected through an online surveys and chart abstraction.

    Time frame: Annually for 6 years

  5. Mental Health

    Data collected through an online survey and chart abstraction.

    Time frame: Annually for 6 years.

  6. ART Adherence

    Data collected through an online survey.

    Time frame: Annually for 6 years

  7. Risk Behaviors (Sexual and Substance Use)

    Data collected through an online survey.

    Time frame: Annually for 6 years

  8. Transition to Adult Functioning

    Data collected through an online survey.

    Time frame: Annually for 6 years.

  9. Hearing Dysfunction

    Data collected through an online survey and chart abstraction.

    Time frame: Annually for 6 years.

07

Study locations

9 sites
  • University of Southern California
    Los Angeles, California 90033, United States
  • David Geffen School of Medicine at UCLA
    Los Angeles, California 90095, United States
  • Emory University School of Medicine
    Atlanta, Georgia 30322, United States
  • Rush University Cook County Hospital Chicago
    Chicago, Illinois 60612, United States
  • Johns Hopkins University
    Baltimore, Maryland 21287, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
  • New York University School of Medicine
    New York, New York 10016, United States
  • SUNY Stony Brook
    Stony Brook, New York 17794, United States
  • Seattle Children's Hospital
    Seattle, Washington 98101, United States
08

References and documents

Publications

  • 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. PubMed 36150048 ↗
  • Olivero R, Williams PL, Sawyer G, Yee LM, Patel K, Hernandez-Diaz S, Powis K, Paul M, Chadwick EG; Pediatric HIV/AIDS Cohort Study and the HOPE study. Birth outcomes following bictegravir exposure during pregnancy. AIDS. 2025 Mar 15;39(4):381-386. doi: 10.1097/QAD.0000000000004041. Epub 2024 Oct 14. PubMed 39411892 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in May 2025, 90 months.

Of 165 non-industry observational studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 83. This study's 90 months is above that.

Counting every sponsor, half of 177 studies reached it within 44 months; a quarter within 19 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2017
First posted
Sep 12, 2017
StartActual
Nov 1, 2017
Primary completionActual
May 31, 2025
CompletionActual
May 31, 2025
Last update
Jun 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03279185
Responsible party
Paige Williams (Senior Lecturer on Biostatistics, Harvard School of Public Health (HSPH)) — Principal investigator
First posted
Sep 12, 2017
Start date
Nov 1, 2017
Primary completion
May 31, 2025
Completion
May 31, 2025
Last update
Jun 27, 2025

Study contacts

Paige L Williams
principal investigator · Harvard School of Public Health (HSPH)
Katherine Tassiopoulos, DSc, MPH
study chair · Harvard School of Public Health (HSPH)
Russell B Van Dyke, MD
study chair · Tulane University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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