Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-12 @ 5:11 AM
Study NCT ID:
NCT02119702
Status:
COMPLETED
Last Update Posted:
2025-06-27
First Post:
2014-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
Sponsor:
Harvard School of Public Health (HSPH)
Organization:
Study Overview
Official Title:
Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMP Up
Brief 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PH300 | OTHER | PHACS Protocol Number | View | |
| 1P01HD103133 | NIH | None | https://reporter.nih.gov/quic… | View |