Adolescent Master Protocol for Participants 18 Years of Age & Older (AMP

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Acquired Immunodeficiency Syndrome
HIV Infections
HIV/AIDS

Clinical Trial Details

NCT number	NCT02119702
Study type	Observational
Source	Harvard School of Public Health (HSPH)
Contact	Liz Salomon, EdM
Phone	617-432-6762
Email	lsalomon@hsph.harvard.edu
Status	Recruiting
Phase
Start date	April 2014
Completion date	July 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03413696` - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed	`NCT03215901` - Life Plans Intervention Study	N/A
Completed	`NCT03289676` - Storytelling Narrative Communication Intervention for Smoking Cessation in Women Living With HIV	Phase 1
Completed	`NCT03268551` - MEMO-Medical Marijuana and Opioids Study
Active, not recruiting	`NCT04064567` - Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK	N/A
Completed	`NCT04013295` - Prize-linked Savings Initiatives for Promoting Better Health and Economic Outcomes in Kenya	N/A
Recruiting	`NCT04405700` - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting	`NCT03984136` - HIV Results Exchange Mechanism on Promoting HIV Testing Among MSM	N/A
Completed	`NCT02928900` - Patient Actor Training to Improve HIV Services for Adolescents in Kenya	N/A
Recruiting	`NCT03268109` - COGnitive ImpairmenT in Older HIV-infected Patients ≥ 65 Years Old
Completed	`NCT02797262` - Measuring and Monitoring Adherence to ART With Pill Ingestible Sensor System	N/A
Completed	`NCT02376582` - Safety and Immunogenicity Study of a DNA Vaccine Combined With Protein Vaccine Against HIV/AIDS	Phase 1
Completed	`NCT01957865` - Real-Time Antiretroviral Therapy Adherence Intervention in Uganda	N/A
Terminated	`NCT01443923` - Boceprevir Drug Combination for Hepatitis C Treatment in People With and Without HIV	Phase 4
Completed	`NCT01616940` - Minority AIDS Initiative Retention and Re-Engagement Project	N/A
Completed	`NCT01910714` - Adapting and Evaluating an EBI to Prevent HIV/AIDS Risk Among Apache Youth	N/A
Completed	`NCT01084421` - A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos	N/A
Completed	`NCT01596322` - International HIV Antiretroviral Adherence, Resistance and Survival	N/A
Completed	`NCT03643705` - A Nurse-led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention	N/A
Completed	`NCT03923231` - Pharmacokinetics of Atazanavir in Special Populations

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms