HIV/AIDS
Conditions
Keywords
HIV/AIDS, perinatal HIV infection
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 as they transition to adulthood.
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.
Interventions
None listed
Sponsors
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 Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Heart, Lung, and Blood Institute (NHLBI)
Harvard School of Public Health (HSPH)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; * Willingness to provide access to existing medical records; and * Willingness to participate and provide legal consent
Exclusion criteria
* Prisoner status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transition to Adult Functioning | Annually for 6 years. | Data collected through an online survey. |
| HIV Disease Progression | 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. |
| Metabolic Anomalies | Annually for 6 years | Data will be collected by chart review, physical assessments, and laboratory evaluations. |
| Sexually Transmitted Infections | Annually for 6 years | Data collected through chart abstraction. |
| Reproductive Health | Annually for 6 years | Data collected through an online surveys and chart abstraction. |
| Mental Health | Annually for 6 years. | Data collected through an online survey and chart abstraction. |
| ART Adherence | Annually for 6 years | Data collected through an online survey. |
| Risk Behaviors (Sexual and Substance Use) | Annually for 6 years | Data collected through an online survey. |
| Hearing Dysfunction | Annually for 6 years. | Data collected through an online survey and chart abstraction. |
Countries
United States
Outcome results
None listed