HIV Clinical Trial - PHASES: Provision of HIV Treatment at ATN Sites: An

Status Completed

Clinical Trial Summary

This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. An Audio Computer- Assisted Self-Interview (ACASI) at study entry will assess demographic and psychosocial variables of study subjects. Data will also be collected to assess clinic level variables. Definitions of engagement, prescription of antiretroviral therapy (ART), and viral suppression in the Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to provide all elements for both the primary and secondary outcomes.

Clinical Trial Description

This is an observational study involving retrospective and prospective medical record review covering a total maximum of 104 weeks (24 months) per subject. Behavioral data will be collected via ACASI at study entry to assess demographic and psychosocial variables of study subjects. All other data (biomedical, ART, healthcare utilization) at subsequent study visits will be collected via medical record abstraction. Information about missed visits as well as other healthcare utilization data can be abstracted from electronic appointment systems or other electronic systems at the clinical sites. Subject data will be abstracted from medical records for up to a maximum 26 weeks prior to the baseline study visit, as well as up to a maximum 78 weeks after the baseline study visit or through January 31, 2017, whichever occurs first, for a total maximum of 104 weeks or two years per subject. Data will also be collected from each Adolescent Medicine Trials Unit to assess clinic level variables at baseline (within 30 days of protocol registration) and 48 and 96 weeks after baseline. Definitions of engagement, prescription of antiretroviral therapy (ART), and viral suppression in the Continuum of Care (CoC) will utilize common definitions including those by U.S. Department of Health and Human Services (DHHS) and Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB). Data will be collected in a large, simple trial design manner to provide all elements for both the primary and secondary outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02438592
Study type	Observational
Source	University of North Carolina, Chapel Hill
Contact
Status	Completed
Phase	N/A
Start date	March 2015
Completion date	February 2016

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06162897` - Case Management Dyad	N/A
Completed	`NCT03999411` - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients	Phase 4
Completed	`NCT02528773` - Efficacy of ART to Interrupt HIV Transmission Networks
Active, not recruiting	`NCT05454839` - Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
Recruiting	`NCT05322629` - Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women	N/A
Completed	`NCT02579135` - Reducing HIV Risk Among Adolescents: Evaluating Project HEART	N/A
Active, not recruiting	`NCT01790373` - Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence	N/A
Not yet recruiting	`NCT06044792` - The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
Completed	`NCT04039217` - Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM	Phase 4
Active, not recruiting	`NCT04519970` - Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)	N/A
Completed	`NCT04124536` - Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women	N/A
Recruiting	`NCT05599581` - Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health	N/A
Active, not recruiting	`NCT04588883` - Strengthening Families Living With HIV in Kenya	N/A
Completed	`NCT02758093` - Speed of Processing Training in Adults With HIV	N/A
Completed	`NCT02500446` - Dolutegravir Impact on Residual Replication	Phase 4
Completed	`NCT03805451` - Life Steps for PrEP for Youth	N/A
Active, not recruiting	`NCT03902431` - Translating the ABCS Into HIV Care	N/A
Completed	`NCT00729391` - Women-Focused HIV Prevention in the Western Cape	Phase 2/Phase 3
Recruiting	`NCT05736588` - Elimisha HPV (Human Papillomavirus)	N/A
Recruiting	`NCT03589040` - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant	Phase 2

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.

PHASES: Provision of HIV Treatment at ATN Sites: An Evaluation for Stakeholders

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms