HIV Clinical Trial - Self-Consent for PrEP Perspectives

Status Completed

Clinical Trial Summary

This study involves a one-time, web-based quantitative structured self-complete ("web-based") survey for all subjects and a qualitative semi-structured ("qualitative") interview for a selected sub-sample of subjects to evaluate the consent processes in association with research outcomes, specifically early adherence to Pre-exposure Prophylaxis (PrEP) and Human Immunodeficiency Virus (HIV) seroconversion at any point during participation in the ATN 110 or ATN 113 study.

Clinical Trial Description

Decisional autonomy is a foundational, nearly inviolable principle of contemporary human subjects research. "Autonomy" refers to a deliberative outcome reflecting an individual's choice, outside of controlling influences of other agents. From the perspective of research participation decision-making, autonomy incorporates five elements of consent: competence; disclosure; understanding; voluntariness; and, consent. Adequate research consent processes are thought to be challenged by group-level qualities that define a "vulnerable population" in need of protection from coercion or undue influence. Age (typically less than age 18 in the United States) is a widely accepted status-defining vulnerability. Sexual minority identity or same-sex behavior does not define a "vulnerable" population but 45 Code of Federal Regulations (CFR) 46 subpart A (Common Rule) allows appropriate protections for other vulnerable populations as determined by an individual Institutional Review Board (IRB).

The specific aims of this study address issues within a larger domain of questions about the primacy of decisional autonomy, and associations of autonomous research consent and subsequent participation-associated outcomes. This mixed-methods study will enroll young men who have sex with men (YMSM) and transgender women who have sex with men who are currently or were previously enrolled in the ATN 110 or ATN 113 study.

Data from the web-based survey will be used to test hypotheses about the relationships between participant age, elements of the consent process, and two key participation outcomes (early adherence to PrEP, HIV seroconversion) in the ATN 110 or ATN 113 study. Data from the qualitative interview will be used to explore in further depth age-related vulnerability and disclosure vulnerabilities manifested for participants and whether/how they influenced ATN 110 and ATN 113 study outcomes. The interview will also assess decisional support and the benefits or harms associated with participation. ;

Study Design

Related Conditions & MeSH terms

HIV
PrEP

Clinical Trial Details

NCT number	NCT02801760
Study type	Observational
Source	University of North Carolina, Chapel Hill
Contact
Status	Completed
Phase	N/A
Start date	November 2015
Completion date	March 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.