An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM)

PHASE2CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

November 30, 2015

Study Completion Date

November 30, 2016

Conditions
HIV Infection
Interventions
BEHAVIORAL

PCC

Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Counselors ask the client to recall and describe a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future.

DRUG

Emtricitabine/tenofovir (FTC/TDF (Truvada®))

All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.

Trial Locations (6)

19104

Childrens Hospital of Philadelphia, Philadelphia

60612

Stroger Hospital of Cook County, Chicago

70112

Tulane Medical Center, New Orleans

80045

University of Colorado - The Children's Hospital of Denver, Aurora

90027

Children's Hospital of Los Angeles, Los Angeles

02215

Fenway Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of North Carolina, Chapel Hill

OTHER

NCT01769456 - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among 15 to 17 Year Old Young Men Who Have Sex With Men (YMSM) | Biotech Hunter | Biotech Hunter