Pre-Exposure Prophylaxis in YMSM

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01033942
First received: December 16, 2009
Last updated: January 21, 2014
Last verified: August 2013
  Purpose

This is an exploratory mixed-methods research study that compares an efficacious behavioral HIV-prevention intervention (3MV) alone to the behavioral HIV-prevention intervention combined with a biomedical intervention (PrEP). After completing the 3MV behavioral intervention, participants will be randomly assigned to one of three study arms: 1) daily FTC/TDF as PrEP, 2) placebo pill control, or 3) "no pill" control. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks. Youth who decline to participate will be asked to complete a brief survey about their opinions on PrEP. Qualitative interviews will be completed with six study participants and the study coordinators at the end of the trial to explore further the issues of trial acceptability and feasibility. Finally, focus groups will be conducted to explore feasibility and acceptability issues with YMSM who meet all eligibility requirements of the study except for not being age 18 or older, but are at least 16 years of age.


Condition Intervention Phase
HIV
Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP
Drug: Placebo
Behavioral: Many Men, Many Voices (3MV)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Acceptability and Feasibility of a Pre-Exposure Prophylaxis (PrEP) Trial With Young Men Who Have Sex With Men (YMSM)

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • To evaluate the specific components of a PrEP delivery protocol that would be necessary to include in a future trial that will examine the effectiveness of PrEP as a prevention approach for YMSM at high risk for HIV infection. [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Examine acceptability, feasibility, and short-term reduction in sexual risk behaviors of combined bio-behavioral HIV risk reduction intervention, placebo pill control, and behavioral intervention alone. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • To explore the acceptability and feasibility of PrEP as a component of a comprehensive HIV risk reduction intervention for YMSM. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: August 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FTC/TDF as PrEP
Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention
Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP
Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.
Behavioral: Many Men, Many Voices (3MV)
Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
Placebo Comparator: Placebo Pill Control
Blinded administration of placebo pill; HIV behavioral intervention
Drug: Placebo
Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.
Behavioral: Many Men, Many Voices (3MV)
Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.
Active Comparator: No Pill Control
Subjects receive HIV behavioral intervention but no pill.
Behavioral: Many Men, Many Voices (3MV)
Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 22 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to independently provide written informed consent;
  • Of male gender at birth;
  • Between the ages of 18 years and 0 days through 22 years and 364 days at the time of signed informed consent;
  • Self-reporting at least one episode of unprotected anal intercourse with a male within the last 12 months at the time of PDA Screening Interview;
  • Tests HIV negative at time of screening (using any FDA-approved HIV diagnostic test);
  • Willing to provide locator information to study staff;
  • Willing to be assigned to any of the three biomedical intervention conditions;
  • Does not report intention to relocate out of the study area during the course of the study; and
  • Does not have job/other obligations that would require long absences from the area (> 4 weeks at a time).

Exclusion Criteria:

  • Transgender (behavioral intervention not targeted toward this population);
  • Presence of serious psychiatric symptoms (e.g., active hallucinations);
  • Visibly distraught at the time of consent (e.g., suicidal, homicidal, exhibiting violent behavior);
  • Intoxicated or under the influence of alcohol or other drugs at the time of consent;
  • Acute or chronic hepatitis B infection (exclude if hepatitis B surface antigen positive);
  • Renal dysfunction (Creatinine Clearance < 75 ml/min); Use Cockroft-Gault equation: GFR = (140-Age in years) x (Weight in kg) / (72 x serum creatinine) for males
  • Any history of bone fractures not explained by trauma;
  • Confirmed proteinuria (repeated positive [> 2+] urine dipstick), unless explained by orthostatic proteinuria;
  • Confirmed glucosuria (repeated positive [> 1+] urine dipstick) in the presence of normal blood glucose (<120 mg/dL);
  • Any Grade 3 toxicity on screening tests/assessments;
  • Concurrent participation in an HIV vaccine study or other investigational drug study; or
  • Known allergy/sensitivity to the study drug or its components.
  • Use of disallowed medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033942

Locations
United States, Illinois
Childrens Memorial Hospital
Chicago, Illinois, United States, 60614
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Investigators
Principal Investigator: Sybil Hosek, PhD Adolescent Trials Network
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01033942     History of Changes
Other Study ID Numbers: ATN 082
Study First Received: December 16, 2009
Last Updated: January 21, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Pre-exposure prophylaxis
HIV Prevention
Truvada
Many Men, Many Voices
Emtricitabine
Tenofovir disoproxil fumarate
Young men who have sex with men
HIV Seronegativity

Additional relevant MeSH terms:
Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 15, 2014