Pre-Exposure Prophylaxis in YMSM

University of North Carolina (UNC)

Status and phase: Completed; Phase 2

Conditions: HIV

Treatments: Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP; Behavioral: Many Men, Many Voices (3MV); Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01033942

ATN 082

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: Male

Ages: 18 to 22 years old

Volunteers: Accepts Healthy Volunteers

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 Personal Digital Assistant (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 Cockcroft-Gault equation: Glomerular Filtration Rate (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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 3 patient groups, including a placebo group

FTC/TDF as PrEP

Experimental group

Description:

Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention

Treatment:

Behavioral: Many Men, Many Voices (3MV)

Drug: coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP

Placebo Pill Control

Placebo Comparator group

Description:

Blinded administration of placebo pill; HIV behavioral intervention

Treatment:

Behavioral: Many Men, Many Voices (3MV)

Drug: Placebo

No Pill Control

Active Comparator group

Description:

Subjects receive HIV behavioral intervention but no pill.

Treatment:

Behavioral: Many Men, Many Voices (3MV)