Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.
An open label demonstration study with PrEP and Client Centered Care Coordination (C4) to assess the initiation, acceptability, safety, and feasibility of PrEP for Black MSM (BMSM) in three US Cities. A subset of participants will also be recruited to participate in qualitative interviews about facilitators and barriers regarding PrEP. The study will recruit HIV-uninfected BMSM at risk for HIV infection in three US Cities. Enrollment will include those aged 18 and over with an effort to recruit an equal number of BMSM under age 25 and over age 25 with a total of 225 participants (75 per site).
Study Type
OBSERVATIONAL
Enrollment
226
HPTN 073 is an observational study in MSM in the United States
UCLA Vine Street Clinic
Los Angeles, California, United States
George Washington University CRS
Washington D.C., District of Columbia, United States
UNC CRS
Chapel Hill, North Carolina, United States
Initiation of PrEP
Documented in either study CRFs or ACASI
Time frame: 30 months
Adherence to PrEP
Adherence will be assessed via self-report (ACASI), PBMCs and plasma concentration
Time frame: 30 months
Adverse events
Graded via DAIDS Toxicity Grading System determined by review of reported adverse events (clinical and laboratory)
Time frame: 30 months
STIs
Rectal and urine GC/CT, and NAAT for syphilis and chlamydia
Time frame: 30 months
Changes in sexual risk-taking behavior
Measured by ACASI assessments
Time frame: 30 months
Initiate or decline PrEP
Refusal rates will be measured by ACASI assessments
Time frame: 30 months
Incident HIV-seroconversions/characteristics
HIV RNA and genotyping will be performed at the NL on samples confirmed to be HIV infected
Time frame: 30 months
Participant perception of care and referral plan
Assessed via interviewer-administered questionnaire
Time frame: 30 months
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