HIV
Conditions
Keywords
AE adverse event, AIDS acquired immunodeficiency syndrome, ALT (SGPT) alanine aminotransferase, ART antiretroviral therapy, AST (SGOT) aspartate aminotransferase, DCF data collection forms, DMC Data Monitoring Committee, FDA (U.S.) Food and Drug Administration, GCP Good Clinical Practice guidelines, HB sAg Hepatitis B surface antigen, ICH International Conference of Harmonisation, IND Investigational New Drug Application, IRB Institutional Review Board, IU International units, mg milligram(s), mm3 cubic millimeter(s), PCR polymerase chain reaction, SAE serious adverse event, µg microgram, ULN upper limit of the normal range, WB Western Blot
Brief summary
Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.
Detailed description
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).
Interventions
OTHERObservational
HPTN 073 is an observational study in MSM in the United States
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
HIV Prevention Trials Network
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
BMSM who meet all of the following criteria are eligible for inclusion in this study: * 18 years of age or older * No prior HIV diagnosis (self-report) * Male at birth * High risk for acquiring HIV infection including any one of the following in the previous 6 months: * Unprotected sex during receptive or insertive anal intercourse with a male partner * Any protected or unprotected: i. Receptive or insertive anal intercourse with more than three male sex partners ii. Exchange of money, gifts, shelter or drugs for receptive or insertive anal sex with a male partner iii. Receptive or insertive anal sex while under the influence of drugs or alcohol (i.e., high or drunk within two hours of the sex act) according to self-report * STI diagnosis (i.e., syphilis, gonorrhea and chlamydia) by self-report * Willing to provide locator information in accordance with the Study Specific Procedures (SSP) Manual * Urine dipstick negative or trace for protein and glucose * Hemoglobin \> 11 g/dL, absolute neutrophil count \> 750 cells/mm3, and platelet count ≥ 100,000/mm3 * Serum creatinine \< upper limit of normal (ULN) and calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula where: o eCcr in mL/min = \[(140 - age in years) x (actual body weight in kg)\] / (72 x serum creatinine in mg/dL) Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \< 3 times the upper limit of normal (ULN) * Total bilirubin \< 2.5 ULN * Hepatitis B surface antigen (HBsAg) negative
Exclusion criteria
BMSM who meet any of the following criteria will be excluded from this study: * Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected * Transgender * Active or chronic hepatitis B infection (as evidenced by HBsAg, HbsAb, and HbcAb testing) * Planning to move out of the area or to travel for more than 3 months during the study follow-up period * Unwilling to adhere to study procedures * Current participation in any research study via self-report (however, strictly non-HIV centered observational studies are not exclusionary) * Previous participation in an HIV vaccine study is exclusionary unless documented evidence of enrollment into a placebo arm * Use of ARV drugs (PrEP or PEP) in the last 60 days * Prior history of a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption (provided by self-report, or obtained from medical history or records) * Receipt of prohibited medications: interleukin therapy, medications with significant nephrotoxic potential (including but not limited to amphotericin B, aminoglycosides, cidofovir, foscarnet and systemic chemotherapy), and medications that may inhibit or compete for elimination via active renal tubular secretion (including but not limited to probenecid) - (provided by self-report, or obtained from medical history or medical records) * Any condition, that in the opinion of study staff, would make participation in the study unsafe, or interfere with achieving the study objective
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of PrEP | 30 months | Documented in either study CRFs or ACASI |
| Adherence to PrEP | 30 months | Adherence will be assessed via self-report (ACASI), PBMCs and plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in sexual risk-taking behavior | 30 months | Measured by ACASI assessments |
| Initiate or decline PrEP | 30 months | Refusal rates will be measured by ACASI assessments |
| Adverse events | 30 months | Graded via DAIDS Toxicity Grading System determined by review of reported adverse events (clinical and laboratory) |
| Participant perception of care and referral plan | 30 months | Assessed via interviewer-administered questionnaire |
| Incident HIV-seroconversions/characteristics | 30 months | HIV RNA and genotyping will be performed at the NL on samples confirmed to be HIV infected |
| STIs | 30 months | Rectal and urine GC/CT, and NAAT for syphilis and chlamydia |
Countries
United States
Outcome results
None listed