HPTN 033
HIV Prevention Preparedness Study
What is HPTN 033?HPTN 033 is a prospective cohort study conducted at HPTN study sites in Xinjiang and Guangxi, China; Chennai, India; and Saint Petersburg, Russia. The study visit and procedures schedule implemented at each study site depended on whether the site elected to perform rapid HIV testing, however, data required to address all study outcomes were collected in a comparable manner across all sites. Each study site targeted enrollment of 500 study participants over the course of a six-month accrual period. This target is consistent with the likely site-specific accrual requirements of future HPTN multi-site HIV prevention studies. All sites implemented the study in accordance with the “core” protocol; however, additional, site-specific, HPTN-sponsored sub-studies may have been incorporated into the study, with prior approval by the HPTN Protocol Review Committee (PRC), DAIDS Prevention Science Review Committee (PSRC), and all applicable local Institutional Review Boards or Ethics Committees (IRBs/ECs). |
Protocol Status: Concluded
Study Purpose: To establish effective standard operating procedures to recruit and retain high risk populations in future HPTN trials, and to characterize the HIV risk behaviors and HIV incidence rates in these populations.
Study Design: Prospective cohort study of 2000 persons at high risk for HIV infection (500 at each of four study sites), with a six-month accrual period and 12 months of follow-up for each enrolled participant.
Study Population: Adult males and females residing in Xinjiang and Guangxi, China; Chennai, India; and Saint Petersburg, Russia; who are at high risk for HIV infection due to sexual and/or drug use behaviors.
Study Size: 2000 participants total (500+ from each of the four HPTUs -- two in China)
Study Duration: Approximately 18 months total. Accrual will require six months, and each enrolled participant will be followed for 12 months.
Treatment Regimen: None, however HIV pre-test, risk reduction, and post-test counseling is provided when HIV testing is performed at study months 6 and 12.
Primary Objectives: To estimate rates of HIV seroincidence among persons targeted for inclusion in future HPTN studies of HIV prevention interventions.
Secondary Objectives: (a) Number of participants screened for the study, and the screening outcome of each screenee. (b) Number of participants enrolled in the study. (c) Number of participants retained for 12 months of study follow-up. (d) Demographic characteristics of persons screened for and/or enrolled in the study. (e) HIV risk behaviors reported by persons screened for and/or enrolled in the study.
No records returned.
| Site |
Target Enrollment |
Cumulative Enrollment |
Implementation Status |
More Info |
|---|---|---|---|---|
|
30274 Nanning, China |
500 |
500 |
De-Registered |
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|
31484 Urumqi, China |
500 |
509 |
De-Registered |
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|
YRG CARE Medical Ctr., VHS CRS 11701 Chennai, India |
500 |
500 |
Closed to Follow Up |
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|
St Petersburg University Biomedical Center 30307 St. Petersburg, Russia |
500 |
520 |
De-Registered |
get more |
