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Study
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Phase Definitions
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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).
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Protocol Status:
Closed to Follow Up
Study Summary
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 with six months of accrual and two semi-annual follow-up visits for enrolled participants.
Study Population: Injection drug users from St. Petersburg, Russia, and sites in Xinjiang and Guangxi, China; women and men at heterosexual risk from Chennai, India
Study Size: 2029 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: To describe the study accrual process and estimate rates of accrual of persons at high risk for HIV infection into a standardized HIV-related research study.
To estimate rates of retention of persons at high risk for HIV infection in a standardized HIV-related research study.
To describe the demographic characteristics and HIV risk behaviors of persons targeted for inclusion in future HTPN studies of HIV prevention interventions.
Protocol Chair:
Robert W. Ryder
get info
CORE Protocol Specialist:
Deborah Hilgenberg
get info
CORE Protocol Specialist:
Scott Rose
get info
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