HPTN 033

HIV Prevention Preparedness Study

Study Summary

What was HPTN 033?

A prospective cohort study 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.

Who participated in the study?

Adult males and females residing in Xinjiang and Guangxi, China; Chennai, India; and Saint Petersburg, Russia; who were at high risk for HIV infection due to sexual and/or drug use behavior (2000 participants total (500+ from each of the four HPTUs -- two in China))

What happened during the study?

No treatment regimen; however HIV pre-test, risk reduction, and post-test counseling was provided when HIV testing was performed at study months 6 and 12.

Study Documents

Study Details

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.

Key Study Personnel

Personnel list available upon request.