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HIV Prevention Preparedness Study in Russia, China, and India

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00021775
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : January 3, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of this study is to set up a system for doing research on HIV prevention in various parts of the world.

In order to plan large, long-term studies on the prevention of HIV in different areas of the world, it is necessary to get certain information first. It is important to know about the rate of HIV infection and how to get people to enroll for any future studies. This study will be done at 4 study locations.

Condition or disease
HIV Infections

Detailed Description:

In order to realistically plan for future Phase III studies on HIV prevention, information must be obtained to characterize study population parameters at HTPN sites. Very different study designs may be required depending on these parameters, such as the ability of HPTN research centers to recruit study participants and the rate of HIV incidence observed in study populations. This study will be conducted at 4 HPTN sites to establish the necessary research knowledge and infrastructure.

This study enrolls participants from St. Petersburg, Russia; Xinjiang and Guangxi, China; and Chennai, India who are at high risk for HIV infection due to sexual and/or drug use behaviors. Participants who meet the screening criteria then complete an HIV risk assessment interview, receive HIV pre-test and risk reduction counseling, and undergo phlebotomy for HIV antibody testing. Participants who test positive are referred to available services and studies. Those who test HIV-negative and meet eligibility criteria are enrolled and maintained in follow-up over the next 12 months. Participants complete "locator contacts" at Months 3 and 9 and have follow-up visits at Months 6 and 12 for similar tests as performed at entry. In a substudy of this trial in China, participants will be interviewed about their drug use, social networks, needs, and perceptions about HIV/AIDS. These results will be used by HPTN to design more culturally sensitive and appropriate trials in the future.

Study Design

Study Type : Observational
Estimated Enrollment : 2000 participants
Official Title: HIV Prevention Preparedness Study
Study Start Date : April 2002
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

Participants may be eligible for this study if they:

  • Are 16 (Saint Petersburg) or 18 (Xinjiang, Guangxi, and Chennai) years of age or older.
  • Are HIV sero-negative.
  • Are available for 12 months of study participation.
  • Have written consent of parent or legal guardian if under age.
  • Are able and willing to provide information on where they can be located or contacted.
  • Meet specific risk-group requirements, for women at heterosexual risk, for men at heterosexual risk, and for injection drug users.

Exclusion Criteria

Participants will not be eligible for this study if they:

  • Have any mental disorders that would cause a problem with the informed consent or study participation.
  • Have any condition that, in the opinion of the doctor, would interfere with the study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021775

China, Guangxi
Guangxi Ctrs. for Disease Control & Prevention and for HIV/AIDS Prevention & Control CRS
Nanning, Guangxi, China, 530028
China, Xinjiang
Xinjiang Uygar Autonomous Region Ctr. for Disease Control & Prevention, HPTN Project Office
Urumqi, Xinjiang, China, 830011
Russian Federation
St. Petersburg Univ. Biomedical Ctr.
St. Petersburg, Russian Federation, 197110
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Study Chair: Robert Ryder
More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00021775     History of Changes
Other Study ID Numbers: HPTN 033
10611 ( Registry Identifier: DAIDS ES Registry Number )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: December 2013

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Risk Factors
Patient Selection
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases