HIV Prevention Preparedness Study in Russia, China, and India

NCT ID: NCT00021775

Last Updated: 2014-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2004-02-29

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.

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.

Conditions

HIV Infections

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Ryder

Role: STUDY_CHAIR

Locations

Guangxi Ctrs. for Disease Control & Prevention and for HIV/AIDS Prevention & Control CRS

Nanning, Guangxi, China

Xinjiang Uygar Autonomous Region Ctr. for Disease Control & Prevention, HPTN Project Office

Ürümqi, Xinjiang, China

St. Petersburg Univ. Biomedical Ctr.

Saint Petersburg, , Russia

Countries

China; Russia

Other Identifiers

10611

Identifier Type: REGISTRY

Identifier Source: secondary_id

HPTN 033

Identifier Type: -

Identifier Source: org_study_id