Chennai: YRG Care is currently recruiting HIV patients for clinical trials

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HIV Prevention Preparedness Study in Russia, China, and India

This study is currently recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases

(NIAID) Purpose

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

HIV Infections

HIV Seronegativity

Study Type: Observational

Study Design: Natural History

Official Title: HIV Prevention Preparedness Study

Further Study Details:

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 HTPN sites to establish the necessary research

knowledge and infrastructure.

This study enrolls participants from St. sburg, 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.

Eligibility

Ages Eligible for Study: 14 Years and above , Genders Eligible for

Study: Both Accepts Healthy Volunteers

Criteria

Inclusion Criteria

Participants may be eligible for this study if they:

Are 16 (Saint sburg) 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.

Expected Total Enrollment: 2000

Location and Contact Information

Ballantyne, M.A.T. 919-544-7040 Ext. 584

sballantyne@...

North Carolina

beth McCauley, Research Triangle Park, North Carolina,

27709, United States; Recruiting

Xinjiang Uygar Autonomous Region, China, ; Recruiting

Kitty Poundstone 86-991-385-0327

China

Guangxi Centers for Disease Control, China, Nanning, 532002I,

China; Recruiting

Rodolph 86 771 532 7110

India

Yr Gaitonde Med and Research Foundation, India, Chennai,

600017, India; Recruiting

Aylur Kailasam Ganesh 91448230702 yrgcare@...

Russian Federation

Biomedical Ctr for AIDS, St. sburg Univ, St sburg,

197110, Russian Federation; Recruiting

Alla Shaboltas 7-812-230-48-72 biomed@...

Study chairs or principal investigators

Ryder, Study Chair

Study ID Numbers HPTN 033

Record last reviewed April 2003

NLM Identifier NCT00021775

ClinicalTrials.gov processed this record on 2003-05-08

http://clinicaltrials.gov/ct/gui/show/NCT00021775?order=2