A Study to Prepare for Future HIV Vaccine Studies

NCT00029744 | Completed

• 2 other identifiers: HVTN 90310064
• Study Type: observational
• Target: N/A
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to determine the ability of HVTN sites to recruit and retain people at risk for HIV infection for possible future HIV vaccine research studies. This study also aims to learn more about the risk behaviors of people at high risk for HIV infection. In order for studies to be successful, study sites must be able to recruit, enroll, retain, and inform groups at high risk for HIV infection. The plan for Phase III HIV vaccine trials will depend on the number of participants enrolled, the rate at which participants become HIV-infected, the length of follow-up, and the number of participants who continue and follow through with the entire study. At existing sites, it is necessary to evaluate the potential to recruit new groups. At possible expansion sites, work is necessary to establish effective procedures to recruit and retain participants and to identify HIV incidence rates. This study will accomplish those goals.

Conditions

HIV Infections

Keywords

AIDS Vaccines; Clinical Protocols; HIV Seronegativity; Patient Selection; Patient Acceptance of Health Care; Demography; HIV Preventive Vaccine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Persons may be eligible for this study if they:
• Are between the ages of 18 and 60
• Are HIV-negative within 30 days of enrollment
• Are available for 12 months
• Are able and willing to provide information so that they may be located
• Are able to verbally show understanding of the study
• Men or women engaging in unprotected sex with a non-monogamous partner in the past 12 months
• Men or women diagnosed with a sexually transmitted disease in the past 12 months
• Men or women engaging in unprotected sex with a partner of the opposite sex diagnosed with a sexually transmitted disease in the past 12 months
• Men or women having sex with more than one partner in the past 12 months
• Men or women engaging in unprotected sex with a partner of the opposite sex who was known to be HIV positive in the past 12 months
• Men who have had anal intercourse with another man in the past 12 months
• Men or women who report exchange of sex for drugs, money, or services in the past 12 months
• Persons are not eligible for this study if they:
• Have a mental disorder that would interfere with the study

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Haiti-GHESKIO, Port-au-Prince, Haiti

Port-au-Prince, Haiti

Location

Iquitos- Peru

Lima, Peru

Location

Related Publications (1)

• Djomand G, Metch B, Zorrilla CD, Donastorg Y, Casapia M, Villafana T, Pape J, Figueroa P, Hansen M, Buchbinder S, Beyrer C; 903 Protocol Team. The HVTN protocol 903 vaccine preparedness study: lessons learned in preparation for HIV vaccine efficacy trials. J Acquir Immune Defic Syndr. 2008 May 1;48(1):82-9. doi: 10.1097/QAI.0b013e31817236ab.

  PMID: 18391750 RESULT

MeSH Terms

Conditions

HIV Infections; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Chris Beyrer

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2002
• First Posted: January 22, 2002
• Study Start: April 1, 2003
• Study Completion: May 1, 2007
• Last Updated: October 31, 2012

Record last verified: 2012-10

Locations

PE (1); HA (1)