A Study to Prepare for Future HIV Vaccine Studies
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

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.
    

Detailed description: 
      To conduct successful trials, the ability of study sites to recruit, enroll, retain, and
      inform cohorts at risk for HIV infection is critical. Building a site's capacity for these
      functions is an essential component of overall preparedness for HIV vaccine trials. The
      design of Phase III HIV vaccine trials to be conducted in the HVTN will depend on the
      interplay of 4 parameters: the number of participants enrolled, the HIV incidence rate among
      enrollees, the duration of follow-up, and the number of participants retained in follow-up.
      Dramatically different study designs may be required depending on these parameters, and
      information must be obtained to characterize these parameters at HVTN sites. Based on
      previous work, many of the HVTN research sites have established effective standard operating
      procedures to recruit and retain high-risk populations in research studies and have
      characterized HIV incidence rates in these populations. Work is now required to establish a
      similar research infrastructure and knowledge base at potential expansion sites not
      previously represented in HIV vaccine research networks and to assess the potential for
      recruitment of new cohorts by existing HVTN sites. This HIV Vaccine Preparedness Study (VPS)
      serves that purpose.

      Each study site targets 1 or more major risk groups (heterosexual men or women at high sexual
      risk, men who have sex with men (MSM), or injection drug users (IDU)) for enrollment. Within
      each group, 200 to 500 HIV-negative participants are enrolled. Potential study participants
      undergo a screening interview to identify persons at high-risk for HIV infection. Those who
      meet the study eligibility criteria (except for HIV testing), as well as any additional
      site-specific criteria, complete a Behavioral Risk Assessment, receive HIV pre-test and risk
      reduction counseling, and are tested for HIV antibody and syphilis. Women must provide a
      urine sample for pregnancy testing. Participants who test HIV-negative and meet all other
      eligibility criteria are enrolled in the study and maintained in follow-up over the next 12
      months. Specifically, participants complete "locator contacts" at Months 3 and 9 and
      follow-up visits at Months 6 and 12. The Months 3 and 9 locator contacts serve the purpose of
      enhancing retention in the study by providing a mechanism to confirm or update participants'
      locator information; confirm or reschedule their next follow-up visit; and reinforce
      instructions to contact the study site to update locator information and/or, if needed,
      request HIV counseling and/or testing between scheduled visits. The follow-up visits at
      Months 6 and 12 will include assessments, counseling, and testing similar to those done at
      the screening visit.
    

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