HIV-1 Resistance at Screening for HIV Prevention Studies

• To identify and evaluate behavioral indicators including self or sexual partner(s) exposures to ARV drugs as risk factors for drug resistant HIV infection in women who present for screening to participate in HIV prevention trials [ Time Frame: 2 years ] [ Designated as safety issue: No ]
• To characterize the degree of immunodeficiency and risk of disease progression by quantifying plasma HIV-1 RNA and CD4-positive T cells among women who test HIV-positive when presenting for screening to participate in HIV prevention trials [ Time Frame: 2 years ] [ Designated as safety issue: No ]

MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of ARV resistance in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. To date, a comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials.

MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of ARV resistance in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. To date, a comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials. Secondary aims include the identification and evaluation of behavioral indicators including self or sexual partner(s) exposures to antiretroviral (ARV) drugs as risk factors for drug resistant HIV infection, as well as the characterization of the degree of immunodeficiency and risk of disease progression by quantifying plasma HIV-1 RNA and CD4-positive T cells among women who test HIV-positive when presenting to screen for participation in an HIV prevention trial. Exploratory aims include the identification of polymorphic or subtype-specific sequence changes in HIV-1 that may impact susceptibility to ARVs, and the estimation of the proportion of HIV-positive women who have chronic versus recent HIV infection.

The finding of significant resistance, or lack thereof, to ARV-based study products delivered vaginally or taken orally may guide decisions related to future microbicide and PrEP studies. In addition, MTN-009 will provide valuable comparison data for the resistance data obtained in MTN-015, the MTN seroconverter study.

Women of reproductive age who are interested in participating in HIV prevention trials

• Procedure: Laboratory Testing
  Completion of behavorial questionnaire; HIV testing;CD4-positive T cell counts; Plasma viral HIV-1 RNA levels (viral load); Identification of drug resistance mutations in HIV-1 by standard and sensitive assays; Categorization of infection as recent or chronic using current incidence testing algorithms; Follow-up visits with laboratory evaluations
• Other: Counseling/referral
  Completion of behavorial questionnaire; HIV testing; Referred to HIV-prevention trial;

• HIV-infected
  Intervention: Procedure: Laboratory Testing
• HIV-uninfected
  Intervention: Other: Counseling/referral

Inclusion Criteria:

• Present to an MTN-009 study site to pre-screen or screen for an HIV prevention trial
• Age 18-40 years, verified per site standard operating procedures (SOP)
• Able and willing to provide written informed consent for participation in MTN-009
• Able and willing to provide adequate locator information, as defined in site SOPs

Exclusion Criteria:

• Any condition that, in the investigator's opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achievement of the study objectives