HIV/AIDS
Conditions
Interventions
HIV Prevention
Sponsors
Fred Hutchinson Cancer Research Center University of Washington
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria The partner (HIV-1 uninfected) participants must meet the following criteria (by self-report, unless otherwise indicated) in order to be eligible for inclusion in the study: • Age =18 and =65 and able to provide independent informed consent for research per local regulations and guidelines • Able and willing to provide written informed consent to be screened for and to take part in the study • Part of a heterosexual couple in which either one or both partners meet the study eligibility criteria for partner (HIV-1 uninfected) participants. Couples are defined by the following criteria: o Partners are sexually active (defined as having had vaginal intercourse with the enrolled partner at least 6 times in the last three months) o Partners plan to remain in the relationship for the duration of the study period. o HIV-1 uninfected status is based on negative HIV-1 rapid tests, at study screening and at the enrollment visit (separate HIV-1 serological testing at both visits must be performed if enrollment is more than 2 weeks after screening) o Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures
Exclusion criteria
Exclusion criteria: Potential partner (HIV-1 uninfected) participants who meet any of the following criteria (by self-report, unless otherwise indicated) will be excluded from the study: • Self-reported use of antiretroviral pre-exposure prophylaxis (PrEP) use prior to enrollment • Active and serious infections, including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy; active clinically significant medical problems including cardiac disease (e.g., symptoms of ischemia, congestive heart failure or arrhythmia), pulmonary disease (steroid dependent chronic obstructive pulmonary disease), diabetes requiring hypoglycemic medication; and previously diagnosed malignancy expected to require further treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of immunological responses to HIV-1 that occur in the genital mucosa. | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of longitudinal immune responses, while also collecting samples for genetic characterization to understand how variants in CD101 and UBE2V1 may modulate host mucosal responses and HIV-1 infection risk. | — |
Countries
Kenya
Contacts
Public ContactPeter Mogere
Regulatory Affairs
Outcome results
None listed