Immunogenetic Modulators of Mucosal Protection from HIV-1: The Kinga Study

Not Applicable

• Conditions: HIV/AIDS

• Registration Number: PACTR202004507940963
• Lead Sponsor: Fred Hutchinson Cancer Research Center University of Washington

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-30
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Other
• Sex: All
• Target Recruitment: 812

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:

oPartners are sexually active (defined as having had vaginal intercourse with the enrolled partner at least 6 times in the last three months)
oPartners plan to remain in the relationship for the duration of the study period.
oHIV-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)
oAble and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified