NCT03301480

Contraceptive/HIV Affecting Risk in Adolescents

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: —

Summary

This study will evaluate the impact of hormonal contraceptives on HIV risk associated with changes to the innate immunity in the female genital tract in a cross-sectional study. HIV risk will be evaluated by the capacity of cervical tissue to replicate HIV when challenged ex vivo and correlated to the number of CD4 T cells, DCs, and macrophages; the capacity of cervicovaginal fluid to inhibit HIV will be correlated to soluble mucosal mediators, and the vaginal microbiota. The lower genital tract samples will be collected from 120 adolescents aged 18-19 (40 using no hormonal contraception, 40 using ENG-I, 40 using LNG-IUS). For comparison, 90 adult women aged 25-45 will be equally distributed between the same groupings.

Conditions

• Contraception
• Hiv

Timeline

• Start date: 2017-07-31
• Primary completion: 2018-09-17
• Completion: 2018-09-17
• First posted: 2017-10-04
• Last updated: 2019-02-07

Locations

1 site across 1 country: United States