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Contraceptive/HIV Affecting Risk in Adolescents

NCT03301480 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2019-02-07

No results posted yet for this study

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Katherine Bunge, MD · University of Pittsburgh

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2018-09-17
Completion
2018-09-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03301480 on ClinicalTrials.gov