Contraceptive/HIV Affecting Risk in Adolescents

NCT03301480 | Terminated

• 1 other identifier: PRO17050002
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• HIV replication in cervical tissue as measured by levels of HIV p24/viral transcripts

  cervical tissue testing

  baseline

• number of immune cells in cervical tissue, including CD45, CD3, CD4, and CD8 and their expression of CCR5, CCR6 and CD69, and CD11c+ DCs and CD14+ macrophages

  cervical tissue testing

  baseline

Secondary Outcomes (3)

• Prevalence of bacterial vaginosis defined as a Nugent score ≥7 on a vaginal smear

  baseline

• prevalence and quantity of lactobacillus species and bacterial vaginosis associated bacteria as measured by traditional culture methods and quantitative PCR

  baseline

• HIV inhibitory activity in mucosal fluid; and soluble mucosal factors identified through pathway analyses and confirmed by targeted ELISA/multiplexing technology (proteases/ anti-proteases, keratin, IFNε, and other molecules)

  baseline

Study Arms (6)

No contraception/18-19 years old

Use of ENG-I/18 - 19 years old

LNG-IUS/18-19 years old

No Contraception/ 25 - 45 years old

Use of ENG-I/25 - 45 years old

LNG-IUS/25-45 years old

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: participants must have a cervix for participation
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

non-pregnant, HIV negative, healthy 18-19 year old women and 25-45 year old women

You may qualify if:

• Meets one of the following age groups (at the time of sample collection):
• Adolescent aged 18-19
• Adult aged 25-45
• Meets one of the following contraception groups:
• Regular menstrual cycles by participant history (if not using hormonal contraception)
• Use of ENG-I (i.e. Implanon/Nexplanon) for at least 30 days by participant history
• Use of LNG-IUS (Mirena or Skyla) for at least 30 days by participant history
• HIV uninfected Note: HIV testing will be done as part of screening. However, if a woman participated in a recent research study and has an HIV test result available from that study, this will suffice provided the date of the test is within 6 months of the study visit.
• Willing to undergo pelvic exam and collection of cervical biopsies
• Willing to provided written informed consent
• Agree to be sexually abstinent for 48 hours prior to the cervical biopsies and for one week after the biopsies.

You may not qualify if:

• Use of any other hormonal contraception other than ENG-I or LNG-IUS
• Use of a diaphragm or spermicide for contraception
• Pregnant or pregnancy within 90 days
• Currently breastfeeding
• Currently menstruating/bleeding (at time of specimen collection) Note: participant can return after cessation of bleeding for specimen collection
• Past participation in more than one study involving cervical biopsies per participant report
• Cervical biopsies within one month of specimen collection visit
• Abnormal vaginal discharge or other genital tract symptoms at the time of specimen collection
• Pelvic findings on the day of specimen collection consistent with cervicitis (i.e. MPC, erythema, edema) or anatomy making cervical biopsies difficult
• Menopausal
• Hysterectomy
• History of malignancy of the genital tract (including cervix, uterus, vagina, and vulva)
• History of immunosuppression (including HIV infection, diabetes, and chronic steroid use)
• Known history of a platelet/bleeding/clotting disorder
• Use of a systemic or vaginal antimicrobial agent within 7 days of specimen collection

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Katherine Bunge, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: October 4, 2017
• Study Start: July 31, 2017
• Primary Completion: September 17, 2018
• Study Completion: September 17, 2018
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

US (1)