DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV; Contraception

Intervention: Depot medroxyprogesterone acetate (DMPA) (Drug); Etonogestrel implant (Eng-Implant) (Drug); Levonorgestrel intrauterine device (Lng-IUD) (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Lisa Haddad

Official(s) and/or principal investigator(s):
Lisa Haddad, MD, Principal Investigator, Affiliation: Emory University
Igho Ofotokun, MD, Principal Investigator, Affiliation: Emory University

Overall contact:
Rachael A Farah-Abraham, PhD, Phone: 404-251 8940, Email: rfarahabraham@emory.edu

Summary

This is a prospective cohort study focusing on HIV negative women. The investigators want to learn how the following types of contraceptive methods: Depot medroxyprogesterone acetate (DMPA), Etonogestrel impant (Eng-Implant) and Levonorgestrel intrauterine device (Lng-IUD) impacts the vaginal immune environment

Clinical Details

Official title: Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome:

Change in HIV target immune cells--CCR5 expressing macrophages and dendritic cells (DCs) including myeloid DCs and Langerhans cells (LCs)

Change in total CD4+ T cells

Change in concentration levels of cytokines and chemokines--Interleukin 1 family (IL-1) and Interleukin 10 (IP10)

Detailed description: The three proposed aims will evaluate the effect of three contraceptive methods: Depot medroxyprogesterone acetate (DMPA), Etonogestrel impant (Eng-Implant) and Levonorgestrel intrauterine device (Lng-IUD) on: (1) HIV target immune cells within the female genital mucosa; (2) markers of T-cell activation and trafficking within the female genital mucosa; and (3) secreted cytokines and chemokines within the female genital mucosa.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female

- Age 18-45 years

- Normal menses (22-35 day intervals) for at least 3 cycles

- Intact uterus and cervix

- Interested in to DMPA, Eng-Implant or Lng-IUD

- Willing to delay initiation of hormonal contraception for up to 1 month

- Willing to use condoms or abstain from sexual intercourse for at least 48 hours

before each genital tract sampling (condoms will be made available)

- Able and willing to provide informed consent, and undergo serial blood and CVL

sampling

- Negative HIV screening.

Exclusion Criteria:

- Pregnant within the last 3 months

- Breastfeeding

- History of loop electrosurgical excision procedure, conization, or cryosurgery within

the past year

- Use of hormonal contraception or IUD in the past 6 months or,

- Known history of medical condition that would interfere with the conduct of the study

- Symptomatic vaginal infection or genital ulcer disease at screening

- Taking medications that interact with selected contraceptive

- Contraindications to selected contraceptive per the CDC medical eligibility

criteria(67) or judgment of clinician.

Locations and Contacts

Rachael A Farah-Abraham, PhD, Phone: 404-251 8940, Email: rfarahabraham@emory.edu

Emory Clinic, Atlanta, Georgia 30322, United States; Recruiting

Emory University Clinical Research Network, Atlanta, Georgia 30322, United States; Recruiting

Grady Health System, Atlanta, Georgia 30303, United States; Recruiting

The Ponce de Leon Center of the Grady Health System, Atlanta, Georgia 30308, United States; Recruiting

Additional Information

Starting date: February 2015
Last updated: August 18, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017