Clinical trial NCT02357368: Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
Official title: Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV
Contraception
Keywords: HIV-negative
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-02-06
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a prospective cohort study focusing on HIV negative women. The investigators want to learn how the contraceptive methods of depot medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and the ParaGard® T 380A Intrauterine Copper Contraceptive impact the vaginal immune environment.

Detailed description: The three proposed aims will evaluate the effect of four contraceptive methods (depot medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and ParaGard® T 380A Intrauterine Copper Contraceptive) 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 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 or ParaGuard
* 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 cervicovaginal lavage (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
* 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 Centers for Disease Control and Prevention (CDC) medical eligibility criteria or judgment of clinician

Primary outcomes:
measure: Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood
timeFrame: Week 1, Week 17
measure: Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood
timeFrame: Week 1, Week 17
measure: Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood
timeFrame: Week 1, Week 17
measure: Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood
timeFrame: Week 1, Week 17
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: The Ponce de Leon Center of the Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University Clinical Research Network
state: Georgia
Study officials:
affiliation: Emory University
name: Lisa Haddad, MD
role: PRINCIPAL_INVESTIGATOR
References: