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Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk

NCT02357368 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2020-11-18

Study results available
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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.

Conditions

  • HIV
  • Contraception

Interventions

DRUG

Depot medroxyprogesterone acetate (DMPA)

DMPA will be administered every 12 weeks at the standard dose of 150 mg IM, beginning from week 3 of study enrollment and repeated at week 15.

DEVICE

Etonogestrel implant (Eng-Implant)

A standard nexplanon rod implant will be placed at study week 3 by a trained clinician.

DEVICE

Levonorgestrel intrauterine device (Lng-IUD)

A standard Mirena IUD will be placed at study week 3 by a trained clinician.

DEVICE

ParaGard® T 380A Intrauterine Copper Contraceptive

A standard ParaGuard IUD will be placed at study week 3 by a trained clinician.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Lisa Haddad

    lead OTHER

Principal Investigators

  • Lisa Haddad, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2019-10-23
Completion
2019-10-23
FDA Drug
Yes
FDA Device
Yes

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 NCT02357368 on ClinicalTrials.gov