CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 59 enrolled
Drug / intervention
Depot medroxyprogesterone acetate (DMPA) +3 moredrug
Likely dose
Depot medroxyprogesterone acetate (DMPA) 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02357368
NCT02357368Phase 4Completed

Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk

Lisa Haddad·interventional·Posted Feb 6, 2015·Updated Nov 18, 2020

In Brief

A Phase 4 clinical trial evaluating Depot medroxyprogesterone acetate (DMPA), Etonogestrel implant (Eng-Implant), and 2 other interventions for HIV and Contraception. Completed, enrolled 59 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, Contraception
CountriesUnited States

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 6, 2015
Enrollment StartFeb 1, 2015
Primary CompletionOct 23, 2019
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 11.4 years ago

Interventions

Depot medroxyprogesterone acetate (DMPA)drug

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.

Etonogestrel implant (Eng-Implant)device

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

Levonorgestrel intrauterine device (Lng-IUD)device

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

ParaGard® T 380A Intrauterine Copper Contraceptivedevice

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