NCT03336346

Brief Summary

The primary aim is to assess if etonogestrel (ENG) implant users taking dolutegravir (DTG) have a 20% or greater change in their ENG plasma levels, compared to women taking no antiretroviral therapy (ART). A secondary aim is to assess whether ENG implant users taking dolutegravir have significantly higher ENG plasma levels than ENG implant users taking efavirenz. This is a cross-sectional, non-randomized evaluation to compare ENG levels between 3 and 12 months post-implant insertion in three groups of women: 1) women using DTG-based ART (n=90), 2) women using EFV-based ART (n=90), and 3) women using no ART (not HIV infected) (n=90). This study will be conducted in Botswana in Southern Africa among women using the ENG implant, and involves a one-time collection of blood and questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

November 15, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

November 6, 2017

Last Update Submit

February 4, 2020

Conditions

Contraceptive UsageHIV InfectionsDrug Interaction

Keywords

DTGDolutegravirEfavirenzEtonogestrel

Outcome Measures

Primary Outcomes (1)

  • Difference (percentage) in ENG plasma levels in the DTG group compared to no ART group

    Difference between the DTG group and no ART group

    Up to 12 months after implant

Secondary Outcomes (1)

  • Difference (percentage) in ENG plasma levels in the DTG group compared to EFV group

    Up to 12 months after implant

Study Arms (3)

DTG group

Reproductive-aged HIV-infected women taking dolutegravir-based ART and using single-rod, etonogestrel-releasing, subdermal implant (ENG implant)

Drug: dolutegravirDevice: ENG implant

No ART group

Reproductive-aged HIV-uninfected women using single-rod, etonogestrel-releasing, subdermal implant (ENG implant)

Device: ENG implant

EFV group

Reproductive-aged HIV-infected women taking efavirenz-based ART and using single-rod, etonogestrel-releasing, subdermal implant (ENG implant)

Device: ENG implantDrug: Efavirenz

Interventions

dolutegravirDRUG

HIV integrase strand transfer inhibitor used in combination ART

Also known as: Tivicay, DTG
DTG group
ENG implantDEVICE

Reversible contraception implant

Also known as: Nexplanon ®, Implanon NXT ®, single-rod, etonogestrel-releasing, subdermal implant
DTG groupEFV groupNo ART group
EfavirenzDRUG

non-nucleoside reverse transcriptase inhibitor used in combination ART

Also known as: Sustiva, EFV
EFV group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Reproductive-aged HIV-infected women using dolutegravir and using single-rod, etonogestrel-releasing subdermal implant. Reproductive-aged HIV-infected women using efavirenz and using single-rod, etonogestrel-releasing subdermal implant. Reproductive-aged HIV-unifected women using single-rod, etonogestrel-releasing subdermal implant.

You may qualify if:

  • Etonogestrel implant as their sole method of hormonal contraception
  • Etonogestrel implant in-situ for three to twelve months.
  • Dolutegravir (DTG) use for at least 60 days (Using DTG-based ART-regimen if applicable)
  • Efavirenz (EFV) use for at least 60 days (Using EFV-based ART-regimen if applicable)

You may not qualify if:

  • Exclude women using concomitant enzyme-inducing drugs, including rifampicin for tuberculosis treatment and anti-convulsant medications (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Botswana-UPenn Partnership

Gaborone, Botswana

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Contraception BehaviorHIV Infections

Interventions

dolutegravirElectronystagmographyefavirenz

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehaviorBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Eye Movement MeasurementsDiagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisVestibular Function TestsDiagnostic Techniques, OtologicalElectrodiagnosis

Study Officials

  • Carolyn L Westhoff, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Population and Family Health; Chief, Division of Family Planning & Preventive Services

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 8, 2017

Study Start

November 15, 2017

Primary Completion

October 30, 2019

Study Completion

December 11, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Locations

BO(1)