NCT00336245

Brief Summary

A randomized trial of the intrauterine contraceptive device (IUD) versus user's choice hormonal contraception (injectable progestins or oral contraceptive pills) among HIV-infected, recently post-partum women in Lusaka, Zambia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P50-P75 for phase_3 pregnancy

Timeline
Completed

Started Jun 2002

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2006

Completed
Last Updated

March 6, 2015

Status Verified

August 1, 2009

Enrollment Period

3.3 years

First QC Date

June 11, 2006

Last Update Submit

March 5, 2015

Conditions

PregnancyHIV Infection

Keywords

ContraceptionWomenHIV/AIDSIUDIUCD

Outcome Measures

Primary Outcomes (1)

  • Incident pregnancy

Secondary Outcomes (2)

  • Safety

  • Method discontinuation rates

Study Arms (2)

Copper T Intrauterine Contraceptive Device

EXPERIMENTAL
Device: Copper T Intrauterine Contraceptive Device

Hormonal Contraception

ACTIVE COMPARATOR
Drug: Hormonal Contraception

Interventions

Copper T Intrauterine Contraceptive DeviceDEVICE
Copper T Intrauterine Contraceptive Device
Hormonal ContraceptionDRUG
Hormonal Contraception

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • desire for at least 2 years of continuous contraception
  • two or fewer sexual partners in the prior year

You may not qualify if:

  • advanced HIV disease (WHO Stage III or IV)
  • history of a bleeding disorder
  • history of PID within the prior five years
  • less than 16 years of age (the "age of majority" in Zambia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Hormonal Contraception

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ContraceptionReproductive TechniquesTherapeutics

Study Officials

  • Jeffrey Stringer, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2006

First Posted

June 13, 2006

Study Start

June 1, 2002

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

March 6, 2015

Record last verified: 2009-08