A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia

March 5, 2015 updated by: University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the year 2000, there were over 37, 000 new acceptors of family planning in the Lusaka District Clinics. A variety of methods were prescribed, including combined oral contraceptive pills, injectable progestins, the intrauterine copper device, condoms, and others. The most recent sentinel survey of reproductive age women estimated that approximately 30% of reproductive age women in Lusaka are HIV-infected. Since voluntary HIV counseling and testing is not yet universally available in many of the district clinics, women receive all different types of contraception regardless of their HIV status.

There is some observational data published recently that suggests hormonal contraception may increase HIV viral load in the female genital tract and potentially increase HIV transmission to the male partner. By contrast, barrier methods have historically been very unpopular in stable couples and are not used consistently in many cases despite intensive counseling. The IUCD represents one of the most inexpensive and effective methods of birth control available in Lusaka. However, it has not been studied adequately to make policy recommendations regarding its use in HIV infected women. The purpose of this study will be to evaluate safety and acceptability of the IUCD versus hormonal methods of contraception in HIV-infected and uninfected women in Lusaka. Specifically, we will 1) compare the contraceptive effectiveness of the IUCD to the standard practices of user-chosen hormonal contraception, 2) compare the rates of pelvic infection between IUD and hormonal contraceptive users, and 3) compare rates of method discontinuation.

Patients who have a continuing second trimester pregnancy, serologically confirmed HIV infection, a desire for 24 months of contraception, and a willingness to be randomly assigned either an IUCD or hormonal contraception postpartum will be screened at 32 weeks in their pregnancies to receive either an IUCD or user chosen hormonal contraception postpartum. Women will then be seen at postpartum weeks 4-6 for method randomization and then at months 6, 12, 18 and 24 to monitor pregnancy, continuation of method, side effects and any other problems. Women will be encouraged to return for problems at any time. At least once yearly, women will have a complete physical exam. CD4 and HIV clinical status will be monitored regularly.

Study Type

Interventional

Enrollment

600

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Copper T Intrauterine Contraceptive Device
Device: Copper T Intrauterine Contraceptive Device
Active Comparator: Hormonal Contraception
Drug: Hormonal Contraception

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incident pregnancy

Secondary Outcome Measures

Outcome Measure
Safety
Method discontinuation rates

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

United States Agency for International Development (USAID)
Elizabeth Glaser Pediatric AIDS Foundation

Investigators

  • Principal Investigator: Jeffrey Stringer, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

June 11, 2006

First Submitted That Met QC Criteria

June 11, 2006

First Posted (Estimate)

June 13, 2006

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGPAF PG-51161

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infection

Clinical Trials on Copper T Intrauterine Contraceptive Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe