Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia
Summary
In this study, 66 HIV-infected women who desire contraception will be randomly assigned to use either an IUD or Depo Provera, and will be followed for six months. The study is intended to help investigators understand potential mechanisms by which hormonal contraception may hasten HIV disease progression.
Description
In this randomized controlled trial, 66 HIV-infected women who desire contraception will be assigned to one of two treatment groups: IUD or Depo Provera. The study builds on findings from a previous study which examined the safety and acceptability of hormonal contraception and IUD among HIV-infected women. Secondary analyses from the previous study indicated that women who were assigned to the hormonal arm appeared to have faster disease progression based on death and decline in CD4+ count as compared to women assigned to the IUD arm. With the current study, investigators seek to understand potential mechanisms for the effect of hormonal contraception on hastening HIV disease progression. Enrolled women will be asked to use the assigned contraception method for a period of six months, and various indicators of disease progression will be collected at four follow-up visits after randomization.
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
HIV
Intervention
Depo Provera, Copper T Intrauterine contraception device
Location
The Centre for Infectious Disease Research in Zambia
Lusaka
Zambia
Status
Active, not recruiting
Source
University of Alabama at Birmingham
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00807625
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Intrauterine Device Migration
The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.
Intrauterine Devices, Copper
Intrauterine contraceptive devices that depend on the release of metallic copper.
Intrauterine Device Expulsion
Spontaneous loss of INTRAUTERINE DEVICES from the UTERUS.
Intrauterine Devices
Contraceptive devices placed high in the uterine fundus with a string extending from the device through the cervical as into the vagina. (UMDNS, 1999)
Contraception, Barrier
Methods of contraception in which physical, chemical, or biological means are used to prevent the SPERM from reaching the fertilizable OVUM.
Clinical Trials
Maintaining Intrauterine Devices (IUDs) in Teens (MINT): A Randomization Trial
This is a pilot study to determine the feasibility for a randomized controlled trial of two forms of intrauterine contraception: the Levonorgestrel intrauterine system (LNG-IUS) and the Co...
A Randomized Trial of IUD Versus Hormonal Contraception in HIV-infected Women in Zambia
A randomized trial of the intrauterine contraceptive device (IUD) versus user's choice hormonal contraception (injectable progestins or oral contraceptive pills) among HIV-infected, recent...
This is a randomized controlled trial to assess the effect of a levonorgesterel-releasing intrauterine device (LNG IUD, Mirena®) versus a copper IUD (Paraguard®) on coagulation parameter...
Misoprostol With Intrauterine Device (IUD) Insertion
The purpose of this study is to see if using misoprostol (a medication that softens the cervix) before placing an IUD (intrauterine device) for contraception reduces pain in women who have...
Safety and Efficacy Study of NBI-56418 in Endometriosis
This study is designed to see how a research compound (NBI-56418) works compared to DMPA-SC (also known as depo-provera) in women with endometriosis and to see how both may affect bone min...
PubMed Articles
Contraception choices in women with underlying medical conditions.
Primary care physicians often prescribe contraceptives to women of reproductive age with comorbidities. Novel delivery systems (e.g., contraceptive patch, contraceptive ring, single-rod implantable de...
{blacktriangledown}Ulipristal - a new emergency contraceptive pill.
Until recently, women in the UK who wanted emergency contraception had two options: an oral hormonal method (levonorgestrel), which is licensed for use up to 3 days after unprotected sexual intercours...
Objective To explore key factors influencing young women when choosing between two methods of emergency contraception (EC). Methods We interviewed 26 young women who accessed community sexual and...
Aim: An intrauterine device (IUD), used by millions of women worldwide, is one of the most efficient methods of contraception. The goal of our study was to compare a group of women using the IUD to...
RATIONALE: The synthetic progestin medroxyprogesterone acetate (MPA), widely used in hormone therapy (HT) and as the contraceptive Depo Provera, is implicated in detrimental cognitive effects in women...
