NCT01191203已完成不适用
Prospective Assessment of Acceptability and Adherence Associated With Use of the Copper Intrauterine Device (CuT380A-IUCD) Compared to Depo-medroxyprogesterone Acetate (DMPA) Among HIV Positive Women in Lilongwe, Malawi
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
The IUD is an extremely effective method of contraception yet few women use it worldwide. Considered safe to use in HIV+ women, few studies have evaluated its use among those using antiretroviral therapy. The only prior randomized trial looking at the IUD compared to hormonal contraception noted a high rate of IUD discontinuations. Understanding IUD acceptability and continuation is critical to improve utilization.
- Objective 1: Determine WHO medical eligibility and the willingness for IUD placement
- Objective 2: Compare method-related side effects and adverse events
- Objective 3: Assess the 1-year acceptability and continuation rates
Methods: To address our objectives the investigators have designed a two Phase Study:
- A cross-sectional screening to evaluate contraceptive medical eligibility and desirability
- A randomized controlled trial that will compare acceptability and adherence to DMPA compared to the Copper IUD: enrolling 200 women stable on antiretroviral therapy to follow for 1 year
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Can provide informed consent
- •Women ages 18-45
- •Known HIV + status on antiretroviral therapy for at least 6 months
- •Not currently pregnant
- •Willing to initiate either DMPA or CuT380A-IUD. Women currently using DMPA or CuT380A-IUD will be excluded
- •Do not desire to become pregnant within next 12 months
- •Intend to stay in Lilongwe region for the duration of the study
- •No known uterine anomalies based upon history
- •Greater than or equal to 4 weeks post partum
- •No known or suspected genital tract cancer
- •No evidence of current pelvic inflammatory disease or cervicitis. Women with cervicitis at the time of examination will be treated with antibiotics and eligibility will be reassessed at a follow-up visit at least 7 days after treatment
- •No pelvic inflammatory disease within prior 3 months
- •No contraindications to DMPA or the CuT380A-IUD per the WHO medical eligibility criteria or Malawi National Reproductive Health Service Delivery Guidelines, 2007
- •Based on clinical assessment, no condition that would preclude start of study intervention
排除标准
- •Women ages younger than18 or older than 45
- •Known HIV + status on antiretroviral therapy less than 6 months or not on antiretroviral therapy
- •Uterine anomaly
- •Less than 4 weeks post partum
- •Suspected genital tract cancer
- •Inclusion Criteria:
- •Current STI or PID
研究组 & 干预措施
Depo Medroxyprogesterone Acetate
Active Comparator
干预措施: Depo Medroxyprogesterone acetate (Drug)
Copper IUD (CuT360)
Active Comparator
干预措施: Copper IUD (Drug)
结局指标
主要结局
Adherence
时间窗: 1 year
Number of clients continuing with method at 1 year
次要结局
- Adverse Events(1 year)
研究者
Lisa Haddad
Principal Investigator
Emory University
研究点 (1)
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