Comparison of Two Intrauterine Devices (IUDs) Among Cape Town HIV-positive Women: A Randomized Controlled Trial Assessing Safety of Registered Products in South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- FHI 360
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)
研究概览
简要总结
This study will inform international medical guidelines as to whether the Levonorgestrel intrauterine device (LNG IUD), a highly effective long-acting reversible contraceptive method, is safe and acceptable as compared to the copper intrauterine device (C-IUD) for HIV-positive women in Cape Town, South Africa. If the LNG IUD is found to be safe and acceptable, the introduction of this method to HIV positive women in developing countries could significantly reduce unplanned pregnancy and mother-to-child transmission of HIV, and confer non-contraceptive benefits to HIV-positive women in Sub-Saharan Africa.
详细描述
Design: Single site, double-blind, randomized controlled trial
Population: HIV-positive South African women between the ages of 18 and 40 years
Study size: At least 166 women
Study intervention: Levonorgestrel intrauterine device (LNG IUD) or the copper T-380 intrauterine device (C-IUD)
Duration & Follow-up: Approximately 48 months in total. Recruitment will take approximately 24 months. After enrollment, each participant will be followed for 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide written informed consent (IC) to be screened for and to participate in the trial
- •Interested and willing to use the intrauterine device (IUD) as a family planning method.
- •Between 18 to 40 years of age (inclusive): This age range includes women during their years of greatest fertility and 18 is the age of majority for research consent in South Africa.
- •Willing to participate in all aspects of the study and to comply with study procedures and visits, for 24 months, including:
- •Be randomized
- •Adhere to follow-up schedule and willing to be contacted by site staff between study visits (by phone and/or in person)
- •Provide contact/locator information
- •Agree for site staff to review clinic chart to confirm HIV status
- •Has documented HIV infection
- •For pre-antiretroviral therapy (ART) entrants:
- •ART-ineligible at screening, based on current South African ART guidelines
- •Be at least 6 months post-delivery and not pregnant or desiring pregnancy for the next 30 months.
- •For ART-using entrants:
- •ART-use demonstrated by clinical records reflecting laboratory measures consistent with ART use and evidence of viral suppression (plasma viral load (VL)<1000 copies/mL) at the most recent VL measure.
- •Be at least 6 weeks post-delivery and not pregnant or desiring pregnancy for the next 30 months.
- •Intending residence in Cape Town area for next 30 months
- •No documented or known history of infertility or sterilization
- •No gross evidence of cervical neoplasia on examination
- •No prior history of ectopic pregnancy
- •No history of or suspected hormonally-dependent neoplasm or undiagnosed abnormal vaginal bleeding
- •Local language fluency and comprehension
- •Not participating in any other clinical trial with a biomedical intervention
- •Have no condition that, based on the opinion of the Site Principal Investigator (PI), would preclude provision of informed consent, make participation in the study unsafe, or complicate interpretation of data.
排除标准
- •Known congenital or acquired uterine anomaly including fibroids distorting the uterine cavity;
- •Known acute liver disease or hepatic neoplasm;
- •Known copper storage disease;
- •Known hypersensitivity to any component of the levonorgestrel IUD (LNG IUD) or copper IUD (C-IUD) or latex allergy
- •Pregnant or desiring pregnancy in next 24 months
- •Gross cervical lesion concerning for neoplasia
- •CD4 lymphocyte count<350 cells/mm3 if not using ART
- •Less than 6 weeks postpartum
研究组 & 干预措施
Copper T-380a Intrauterine Device (C-IUD)
Copper T-380A Intrauterine Device with approximately 380 mm2 exposed copper. Devices used were those included as part of the South African public sector health formulary.
干预措施: Copper T-380a IUD (Device)
Levonorgestrel IUD (LNG-IUD)
Levonorgestrel IUD containing 52 mg levonorgestrel registered for contraceptive use in South Africa at the time of the trial.
干预措施: Mirena levonorgestrel IUD (Device)
结局指标
主要结局
Participants With Detectable Genital Tract HIV Ribonucleic Acid (RNA) Viral Load (VL)
时间窗: Enrollment to 24 months
Number of women with detectable genital tract HIV RNA as measured with menstrual cup sampling at each scheduled visit. Level of detection was 20-40 copies/mL depending on assay; outcome was dichotomous with copies above level of detection coded as detectable and those below level of detection considered undetectable.
次要结局
- Mean Hemoglobin Concentration as Part of Intrauterine Contraceptive Safety(Enrollment to 24 months)
- HIV Ribonucleic Acid (RNA) Concentration by Lower Female Genital Tract Sampling Method(6 months)
- Participants With Detectable Plasma HIV Ribonucleic Acid (RNA) Viral Load Among Those Using Antiretroviral Therapy (ART)(Enrollment to 24 months)
- Participants Continuing Use of the Allocated Intrauterine Device (IUD)(Enrollment to 24 months)