Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- T-cell activation
研究概览
简要总结
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.
详细描述
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.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed HIV status by local rapid test algorithm
- •Willingness to be randomized to a contraceptive method and continue that method for at least 6 months.
- •Intention to stay in the study area for at least 6 months
排除标准
- •Currently pregnant or pregnant within the prior 6 months
- •Currently breastfeeding
- •Documented liver disease
- •History of coagulation disorder
- •Active tuberculosis
- •Anemia, defined as Hgb <8gm/dL
- •Age < 16 years (the age of consent in Zambia);
- •Eligible for antiretroviral therapy based on Zambian National Guidelines (CD4+ < 200, or WHO stage IV, or CD4+< 350 and WHO stage III)
- •Currently using an IUD or hormonal method of contraception, or have used a hormonal contraceptive in the past 6 months
研究组 & 干预措施
IUCD
Assigned to use a copper intrauterine device
干预措施: Copper T Intrauterine contraception device (Device)
DMPA
Assigned to use Depo Provera
干预措施: Depo Provera (Drug)
结局指标
主要结局
T-cell activation
时间窗: 4, 8, 12, and 24 weeks post-randomization
次要结局
- CD4+ cell decline(4, 8, 12, and 24 weeks post-randomization)
- Cervical viral load(4, 8, 12, and 24 weeks post-randomization)