Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 4
- 主要终点
- Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood
研究概览
简要总结
This is a prospective cohort study focusing on HIV negative women. The investigators want to learn how the contraceptive methods of depot medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and the ParaGard® T 380A Intrauterine Copper Contraceptive impact the vaginal immune environment.
详细描述
The three proposed aims will evaluate the effect of four contraceptive methods (depot medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and ParaGard® T 380A Intrauterine Copper Contraceptive) on: (1) HIV target immune cells within the female genital mucosa; (2) markers of T-cell activation and trafficking within the female genital mucosa; and (3) secreted cytokines and chemokines within the female genital mucosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Age 18-45 years
- •Normal menses (22-35 day intervals) for at least 3 cycles
- •Intact uterus and cervix
- •Interested in to DMPA, Eng-Implant or Lng-IUD or ParaGuard
- •Willing to delay initiation of hormonal contraception for up to 1 month
- •Willing to use condoms or abstain from sexual intercourse for at least 48 hours before each genital tract sampling (condoms will be made available)
- •Able and willing to provide informed consent, and undergo serial blood and cervicovaginal lavage (CVL) sampling
- •Negative HIV screening
排除标准
- •Pregnant within the last 3 months
- •Breastfeeding
- •History of loop electrosurgical excision procedure, conization, or cryosurgery within the past year
- •Use of hormonal contraception or IUD in the past 6 months
- •Known history of medical condition that would interfere with the conduct of the study
- •Symptomatic vaginal infection or genital ulcer disease at screening
- •Taking medications that interact with selected contraceptive
- •Contraindications to selected contraceptive per the Centers for Disease Control and Prevention (CDC) medical eligibility criteria or judgment of clinician
研究组 & 干预措施
Depot medroxyprogesterone acetate (DMPA)
DMPA will be administered every 12 weeks at 150 mg by intramuscular (IM) injection at week 3 of study enrollment and repeated at week 15.
干预措施: Depot medroxyprogesterone acetate (DMPA) (Drug)
Etonogestrel implant (Eng-Implant)
A standard Nexplanon rod Implant will be placed at study week 3.
干预措施: Etonogestrel implant (Eng-Implant) (Device)
Levonorgestrel intrauterine device (Lng-IUD)
A standard Mirena IUD will be placed at study week 3.
干预措施: Levonorgestrel intrauterine device (Lng-IUD) (Device)
ParaGard® T 380A Intrauterine Copper Contraceptive
A standard ParaGuard IUD will be placed at study week 3.
干预措施: ParaGard® T 380A Intrauterine Copper Contraceptive (Device)
结局指标
主要结局
Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood
时间窗: Week 1, Week 17
Following exposure to HIV, initial infection occurs at the genital mucosa and may involve complex interactions between a number of HIV target immune cells. HIV often uses C-C Chemokine Receptor Type 5 (CCR5) for entrance into target immune cells, causing infection of the cell. The amount of CCR5 expressing macrophages is associated with HIV infection. Cluster of differentiation 4 (CD4) T Cells are targeted and infected by HIV and CD4 percentages are used to assess immune status. CD4 counts vary by individuals and generally decrease with HIV infection.
Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood
时间窗: Week 1, Week 17
CD4/CD8 ratios above 1 indicate a strong immune system while lower ratios indicate a viral infection.
Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood
时间窗: Week 1, Week 17
T cell activation correlates with HIV infection progression and this study seeks to gain better understanding of these underlying mechanisms by assessment of HIV target cells. Changes in cluster of differentiation 38 (CD38) expression are indicators of HIV disease progression with increases seen in CD38+ when a chronic HIV infection is progressing. Human leukocyte antigen-antigen D related (HLA-DR)+ expression appears to be involved in HIV proliferation.
Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood
时间窗: Week 1, Week 17
The concentration levels of interleukin 1 (IL-1) family cytokines and interferon gamma-induced protein 10 (IP-10) chemokines were determined using multiplex Luminex® assays combined with a customized multi-analytical panel of 22 human cytokines and chemokines. IL-1 and IP-10 have been found to influence recruitment of HIV target cells to the female reproductive tract and this study is examining changes in IL-1 and PI-10 to gain further understanding of these mechanisms.
次要结局
未报告次要终点
研究者
Lisa Haddad
Asscoiate Professor
Emory University