Immune markers and their association with genetic signatures among HIV/HPV coinfected women:A study from 2 tertiary care hospitals in Mumbai.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- 1.Comparison of Systemic and Cervical immune expression
研究概览
简要总结
The study is an exploratory study consisting of sampling of study participants at two sites Site 1: B.Y.L. Nair Hospital, Site 2: Dr. R.N Cooper Municipal General Hospitalto achieve a target Sample size 120 women who will be grouped into two cohorts. a) HIV+ women (60) and b) HIV- women (60).
The patients visiting the ICTC as part of routine care will undergo pretest counselling and consent prior to blood collection for HIV testing (1st visit to the ICTC). The patients will be called to ICTC after 24hrs to colectys the HIV report and will undergo post-test counselling irrespective of the HIV test result. At this timepoint, after obtaining consent from the patient the peripheral blood and cervical sample will be collected at the respective site.
Based on the HPV results, the women will further be grouped into 4 sub-groups: HIVpos-HPVpos, HIVneg-HPVpos, HIVpos-HPVneg, HIVneg HPV neg.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Sexually active women in the age group ≥18 years visiting the Integrated Counselling and Testing Centre (ICTC) for HIV testing.
排除标准
- •1.Women with history of any ongoing active infections e.g. TB or any other immunomodulatory disease.
- •2.Women currently on ART therapy, steroid treatment and pre-operative cases.
- •3.Women who are pregnant.
- •4.Women undergoing cryotherapy, Loop Electrosurgical Excision Procedure(LEEP), Chemo or radiotherapy.
结局指标
主要结局
1.Comparison of Systemic and Cervical immune expression
时间窗: As this is an observational study there are no defined time lines.
2.Influence of the specific HPV genotype and genetic signature on the immune markers during a coinfection.
时间窗: As this is an observational study there are no defined time lines.
3.Immunophenotype and cytokine profile of patients infect with HIV, HPV & having a HIV-HPV coinfection
时间窗: As this is an observational study there are no defined time lines.
4.Comparison of Systemic and Cervical immune expression
时间窗: As this is an observational study there are no defined time lines.
次要结局
- NA(NA)
研究者
Dr Jayanthi Shastri
COE in Research and Training in Infectious Diseases