HIV Prevention Preparedness Study
研究概览
详细说明
This study is designed to prepare for the implementation of a second study, HPTN 035: A Phase II/III Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and PRO 2000/5 Gel (P) for the Prevention of HIV Infection in Women. HPTN 035 requires an average HIV seroincidence rate of 5-6 percent among enrolled participants. The primary objective of the present study is to estimate the rates of HIV seroincidence among women targeted for inclusion in HPTN 035.
Women will be enrolled in this study for 6 to 12 months. Study visits will take place monthly. At each visit, participants will complete a medical/menstrual history and undergo pregnancy testing. Each quarter, participants will undergo a structured interview about sexual practices and will receive HIV and STD tests, education, and counseling. Participants will also undergo a pelvic exam with wet mount testing for bacterial vaginosis, candidiasis, and trichomoniasis. Colposcopic evaluations will be performed at selected sites. Pap smears will be performed at sites with the capacity and expertise to prepare and interpret the smears and provide appropriate follow-up care to participants with abnormal results.
研究类型
注册
联系人和位置
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
- Sexually active (defined as having had vaginal intercourse at least once in the 3 months prior to screening).
- HIV-uninfected at screening.
- Able and willing to provide adequate locator information for study retention purposes.
Exclusion criteria:
- History of adverse reaction to latex.
- Non-therapeutic injection drug use in the 12 months prior to screening.
- Vaginal intercourse more than an average of 2 times per day in the 2 weeks prior to screening.
- Plans to travel away from the study site for more than 3 consecutive months in the next 12 months.
- Plans to relocate away from the study site in the next 12 months.
- Pregnancy or plans to become pregnant in the next 12 months.
- Pregnancy within 42 days prior to enrollment.
- Enrollment in any other study of a vaginally-applied product.
- Clinically apparent pelvic exam finding involving deep epithelial disruption.
- Diagnosis with a current STD and/or other reproductive tract infection requiring treatment.
- Conditions that would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
学习计划
研究是如何设计的？
设计细节
- 时间观点：预期
合作者和调查者
合作者
调查人员
- 学习椅：Saidi Kapiga, MD, MPH, SCD、Harvard School of Public Health (HSPH)
- 学习椅：Gita Ramjee, PhD、South Africa Medical Research Council
- 学习椅：Stephen Weiss, PhD、University of Miami
出版物和有用的链接
一般刊物
- Kapiga S, Kelly C, Weiss S, Daley T, Peterson L, Leburg C, Ramjee G. Risk factors for incidence of sexually transmitted infections among women in South Africa, Tanzania, and Zambia: results from HPTN 055 study. Sex Transm Dis. 2009 Apr;36(4):199-206. doi: 10.1097/OLQ.0b013e318191ba01.
- Ramjee G, Kapiga S, Weiss S, Peterson L, Leburg C, Kelly C, Masse B; HPTN 055 Study Team. The value of site preparedness studies for future implementation of phase 2/IIb/III HIV prevention trials: experience from the HPTN 055 study. J Acquir Immune Defic Syndr. 2008 Jan 1;47(1):93-100. doi: 10.1097/QAI.0b013e31815c71f7.
- Schreiber CA, Sammel M, Hillier SL, Barnhart KT. A little bit pregnant: modeling how the accurate detection of pregnancy can improve HIV prevention trials. Am J Epidemiol. 2009 Feb 15;169(4):515-21. doi: 10.1093/aje/kwn345. Epub 2008 Dec 18.
研究记录日期
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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