HIV Prevention Preparedness Study
調査の概要
詳細な説明
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.
研究の種類
入学
連絡先と場所
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 時間の展望：見込みのある
協力者と研究者
協力者
捜査官
- スタディチェア：Saidi Kapiga, MD, MPH, SCD、Harvard School of Public Health (HSPH)
- スタディチェア：Gita Ramjee, PhD、South Africa Medical Research Council
- スタディチェア：Stephen Weiss, PhD、University of Miami
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。