The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER) (SAFER)
2019年9月27日 更新者:Joelle Brown, MPH, PhD、University of California, San Francisco
The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples
This is a prospective, non-randomized, open-label study to look at the uptake, adherence to, and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing, and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in Zimbabwe.
研究概览
地位
完全的
条件
详细说明
The reproductive needs of HIV-discordant couples who desire pregnancy represent an urgent public health problem that has been neglected in HIV prevention research.
In Zimbabwe , and across sub-Saharan Africa, the vast majority of HIV-infected individuals are adults of reproductive age.
Pregnancy and the desire for children are common among HIV-infected individuals, and HIV-discordant couples face a difficult choice between attempting pregnancy and risking HIV transmission to their partners.
Recent surveys have found that 30-50% of HIV-infected individuals in sub-Saharan Africa are involved in stable, HIV-discordant relationships, and HIV transmission within married, cohabitating HIV-discordant couples accounts for 44-60% of new HIV infections in some regions of sub-Saharan Africa.
While knowledge of HIV discordance can lead to increased condom use, many discordant couples have unprotected intercourse often motivated by the desire to conceive.
Currently, HIV discordant couples who attempt to conceive place themselves at considerable risk of transmission.
This research study aims to help promote couples' rights to conceive while at the same time decreasing the risk of HIV transmission.
研究类型
观察性的
注册 (实际的)
46
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Harare、津巴布韦
- UZCHS-UCSF CTRC Zengeza Clinical Research Site
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 35年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
HIV-discordant couples in Harare, Zimbabwe who are trying to get pregnant
描述
Inclusion Criteria:
For all couples:
- Couple expresses a desire to conceive
- Sexually active (defined as having vaginal sex with one another at least 6 times in the past 3 months
- Willing to enter the study as a couple and intending to remain as a couple and have a sexual relationship for the next 12 months
- Willing to use at least one safer conception strategy
- For men, age ≥18 years. For women, age 18 - 35 years;
- Able and willing to provide written informed consent
For HIV-uninfected members of the couple
- HIV-negative based on parallel negative HIV rapid tests, both at study screening and enrollment visit
- Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min
For HIV-infected members of the couple
- HIV-positive based on parallel positive HIV rapid tests, based on national algorithm
- No current AIDS-defining illness
Exclusion Criteria:
- Amenorrheic
- Currently pregnant
- Active and serious infections, including active tuberculosis infection; active clinically significant medical problems including cardiac disease, pulmonary disease, and previously diagnosed malignancy expected to require further treatment.
- History of infertility defined as a year or more of regular unprotected intercourse with current partner without pregnancy, or otherwise medically diagnosed infertility
- Currently on any concomitant medication that requires the participant to avoid use of PrEP
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
HIV+male/HIV-female
discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing
|
oral, daily Truvada for HIV-negative participants
其他名称:
oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant
其他名称:
collection of semen from an HIV-positive man, processing semen to remove HIV, followed by intrauterine insemination
|
HIV+female/HIV-male
discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination
|
oral, daily Truvada for HIV-negative participants
其他名称:
oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant
其他名称:
collection of semen from an HIV-negative man, followed by intravaginal insemination
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Uptake of safer conception strategies
大体时间:12 months
|
proportion of couples choosing the strategy
|
12 months
|
Acceptability of safer conception strategies
大体时间:12 months
|
proportion of couples remaining on strategy; reports of satisfaction
|
12 months
|
Adherence to safer conception strategies
大体时间:12 months
|
proportion of couples with high adherence to strategy
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Effectiveness of safer conception strategies on HIV prevention
大体时间:12 months
|
incidence of HIV
|
12 months
|
Effectiveness of safer conception strategies on achieving pregnancy
大体时间:12 months
|
incidence of pregnancy
|
12 months
|
costs of providing safer conception services
大体时间:12 months
|
costs
|
12 months
|
cost-effectiveness of safer conception strategies
大体时间:12 months
|
model the cost effectiveness of various combinations of safer conception strategies
|
12 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Joelle M Brown, PhD, MPH、University of California, San Francisco
- 首席研究员:Felix Mhlanga, MBChB, MMed、UZ-UCSF Collaborative Research Programme
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月13日
初级完成 (实际的)
2019年6月3日
研究完成 (实际的)
2019年7月31日
研究注册日期
首次提交
2017年2月7日
首先提交符合 QC 标准的
2017年2月7日
首次发布 (估计)
2017年2月9日
研究记录更新
最后更新发布 (实际的)
2019年9月30日
上次提交的符合 QC 标准的更新
2019年9月27日
最后验证
2019年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- A126763
- K01MH100994 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
De-identified data will be made available at the end of the study on an online repository.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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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Hospital Clinic of Barcelona完全的
-
Centers for Disease Control and PreventionGilead Sciences; CDC Foundation完全的
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AIDS Healthcare FoundationUniversity of California, Los Angeles完全的
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-
Hilary L Surratt, PhDNational Institute on Drug Abuse (NIDA)完全的
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University of WashingtonKenyatta National Hospital; Fogarty International Center of the National Institute of Health主动,不招人
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-
University of California, San FranciscoNational Institute of Nursing Research (NINR); San Francisco Department of Public Health完全的
-
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