The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Uptake of safer conception strategies
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
HIV+male/HIV-female
discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing
干预措施: PrEP (Truvada) (Drug)
HIV+male/HIV-female
discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing
干预措施: Antiretrovirals (Drug)
HIV+male/HIV-female
discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing
干预措施: Semen washing (Procedure)
HIV+female/HIV-male
discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination
干预措施: PrEP (Truvada) (Drug)
HIV+female/HIV-male
discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination
干预措施: Antiretrovirals (Drug)
HIV+female/HIV-male
discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination
干预措施: Artificial vaginal insemination (Procedure)
结局指标
主要结局
Uptake of safer conception strategies
时间窗: 12 months
proportion of couples choosing the strategy
Adherence to safer conception strategies
时间窗: 12 months
proportion of couples with high adherence to strategy
Acceptability of safer conception strategies
时间窗: 12 months
proportion of couples remaining on strategy; reports of satisfaction
次要结局
- Effectiveness of safer conception strategies on achieving pregnancy(12 months)
- cost-effectiveness of safer conception strategies(12 months)
- costs of providing safer conception services(12 months)
- Effectiveness of safer conception strategies on HIV prevention(12 months)
研究者
Joelle Brown, MPH, PhD
Principal Investigator
University of California, San Francisco