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Abstract：
We developed the Healthy Families-PrEP intervention to support HIV-prevention during periconception and pregnancy. We evaluated preexposure prophylaxis (PrEP) use with three objective measures.
This single-arm intervention study enrolled women in KwaZulu-Natal, South Africa, who were HIV-uninfected, not pregnant, in a relationship with a partner with HIV or unknown-serostatus, and with pregnancy plans. PrEP was offered as part of a comprehensive HIV prevention intervention. Participants were followed for 12 months.
We evaluated periconception PrEP uptake and adherence using quarterly plasma tenofovir concentrations. We modeled factors associated with PrEP uptake and high plasma tenofovir (past day dosing). Patterns of use were analyzed using electronic pillcap data. Dried blood spots to measure intracellular tenofovir product (past 2 months dosing) were analyzed for a subset of women.
Three hundred thirty women with median age 24 (IQR: 22-27) years enrolled. Partner HIV-serostatus was unknown by 96% ( N = 316); 60% (195) initiated PrEP. High plasma tenofovir concentrations were seen in 35, 25, 22, and 20% of samples at 3, 6, 9, and 12 months, respectively. Similar adherence was measured by pillcap and dried blood spots. In adjusted models, lower income, alcohol use, and higher HIV stigma were associated with high plasma tenofovir. Eleven HIV-seroconversions were observed (incidence rate: 4.04/100 person-years [95% confidence interval: 2.24-7.30]). None had detectable plasma tenofovir.
The Healthy Families-PrEP intervention supported women in PrEP use. We observed high interest in periconception PrEP and over one-third adhered to PrEP in the first quarter; one-fifth were adherent over a year. High HIV incidence highlights the importance of strategies to reduce HIV incidence among periconception women.
NCT03194308.
This single-arm intervention study enrolled women in KwaZulu-Natal, South Africa, who were HIV-uninfected, not pregnant, in a relationship with a partner with HIV or unknown-serostatus, and with pregnancy plans. PrEP was offered as part of a comprehensive HIV prevention intervention. Participants were followed for 12 months.
We evaluated periconception PrEP uptake and adherence using quarterly plasma tenofovir concentrations. We modeled factors associated with PrEP uptake and high plasma tenofovir (past day dosing). Patterns of use were analyzed using electronic pillcap data. Dried blood spots to measure intracellular tenofovir product (past 2 months dosing) were analyzed for a subset of women.
Three hundred thirty women with median age 24 (IQR: 22-27) years enrolled. Partner HIV-serostatus was unknown by 96% ( N = 316); 60% (195) initiated PrEP. High plasma tenofovir concentrations were seen in 35, 25, 22, and 20% of samples at 3, 6, 9, and 12 months, respectively. Similar adherence was measured by pillcap and dried blood spots. In adjusted models, lower income, alcohol use, and higher HIV stigma were associated with high plasma tenofovir. Eleven HIV-seroconversions were observed (incidence rate: 4.04/100 person-years [95% confidence interval: 2.24-7.30]). None had detectable plasma tenofovir.
The Healthy Families-PrEP intervention supported women in PrEP use. We observed high interest in periconception PrEP and over one-third adhered to PrEP in the first quarter; one-fifth were adherent over a year. High HIV incidence highlights the importance of strategies to reduce HIV incidence among periconception women.
NCT03194308.
摘要：
目的：我们开发了HealthyFamilies-PrEP干预措施，以支持在怀孕期间预防HIV。我们用三个客观指标评估了暴露前预防（PrEP）的使用。
方法：这项单臂干预研究招募了夸祖鲁-纳塔尔省的女性，南非,他们未感染艾滋病毒，没有怀孕,在与艾滋病毒或未知血清状态的伴侣的关系中，还有怀孕计划.PrEP是作为全面的HIV预防干预措施的一部分提供的。参与者被随访12#$##x0200A;个月。
方法：我们使用季度血浆替诺福韦浓度评估了预感摄取和依从性。我们模拟了与PrEP摄取和高血浆替诺福韦（过去一天给药）相关的因素。使用电子药丸数据分析了使用模式。分析用于测量细胞内替诺福韦产品的干燥血斑(过去2#$##x0200A;月给药)的女性子集。
结果：招募年龄中位数为24岁（IQR：22#$#ndash;27）的妇女。96%(N#$##x0200A;#$#等于;#$##x0200A;316);60%(195)开始PrEP。在3、6、9和12#$##x0200A的35、25、22和20％的样品中观察到高血浆替诺福韦浓度;月，分别。通过柱帽和干燥的血斑测量类似的粘附性。在调整后的模型中，收入较低,酒精使用,和较高的HIV污名与高血浆替诺福韦相关。观察到11例HIV-血清转化(发生率:4.04/100人年[95%置信区间:2.24#$#ndash;7.30])。没有检测到的血浆替诺福韦。
结论：健康家庭-PrEP干预支持女性使用PrEP。我们观察到人们对感知PrEP的兴趣很高，第一季度有超过三分之一的人坚持使用PrEP；五分之一的人坚持一年以上。艾滋病毒的高发病率凸显了减少观念妇女中艾滋病毒发病率的战略的重要性。
背景：NCT03194308。
方法：这项单臂干预研究招募了夸祖鲁-纳塔尔省的女性，南非,他们未感染艾滋病毒，没有怀孕,在与艾滋病毒或未知血清状态的伴侣的关系中，还有怀孕计划.PrEP是作为全面的HIV预防干预措施的一部分提供的。参与者被随访12#$##x0200A;个月。
方法：我们使用季度血浆替诺福韦浓度评估了预感摄取和依从性。我们模拟了与PrEP摄取和高血浆替诺福韦（过去一天给药）相关的因素。使用电子药丸数据分析了使用模式。分析用于测量细胞内替诺福韦产品的干燥血斑(过去2#$##x0200A;月给药)的女性子集。
结果：招募年龄中位数为24岁（IQR：22#$#ndash;27）的妇女。96%(N#$##x0200A;#$#等于;#$##x0200A;316);60%(195)开始PrEP。在3、6、9和12#$##x0200A的35、25、22和20％的样品中观察到高血浆替诺福韦浓度;月，分别。通过柱帽和干燥的血斑测量类似的粘附性。在调整后的模型中，收入较低,酒精使用,和较高的HIV污名与高血浆替诺福韦相关。观察到11例HIV-血清转化(发生率:4.04/100人年[95%置信区间:2.24#$#ndash;7.30])。没有检测到的血浆替诺福韦。
结论：健康家庭-PrEP干预支持女性使用PrEP。我们观察到人们对感知PrEP的兴趣很高，第一季度有超过三分之一的人坚持使用PrEP；五分之一的人坚持一年以上。艾滋病毒的高发病率凸显了减少观念妇女中艾滋病毒发病率的战略的重要性。
背景：NCT03194308。
