High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: A cohort study.
High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: A cohort study.
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DOI：
10.1371/journal.pmed.1004088
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发表时间：
2023-02
期刊：
影响因子：
15.8
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中科院分区：
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在乌干达，生育率和成人艾滋病毒感染率很高，许多妇女与感染艾滋病毒的伴侣一起怀孕。暴露前预防 (PrEP) 可减少女性以及婴儿感染艾滋病毒的机会。我们制定了健康家庭-PrEP 干预措施，以支持使用 PrEP 作为围孕期和怀孕期间艾滋病毒预防的一部分。我们进行了一项纵向队列研究，以评估参与干预的女性口服 PrEP 的使用情况。我们招募了计划怀孕且伴侣感染或被认为感染 HIV 的 HIV 阴性女性（2017 年至 2020 年），以评估参与健康家庭 PrEP 干预的女性的 PrEP 使用情况。为期 9 个月的季度研究访问包括艾滋病毒和妊娠检测以及艾滋病毒预防咨询。 PrEP 在电子药盒中提供，提供主要的依从性测量（当药盒打开 ≥80% 的天数时“高”依从性）。登记问卷评估了与 PrEP 使用相关的因素。每季度测定感染 HIV 的女性和随机选择的未感染 HIV 女性的血浆替诺福韦 (TFV) 和红细胞内 TFV-二磷酸 (TFV-DP) 浓度；浓度 TFV ≥40 ng/mL 和 TFV-DP ≥600 fmol/punch 被归类为“高”。怀孕的女性最初是有意从队列中退出的。从 2019 年 3 月开始，意外怀孕的女性仍留在研究中，每季度进行一次随访，直至妊娠结果。主要结局包括 (1) PrEP 的采用率（发起 PrEP 的比例）； (2) PrEP 依从性（PrEP 开始后前 3 个月期间药盒开口的天数比例）。我们使用单变量和多变量调整线性回归来评估基于 3 个月平均依从性概念框架选择的基线预测变量。我们还评估了 9 个月的随访期间和怀孕期间的平均每月依从性。我们招募了 131 名女性，平均年龄 28.7 岁（95% CI：27.8 至 29.5）。 97 人 (74%) 报告其伴侣感染了艾滋病毒，79 人 (60%) 报告无安全套性行为。大多数女性（N = 118；90%）开始了 PrEP。开始后 3 个月内的平均电子依从率为 87%（95% CI：83%、90%）。没有协变量与 3 个月的服药行为相关。第3、6和9个月时，血浆TFV和TFV-DP浓度分别较高，分别为66%和47%、56%和41%、45%和45%。我们观察到 131 名女性中有 53 例怀孕（1 年累积发病率为 53% [95% CI: 43%, 62%]），一名非孕妇中有 1 例 HIV 血清转化。进行妊娠随访的 PrEP 使用者 (N = 17) 的平均药丸依从率为 98% (95% CI: 97%, 99%)。研究设计的局限性包括缺乏对照组。乌干达有 PrEP 适应症并计划怀孕的妇女选择使用 PrEP。通过电子药丸，大多数人能够在怀孕前和怀孕期间维持每日口服 PrEP 的高度依从性。依从性衡量标准的差异凸显了依从性评估的挑战；全血中 TFV-DP 的一系列测量表明，41% 至 47% 的女性采取了足够的围孕期 PrEP 来预防 HIV。这些数据表明，应优先考虑计划怀孕和已怀孕的妇女实施 PrEP，特别是在生育率高和艾滋病毒普遍流行的地区。这项工作的未来迭代应该将结果与当前的护理标准进行比较。 ClinicalTrials.gov 标识符：NCT03832530 https://clinicaltrials.gov/ct2/show/NCT03832530?term=lynn+matthews&cond=hiv&cntry=UG&draw=2&rank=1。 Lynn T. Matthews 及其同事评估了参与健康家庭 PrEP 干预的女性中口服暴露前预防的使用情况。替诺福韦 (TFV) 富马酸二吡呋酯/恩曲他滨作为暴露前预防 (PrEP) 可预防 HIV，在怀孕和母乳喂养期间是安全的，世界卫生组织、疾病预防控制中心和乌干达卫生部 (MOH) 推荐用于暴露于 HIV 的人群，包括在围孕期、怀孕和产后。许多女性选择与可能感染艾滋病毒的伴侣一起怀孕，但坚持每日口服 PrEP 可能具有挑战性。我们在乌干达乡村医院 HIV 诊所设计并测试了为期 3 期的健康家庭 PrEP 干预措施，并评估了围孕期和妊娠期间 PrEP 的依从性。我们向计划怀孕的妇女提供如何在避免感染艾滋病毒的同时生孩子的建议，并提供 PrEP，并且对于选择 PrEP 的妇女，每季度提供依从性支持。大约 131 名女性参与了研究，90% 的女性开始了 PrEP，其中 85% 的女性在 9 个月内服用了至少 80% 的剂量（通过电子药丸测量）。对于在怀孕期间继续 PrEP 的女性，通过服用药丸可以坚持 9 个月以上。第 3、6 和 9 个月时，血浆 TFV 浓度分别高达 66%、56% 和 45%。第 3、6 和 9 个月时，TFV-DP 浓度在 47%、41% 和 45% 的女性中分别较高。乌干达有 PrEP 适应症并计划怀孕的妇女选择使用 PrEP，大多数妇女能够在怀孕前和怀孕期间保持每日口服 PrEP 的高度坚持。这些研究结果表明，计划怀孕和已怀孕的妇女应优先实施 PrEP，特别是在生育率高和艾滋病毒普遍流行的环境中。
In Uganda, fertility rates and adult HIV prevalence are high, and many women conceive with partners living with HIV. Pre-exposure prophylaxis (PrEP) reduces HIV acquisition for women and, therefore, infants. We developed the Healthy Families-PrEP intervention to support PrEP use as part of HIV prevention during periconception and pregnancy periods. We conducted a longitudinal cohort study to evaluate oral PrEP use among women participating in the intervention. We enrolled HIV–negative women with plans for pregnancy with a partner living, or thought to be living, with HIV (2017 to 2020) to evaluate PrEP use among women participating in the Healthy Families-PrEP intervention. Quarterly study visits through 9 months included HIV and pregnancy testing and HIV prevention counseling. PrEP was provided in electronic pillboxes, providing the primary adherence measure (“high” adherence when pillbox was opened ≥80% of days). Enrollment questionnaires assessed factors associated with PrEP use. Plasma tenofovir (TFV) and intraerythrocytic TFV-diphosphate (TFV-DP) concentrations were determined quarterly for women who acquired HIV and a randomly selected subset of those who did not; concentrations TFV ≥40 ng/mL and TFV-DP ≥600 fmol/punch were categorized as “high.” Women who became pregnant were initially exited from the cohort by design; from March 2019, women with incident pregnancy remained in the study with quarterly follow-up until pregnancy outcome. Primary outcomes included (1) PrEP uptake (proportion who initiated PrEP); and (2) PrEP adherence (proportion of days with pillbox openings during the first 3 months following PrEP initiation). We used univariable and multivariable-adjusted linear regression to evaluate baseline predictors selected based on our conceptual framework of mean adherence over 3 months. We also assessed mean monthly adherence over 9 months of follow-up and during pregnancy. We enrolled 131 women with mean age 28.7 years (95% CI: 27.8 to 29.5). Ninety-seven (74%) reported a partner with HIV and 79 (60%) reported condomless sex. Most women (N = 118; 90%) initiated PrEP. Mean electronic adherence during the 3 months following initiation was 87% (95% CI: 83%, 90%). No covariates were associated with 3-month pill-taking behavior. Concentrations of plasma TFV and TFV-DP were high among 66% and 47%, 56% and 41%, and 45% and 45% at months 3, 6, and 9, respectively. We observed 53 pregnancies among 131 women (1-year cumulative incidence 53% [95% CI: 43%, 62%]) and 1 HIV-seroconversion in a non-pregnant woman. Mean pillcap adherence for PrEP users with pregnancy follow-up (N = 17) was 98% (95% CI: 97%, 99%). Study design limitations include lack of a control group. Women in Uganda with PrEP indications and planning for pregnancy chose to use PrEP. By electronic pillcap, most were able to sustain high adherence to daily oral PrEP prior to and during pregnancy. Differences in adherence measures highlight challenges with adherence assessment; serial measures of TFV-DP in whole blood suggest 41% to 47% of women took sufficient periconception PrEP to prevent HIV. These data suggest that women planning for and with pregnancy should be prioritized for PrEP implementation, particularly in settings with high fertility rates and generalized HIV epidemics. Future iterations of this work should compare the outcomes to current standard of care. ClinicalTrials.gov Identifier: NCT03832530 https://clinicaltrials.gov/ct2/show/NCT03832530?term=lynn+matthews&cond=hiv&cntry=UG&draw=2&rank=1. Lynn T. Matthews and colleagues evaluate oral pre-exposure prophylaxis use among women participating in the Healthy-Families-PrEP intervention. Tenofovir (TFV) disoproxil fumarate/emtricitabine as pre-exposure prophylaxis (PrEP) prevents HIV, is safe during pregnancy and breastfeeding, and is recommended by the WHO, CDC, and the Uganda Ministry of Health (MOH) for people exposed to HIV, including during periconception, pregnancy, and postpartum. Many women choose to conceive with partners who may be living with HIV but adherence to daily oral PrEP can be challenging. We designed and tested a 3-session Healthy Families-PrEP intervention in a rural Ugandan hospital HIV clinic and evaluated adherence to PrEP during periconception and pregnancy. Women planning pregnancy were counseled on ways to have a child while avoiding HIV acquisition, offered PrEP, and, for those choosing PrEP, provided with quarterly adherence support. Approximately 131 women enrolled, 90% initiated PrEP and, among those, 85% took at least 80% of doses (measured via electronic pillcap) over 9 months. For women continuing PrEP in pregnancy, adherence persisted, by pillcap, over 9 months. Plasma TFV concentrations were high among 66%, 56%, and 45% at months 3, 6, and 9, respectively. TFV-DP concentrations were high among 47%, 41%, and 45% of women at months 3, 6, and 9, respectively. Women in Uganda with PrEP indications and planning for pregnancy chose to use PrEP and most were able to sustain high adherence to daily oral PrEP prior to and during pregnancy. These findings suggest that women planning for and with pregnancy should be prioritized for PrEP implementation, particularly in settings with high fertility rates and generalized HIV epidemics.
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影响因子：
15.8
作者：
Baeten JM;Heffron R;Kidoguchi L;Mugo NR;Katabira E;Bukusi EA;Asiimwe S;Haberer JE;Morton J;Ngure K;Bulya N;Odoyo J;Tindimwebwa E;Hendrix C;Marzinke MA;Ware NC;Wyatt MA;Morrison S;Haugen H;Mujugira A;Donnell D;Celum C;Partners Demonstration Project Team
通讯作者：
Partners Demonstration Project Team
DOI：
10.1097/qai.0000000000000172
发表时间：
2014-07-01
期刊：
Journal of acquired immune deficiency syndromes (1999)
影响因子：
--
作者：
Donnell D;Baeten JM;Bumpus NN;Brantley J;Bangsberg DR;Haberer JE;Mujugira A;Mugo N;Ndase P;Hendrix C;Celum C
通讯作者：
Celum C
DOI：
10.1002/bs.3830190102
发表时间：
1974-01-01
期刊：
BEHAVIORAL SCIENCE
影响因子：
--
作者：
DEROGATIS, LR;LIPMAN, RS;COVI, L
通讯作者：
COVI, L
影响因子：
6
作者：
Joseph Davey DL;Mvududu R;Mashele N;Lesosky M;Khadka N;Bekker LG;Gorbach P;Coates TJ;Myer L
通讯作者：
Myer L
在FEM-PREP临床试验中坚持研究丸的促进者。
影响因子：
3.7
作者：
Corneli A;Perry B;Agot K;Ahmed K;Malamatsho F;Van Damme L
通讯作者：
Van Damme L