Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.
Uganda Virus Research Institute, Entebbe, Uganda.
PLoS One. 2024 Apr 19;19(4):e0297652. doi: 10.1371/journal.pone.0297652. eCollection 2024.
Despite the scale-up of Option B+, long-term retention of women in HIV care during pregnancy and the postpartum period remains an important challenge. We compared adherence to clinic appointments and antiretroviral therapy (ART) at 6 weeks, 6, and and 24 months postpartum among pregnant women living with HIV and initiating Option B+. Women were randomized to a peer group support, community-based drug distribution and income-generating intervention called "Friends for Life Circles" (FLCs) versus the standard of care (SOC). Our secondary outcome was infant HIV status and HIV-free survival at 6 weeks and 18 months postpartum.
Between 16 May 2016 and 12 September 2017, 540 ART-naïve pregnant women living with HIV at urban and rural health facilities in Uganda were enrolled in the study at any gestational age. Participants were randomized 1:1 to the unblinded FLC intervention or SOC at enrolment and assessed for adherence to the prevention of mother-to-child HIV transmission (PMTCT) clinic appointments at 6 weeks, 12, and 24 months postpartum, self-reported adherence to ART at 6 weeks, 6 and 24 months postpartum and supported by plasma HIV-1 RNA viral load (VL) measured at the same time points, retention in care through the end of study, and HIV status and HIV-free survival of infants at 18 months postpartum. The FLC groups were formed during pregnancy within 4 months of enrollment and held monthly meetings in their communites, and were followed up until the last group participant reached 24 months post delivery. We used Log-rank and Chi-Square p-values to test the equality of Kaplan-Meier survival probabilities and hazard rates (HR) for failure to retain in care for any reason by study arm.
There was no significant difference in adherence to PMTCT clinic visits or to ART or in median viral loads between FLC and SOC arms at any follow-up time points. Retention in care through the end of study was high in both arms but significantly higher among participants randomized to FLC (86.7%) compared to SOC (79.3%), p = 0.022. The adjusted HR of visit dropout was 2.4 times greater among participants randomized to SOC compared to FLC (aHR = 2.363, 95% CI: 1.199-4.656, p = 0.013). Median VL remained < 400 copies/ml in both arms at 6 weeks, 6, and 24 months postpartum. Eight of the 431 infants tested at 18 months were HIV positive (1.9%), however, this was not statistically different among mothers enrolled in the FLC arm compared to those in the SOC arm. At 18 months, HIV-free survival of children born to mothers in the FLC arm was significantly higher than that of children born to mothers in the SOC arm.
Our findings suggest that programmatic interventions that provide group support, community-based ART distribution, and income-generation activities may contribute to retention in PMTCT care, HIV-free survival of children born to women living with HIV, and ultimately, to the elimination of mother-to-child HIV transmission (EMTCT).
NCT02515370 (04/08/2015) on ClinicalTrials.gov.
尽管 Option B+ 已经推广，但是在怀孕期间和产后期间，将女性长期保留在艾滋病毒护理中仍然是一个重要的挑战。我们比较了在妊娠期间开始接受 Option B+的艾滋病毒感染者的诊所预约和抗逆转录病毒治疗（ART）的依从性，分别在 6 周、6 个月和 24 个月时进行。女性被随机分配到一个名为“朋友生活圈”（FLC）的同伴小组支持、社区为基础的药物分发和创造收入的干预组，或标准护理（SOC）组。我们的次要结果是婴儿的 HIV 状况和产后 6 周和 18 个月的无 HIV 生存情况。
在 2016 年 5 月 16 日至 2017 年 9 月 12 日期间，乌干达城乡卫生机构的 540 名接受 ART 的初孕妇在任何妊娠年龄被纳入该研究。参与者在入组时被随机分为 1:1 的 FLC 干预组或 SOC 组，并在产后 6 周、12 个月和 24 个月评估预防母婴传播（PMTCT）诊所的就诊依从性、6 周、6 个月和 24 个月时自我报告的 ART 依从性，并通过同时测量血浆 HIV-1 RNA 病毒载量（VL）进行支持，通过研究结束时的保留在护理中，并在产后 18 个月时评估婴儿的 HIV 状况和无 HIV 生存情况。FLC 组在入组后 4 个月内形成，并在其社区中每月举行一次会议，直到最后一组参与者达到 24 个月产后。我们使用 Log-rank 和 Chi-Square p 值来测试 Kaplan-Meier 生存概率和危险比（HR）在任何随访时间点上因任何原因而未能保留在护理中的差异。在两个组中，通过研究结束时的保留在护理中都很高，但随机分配到 FLC 组的参与者（86.7%）明显高于 SOC 组（79.3%），p=0.022。与 FLC 相比，SOC 组的参与者的就诊脱落的调整 HR 高出 2.4 倍（aHR=2.363，95%CI：1.199-4.656，p=0.013）。在产后 6 周、6 个月和 24 个月时，两组的中位 VL 均<400 拷贝/ml。在 18 个月时，431 名婴儿中有 8 名（1.9%）检测到 HIV 阳性，但这在 FLC 臂和 SOC 臂的母亲中没有统计学差异。在 18 个月时，出生于 FLC 臂的儿童的 HIV 无生存状况明显高于 SOC 臂的儿童。
我们的研究结果表明，提供团体支持、社区为基础的 ART 分发和创造收入的项目干预措施可能有助于保留在 PMTCT 护理中，HIV 阳性妇女所生儿童的无 HIV 生存，最终有助于消除母婴 HIV 传播（EMTCT）。
NCT02515370（04/08/2015）在 ClinicalTrials.gov。
