Department of Global Health, Boston University School of Public Health, 801 Massachusetts Avenue, Boston, MA, 02118, USA.
Kenya Medical Research Institute, Kericho, Kenya/U.S. Army Medical Research Directorate-Africa, Nairobi, Kenya.
BMC Infect Dis. 2023 Apr 25;23(1):257. doi: 10.1186/s12879-023-08246-4.
BACKGROUND: This study evaluated the effect of revisions to existing peer-counselor services, called Mentor Mothers (MM), at maternal and child health clinics on medication adherence for women living with HIV (WLWH) in Kenya and on early infant HIV testing. METHODS: The Enhanced Mentor Mother Program study was a 12-site, two-arm cluster-randomized trial enrolling pregnant WLWH from March 2017 to June 2018 (with data collection through September 2020). Six clinics were randomized to continued MM-supported standard care (SC). Six clinics were randomized to the intervention arm (INT = SC plus revised MM services to include more one-on-one interactions). Primary outcomes for mothers were defined as: (PO1) the proportion of days covered (PDC) with antiretroviral therapy (ART) ≥ 0.90 during the last 24-weeks of pregnancy; and (PO2) ≥ 0.90 PDC during the first 24-weeks postpartum. Secondary outcomes were infant HIV testing according to national guidelines (at 6, 24, and 48 weeks). Crude and adjusted risk differences between study arms are reported. RESULTS: We enrolled 363 pregnant WLHV. After excluding known transfers and subjects with incomplete data extraction, data were analyzed for 309 WLWH (151 SC, 158 INT). A small share achieved high PDC during the prenatal and postnatal periods (0.33 SC/0.24 INT achieved PO1; 0.30 SC/0.31 INT achieved PO2; crude or adjusted risk differences were not statistically significant). In addition, ~ 75% in both study arms completed viral load testing during year two after enrollment, with > 90% suppressed in both arms. For infants, ≥ 90% in both arms had at least one HIV test through study follow up (76 weeks) but testing on schedule according to PMTCT guidelines was uncommon. CONCLUSIONS: While national guidelines in Kenya recommended that all HIV-infected pregnant women take a daily antiretroviral regimen for life following a HIV diagnosis, results presented here indicate that a minor share achieved high medication coverage during the prenatal and postnatal periods analyzed. In addition, adjustments to Mentor-Mother services showed no improvement in study outcomes. The lack of effect for this behavioral intervention is relatively consistent with the existing literature to improve mother-infant outcomes along the PMTCT care cascade. CLINICAL TRIAL NUMBER: NCT02848235. Date of first trial registration 28/07/2016.
背景：本研究评估了对现有的同伴辅导员服务（称为导师母亲（MM））进行修订，在肯尼亚的母婴健康诊所中对感染艾滋病毒的妇女（WLWH）的药物依从性以及早期婴儿艾滋病毒检测的影响。
方法：增强型导师母亲计划研究是一项 12 个地点、2 臂的集群随机试验，招募了 2017 年 3 月至 2018 年 6 月期间的怀孕 WLWH（数据收集截至 2020 年 9 月）。6 个诊所被随机分配到继续接受 MM 支持的标准护理（SC）。6 个诊所被随机分配到干预组（INT=SC 加修订的 MM 服务，包括更多的一对一互动）。母亲的主要结局定义为：（PO1）在妊娠的最后 24 周内抗逆转录病毒治疗（ART）的覆盖天数（PDC）≥0.90；（PO2）产后 24 周内 PDC≥0.90。根据国家指南（在 6、24 和 48 周时）报告婴儿艾滋病毒检测的次要结局。报告了研究臂之间的粗风险差异和调整风险差异。
结果：我们招募了 363 名怀孕的 WLHV。在排除已知的转移和数据提取不完整的受试者后，对 309 名 WLWH（151 名 SC，158 名 INT）进行了数据分析。一小部分人在产前和产后期间达到了较高的 PDC（0.33 SC/0.24 INT 达到 PO1；0.30 SC/0.31 INT 达到 PO2；粗或调整风险差异无统计学意义）。此外，在研究入组后的第二年，约有 75%的研究对象完成了病毒载量检测，在两个研究臂中都有超过 90%的人得到了抑制。对于婴儿，在研究随访期间（76 周），两个研究臂中都有≥90%的婴儿至少进行了一次艾滋病毒检测，但按照 PMTCT 指南进行定期检测的情况并不常见。
结论：尽管肯尼亚的国家指南建议所有感染艾滋病毒的孕妇在 HIV 诊断后终身每天服用抗逆转录病毒药物，但这里介绍的结果表明，在分析的产前和产后期间，只有一小部分人达到了较高的药物覆盖率。此外，对导师母亲服务的调整并没有改善研究结果。这种行为干预没有效果，这与现有的改善母婴结局的 PMTCT 护理链文献相对一致。
临床试验编号：NCT02848235。首次试验注册日期为 2016 年 7 月 28 日。
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