Department of Pediatrics, University of Colorado Denver, Aurora, Colorado, USA.
Center for Global Health, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
J Int AIDS Soc. 2022 Jan;25(1):e25852. doi: 10.1002/jia2.25852.
INTRODUCTION: Retention in HIV care and adherence to antiretroviral therapy (ART) during pregnancy and postpartum for women living with HIV (WLWH) are necessary to optimize health outcomes for women and infants. The objective of this study was to evaluate the impact of two evidenced-based behavioural interventions on postpartum adherence and retention in WLWH in Kenya. METHODS: The Mother-Infant Visit Adherence and Treatment Engagement (MOTIVATE) study was a cluster-randomized trial enrolling pregnant WLWH from December 2015 to August 2017. Twenty-four health facilities in southwestern Kenya were randomized to: (1) standard care (control), (2) text-messaging, (3) community-based mentor mothers (cMM) or (4) text-messaging and cMM. Primary outcomes included retention in care and ART adherence at 12 months postpartum. Analyses utilized generalized estimating equations and competing risks regression. Per-protocol analyses examined differences in postpartum retention for women with high versus low levels of exposure to the interventions. RESULTS: We enrolled 1331 pregnant WLWH (mean age 28 years). At 12 months postpartum, 1140 (85.6%) women were retained in care, 96 women (7.2%) were lost-to-follow-up (LTFU) and 95 (7.1%) were discontinued from the study. In intention-to-treat analyses, the relative risk of being retained at 12-months postpartum was not significantly higher in the intervention arms versus the control arm. In time-to-event analysis, the cMM and text arm had significantly lower rates of LTFU (hazard ratio 0.44, p = 0.019). In per-protocol analysis, the relative risk of 12-month postpartum retention was 24-29% higher for women receiving at least 80% of the expected intervention compared to the control arm; text message only risk ratio (RR) 1.24 (95% confidence interval [CI] 1.16-1.32, p<0.001), cMM only RR 1.29 (95% CI 1.21-1.37, p<0.001) and cMM plus text RR 1.29 (1.21-1.37, p<0.001). Women LTFU were younger (p<0.001), less likely to be married (p<0.001) and more likely to be newly diagnosed with HIV during pregnancy (p<0.001). Self-reported ART adherence did not vary by study arm. CONCLUSIONS: Behavioural interventions using peer support and text messages did not appear to improve 12-month postpartum retention and adherence in intention-to-treat analyses. Higher levels of exposure to the interventions may be necessary to achieve the desired effects.
介绍：艾滋病毒感染者（WLWH）在怀孕期间和产后坚持接受艾滋病毒护理和抗逆转录病毒治疗（ART）对于优化妇女和婴儿的健康结果是必要的。本研究的目的是评估两项基于证据的行为干预措施对肯尼亚产后 WLWH 依从性和保留率的影响。 方法：母婴探访依从性和治疗参与度（MOTIVATE）研究是一项于 2015 年 12 月至 2017 年 8 月期间招募来自西南部肯尼亚的孕妇 WLWH 的集群随机试验。24 个卫生机构被随机分配到以下 4 组：（1）标准护理（对照组）、（2）短信、（3）社区导师母亲（cMM）或（4）短信和 cMM。主要结局包括产后 12 个月的护理保留率和 ART 依从性。分析采用广义估计方程和竞争风险回归。按方案分析检查了在接受干预措施的高暴露水平和低暴露水平的妇女之间产后保留率的差异。 结果：我们招募了 1331 名孕妇 WLWH（平均年龄 28 岁）。在产后 12 个月时，1140 名（85.6%）妇女得到了保留，96 名妇女（7.2%）失访（LTFU），95 名（7.1%）退出了研究。在意向治疗分析中，干预组与对照组在产后 12 个月时保持的相对风险没有显著增加。在时间事件分析中，cMM 和短信组的 LTFU 率显著降低（危险比 0.44，p = 0.019）。在按方案分析中，与对照组相比，接受至少 80%预期干预的妇女产后 12 个月保留率相对风险增加了 24-29%；短信组仅风险比（RR）1.24（95%置信区间[CI] 1.16-1.32，p<0.001），cMM 组 RR 1.29（95% CI 1.21-1.37，p<0.001）和 cMM 加短信 RR 1.29（1.21-1.37，p<0.001）。LTFU 的妇女更年轻（p<0.001），已婚的可能性更低（p<0.001），且在怀孕期间更有可能被新诊断为 HIV（p<0.001）。自我报告的 ART 依从性并未因研究组而异。 结论：使用同伴支持和短信的行为干预措施似乎并没有提高意向治疗分析中的产后 12 个月保留率和依从性。更高水平的干预措施暴露可能是实现预期效果所必需的。
PLOS Glob Public Health. 2024-2-20
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