Department of Research & Programs, Kenyatta National Hospital, Nairobi, Kenya.
Department of Obstetrics and Gynecology, Women and Infants Hospital, Warren Alpert Medical School of Brown University, Providence, Rhode Island, United States of America.
PLoS One. 2024 Apr 1;19(4):e0300642. doi: 10.1371/journal.pone.0300642. eCollection 2024.
Women living with HIV (WLWH) face unique reproductive health (RH) barriers which increase their risks of unmet need for contraception, contraceptive failure, unintended pregnancy, and pregnancy-related morbidity and mortality and may prevent them from achieving their reproductive goals. Patient-centered counseling interventions that support health care workers (HCWs) in providing high-quality RH counseling, tailored to the needs of WLWH, may improve reproductive health outcomes.
We are conducting a non-blinded cluster randomized controlled trial (cRCT) of a digital health intervention for WLWH (clinicaltrials.gov #NCT05285670). We will enroll 3,300 WLWH seeking care in 10 HIV care and treatment centers in Nairobi and Western Kenya. WLWH at intervention sites receive the Mobile WACh Empower intervention, a tablet-based RH decision-support counseling tool administered at baseline and SMS support during two years of follow-up. WLWH at control sites receive the standard of care FP counseling. The decision-support tool is a logic-based tool for family planning (FP) counseling that uses branching logic to guide RH questions based on participants' reproductive life plans, tailoring counseling based on the responses. Follow-up SMSs are based in the Information-Motivation-Behavioral (IMB) Skills model of behavioral change and are tailored to participant characteristics and reproductive needs through separate SMS "tracks". Follow-up visits are scheduled quarterly for 2 years to assess plans for pregnancy, pregnancy prevention, and contraceptive use. The primary outcome, FP discontinuation, will be compared using an intent-to-treat analysis. We will also assess the unmet need for FP, dual method use, viral load suppression at conception and unintended pregnancy.
The Mobile WACh Empower intervention is innovative as it combines a patient-centered counseling tool to support initial reproductive life decisions with longitudinal SMS for continued RH support and may help provide RH care within the context of provision of HIV care.
感染艾滋病毒的女性（WLWH）面临独特的生殖健康（RH）障碍，这增加了她们避孕需求未得到满足、避孕失败、意外怀孕以及与妊娠相关的发病率和死亡率的风险，并且可能阻止她们实现生殖目标。以患者为中心的咨询干预措施可以支持卫生保健工作者（HCWs）提供高质量的 RH 咨询，根据 WLWH 的需求进行定制，从而改善生殖健康结局。
我们正在进行一项针对感染艾滋病毒的女性（WLWH）的数字健康干预措施的非盲、集群随机对照试验（cRCT）（clinicaltrials.gov #NCT05285670）。我们将招募 3300 名在奈洛比和肯尼亚西部的 10 个艾滋病毒护理和治疗中心寻求护理的 WLWH。干预点的 WLWH 将接受基于移动设备的 WACh Empower 干预措施，这是一种基于平板电脑的 RH 决策支持咨询工具，在基线时进行管理，并在两年的随访期间提供短信支持。对照点的 WLWH 将接受标准的 FP 咨询。决策支持工具是一种用于计划生育（FP）咨询的基于逻辑的工具，它使用分支逻辑根据参与者的生殖生活计划引导 RH 问题，根据回答定制咨询。后续短信基于行为改变的信息-动机-行为（IMB）技能模型，并通过单独的短信“轨道”根据参与者的特征和生殖需求进行定制。在接下来的两年中，将每季度安排一次随访，以评估怀孕、妊娠预防和避孕使用的计划。使用意向治疗分析比较主要结局 FP 停药。我们还将评估 FP 的未满足需求、双重方法使用、受孕时的病毒载量抑制和意外怀孕。
Mobile WACh Empower 干预措施具有创新性，因为它将以患者为中心的咨询工具结合起来，支持初始生殖生活决策，并通过纵向短信提供持续的 RH 支持，这可能有助于在提供 HIV 护理的背景下提供 RH 护理。
