Department of Epidemiology, Fielding School of Public Health, University of California Los Angeles, Los Angeles, CA, USA.
Division of Epidemiology and Biostatistics, School of Public Health, University of Cape Town, Cape Town, South Africa.
BMC Public Health. 2022 Jul 7;22(1):1306. doi: 10.1186/s12889-022-13652-5.
HIV incidence among pregnant and postpartum women remains high in South Africa. Pre-exposure prophylaxis (PrEP) use remains suboptimal in this population, particularly during the postpartum period when women's engagement with routine clinic visits outside PrEP decreases. Key barriers to sustained PrEP use include the need for ongoing contact with the health facility and suboptimal counseling around effective PrEP use.
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum women (SCOPE-PP), is a two-stepped unblinded, individually randomized controlled trial (RCT) that aims to optimize peripartum and postpartum PrEP use by providing a stepped package of evidence-based interventions. We will enroll 650 pregnant women (> 25 weeks pregnant) who access PrEP at a busy antenatal clinic in Cape Town at the time of recruitment and follow them for 15 months. We will enroll and individually randomize pregnant women > 16 years who are not living with HIV who are either on PrEP or interested in starting PrEP during pregnancy. In step 1, we will evaluate the impact of enhanced adherence counselling and biofeedback (using urine tenofovir tests for biofeedback) and rapid PrEP collection (to reduce time required) on PrEP use in early peripartum compared to standard of care (SOC) (n = 325 per arm). The primary outcome is PrEP persistence per urine tenofovir levels and dried blood spots of tenofovir diphosphate (TFV-DP) after 6-months. The second step will enroll and individually randomize participants from Step 1 who discontinue taking PrEP or have poor persistence in Step 1 but want to continue PrEP. Step 2 will test the impact of enhanced counseling and biofeedback plus rapid PrEP collection compared to community PrEP delivery with HIV self-testing on PrEP use (n = up to 325 postpartum women). The primary outcome is PrEP continuation and persistence 6-months following second randomization (~ 9-months postpartum). Finally, we will estimate the cost effectiveness of SCOPE-PP vs. SOC per primary outcomes and disability-adjusted life-years (DALYs) averted in both Step 1 and 2 using micro-costing with trial- and model-based economic evaluation.
This study will provide novel insights into optimal strategies for delivering PrEP to peripartum and postpartum women in this high-incidence setting.
NCT05322629 : Date of registration: April 12, 2022.
南非孕妇和产后妇女的艾滋病毒发病率仍然很高。在这一人群中，暴露前预防（PrEP）的使用仍然不理想，特别是在产后期间，妇女与常规诊所就诊的接触减少。持续使用 PrEP 的主要障碍包括需要与卫生机构保持持续联系，以及围绕有效使用 PrEP 提供的咨询服务欠佳。
优化妊娠和产后妇女 PrEP 效果的分级护理（SCOPE-PP）是一项两阶段、非盲、个体随机对照试验（RCT），旨在通过提供一套基于证据的干预措施来优化围产期和产后 PrEP 的使用。我们将招募 650 名在开普敦繁忙的产前诊所招募时已开始接受 PrEP 的妊娠妇女（妊娠 25 周以上），并对她们进行 15 个月的随访。我们将招募并对每一位随机分配的、年龄大于 16 岁的、未感染艾滋病毒的孕妇进行评估，她们或正在接受 PrEP，或在妊娠期间有兴趣开始使用 PrEP。在第 1 阶段，我们将评估强化依从性咨询和生物反馈（使用尿液替诺福韦检测进行生物反馈）以及快速 PrEP 收集（减少所需时间）对早期围产期 PrEP 使用的影响，与标准护理（SOC）相比（每组 325 人）。主要结局是使用尿液替诺福韦水平和干血斑检测替诺福韦二磷酸（TFV-DP）后 6 个月的 PrEP 持续时间。第 2 阶段将招募第 1 阶段停止服用 PrEP 或第 1 阶段 PrEP 持续时间不佳但希望继续服用 PrEP 的参与者，并对他们进行随机分组。第 2 阶段将测试强化咨询和生物反馈加快速 PrEP 收集与社区提供 PrEP 加 HIV 自我检测对 PrEP 使用的影响（最多 325 名产后妇女）。主要结局是第二次随机分组后 6 个月（约产后 9 个月）的 PrEP 持续和持续时间。最后，我们将使用基于试验和模型的经济评估的微观成本法，分别估计 SCOPE-PP 与 SOC 相比，在第 1 阶段和第 2 阶段每个主要结局和避免的残疾调整生命年（DALYs）的成本效益。
这项研究将为在这一高发病率环境中为围产期和产后妇女提供 PrEP 的最佳策略提供新的见解。
NCT05322629 ；注册日期：2022 年 4 月 12 日。
