Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial.
Stepped care to optimize pre-exposure prophylaxis (PrEP) effectiveness in pregnant and postpartum women (SCOPE-PP) in South Africa: a randomized control trial.
复制标题
DOI：
10.1186/s12889-022-13652-5
复制
发表时间：
2022-07-07
影响因子：
4.5
通讯作者：
Myer, Landon
中科院分区：
文献类型：
--
作者：
Davey, Dvora Leah Joseph;Dovel, Kathryn;Cleary, Susan;Khadka, Nehaa;Mashele, Nyiko;Silliman, Miriam;Mvududu, Rufaro;Nyemba, Dorothy C.;Coates, Thomas J.;Myer, Landon
关键词：
南非孕妇和产后妇女的艾滋病毒感染率仍然很高。暴露前预防（PrEP）的使用在这一人群中仍然是次优的，特别是在产后期间，当妇女参与PrEP以外的常规诊所就诊减少时。持续使用PrEP的主要障碍包括需要与卫生机构持续接触，以及围绕有效使用PrEP的次优咨询。分步护理以优化PrEP在孕妇和产后妇女中的有效性（SCOPE-PP）是一项两步非盲、个体随机对照试验（RCT），旨在通过提供一系列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名孕妇（妊娠> 25周），她们在招募时在开普敦的一家忙碌产前诊所接受PrEP，并随访15个月。我们将招募并单独随机分配16岁以上未感染艾滋病毒的孕妇，这些孕妇正在接受PrEP或有兴趣在怀孕期间开始PrEP。在第1步中，我们将评估增强依从性咨询和生物反馈（使用尿液替诺福韦试验进行生物反馈）和快速PrEP收集（以减少所需时间）对围产期早期PrEP使用的影响，与标准护理（SOC）相比（每组n = 325）。主要结果是6个月后根据尿液替诺福韦水平和替诺福韦二磷酸盐（TFV-DP）的干血斑的PrEP持续性。第二步将招募并单独随机分配第1步中停止服用PrEP或在第1步中坚持性较差但希望继续PrEP的参与者。第2步将测试增强咨询和生物反馈加上快速PrEP收集与社区PrEP交付与HIV自我检测对PrEP使用的影响（n =多达325名产后妇女）。主要结局是第二次随机化后6个月（产后约9个月）PrEP的持续性和持久性。最后，我们将使用基于试验和模型的经济学评价的微成本法，根据主要结局和步骤1和步骤2中避免的残疾调整生命年（DADs），估计SCOPE-PP与SOC的成本效益。这项研究将为在这种高发病率环境中向围产期和产后妇女提供PrEP的最佳策略提供新的见解。NCT 05322629：注册日期：2022年4月12日。
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.
登录
查看更多内容
DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
--
作者：
Damschroder LJ;Aron DC;Keith RE;Kirsh SR;Alexander JA;Lowery JC
通讯作者：
Lowery JC
在肯尼亚和乌干达的艾滋病毒血清伴侣中预防前预防的示威计划中，遵守性和艾滋病毒获取风险的比对：预防有效依从性的前瞻性分析。
影响因子：
6
作者：
Haberer JE;Kidoguchi L;Heffron R;Mugo N;Bukusi E;Katabira E;Asiimwe S;Thomas KK;Celum C;Baeten JM
通讯作者：
Baeten JM
DOI：
10.1097/qai.0000000000000158
发表时间：
2014-07-01
影响因子：
3.6
作者：
Corneli, Amy L.;Deese, Jennifer;Van Damme, Lut
通讯作者：
Van Damme, Lut
影响因子：
3.2
作者：
Edoka, Ijeoma P.;Stacey, Nicholas K.
通讯作者：
Stacey, Nicholas K.
DOI：
10.1097/qai.0000000000002486
发表时间：
2020-12-01
影响因子：
3.6
作者：
Hebel, Shane;Kahn-Woods, Elijah;Daughtridge, Giffin
通讯作者：
Daughtridge, Giffin