Adaptive HIV pre-exposure prophylaxis adherence interventions for young South African women: Study protocol for a sequential multiple assignment randomized trial.
Adaptive HIV pre-exposure prophylaxis adherence interventions for young South African women: Study protocol for a sequential multiple assignment randomized trial.
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DOI：
10.1371/journal.pone.0266665
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发表时间：
2022
期刊：
影响因子：
3.7
通讯作者：
Delany-Moretlwe, Sinead
中科院分区：
文献类型：
--
作者：
Velloza, Jennifer;Poovan, Nicole;Ndlovu, Nontokozo;Khoza, Nomhle;Morton, Jennifer F.;Omony, Jeanne;Mkwanazi, Edwin;Grabow, Cole;Donnell, Deborah;Munthali, Richard;Baeten, Jared M.;Hosek, Sybil;Celum, Connie;Delany-Moretlwe, Sinead
暴露前预防（PrEP）是一种非常有效的艾滋病毒预防策略，建议用于艾滋病毒风险人群，包括艾滋病毒流行环境中的少女和年轻妇女（AGYW）。然而，PrEP的持续性和高依从性仍然是其影响的挑战。现有的PrEP依从性干预措施可能是时间和成本密集型的。大规模的PrEP提供将需要为具有不同预防需求的AGYW确定分层的PrEP支持策略。我们描述了一项序贯多分配随机试验（SMART）的设计，以评估南非AGYW中使用可扩展的阶梯式干预措施的PrEP依从性支持模型。“PrEP SMART”是在南非约翰内斯堡进行的一项随机试验，招募年龄在18至25岁之间，性活跃，新开始PrEP，并定期使用移动的电话的AGYW。参与者以1：1的比例随机接受标准护理PrEP咨询，并提供双向短信或WhatsApp小组依从性支持。在三个月时使用来自在第2个月收集的干血斑的二磷酸替诺福韦（TFV-DP）水平评估依从性，以将参与者分类为“应答者”（TFV-DP ≥500 fmol/punch）或“无应答者”（TFV-DP <500 fmol/punch）。AGYW被定义为“无应答者”，除了他们的一级干预外，还进行了二级1：1随机分组，分为季度药物水平反馈咨询或每月以问题为中心的咨询。主要结局是9个月时的PrEP依从性（TFV-DP ≥700 fmol/punch）。我们将评估两种初始干预措施对应答者TFV-DP水平的影响，评估强化干预措施对无应答者TFV-DP水平的影响，并确定9个月内依从性干预的最佳顺序。ClinicalTrials.gov，NCT 04038060。于2019年7月30日注册。
Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention strategy and is recommended for populations at risk of HIV, including adolescent girls and young women (AGYW) in HIV endemic settings. However, PrEP continuation and high adherence remain challenges to its impact. Existing PrEP adherence interventions can be time- and cost-intensive. Widescale PrEP delivery will require the identification of layered PrEP support strategies for AGYW with diverse prevention needs. We describe the design of a sequential multiple assignment randomized trial (SMART) to evaluate a PrEP adherence support model using scalable, stepped interventions in AGYW in South Africa. “PrEP SMART” is a randomized trial in Johannesburg, South Africa, enrolling AGYW who are between 18 and 25 years of age, sexually active, newly initiating PrEP, and have regular access to a mobile phone. Participants are randomized 1:1 to standard-of-care PrEP counseling with either two-way SMS or WhatsApp group adherence support. Adherence is assessed at three months using tenofovir diphosphate (TFV-DP) levels from dried blood spots collected at month 2 to categorize participants as “responders” (TFV-DP ≥500 fmol/punch) or “non-responders” (TFV-DP <500 fmol/punch). AGYW defined as ‘non-responders’ undergo a secondary 1:1 randomization to either quarterly drug-level feedback counseling or monthly issue-focused counseling, in addition to their first-level intervention. The primary outcome is PrEP adherence at nine months (TFV-DP ≥700 fmol/punch). We will assess the effect of our two initial interventions on TFV-DP levels among responders, assess the effect of our intensified interventions on TFV-DP levels among non-responders, and identify the optimal sequence of adherence interventions through nine months. ClinicalTrials.gov, NCT04038060. Registered on 30 July 2019.
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影响因子：
4.4
作者：
Horvath, Keith J.;Oakes, J. Michael;Rosser, B. R. Simon;Danilenko, Gene;Vezina, Heather;Amico, K. Rivet;Williams, Mark L.;Simoni, Jane
通讯作者：
Simoni, Jane
影响因子：
15.8
作者：
Baeten JM;Heffron R;Kidoguchi L;Mugo NR;Katabira E;Bukusi EA;Asiimwe S;Haberer JE;Morton J;Ngure K;Bulya N;Odoyo J;Tindimwebwa E;Hendrix C;Marzinke MA;Ware NC;Wyatt MA;Morrison S;Haugen H;Mujugira A;Donnell D;Celum C;Partners Demonstration Project Team
通讯作者：
Partners Demonstration Project Team
DOI：
10.1016/s2352-3018(17)30156-x
发表时间：
2018-03
期刊：
The lancet. HIV
影响因子：
--
作者：
Bekker LG;Roux S;Sebastien E;Yola N;Amico KR;Hughes JP;Marzinke MA;Hendrix CW;Anderson PL;Elharrar V;Stirratt M;Rooney JF;Piwowar-Manning E;Eshleman SH;McKinstry L;Li M;Dye BJ;Grant RM;HPTN 067 (ADAPT) study team
通讯作者：
HPTN 067 (ADAPT) study team
DOI：
10.1097/qai.0000000000001179
发表时间：
2017-01-01
期刊：
Journal of acquired immune deficiency syndromes (1999)
影响因子：
--
作者：
Hosek SG;Rudy B;Landovitz R;Kapogiannis B;Siberry G;Rutledge B;Liu N;Brothers J;Mulligan K;Zimet G;Lally M;Mayer KH;Anderson P;Kiser J;Rooney JF;Wilson CM;Adolescent Trials Network (ATN) for HIVAIDS Interventions
通讯作者：
Adolescent Trials Network (ATN) for HIVAIDS Interventions
影响因子：
168.9
作者：
Lester, Richard T.;Ritvo, Paul;Plummer, Francis A.
通讯作者：
Plummer, Francis A.