The Community PrEP Study

社区 PrEP 研究

• 批准号: 10222527
• 负责人: Linda-Gail Gail Bekker
• 金额: $ 40.56万
• 依托单位: FOUNDATION FOR PROFESSIONAL DEVELOPMENT
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-19 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10222527
• 关键词: AIDS prevention; Adherence; African; Age; Area; Behavioral; Blood; Caring; Clinic; Clinical Trials; Cognitive; Collaborations; Communities; Community Health; Community based prevention; Control Groups; Counseling; Development; Eastern Africa; Enrollment; Epidemic; Female; Female Adolescents; Foundations; HIV; HIV Infections; HIV prevention trial; HIV/STD; Health Club; Health Services; Health system; Human immunodeficiency virus test; Incidence; Individual; Intervention; Knowledge; Link; Measures; Methods; Oral; Participant; Pattern; Perception; Persons; Pharmaceutical Preparations; Policies; Population; Positioning Attribute; Prevention; Prevention program; Prevention strategy; Province; Qualitative Methods; Randomized; Recommendation; Regimen; Reproductive Health; Research; Research Personnel; Resources; Risk; Rural; Self Perception; Services; Sex Behavior; South Africa; South African; Southern Africa; Speed; Tenofovir; Testing; Time; United States; Woman; Work; Youth; adolescent health; aged; arm; base; control trial; emtricitabine; experience; home test; implementation research; improved; innovation; interest; low and middle-income countries; male; medication compliance; open label; pre-exposure prophylaxis; prevention service; preventive intervention; primary outcome; programs; risk perception; rural setting; sex; testing services; transmission process; uptake; urban setting; young woman

PROJECT ABSTRACT Worldwide, about 1.9 million people became infected with HIV in 2015, most of whom live in Southern and Eastern Africa. In South Africa, the HIV incidence rate among female youth aged 15-24 (2.5%) is four times higher than their male counterparts (0.6%). Recent HIV prevention trials in South Africa documented incidence rates of 5-6% per year in 15-24 year old adolescent girls and young women (AGYW). Given this high incidence of HIV, implementing effective HIV prevention strategies – including PrEP – is crucial to controlling HIV globally. The proposed study leverages existing community-based HIV counseling and testing platforms in South Africa and evaluates, using a mixed methods approach, a community-based prevention-effective PrEP adherence program in AGYW whilst optimizing the PrEP cascade. This study will take place in the urban Mamelodi Township in Gauteng Provence and rural Govan Mbeki sub-district in Mpumalanga Province, both of which are very high HIV transmission areas. Numerous barriers have been described that delay or block AGYW from accessing clinic-based health services, especially reproductive health and HIV testing and prevention services. Consequently, reaching AGYW at large scale with HIV prevention services requires the health system to think of delivery platforms outside of clinic-based facilities. Community-based counseling and testing programs have shown the greatest coverage and potential to achieve high levels of knowledge of HIV serostatus and linkage to HIV care. Using community-based counseling and testing programs, this proposal will deliver PrEP as part of a population-level combination prevention program which is necessary to substantially reduce HIV incidence. We propose to answer our key research questions through the following Specific Aims: 1) Assess adolescent girls and young women's uptake of PrEP when delivered through large- scale community-based HIV counseling and testing (CBCT) platforms in urban and rural settings in South Africa, 2) Evaluate community-based scalable interventions to achieve prevention-effective adherence to PrEP among AGYW, and 3) Measure differences in risk profiles of PrEP acceptors, non-acceptors and delayed initiators. In order to achieve Aim 1, we will leverage our on-going, at-scale CBCT program and platforms (mobile unit and systematic home-based testing) to identify and link AGYW to community-based PrEP initiation services. In order to achieve Aim 2, we will perform a 3-arm randomized control trial, with participants randomised to one of the following arms: Arm 1) a group-based community health club akin to an ART adherence club; Arm 2) one-on-one adherence counseling and support; Arm 3) community-based medication dispensary. And finally, while PrEP acceptors are being enrolled into the study as part of Aim 1, 516 individuals that decline PrEP will be enrolled as a control group to (a) measure the incidence of STI and HIV infections in PrEP acceptors and non-acceptors, (b): assess sexual behaviors and self- perception risk in those that accept and did not accept PrEP, and (c): determine the proportion of individuals that delay PrEP initiation and describe their reasons for delayed initiation.

项目摘要 全球，2015年约有190万人感染了艾滋病毒，其中大多数人居住在南部和 东非。在南非，15-24岁的女性青年的艾滋病毒事件率为四倍 高于男性同行（0.6％）。南非最近的艾滋病毒预防试验记录了事件 15-24岁的青少年女孩和年轻妇女（AGYW）的年龄为5-6％。考虑到这一高事件 在艾滋病毒中，实施有效的艾滋病毒预防策略（包括PREP）对于全球控制艾滋病毒至关重要。 拟议的研究利用了南非现有的基于社区的艾滋病毒咨询和测试平台 并使用混合方法方法评估一种基于社区的预防有效的准备依从性 在AGYW中进行程序，同时优化准备级联。这项研究将在城市Mamelodi中进行 豪登省普罗旺斯（Gauteng Provence）和姆普马兰加（Mpumalanga）省的乡村Govan Mbeki分区 非常高的艾滋病毒传播区域。已经描述了许多障碍，延迟或阻止Agyw从 访问基于诊所的卫生服务，尤其是生殖健康和艾滋病毒测试和预防服务。 因此，通过艾滋病毒预防服务大规模达到AGYW，需要卫生系统思考 基于诊所的设施之外的交付平台。基于社区的咨询和测试计划 显示出最大的覆盖范围和潜力，可以实现高水平的HIV知识以及与 艾滋病毒护理。使用基于社区的咨询和测试计划，该建议将提供准备作为 人口级预防计划是基本减少艾滋病毒事件所必需的。 我们建议通过以下特定目的回答我们的关键研究问题：1）评估青少年 通过大型社区的艾滋病毒咨询服务时，女孩和年轻妇女对PREP的吸收 以及南非城市和粗糙环境中的测试（CBCT）平台，2）评估基于社区的可扩展 干预措施以实现预防有效的遵守AGYW的准备，3）衡量差异 准备受体，非受体和延迟的发起人的风险概况。为了实现目标1，我们将利用 我们正在进行的，规模的CBCT计划和平台（移动设备和系统家庭测试）以识别 并将AGYW链接到基于社区的准备计划服务。为了实现目标2，我们将执行3臂 随机对照试验，参与者随机分配到以下臂之一：ARM 1）基于小组的 类似于艺术依从俱乐部的社区健康俱乐部；手臂2）一对一的依从性咨询和支持； ARM 3）基于社区的药物药房。最后，当准备受体被注册到 作为目标1的一部分，研究将作为对照组招募516个衰落准备的人，以（a）测量 PREP受体和非接受者中性传播感染和HIV感染的发病率，（b）：评估性行为和自我 那些接受和不接受准备的人的感知风险，（c）：确定个人比例 延迟准备计划，并描述其延迟主动性的原因。

项目成果

Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa.

• DOI: 10.1002/jia2.26175
• 发表时间: 2023-09
• 期刊: JOURNAL OF THE INTERNATIONAL AIDS SOCIETY
• 影响因子: 6
• 作者: de Vos, Lindsey;Mudzingwa, Emily Krogstad;Fynn, Lauren;Atujuna, Millicent;Mugore, Matinatsa;Gandhi, Monica;Celum, Connie;Hosek, Sybil;Bekker, Linda-Gail;Daniels, Joseph;Medina-Marino, Andrew
• 通讯作者: Medina-Marino, Andrew

Outcomes from a multimodal, at-scale community-based HIV counselling and testing programme in twelve high HIV burden districts in South Africa.

• DOI: 10.1002/jia2.25678
• 发表时间: 2021-03
• 期刊: Journal of the International AIDS Society
• 影响因子: 6
• 作者: Medina-Marino A;Daniels J;Bezuidenhout D;Peters R;Farirai T;Slabbert J;Guloba G;Johnson S;Bekker LG;Nkhwashu N
• 通讯作者: Nkhwashu N

"I know why I am taking this pill": Young women navigation of disclosure and support for PrEP uptake and adherence in Eastern Cape Province, South Africa.

• DOI: 10.1371/journal.pgph.0000636
• 发表时间: 2023
• 期刊: PLOS global public health

Incremental costs of integrated PrEP provision and effective use counselling in community-based platforms for adolescent girls and young women in South Africa: an observational study.

• DOI: 10.1002/jia2.25875
• 发表时间: 2022-03
• 期刊: Journal of the International AIDS Society
• 影响因子: 6
• 作者: Mudimu E;Sardinia J;Momin S;Medina-Marino A;Bezuidenhout C;Bekker LG;Barnabas RV;Peebles K
• 通讯作者: Peebles K

The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa-study protocol.

• DOI: 10.1186/s13063-021-05402-6
• 发表时间: 2021-07-26
• 期刊: Trials
• 影响因子: 2.5
• 作者: Medina-Marino A;Bezuidenhout D;Hosek S;Barnabas RV;Atujuna M;Bezuidenhout C;Ngwepe P;Peters RPH;Little F;Celum CL;Daniels J;Bekker LG
• 通讯作者: Bekker LG