RP5 MPT Study

RP5 MPT 研究

基本信息

  • 批准号:
    10595905
  • 负责人:
  • 金额:
    $ 73.09万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2023
  • 资助国家:
    美国
  • 起止时间:
    2023-01-25 至 2029-11-30
  • 项目状态:
    未结题

项目摘要

PROJECT SUMMARY Adolescents assigned female at birth (AFAB) in the United States (US) have unmet needs for pregnancy and HIV prevention; 75% of pregnancies in adolescents are unplanned and 12% of new HIV diagnoses occur in youth aged 13-24 years AFAB. Sexual and gender minority (SGM) youth may have particular vulnerabilities and yet their sexual and reproductive health needs are often overlooked or misunderstood. Multi-purpose prevention technology (MPT) products that can simultaneously prevent pregnancy, suppress menses, and prevent HIV are desirable, may bring efficiencies to both users and healthcare systems, and may serve to improve uptake of HIV prevention products among youth. Early studies suggest that adolescents AFAB would prefer an MPT that is discreet and long-lasting, with injections being a preferred delivery modality. The success of cabotegravir (CAB) as the first generally safe and highly effective long-acting systemic agent for HIV prevention opens up opportunities for the development of an injectable MPT that combines CAB with an effective contraceptive, like levonorgestrel (LNG); LNG has been widely used and has an established safety track record. CONRAD has developed a first-in-class long acting systemic MPT that consists of a bioresorbable injectable depot and that employs a novel drug delivery technology to deliver both CAB and LNG together for at least three months, and possibly longer. Pre-clinical studies in rats and non-human primates show promise. To advance the development of this injectable CAB/LNG MPT our team with complementary expertise will conduct studies to 1) assess the values and preferences for a novel MPT for pregnancy and HIV prevention in adolescent cisgender women (CW) and transgender men (TM) AFAB aged 16-24 years in the USA, using a combination of qualitative interviews and participatory attitudinal ranking approaches to inform the selection of attributes and levels for a Discrete Choice Experiment to be conducted in a sample of 200 CW and 200 TM AFAB; and 2) conduct a multi-site, phase I, single arm PK trial of the CAB/LNG injectable biodegradable depot in a sample of 16 healthy, HIV-negative adolescents and young adults AFAB, ages 18-24, to assess the safety and pharmacokinetic profile of the products in CW and TM AFAB who are receiving gender-affirming hormone therapy. Incorporation of end-user preferences for MPTs early on in product development can enhance acceptability, optimize uptake and use, and ultimately ensure public health benefit. The evaluation of the safety, acceptability and pharmacology of a first in-human CAB/LNG biodegradable depot injection in CW and TM youth will ensure that data on adolescents across genders is available for regulators should co-formulated CAB/LNG move forward for licensure. The availability of a highly effective, long-acting MPT that places a premium on safety and acceptability in adolescents AFAB across genders, has the potential to accelerate access to effective sexual and reproductive health, to potentially address disparities in health access for SGM populations, and to have a substantial impact on the HIV epidemic.
项目总结

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

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Lisa B Hightow-Weidman其他文献

Studying the Digital Intervention Engagement–Mediated Relationship Between Intrapersonal Measures and Pre-Exposure Prophylaxis Adherence in Sexual and Gender Minority Youth: Secondary Analysis of a Randomized Controlled Trial
研究数字干预参与度——性少数青年中人际测量与暴露前预防依从性之间的中介关系:一项随机对照试验的二次分析
  • DOI:
    10.2196/57619
  • 发表时间:
    2025-01-01
  • 期刊:
  • 影响因子:
    6.000
  • 作者:
    Michael P Williams;Justin Manjourides;Louisa H Smith;Crissi B Rainer;Lisa B Hightow-Weidman;Danielle F Haley
  • 通讯作者:
    Danielle F Haley

Lisa B Hightow-Weidman的其他文献

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{{ truncateString('Lisa B Hightow-Weidman', 18)}}的其他基金

Scientific Leadership Group Core
科学领导小组核心
  • 批准号:
    10595900
  • 财政年份:
    2023
  • 资助金额:
    $ 73.09万
  • 项目类别:
RP4 LEAP
RP4飞跃
  • 批准号:
    10595904
  • 财政年份:
    2023
  • 资助金额:
    $ 73.09万
  • 项目类别:
RP3 PrEP Choice
RP3 PrEP 选择
  • 批准号:
    10595903
  • 财政年份:
    2023
  • 资助金额:
    $ 73.09万
  • 项目类别:
Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Scientific Leadership Center
艾滋病毒/艾滋病干预青少年医学试验网络 (ATN) 科学领导中心
  • 批准号:
    10595899
  • 财政年份:
    2023
  • 资助金额:
    $ 73.09万
  • 项目类别:
RP1 Screen 2 Prevent
RP1 屏蔽 2 预防
  • 批准号:
    10595901
  • 财政年份:
    2023
  • 资助金额:
    $ 73.09万
  • 项目类别:
RP7 Impact
RP7 影响
  • 批准号:
    10595907
  • 财政年份:
    2023
  • 资助金额:
    $ 73.09万
  • 项目类别:
Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)Scientific Leadership Center; ADMIN SUPPLEMENT
艾滋病毒/艾滋病干预青少年医学试验网络 (ATN) 科学领导中心;
  • 批准号:
    10855435
  • 财政年份:
    2023
  • 资助金额:
    $ 73.09万
  • 项目类别:
PrEP Choice: Increasing the Use of HIV Pre-exposure Prophylaxis in an Era of Choices
PrEP 选择:在选择时代增加 HIV 暴露前预防的使用
  • 批准号:
    10775220
  • 财政年份:
    2022
  • 资助金额:
    $ 73.09万
  • 项目类别:
PrEP Choice: Increasing the Use of HIV Pre-exposure Prophylaxis in an Era of Choices
PrEP 选择:在选择时代增加 HIV 暴露前预防的使用
  • 批准号:
    10804710
  • 财政年份:
    2022
  • 资助金额:
    $ 73.09万
  • 项目类别:
The UNC/Emory Center for Innovative Technology (iTech) across the prevention and care continuum
北卡罗来纳大学/埃默里大学创新技术中心 (iTech) 涵盖预防和护理连续体
  • 批准号:
    10399185
  • 财政年份:
    2021
  • 资助金额:
    $ 73.09万
  • 项目类别:

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