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临床试验/NCT07006246
NCT07006246进行中(未招募)4 期

Utilizing Private Pharmacies to Initiate High Risk Young Women and Men on Pre-exposure Prophylaxis (PrEP) in South Africa

Professor Francois Venter1 个研究点 分布在 1 个国家目标入组 1,900 人开始时间: 2023年5月19日最近更新:
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
1,900
试验地点
1
主要终点
Number of pharmacies providing Prep services over 13 months

研究概览

简要总结

This is a funded implementation study designed to evaluate the efficacy of recruiting and retaining high-risk individuals on pre-exposure prophylaxis (PrEP) within multiple private pharmacies (and online platforms in South Africa)

详细描述

This is a two-stage (formative and implementation) study. It will employ a mixed-method approach-specifically, a divergent parallel design. The study will use the EPIS framework (Exploration, Preparation, Implementation, and Sustainability) as an overarching implementation structure to Formalise stakeholder partnerships and tailor the proposed service delivery models (intervention package) for the implementation context.

The study chose EPIS as it considers the multilevel nature of healthcare, organizations within systems, and patient needs. Using the capability, opportunity, and motivation for behaviour (COM-B) change model, the study will assess the readiness of pharmacists, pharmacy nurses, and pharmacy clinics to adopt and implement the service delivery models. The study will use participatory human-centred stakeholder engagement to inform appropriateness, acceptability, and feasibility of the service delivery models, priorities for tailoring, and responsibilities for implementation.

As a multi-centre pharmacy-initiated implementation study, the project is designed to assess the feasibility and acceptability of in-pharmacy oral PrEP initiation, and oral PrEP initiation utilizing a virtual model and in-pharmacy administration. Additionally, this study will provide information about tolerability, safety, and preferences on accessing prophylactic HIV services. In the formative phase, cross-sectional data collection will take place, while during the implementation stage, young women and men will be screened and recruited to the study across sites in Gauteng and the Western Cape and will be followed over 13 months (prospective, longitudinal).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult male or female (≥18 and ≤ 35 years old)
  • HIV negative at the time of study enrolment (as determined by a rapid blood test for HIV 1,2)
  • Absence of symptoms of acute HIV infection*
  • Body weight ≥ 35 kg
  • Creatinine clearance ≥ 50 mL/min
  • Willingness to take PrEP as prescribed and to comply with study procedures.
  • Willingness to be followed up throughout the duration of the study.

排除标准

  • Confirmed HIV positive by routine antibody testing
  • Presence of symptoms of acute HIV infection*
  • Creatinine clearance (eGFR) of:
  • Less than 50 mL/min/1.73m2 for adults
  • For pregnant women: serum creatinine (sCr) greater than 85 µmol/L
  • Known hypersensitivity to or specific contraindications to the use of TDF or FTC/3TC
  • Self-reported presence or history of liver cirrhosis (Child-Pugh Class B or greater), with or without viral hepatitis co-infection
  • Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the participant. This will be an investigator-led determination based on the medical history of the participant. This includes, but is not limited to:
  • Severe hepatic impairment or history of liver cirrhosis with or without viral hepatitis co-infection.
  • Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results.
  • Inability or unwillingness to be followed up for the study period
  • Pregnant and lactating women

研究组 & 干预措施

Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC)

Other

Dosage Formulation: 300 mg / 200 mg (300mg) fixed dose combination tablet Route of Administration: Oral Dosing Instructions: 1 tablet (300/200/ TDF/FTC) daily or (300/300/TDF/3TC) daily

干预措施: Tenofovir disoproxil fumarate + lamivudine/emtricitabine (TDF+3TC /FTC) (Drug)

结局指标

主要结局

Number of pharmacies providing Prep services over 13 months

时间窗: 13 Months

Acceptability of pharmacy-delivered PrEP services will be determined by qualitative and quantitative assessment using piloted and validated semi-structured questionnaires for acceptability.

Number of participants accessing PrEP online services over 13 months

时间窗: 13 Months

Acceptability of online-delivered PrEP services will be determined by qualitative and quantitative assessment using piloted and validated semi-structured questionnaires for acceptability.

次要结局

  • To describe provider experiences and perceptions of pharmacy and online-delivered PrEP(13 Months)
  • To describe user experiences and perceptions of pharmacy and online-delivered PrEP(13 Months)

研究者

发起方
Professor Francois Venter
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Professor Francois Venter

Executive Director: Ezintsha

University of Witwatersrand, South Africa

研究点 (1)

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