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临床试验/NCT03874663
NCT03874663已完成不适用

Acceptability and Performance of HIV Self-Testing in a Youth Population in Nigeria

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 652 人开始时间: 2018年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
652
试验地点
1
主要终点
Performance of HIV Self-testing

研究概览

简要总结

The purpose of this study is to evaluate the acceptability and performance of a directly assisted oral HIV self-testing (HIVST) program in a youth population aged 14-24 in Nigeria. The study is oral HIV self-testing (HIVST) program in a youth population aged 14-24 in Nigeria. The study is focused on assessing young people's ability to correctly perform the test.

详细描述

Nigerian youth aged 14-24 make up a significant proportion of Sub-Saharan African youth newly diagnosed with HIV. However, they do not access essential HIV prevention services, like routine HIV testing, pre-exposure prophylaxis (PrEP) and sexually transmitted infection (STI) testing.This is partly explained by barriers that are individual (fear, and low perceived risk), social (insufficient social support) and structural (poor access to testing) factors. Additionally, the most affected groups of young people have remained largely unreached by traditional HIV testing services.

HIV self-testing (HIVST) can mitigate some of these barriers by decentralizing HIV testing,decreasing stigma, and linking HIV-negative individuals with preventive services. HIVST is a process in which a person collects his or her own specimen (oral fluid or blood) using a simple rapid HIV test and then performs the test and interprets the result, often in a private setting, either alone or with someone he or she trusts. HIVST offers an alternative to facility-based HIV testing services, particularly for youth populations who may fear to get tested for HIV due to stigma and discrimination. Recognizing the expanding evidence supporting the effectiveness of HIVST, particularly the OraQuick HIV self-testing kits (see Tun et al, 2018; Nagendo et al., 2017; Kurth et al., 2016; Choko et al., 2016; and WHO pre-qualification report under the Publications Tab), the World Health Organization released HIVST guidelines in 2016.

This study is in part with a parent study called ITEST (Innovative Tools to Expand HIV Self-Testing) aimed at developing and implementing innovative youth-friendly HIV self-testing services through open challenges and apprenticeships that provides youth opportunities to learn about social problems (like HIV) that affect their lives and then propose actions to address these problems, informed by the youth participatory action research framework (YPAR).

Recent study conducted in Nigeria, already demonstrate the feasibility and acceptability of HIVST among 257 men sleeping with men (MSMs) in Nigeria (see paper by Tun, 2018). In that study, 97% reported using the HIVST kits. Almost all participants reported that the HIVST kit instructions were easy or somewhat easy to understand (99.6%) and perform the test (98.0%).The most common reasons they liked the test were ease of use (87.3%), confidentiality/privacy (82.1%), convenience (74.1%) and absence of needle pricks (64.9%).

However given the need for youth friendly HIV testing services that are accessible, acceptable, appropriate and effective to address the specialized needs of young people and the public health implications of unknown HIV status, especially among young people, the purpose of this study is to evaluate the acceptability and performance of directly assisted oral HIVST in a youth population in Nigeria.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who are agree to provide consent
  • Residing in Lagos
  • Between the ages of 14 to 24 years

排除标准

  • Younger than 14 and older than 24
  • Inability to comply with study protocol
  • Illness, cognitive impairment or threatening behavior with acute risk to self or others
  • No informed consent
  • Do not reside in Nigeria

结局指标

主要结局

Performance of HIV Self-testing

时间窗: Specifically for data collection, we anticipate that the entire study will take 2 hours to complete, 1 hours and 30 minutes for HIV self-testing and confirmatory rapid HIV blood-prick test and 30 minutes for the pre-and-post test HIV questionnaires.

The ability of participants with unknown HIV status to correctly perform and interpret an oral HIV self-test and compare their results to staff/lab testing.

HIV Self-testing Acceptability

时间窗: Specifically for data collection, we anticipate that the entire study will take 2 hours to complete, 1 hours and 30 minutes for HIV self-testing and confirmatory rapid HIV blood-prick test and 30 minutes for the pre-and-post test HIV questionnaires.

Pre- and post-HIV self-testing importance, confidence, and acceptability

次要结局

  • Acceptability of HIV self-testing photo verification app(Specifically for data collection, we anticipate that the entire study will take 2 hours to complete, 1 hours and 30 minutes for HIV self-testing and confirmatory rapid HIV blood-prick test and 10 minutes to complete the acceptability questions.)
  • Appropriateness of HIV self-testing photo verification app(Specifically for data collection, we anticipate that the entire study will take 2 hours to complete, 1 hours and 30 minutes for HIV self-testing and confirmatory rapid HIV blood-prick test and 10 minutes to complete the appropriateness questions.)
  • HIV self-testing knowledge(Specifically for data collection, we anticipate that the entire study will take 2 hours to complete, 1 hours and 30 minutes for HIV self-testing and confirmatory rapid HIV blood-prick test and 30 minutes for the pre-and-post test HIV questionnaires.)
  • Feasibility of HIV self-testing photo verification app(Specifically for data collection, we anticipate that the entire study will take 2 hours to complete, 1 hours and 30 minutes for HIV self-testing and confirmatory rapid HIV blood-prick test and 10 minutes to complete the feasibility questions.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juliet Iwelunmor, PhD

Professor of Medicine Washington University School of Medicine in St. Louis

Washington University School of Medicine

研究点 (1)

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