Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 83842 for:    testing
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03874663
Recruitment Status : Active, not recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborators:
Nigerian Institute of Medical Research
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Juliet Iwelunmor, PhD, St. Louis University

Brief Summary:
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.

Condition or disease Intervention/treatment
HIV Prevention Device: Directly assisted oral HIV self-testing (HIVST)

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acceptability and Performance of HIV Self-Testing in a Youth Population in Nigeria
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Oral HIV Self-testing
Evaluate the acceptability and performance of a directly assisted oral HIV self-testing (HIVST) in a youth population aged 14-24 in Nigeria
Device: Directly assisted oral HIV self-testing (HIVST)
  1. To determine the ability of participants with unknown HIV status to correctly perform oral HIVST;
  2. To compare the results of the oral HIVST with confirmatory rapid finger prick HIV test.
  3. To explore participants attitudes and preferences towards oral HIVST.
Other Name: OraQuick ADVANCE Rapid HIV 1/2 Antibody Test




Primary Outcome Measures :
  1. Performance of HIV Self-testing [ Time Frame: 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.

  2. HIV Self-testing Acceptability [ Time Frame: 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


Secondary Outcome Measures :
  1. HIV self-testing knowledge [ Time Frame: 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. ]
    Questions related to HIV self-testing knowledge is included in the pre- and post- questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals aged 14-24 years old and residing in Lagos, Nigeria. Individuals who do not know their HIV status because they have never tested or their last HIV test was negative.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874663


Locations
Layout table for location information
Nigeria
Nigerian Institute of Medical Research
Yaba, Lagos, Nigeria, 00000
Sponsors and Collaborators
St. Louis University
Nigerian Institute of Medical Research
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Juliet Iwelunmor, PhD St. Louis University

Additional Information:
Publications:
Nigeria Framework. National HIV and AIDS Strategic Framework. 2017-2021.
NACA. Federal Republic of Nigeria, Global AIDS Report: Country Progress Report. 2015. Accessed Novembner, 2015.
NDHS. National Population Commision; Nigerian Demographic and Health Survey Reports. 2013.
WHO. HIV Testing Services: WHO recommends HIV Self-testing. Geneva2016.
Ozer EJ, Piatt AA, Holsen I, Larsen T, Lester J, Ozer EM. INNOVATIVE APPROACHES TO PROMOTING POSITIVE YOUTH DEVELOPMENT IN DIVERSE CONTEXTS. Positive Youth Development in Global Contexts of Social and Economic Change. 2016:12
Ozer EJ. Youth-led participatory action research. Handbook of methodological approaches to community-based research: Qualitative, quantitative, and mixed methods. 2016:263-272
Cammarota J, Fine M. Revolutionizing education : youth participatory action research in motion. New York, NY: Routledge; 2008

Layout table for additonal information
Responsible Party: Juliet Iwelunmor, PhD, Dr., St. Louis University
ClinicalTrials.gov Identifier: NCT03874663     History of Changes
Other Study ID Numbers: 29882
1UG3HD096929-01 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Juliet Iwelunmor, PhD, St. Louis University:
HIV
HIV self-testing
young people
Nigeria