NCT03874663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
652

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2020

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

March 12, 2019

Last Update Submit

March 7, 2024

Conditions

HIV Prevention

Keywords

HIVHIV self-testingyoung peopleNigeria

Outcome Measures

Primary Outcomes (2)

  • Performance of HIV Self-testing

    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.

    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.

  • HIV Self-testing Acceptability

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

    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.

Secondary Outcomes (4)

  • 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.

  • 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.

Study Arms (1)

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)

Interventions

Directly assisted oral HIV self-testing (HIVST)DEVICE

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. 4. To explore the feasibility, acceptability and appropriateness of using a mobile photo verification app to verify HIV self-testing results.

Also known as: OraQuick ADVANCE Rapid HIV 1/2 Antibody Test
Oral HIV Self-testing

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigerian Institute of Medical Research

Yaba, Lagos, 00000, Nigeria

Location

Related Publications (16)

  • Nigeria Framework. National HIV and AIDS Strategic Framework. 2017-2021.

    BACKGROUND

  • NACA. Federal Republic of Nigeria, Global AIDS Report: Country Progress Report. 2015. Accessed Novembner, 2015.

    BACKGROUND

  • NDHS. National Population Commision; Nigerian Demographic and Health Survey Reports. 2013.

    BACKGROUND

  • Asaolu IO, Gunn JK, Center KE, Koss MP, Iwelunmor JI, Ehiri JE. Predictors of HIV Testing among Youth in Sub-Saharan Africa: A Cross-Sectional Study. PLoS One. 2016 Oct 5;11(10):e0164052. doi: 10.1371/journal.pone.0164052. eCollection 2016.

    PMID: 27706252BACKGROUND

  • Sekoni AO, Somefun EO, Fatoba OO, Onajole AT. Use of HIV Screening Services and Sexual Behavior of In-School Adolescents in Surulere LGA, Lagos State. Nig Q J Hosp Med. 2015 Jul-Sep;25(3):202-8.

    PMID: 27295814BACKGROUND

  • Sam-Agudu NA, Folayan MO, Ezeanolue EE. Seeking wider access to HIV testing for adolescents in sub-Saharan Africa. Pediatr Res. 2016 Jun;79(6):838-45. doi: 10.1038/pr.2016.28. Epub 2016 Feb 16.

    PMID: 26882367BACKGROUND

  • Tucker JD, Wei C, Pendse R, Lo YR. HIV self-testing among key populations: an implementation science approach to evaluating self-testing. J Virus Erad. 2015 Jan;1(1):38-42. doi: 10.1016/S2055-6640(20)31145-6.

    PMID: 26005717BACKGROUND

  • Indravudh PP, Sibanda EL, d'Elbee M, Kumwenda MK, Ringwald B, Maringwa G, Simwinga M, Nyirenda LJ, Johnson CC, Hatzold K, Terris-Prestholt F, Taegtmeyer M. 'I will choose when to test, where I want to test': investigating young people's preferences for HIV self-testing in Malawi and Zimbabwe. AIDS. 2017 Jul 1;31 Suppl 3(Suppl 3):S203-S212. doi: 10.1097/QAD.0000000000001516.

    PMID: 28665878BACKGROUND

  • Smith P, Wallace M, Bekker LG. Adolescents' experience of a rapid HIV self-testing device in youth-friendly clinic settings in Cape Town South Africa: a cross-sectional community based usability study. J Int AIDS Soc. 2016 Jan;19(1):21111. doi: 10.7448/IAS.19.1.21111. Epub 2016 Dec 23.

    PMID: 28406597BACKGROUND

  • Jennings L, Conserve DF, Merrill J, Kajula L, Iwelunmor J, Linnemayr S, Maman S. Perceived Cost Advantages and Disadvantages of Purchasing HIV Self-Testing Kits among Urban Tanzanian Men: An Inductive Content Analysis. J AIDS Clin Res. 2017 Aug;8(8):725. doi: 10.4172/2155-6113.1000725. Epub 2017 Aug 31.

    PMID: 29051841BACKGROUND

  • WHO. HIV Testing Services: WHO recommends HIV Self-testing. Geneva2016.

    BACKGROUND

  • Ozer EJ. Youth-Led Participatory Action Research: Developmental and Equity Perspectives. Adv Child Dev Behav. 2016;50:189-207. doi: 10.1016/bs.acdb.2015.11.006. Epub 2016 Jan 25.

    PMID: 26956074BACKGROUND

  • 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

    BACKGROUND

  • Ozer EJ. Youth-led participatory action research. Handbook of methodological approaches to community-based research: Qualitative, quantitative, and mixed methods. 2016:263-272

    BACKGROUND

  • Cammarota J, Fine M. Revolutionizing education : youth participatory action research in motion. New York, NY: Routledge; 2008

    BACKGROUND

  • Tun W, Vu L, Dirisu O, Sekoni A, Shoyemi E, Njab J, Ogunsola S, Adebajo S. Uptake of HIV self-testing and linkage to treatment among men who have sex with men (MSM) in Nigeria: A pilot programme using key opinion leaders to reach MSM. J Int AIDS Soc. 2018 Jul;21 Suppl 5(Suppl Suppl 5):e25124. doi: 10.1002/jia2.25124.

    PMID: 30033680BACKGROUND

Related Links

Study Officials

  • Juliet Iwelunmor, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine Washington University School of Medicine in St. Louis

Study Record Dates

First Submitted

March 12, 2019

First Posted

March 14, 2019

Study Start

November 20, 2018

Primary Completion

May 8, 2020

Study Completion

May 8, 2020

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

NG(1)