NCT03874663|CompletedDMCFDA Device
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Sponsor study identifier
Secondary identifiers
NIH
observational
652
1 country
1
Study Start
November 20, 2018
Actual (reported)Primary Completion
May 8, 2020
Actual (reported)Study Completion
May 8, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 8, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 20, 2018
Actual (reported)March 12, 2019
Actual (reported)March 14, 2019
Actual (reported)May 8, 2020
Actual (reported)May 8, 2020
Actual (reported)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.
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.
Evaluate the acceptability and performance of a directly assisted oral HIV self-testing (HIVST) in a youth population aged 14-24 in Nigeria
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Nigerian Institute of Medical Research
Yaba, Lagos, 00000, Nigeria
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.
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.
Juliet Iwelunmor, PhD
Washington University School of Medicine
652 participants (actual enrollment reported by the registry).
First Submitted
March 12, 2019
First Posted
March 14, 2019
Study Start
November 20, 2018
Actual (reported)Scalable Interventions to Increase PrEP Adherence: Value Affirmation and Future Selves
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
WHO. HIV Testing Services: WHO recommends HIV Self-testing. Geneva2016.
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.
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
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.
Primary Completion
May 8, 2020
Actual (reported)Study Completion
May 8, 2020
Actual (reported)Last Updated
March 12, 2024
Record last verified: 2024-03
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