NCT04070287

Brief Summary

The I-TEST study builds upon two participatory approaches, open challenge contests and entrepreneurship training. The study utilizes open challenge contest to generate youth-driven interventions on strategies to promote HIV self-testing and other testing for other sexually transmitted infections (STIs) among young people in Nigeria. Open challenge contests involves leveraging on the knowledge and strengths of the crowd (in this case young people) to generate solutions to an issue. Following completion of one of the open challenge contest, was the Designathon contest where young people in Nigeria collaborated to develop new services and products for promoting self-testing for HIV and other sexually transmitted diseases, guided by human-centered, design thinking framework. After which, six teams from the Designathon were selected to move onto an Innovation bootcamp. The Innovation bootcamp was a 4-week long accelerated training program for young people to delve into the world of entrepreneurial and innovation management skills, while applying basic research principles. At the end of the course, 5 finalist teams were selected to pilot test their innovation plan in the community for a duration of 6 months, beginning July 2019. This study is focused on evaluating the effectiveness of these five youth participatory interventions on HIV testing and other key prevention among at risk youth (14-24 years old in Nigeria).This research study will involve undertaking a prospective one-year assessment of these five pilot interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
388

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2019

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

July 1, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

September 14, 2021

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

July 20, 2019

Results QC Date

July 27, 2021

Last Update Submit

December 19, 2023

Conditions

Keywords

HIV PreventionHIV self-testingyoung peopleNigeria

Outcome Measures

Primary Outcomes (1)

  • Uptake of HIV Self-testing Over the 3 Months Follow-up

    Proportion of participants who reported to have self-tested for HIV at 3-month after baseline.

    3 months following the first encounter

Secondary Outcomes (5)

  • Uptake of HIV Testing Over the 6 Months Follow-up

    6-month

  • Uptake of Syphilis Testing

    6-month

  • Uptake of Gonorrhea Testing

    6-month

  • Uptake of Hepatitis b Testing

    6-month

  • Uptake of Chlamydia Testing

    6-month

Study Arms (5)

SMART Pack

ACTIVE COMPARATOR

This involves using "SMART Pack" a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers.

Combination Product: SMART Pack

Luv Box

ACTIVE COMPARATOR

The intervention involves using "Luv Box" a box that include personal hygiene products and HIV self-testing kit as strategy to promote uptake of HIV testing among young people.

Combination Product: Luv Box

Bili Vibes

ACTIVE COMPARATOR

The intervention involves using a program program called "Bili" that leverages community youth events such as football matches as a strategy to promote the uptake of HIV self-testing among young people.

Combination Product: Bili Vibes

BeterDoc

ACTIVE COMPARATOR

This intervention involve using "BeterDoc Safety kits" that includes HIV self-testing kit, location and phone number to the health centers in the community as a strategy to promote update of HIV self-testing among young people.

Combination Product: BeterDoc

IUNGO

ACTIVE COMPARATOR

This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people.

Combination Product: IUNGO

Interventions

SMART PackCOMBINATION_PRODUCT

The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state.

Also known as: The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
SMART Pack
Luv BoxCOMBINATION_PRODUCT

The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "Luv Box" and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state.

Also known as: The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Luv Box
Bili VibesCOMBINATION_PRODUCT

The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state.

Also known as: The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Bili Vibes
BeterDocCOMBINATION_PRODUCT

The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the "BeterDoc Safety Kits" and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state.

Also known as: The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
BeterDoc
IUNGOCOMBINATION_PRODUCT

The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state.

Also known as: The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
IUNGO

Eligibility Criteria

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

You may qualify if:

  • Age 14-24
  • Self-reported HIV negative or unknown HIV status
  • Current resident of Lagos, Ondo, Oyo, and Enugu with plans to stay in city for the next 6 months
  • Able to complete survey in English (the national language of Nigeria)
  • All participants must agree to an informed consent and provide their cell mobile number for follow-up and retention

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
  • No contact phone number
  • Do not reside in Lagos, Ondo, Oyo, and Enugu

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigerian Institute of Medical Research

Yaba, Lagos, 00000, Nigeria

Location

Related Publications (23)

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

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

    BACKGROUND
  • Ozer EJ, Newlan S, Douglas L, Hubbard E. "Bounded" empowerment: analyzing tensions in the practice of youth-led participatory research in urban public schools. Am J Community Psychol. 2013 Sep;52(1-2):13-26. doi: 10.1007/s10464-013-9573-7.

    PMID: 23444005BACKGROUND
  • Jacquez F, Vaughn LM, Wagner E. Youth as partners, participants or passive recipients: a review of children and adolescents in community-based participatory research (CBPR). Am J Community Psychol. 2013 Mar;51(1-2):176-89. doi: 10.1007/s10464-012-9533-7.

    PMID: 22718087BACKGROUND
  • Zhang Y, Kim JA, Liu F, Tso LS, Tang W, Wei C, Bayus BL, Tucker JD. Creative Contributory Contests to Spur Innovation in Sexual Health: 2 Cases and a Guide for Implementation. Sex Transm Dis. 2015 Nov;42(11):625-8. doi: 10.1097/OLQ.0000000000000349.

    PMID: 26462186BACKGROUND
  • Halpern R. The means to grow up: Reinventing apprenticeship as a developmental support in adolescence. Routledge; 2013.

    BACKGROUND
  • Louw J, Peltzer K, Chirinda W. Correlates of HIV risk reduction self-efficacy among youth in South Africa. ScientificWorldJournal. 2012;2012:817315. doi: 10.1100/2012/817315. Epub 2012 Nov 28.

    PMID: 23251106BACKGROUND
  • Sayles JN, Pettifor A, Wong MD, MacPhail C, Lee SJ, Hendriksen E, Rees HV, Coates T. Factors associated with self-efficacy for condom use and sexual negotiation among South african youth. J Acquir Immune Defic Syndr. 2006 Oct 1;43(2):226-33. doi: 10.1097/01.qai.0000230527.17459.5c.

    PMID: 16951647BACKGROUND
  • Tiffany JS, Exner-Cortens D, Eckenrode J. A New Measure for Assessing Youth Program Participation. J Community Psychol. 2012 Apr 1;40(3):277-291. doi: 10.1002/jcop.20508.

    PMID: 23843679BACKGROUND
  • Gbaja-Biamila T, Obiezu-Umeh C, Nwaozuru U, Rosenberg NE, Igbokwe M, Oladele D, Musa AZ, Idigbe I, Conserve D, Day S, Tahlil K, Ong J, Muessig K, Nkengasong S, Xian H, Tucker JD, Ezechi O, Iwelunmor J. Awareness of, willingness to use, and experiences with Pre-exposure prophylaxis among youth in Nigeria. BMC Health Serv Res. 2024 Sep 27;24(1):1128. doi: 10.1186/s12913-024-11459-1.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Juliet Iwelunmor
Organization
Saint Louis University

Study Officials

  • Juliet Iwelunmor, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR
  • Joseph Tucker, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR
  • Oliver Ezechi, MD

    Nigerian Institute of Medical Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Intervention Pilot This study protocol will involve undertaking a prospective one-year assessment of five youth participatory interventions. These interventions are focused on promoting HIV self-testing and referrals to health facilities for other sexually transmitted infections test.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine Washington University School of Medicine

Study Record Dates

First Submitted

July 20, 2019

First Posted

August 28, 2019

Study Start

July 1, 2019

Primary Completion

July 31, 2020

Study Completion

September 1, 2020

Last Updated

December 21, 2023

Results First Posted

September 14, 2021

Record last verified: 2023-12

Locations