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Innovative Tools to Expand HIV Self-Testing (I-TEST)

Primary Purpose

HIV/AIDS, Sexually Transmitted Diseases

Status
Completed
Phase
Early Phase 1
Locations
Nigeria
Study Type
Interventional
Intervention
SMART Pack
Luv Box
Bili Vibes
BeterDoc
IUNGO
Sponsored by
St. Louis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring HIV Prevention, HIV self-testing, young people, Nigeria

Eligibility Criteria

14 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Younger than 14 and older than 24
  2. Inability to comply with study protocol
  3. Illness, cognitive impairment or threatening behavior with acute risk to self or others
  4. No informed consent
  5. No contact phone number
  6. Do not reside in Lagos, Ondo, Oyo, and Enugu

Sites / Locations

  • Nigerian Institute of Medical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

SMART Pack

Luv Box

Bili Vibes

BeterDoc

IUNGO

Arm Description

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

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.

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Uptake of HIV Testing Over the 6 Months Follow-up
Proportion of participants who reported to have self-tested for HIV at 6-month after baseline.
Uptake of Syphilis Testing
Proportion of participants who reported syphilis testing at baseline and 6-month.
Uptake of Gonorrhea Testing
Proportion of participants who reported gonorrhea testing at baseline and 6-month.
Uptake of Hepatitis b Testing
Proportion of participants who reported hepatitis B testing.
Uptake of Chlamydia Testing
Proportion of participants who reported chlamydia testing at baseline and 6-month.

Full Information

First Posted
July 20, 2019
Last Updated
September 13, 2021
Sponsor
St. Louis University
Collaborators
National Institutes of Health (NIH), Nigerian Institute of Medical Research, University of North Carolina, Chapel Hill, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04070287
Brief Title
Innovative Tools to Expand HIV Self-Testing
Acronym
I-TEST
Official Title
Innovative Tools to Expand HIV Self-Testing
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
Collaborators
National Institutes of Health (NIH), Nigerian Institute of Medical Research, University of North Carolina, Chapel Hill, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Step 1: Participant enrollment. This will involve recruiting youth to participate in the pilot study. Participant recruitment strategies will include: social media, online, event- and venue based, participant referral, and walk-ins at study clinics. Participant enrollment will be completed by study team. Step 2: Intervention implementation. Following participant recruitment and enrollment in the study. Study participants will be assigned to one of the 5 youth participatory interventions focused on expanding the uptake of HIV self-testing and key HIV prevention services. The pilot intervention implementation would occur for 6 months. Nigerian Institute of Medical Research (NMIR) will provide local training on HIV prevention to the five participatory interventions following their existing guidelines.The participatory interventions will be conducted in the locations of the five teams who emerged as winners from the innovation boot-camp. These participatory interventions will only provide HIV self-testing kits and instructions of how to perform the test to participants. They will also provide referral coupons to youth friendly centers for sexually transmitted infections (STI) screening and treatment and pre-exposure prophylaxis (PrEP) awareness and initiation for at-risk youth. The referral coupons are intended to provide study participants information on trained youth friendly centers that are involved with the research. The referral coupons give the study participants access to other sexually transmitted infections (STI) screening and treatment and pre-exposure prophylaxis (PrEP) awareness and initiation at these health facilities. The intervention only provide participants with the HIV self-testing kits and then refer them to youth-friendly health facilities for other testing services. The intervention does not involve monitoring HIV self-testing procedure, the investigators will only be asking for self-reported HIV testing and other sexually transmitted diseases testing. Step 3: Baseline data collection. After allocation of participants into the intervention, study team will collect baseline data on HIV testing history, sexual behavior history, youth participation experience, and other related outcomes will be collected (survey questionnaire attached) from recruited participants. Participants mobile phone numbers will also be collected as tracking information for follow-up and retention in a coupon format. The mobile phone numbers would be used to contact study participants through text messages and phone calls. These contacts would serve as reminders for participants to participate in follow-up data collection. The mobile phone service charge would be covered by the research. No other personal identifiers will be collected and no biological specimens will be collected at baseline. The investigators will obtain informed consent before proceeding with any data collection. Step 4:Health facilities training. For the purposes of this research study, the Nigerian Institute of Medical Research team would provide training to youth-friendly health centers currently working with the Nigerian Institute of Medical Research based on the World Health Organization guidebook for youth-friendly health services (handbook is attached).The training would be to ensure that these health facilities are trained to provide youth friendly services to participants who be referred to receive STI screening, STI treatment and PrEP awareness and initiation. Following the training, the NIMR research team would in charge of collecting data to record record participants HIV self-testing uptake as well as uptake of STI screening, STI treatment and PrEP awareness and initiation. Step 5: Follow up surveys at 3 and 6 months: At 3 and 6 months post intervention implementation, study team will collect similar baseline data from study participants. The follow-up survey will assess HIV testing, sexual behavior history, youth participation experience and other related outcomes will be collected (survey questionnaire attached) from recruited participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Sexually Transmitted Diseases
Keywords
HIV Prevention, HIV self-testing, young people, Nigeria

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMART Pack
Arm Type
Active Comparator
Arm Description
This involves using "SMART Pack" a HIV self-testing kit to promote uptake of HIV self-testing among young people at community centers.
Arm Title
Luv Box
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Bili Vibes
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BeterDoc
Arm Type
Active Comparator
Arm Description
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.
Arm Title
IUNGO
Arm Type
Active Comparator
Arm Description
This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people.
Intervention Type
Combination Product
Intervention Name(s)
SMART Pack
Other Intervention Name(s)
The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Luv Box
Other Intervention Name(s)
The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Bili Vibes
Other Intervention Name(s)
The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
BeterDoc
Other Intervention Name(s)
The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
IUNGO
Other Intervention Name(s)
The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Uptake of HIV Self-testing Over the 3 Months Follow-up
Description
Proportion of participants who reported to have self-tested for HIV at 3-month after baseline.
Time Frame
3 months following the first encounter
Secondary Outcome Measure Information:
Title
Uptake of HIV Testing Over the 6 Months Follow-up
Description
Proportion of participants who reported to have self-tested for HIV at 6-month after baseline.
Time Frame
6-month
Title
Uptake of Syphilis Testing
Description
Proportion of participants who reported syphilis testing at baseline and 6-month.
Time Frame
6-month
Title
Uptake of Gonorrhea Testing
Description
Proportion of participants who reported gonorrhea testing at baseline and 6-month.
Time Frame
6-month
Title
Uptake of Hepatitis b Testing
Description
Proportion of participants who reported hepatitis B testing.
Time Frame
6-month
Title
Uptake of Chlamydia Testing
Description
Proportion of participants who reported chlamydia testing at baseline and 6-month.
Time Frame
6-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 No contact phone number Do not reside in Lagos, Ondo, Oyo, and Enugu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliet Iwelunmor, PhD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Tucker, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oliver Ezechi, MD
Organizational Affiliation
Nigerian Institute of Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nigerian Institute of Medical Research
City
Yaba
State/Province
Lagos
ZIP/Postal Code
00000
Country
Nigeria

12. IPD Sharing Statement

Citations:
Citation
Nigeria Framework. National HIV and AIDS Strategic Framework. 2017-2021.
Results Reference
background
Citation
NACA. Federal Republic of Nigeria, Global AIDS Report: Country Progress Report. 2015. Accessed Novembner, 2015.
Results Reference
background
Citation
NDHS. National Population Commision; Nigerian Demographic and Health Survey Reports. 2013.
Results Reference
background
PubMed Identifier
27706252
Citation
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.
Results Reference
background
PubMed Identifier
27295814
Citation
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.
Results Reference
background
PubMed Identifier
26882367
Citation
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.
Results Reference
background
PubMed Identifier
26005717
Citation
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.
Results Reference
background
PubMed Identifier
28665878
Citation
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.
Results Reference
background
PubMed Identifier
28406597
Citation
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.
Results Reference
background
PubMed Identifier
29051841
Citation
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.
Results Reference
background
Citation
WHO. HIV Testing Services: WHO recommends HIV Self-testing. Geneva2016.
Results Reference
background
PubMed Identifier
26956074
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Cammarota J, Fine M. Revolutionizing education : youth participatory action research in motion. New York, NY: Routledge; 2008.
Results Reference
background
PubMed Identifier
23444005
Citation
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.
Results Reference
background
PubMed Identifier
22718087
Citation
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.
Results Reference
background
PubMed Identifier
26462186
Citation
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.
Results Reference
background
Citation
Halpern R. The means to grow up: Reinventing apprenticeship as a developmental support in adolescence. Routledge; 2013.
Results Reference
background
PubMed Identifier
23251106
Citation
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.
Results Reference
background
PubMed Identifier
16951647
Citation
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.
Results Reference
background
PubMed Identifier
23843679
Citation
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.
Results Reference
background

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