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

December 19, 2023 updated by: Juliet Iwelunmor, Washington University School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

388

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Lagos
      • Yaba, Lagos, Nigeria, 00000
        • Nigerian Institute of Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SMART Pack
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
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.
Other Names:
  • The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Active Comparator: Luv Box
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
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.
Other Names:
  • The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Active Comparator: Bili Vibes
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
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.
Other Names:
  • The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Active Comparator: BeterDoc
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
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.
Other Names:
  • The OraQuick®ADVANCERapid HIV-1/2 Antibody Test
Active Comparator: IUNGO
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
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.
Other Names:
  • The OraQuick®ADVANCERapid HIV-1/2 Antibody Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of HIV Self-testing Over the 3 Months Follow-up
Time Frame: 3 months following the first encounter
Proportion of participants who reported to have self-tested for HIV at 3-month after baseline.
3 months following the first encounter

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
University of North Carolina, Chapel Hill
Nigerian Institute of Medical Research

Investigators

  • Principal Investigator: Oliver Ezechi, MD, Nigerian Institute of Medical Research
  • Principal Investigator: Joseph Tucker, MD, University of North Carolina, Chapel Hill
  • Principal Investigator: Juliet Iwelunmor, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

July 20, 2019

First Submitted That Met QC Criteria

August 25, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30347
  • 1UG3HD096929-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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