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Innovative Tools to Expand HIV Self-Testing

Innovative Tools to Expand HIV Self-Testing

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04070287
Acronym
I-TEST
Enrollment
388
Registered
2019-08-28
Start date
2019-07-01
Completion date
2020-09-01
Last updated
2023-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS, Sexually Transmitted Diseases

Keywords

HIV Prevention, HIV self-testing, young people, Nigeria

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.

Interventions

COMBINATION_PRODUCTSMART 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.

COMBINATION_PRODUCTLuv 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.

COMBINATION_PRODUCTBili 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.

COMBINATION_PRODUCTBeterDoc

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.

COMBINATION_PRODUCTIUNGO

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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Nigerian Institute of Medical Research
CollaboratorOTHER_GOV
University of North Carolina, Chapel Hill
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
14 Years to 24 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Uptake of HIV Self-testing Over the 3 Months Follow-up3 months following the first encounterProportion of participants who reported to have self-tested for HIV at 3-month after baseline.

Secondary

MeasureTime frameDescription
Uptake of HIV Testing Over the 6 Months Follow-up6-monthProportion of participants who reported to have self-tested for HIV at 6-month after baseline.
Uptake of Syphilis Testing6-monthProportion of participants who reported syphilis testing at baseline and 6-month.
Uptake of Gonorrhea Testing6-monthProportion of participants who reported gonorrhea testing at baseline and 6-month.
Uptake of Hepatitis b Testing6-monthProportion of participants who reported hepatitis B testing.
Uptake of Chlamydia Testing6-monthProportion of participants who reported chlamydia testing at baseline and 6-month.

Countries

Nigeria

Participant flow

Recruitment details

Recruitment occurred through a combination of community-based events, social media platforms, and peer referral.

Participants by arm

ArmCount
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. 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.
114
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. 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.
86
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. 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.
81
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. 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.
11
IUNGO
This intervention involves using a program utilizes community vocational skills training centers to promote uptake of HIV self-testing among young people. 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.
96
Total388

Baseline characteristics

CharacteristicSMART PackLuv BoxBili VibesBeterDocIUNGOTotal
Age, Continuous21.0 years
STANDARD_DEVIATION 2.8
21.3 years
STANDARD_DEVIATION 2.3
21.1 years
STANDARD_DEVIATION 1.5
20.7 years
STANDARD_DEVIATION 2.1
21.1 years
STANDARD_DEVIATION 2.1
21.1 years
STANDARD_DEVIATION 2.3
Race/Ethnicity, Customized
Igbo
30 Participants20 Participants70 Participants0 Participants10 Participants130 Participants
Race/Ethnicity, Customized
Missing
0 Participants0 Participants4 Participants0 Participants1 Participants5 Participants
Race/Ethnicity, Customized
Other ethnicity (i.e. Hausa/Fulani)
35 Participants9 Participants7 Participants1 Participants14 Participants66 Participants
Race/Ethnicity, Customized
Yoruba
49 Participants57 Participants0 Participants10 Participants71 Participants187 Participants
Sex: Female, Male
Female
54 Participants40 Participants30 Participants4 Participants32 Participants160 Participants
Sex: Female, Male
Male
60 Participants46 Participants51 Participants7 Participants64 Participants228 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
deaths
Total, all-cause mortality
0 / 1140 / 860 / 810 / 110 / 96
other
Total, other adverse events
0 / 1140 / 860 / 810 / 110 / 96
serious
Total, serious adverse events
0 / 1140 / 860 / 810 / 110 / 96

Outcome results

Primary

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.

Time frame: 3 months following the first encounter

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SMART PackUptake of HIV Self-testing Over the 3 Months Follow-up19 Participants
Luv BoxUptake of HIV Self-testing Over the 3 Months Follow-up7 Participants
Bili VibesUptake of HIV Self-testing Over the 3 Months Follow-up24 Participants
BeterDocUptake of HIV Self-testing Over the 3 Months Follow-up4 Participants
IUNGOUptake of HIV Self-testing Over the 3 Months Follow-up22 Participants
p-value: <0.05Chi-squared
Secondary

Uptake of Chlamydia Testing

Proportion of participants who reported chlamydia testing at baseline and 6-month.

Time frame: 6-month

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
SMART PackUptake of Chlamydia TestingBaseline1 Participants
SMART PackUptake of Chlamydia Testing6-month45 Participants
Luv BoxUptake of Chlamydia TestingBaseline3 Participants
Luv BoxUptake of Chlamydia Testing6-month3 Participants
Bili VibesUptake of Chlamydia TestingBaseline1 Participants
Bili VibesUptake of Chlamydia Testing6-month21 Participants
BeterDocUptake of Chlamydia Testing6-month0 Participants
BeterDocUptake of Chlamydia TestingBaseline0 Participants
IUNGOUptake of Chlamydia TestingBaseline0 Participants
IUNGOUptake of Chlamydia Testing6-month73 Participants
p-value: <0.05Chi-squared
Secondary

Uptake of Gonorrhea Testing

Proportion of participants who reported gonorrhea testing at baseline and 6-month.

Time frame: 6-month

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
SMART PackUptake of Gonorrhea TestingBaseline5 Participants
SMART PackUptake of Gonorrhea Testing6-month46 Participants
Luv BoxUptake of Gonorrhea TestingBaseline5 Participants
Luv BoxUptake of Gonorrhea Testing6-month2 Participants
Bili VibesUptake of Gonorrhea TestingBaseline3 Participants
Bili VibesUptake of Gonorrhea Testing6-month23 Participants
BeterDocUptake of Gonorrhea Testing6-month0 Participants
BeterDocUptake of Gonorrhea TestingBaseline0 Participants
IUNGOUptake of Gonorrhea TestingBaseline5 Participants
IUNGOUptake of Gonorrhea Testing6-month64 Participants
p-value: <0.05Chi-squared
Secondary

Uptake of Hepatitis b Testing

Proportion of participants who reported hepatitis B testing.

Time frame: 6-month

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
SMART PackUptake of Hepatitis b TestingBaseline3 Participants
SMART PackUptake of Hepatitis b Testing6-month46 Participants
Luv BoxUptake of Hepatitis b TestingBaseline8 Participants
Luv BoxUptake of Hepatitis b Testing6-month6 Participants
Bili VibesUptake of Hepatitis b TestingBaseline31 Participants
Bili VibesUptake of Hepatitis b Testing6-month45 Participants
BeterDocUptake of Hepatitis b Testing6-month2 Participants
BeterDocUptake of Hepatitis b TestingBaseline3 Participants
IUNGOUptake of Hepatitis b TestingBaseline8 Participants
IUNGOUptake of Hepatitis b Testing6-month75 Participants
p-value: <0.05Chi-squared
Secondary

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.

Time frame: 6-month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
SMART PackUptake of HIV Testing Over the 6 Months Follow-up98 Participants
Luv BoxUptake of HIV Testing Over the 6 Months Follow-up32 Participants
Bili VibesUptake of HIV Testing Over the 6 Months Follow-up64 Participants
BeterDocUptake of HIV Testing Over the 6 Months Follow-up4 Participants
IUNGOUptake of HIV Testing Over the 6 Months Follow-up91 Participants
p-value: <0.05Chi-squared
Secondary

Uptake of Syphilis Testing

Proportion of participants who reported syphilis testing at baseline and 6-month.

Time frame: 6-month

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
SMART PackUptake of Syphilis TestingBaseline3 Participants
SMART PackUptake of Syphilis Testing6-month47 Participants
Luv BoxUptake of Syphilis TestingBaseline4 Participants
Luv BoxUptake of Syphilis Testing6-month5 Participants
Bili VibesUptake of Syphilis TestingBaseline8 Participants
Bili VibesUptake of Syphilis Testing6-month25 Participants
BeterDocUptake of Syphilis Testing6-month0 Participants
BeterDocUptake of Syphilis TestingBaseline0 Participants
IUNGOUptake of Syphilis TestingBaseline3 Participants
IUNGOUptake of Syphilis Testing6-month73 Participants
p-value: <0.05Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026