Early Phase 1
N=388
Innovative Tools to Expand HIV Self-Testing
HIV/AIDS · Sexually Transmitted Diseases
Bottom Line
View on ClinicalTrials.gov: NCT04070287 ↗Enrolled (actual)
388
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Uptake of HIV Self-testing Over the 3 Months Follow-up — 19; 7; 24; 4 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- SMART Pack (Combination_product); Luv Box (Combination_product); Bili Vibes (Combination_product); BeterDoc (Combination_product); IUNGO (Combination_product)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Uptake of HIV Self-testing Over the 3 Months Follow-up |
19; 7; 24; 4; 22 | <0.05 sig |
| SECONDARY Uptake of HIV Testing Over the 6 Months Follow-up |
98; 32; 64; 4; 91 | <0.05 sig |
| SECONDARY Uptake of Syphilis Testing |
3; 4; 8; 0; 3; 47 | <0.05 sig |
| SECONDARY Uptake of Gonorrhea Testing |
5; 5; 3; 0; 5; 46 | <0.05 sig |
| SECONDARY Uptake of Hepatitis b Testing |
3; 8; 31; 3; 8; 46 | <0.05 sig |
| SECONDARY Uptake of Chlamydia Testing |
1; 3; 1; 0; 0; 45 | <0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT04070287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.