HIV/AIDSI-TESTNCT04710784
A Pragmatic Trial to Expand Youth-friendly HIV Self-testing
A study testing Sexual health information, I-TEST branded HIVST package and Follow-up testing and clinic assessments in people with HIV/AIDS and Sexually Transmitted Infections, run by Washington University School of Medicine at 1 site in Nigeria.
Trial summary
The current study extends the study team's earlier efforts described in ClinicalTrail ID#: NCT04070287 and NCT03874663. The I-TEST (Innovative Tools to Expand Youth-friendly HIV Self-Testing) study known locally as the 4 Youth by Youth project, sought to develop and evaluate novel youth-friendly HIVST services in… Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Sexually Transmitted Infections
- What is being tested?
- Sexual health information, I-TEST branded HIVST package and Follow-up testing and clinic assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteNigeria
- Study dates
- 10 May 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 14-24
- Self-reported HIV negative or unknown HIV status
- Currently and planning on residing in one of the 30 areas during the next 12 months
- Able to complete the survey in English (the national language of Nigeria)
- All participants must agree to informed consent and provide their cell mobile number for follow-up and retention
Who cannot join
- Younger than 14 and older than 24
- Inability to comply with the study protocol
- Illness, cognitive impairment, or threatening behavior with acute risk to self or others
- No informed consent
- No contact phone number
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The 4 Youth by Youth Project: a Pragmatic Stepped-wedge Cluster Randomized Controlled Trial to Expand Youth-friendly HIV Self-testing Services in Nigeria
The current study extends the study team's earlier efforts described in ClinicalTrail ID#: NCT04070287 and NCT03874663. The I-TEST (Innovative Tools to Expand Youth-friendly HIV Self-Testing) study known locally as the 4 Youth by Youth project, sought to develop and evaluate novel youth-friendly HIVST services in Nigeria using open challenges and apprenticeship training informed by a participatory learning collaborative model. The study thus aims to reach young Nigerians that remain undiagnosed for HIV and to facilitate linkage and retention in preventive services (includes STI testing/treatment, PrEP referral, condom use).
Read the detailed description
Following the completion of the open contests and apprenticeship training, four youth teams (with four distinct interventions) were selected to undergo a one-year pilot assessment in the community. Preliminary findings from the feasibility study suggest that the youth-developed interventions have the potential to impact HIV testing as well as uptake of sexually transmitted infections (STI) testing among young people in Nigeria. As a result, the investigators identified key components from the four interventions to form a single intervention that will be evaluated in the next phase of the research. Thus, the current protocol is focused on evaluating the effectiveness of a combined, youth-developed intervention on HIV testing and other HIV prevention outcomes (i.e. condom use, PrEP referral, STI testing).
Using a stepped-wedge cluster randomized controlled trial design, the I-TEST intervention package will be implemented sequentially across 32 local government areas (LGA) whereby each LGA will be exposed to a pre-intervention (control), intervention (implementing the intervention), and post-intervention condition, according to a randomized schedule. Young people between the ages of 14-24 years will be recruited from the selected 32 local government areas through in-person events, social media platforms, and online advertisements, clinics, and community centers that cater to young people. We included two additional LGAs in November 2021 to account for civil unrest activities that are taking place across two other study sites. Due to the civil unrest, the implementation of the intervention has been affected hence the addition of the two new sites. Upon enrollment, the study team will collect baseline data on HIV testing history, sexual behavior history, youth participation experience, and other related outcomes from the study participants. Two trained youth alongside one trained supervisor will implement the I-TEST intervention at the LGAs.
- Conditions
- HIV/AIDS, Sexually Transmitted Infections
- Being tested
- Sexual health information, I-TEST branded HIVST package, Follow-up testing and clinic assessments
- Keywords
- HIV Prevention, HIV Self-testing, Young people, Nigeria, 4 Youth by Youth
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual health informationBehavioural
Also called Pre-Implementation (Control Phase)
We will provide participants with sexual health information, that is basic, accurate, and directly contributes to health-promoting decisions and behavior, once a week at the beginning of the study.
I-TEST branded HIVST packageBehavioural
Also called Intervention Implementation
The I-TEST branded HIVST package will include HIV self-testing (HIVST) kits, referral coupons, condoms, female or male hygiene products, and instructions on how to use the I-TEST photo verification App or USSD (Unstructured Supplementary Service Data) system to verify the HIVST results. Study participants will be referred to a youth-friendly health clinic for confirmatory HIV testing, STI testing (syphilis, gonorrhea, chlamydia, and hepatitis B), STI treatment and PrEP referral.
Follow-up testing and clinic assessmentsOther
Also called Post-Implementation
Information to encourage routine retesting for HIV every 6 months and linkage to the youth-friendly clinic for confirmatory HIV testing, STI testing (syphilis, gonorrhea, chlamydia, and hepatitis B), STI treatment, and PrEP referral. Additionally, follow-up surveys will be administered to assess HIV testing, sexual behavior history, youth participation experience, and other related outcomes will be collected from enrolled participants.
| Study group | Role | What they receive |
|---|---|---|
| I-TEST Intervention Package | Experimental | Each study site will begin in the baseline, pre-implementation phase, and then be randomized to implement the I-TEST intervention package for a duration of three months, followed by the post-implementation phase. Receives: Behavioral: Sexual health information; Behavioral: I-TEST branded HIVST package; Other: Follow-up testing and clinic assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of HIV Self-testing
The number of persons who tested with an HIV self-test. We will assess the number of persons who tested with an HIV self-test among the total number of participants in the study. The primary outcome will be ascertained using a photographic verification approach via a mobile application or a USSD (Unstructured Supplementary Service Data) system. We will also use self-reported data on HIVST results for those unable to use both systems accurately.
Measured: Up to 24 months
Secondary outcomes (7)
Uptake of Facility-Based HIV testing
The number of persons who received an HIV test at a youth-friendly clinic among the total number of participants in the study.
Measured: Up to 24 months
Sexually Transmitted Infection (STI) Testing
The number of persons who completed a consultation at the youth-friendly clinic for STI testing. In addition, the baseline and follow-up surveys include items on knowledge and testing of sexually transmitted infections (gonorrhea, chlamydia, syphilis, and hepatitis B virus).
Measured: Up to 24 months
Sexually Transmitted Infection (STI) Treatment
The number of persons initiating STI treatment among the total number of persons with active infection linked to care.
Measured: Up to 24 months
PrEP Referral
PrEP referral will be assessed based on the proportion of participants who are "optimal" (assessed based on the sexual behavioral history and willingness to use PrEP) candidates for PrEP referral and the total number of participants referred for PrEP initiation at the health care facilities.
Measured: Up to 24 months
100% Condom Use
The baseline and follow-up survey includes items on condom usage in the last sexual intercourse and a 4-item Condom Use Self Efficacy Scale.
Measured: Up to 24 months
Youth Engagement
A 12-item scale on youth engagement will be used to assess the HIV prevention services proposed by the youth teams. The scale was adapted from the 20-item Tiffany-Eckenrode Program Participation Scale (TEPPS). Responses to the participation items were measured on a 5-point Likert-type scale, ranging from "strongly disagree (0)" to "Strongly agree (4)". Higher TEPPS scores indicate higher levels of program participation. The item is only included in the follow-up survey.
Measured: Up to 24 months
Cost effectiveness of the intervention
The incremental cost-effectiveness ratio of participants involved in the I-TEST intervention phase compared to the control phase.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start10 May 2021
- Primary completion31 Aug 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Stepped-wedge cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Nigerian Institute of Medical Research
- Responsible party
- Principal investigator, Juliet Iwelunmor, PhD, Washington University School of Medicine
- Investigators
- Juliet Iwelunmor, PhD, Principal investigator, St. Louis UniversityOliver Ezechi, MD, Principal investigator, Nigerian Institute of Medical ResearchJoseph Tucker, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710784
- Sponsor's protocol ID
- 31457
- Other IDs
- 4UH3HD096929
- Acronym
- I-TEST
- Status last verified
- Jul 2024
- First submitted
- 19 Dec 2020
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with Saint Louis University.
Publications
WHO/TDR. (2018). Crowdsourcing in Health and Health Research: A Practical Guide (TDR/STRA/18.4). Retrieved from Geneva: https://www.who.int/tdr/publications/year/2018/crowdsourcing-practical-guide/en/
Iwelunmor J, Ezechi O, Obiezu-Umeh C, Gbaja-Biamila T, Nwaozuru U, Oladele D, Musa AZ, Idigbe I, Uzoaru F, Airhihenbuwa C, Muessig K, Conserve DF, Kapogiannis B, Tucker JD. The 4 youth by youth HIV self-testing crowdsourcing contest: A qualitative evaluation. PLoS One. 2020 May 29;15(5):e0233698. doi: 10.1371/journal.pone.0233698. eCollection 2020.
PubMed 32469971Obiezu-Umeh C, Gbajabiamila T, Ezechi O, Nwaozuru U, Ong JJ, Idigbe I, Oladele D, Musa AZ, Uzoaru F, Airhihenbuwa C, Tucker JD, Iwelunmor J. Young people's preferences for HIV self-testing services in Nigeria: a qualitative analysis. BMC Public Health. 2021 Jan 7;21(1):67. doi: 10.1186/s12889-020-10072-1.
PubMed 33413246Nwaozuru U, Iwelunmor J, Ong JJ, Salah S, Obiezu-Umeh C, Ezechi O, Tucker JD. Preferences for HIV testing services among young people in Nigeria. BMC Health Serv Res. 2019 Dec 27;19(1):1003. doi: 10.1186/s12913-019-4847-x.
PubMed 31881959Iwelunmor J, Obiezu-Umeh C, Gbaja-Biamila T, Oladele D, Nwaozuru U, Musa AZ, Abodunrin OR, Akinsolu FT, Ojo T, Olusanya O, Bamidele T, Ezeama N, Okeke C, Johnny I, Ekene M, Rahman N, Musari-Martins T, Ajibaye S, Lateef A, Ojo V, Babatunde Y, Airhihenbuwa CO, Muessig K, Rosenberg N, BeLue R, Xian H, Conserve DF, Zou Z, Ong JJ, Zhang L, Curley J, Nkengasong S, Mason S, Tang W, Bayus B, Ogedegbe G, Tucker JD, Ezechi O. The 4 youth by youth (4YBY) crowdsourced HIV prevention intervention: A stepped-wedge longitudinal trial on HIV self-testing uptake among adolescents and young people in Nigeria. Contemp Clin Trials. 2025 Jul;154:107919. doi: 10.1016/j.cct.2025.107919. Epub 2025 Apr 20.
PubMed 40262659Anikamadu O, Ezechi O, Engelhart A, Nwaozuru U, Obiezu-Umeh C, Ogunjemite P, Bale BI, Nwachukwu D, Gbaja-Biamila T, Oladele D, Musa AZ, Mason S, Ojo T, Tucker J, Iwelunmor J. Expanding Youth-Friendly HIV Self-Testing Services During the COVID-19 Pandemic: Qualitative Analysis of a Crowdsourcing Open Call in Nigeria. JMIR Form Res. 2024 Apr 30;8:e46945. doi: 10.2196/46945.
PubMed 38687582Iwelunmor J, Tucker JD, Obiezu-Umeh C, Gbaja-Biamila T, Oladele D, Nwaozuru U, Musa AZ, Airhihenbuwa CO, Muessig K, Rosenberg N, BeLue R, Xian H, Conserve DF, Ong JJ, Zhang L, Curley J, Nkengasong S, Mason S, Tang W, Bayus B, Ogedegbe G, Ezechi O. The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability: Study protocol in Nigeria. Contemp Clin Trials. 2022 Mar;114:106628. doi: 10.1016/j.cct.2021.106628. Epub 2021 Nov 17.
PubMed 34800699
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 4 Youth by Youth Project: a Pragmatic Stepped-wedge Cluster Randomized Controlled Trial to Expand Youth-friendly HIV Self-testing Services in Nigeria
- ClinicalTrials.gov ID
- NCT04710784
- Acronym / sponsor ID
- I-TEST / 31457
- Conditions
- HIV/AIDS, Sexually Transmitted Infections
- Keywords
- HIV Prevention, HIV Self-testing, Young people, Nigeria, 4 Youth by Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Nigerian Institute of Medical Research
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study extends the study team's earlier efforts described in ClinicalTrail ID#: NCT04070287 and NCT03874663. The I-TEST (Innovative Tools to Expand Youth-friendly HIV Self-Testing) study known locally as the 4 Youth by Youth project, sought to develop and evaluate novel youth-friendly HIVST services in Nigeria using open challenges and apprenticeship training informed by a participatory learning collaborative model. The study thus aims to reach young Nigerians that remain undiagnosed for HIV and to facilitate linkage and retention in preventive services (includes STI testing/treatment, PrEP referral, condom use).
Detailed description
Following the completion of the open contests and apprenticeship training, four youth teams (with four distinct interventions) were selected to undergo a one-year pilot assessment in the community. Preliminary findings from the feasibility study suggest that the youth-developed interventions have the potential to impact HIV testing as well as uptake of sexually transmitted infections (STI) testing among young people in Nigeria. As a result, the investigators identified key components from the four interventions to form a single intervention that will be evaluated in the next phase of the research. Thus, the current protocol is focused on evaluating the effectiveness of a combined, youth-developed intervention on HIV testing and other HIV prevention outcomes (i.e. condom use, PrEP referral, STI testing).
Using a stepped-wedge cluster randomized controlled trial design, the I-TEST intervention package will be implemented sequentially across 32 local government areas (LGA) whereby each LGA will be exposed to a pre-intervention (control), intervention (implementing the intervention), and post-intervention condition, according to a randomized schedule. Young people between the ages of 14-24 years will be recruited from the selected 32 local government areas through in-person events, social media platforms, and online advertisements, clinics, and community centers that cater to young people. We included two additional LGAs in November 2021 to account for civil unrest activities that are taking place across two other study sites. Due to the civil unrest, the implementation of the intervention has been affected hence the addition of the two new sites. Upon enrollment, the study team will collect baseline data on HIV testing history, sexual behavior history, youth participation experience, and other related outcomes from the study participants. Two trained youth alongside one trained supervisor will implement the I-TEST intervention at the LGAs.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stepped-wedge cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| I-TEST Intervention Package | Experimental | Behavioral: Sexual health information, Behavioral: I-TEST branded HIVST package, Other: Follow-up testing and clinic assessmentsEach study site will begin in the baseline, pre-implementation phase, and then be randomized to implement the I-TEST intervention package for a duration of three months, followed by the post-implementation phase. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 14-24
- Self-reported HIV negative or unknown HIV status
- Currently and planning on residing in one of the 30 areas during the next 12 months
- Able to complete the survey in English (the national language of Nigeria)
- All participants must agree to informed consent and provide their cell mobile number for follow-up and retention
Key exclusion criteria (5 listed)
- Younger than 14 and older than 24
- Inability to comply with the study protocol
- Illness, cognitive impairment, or threatening behavior with acute risk to self or others
- No informed consent
- No contact phone number
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual health informationAlso: Pre-Implementation (Control Phase)We will provide participants with sexual health information, that is basic, accurate, and directly contributes to health-promoting decisions and behavior, once a week at the beginning of the study. | Behavioural | I-TEST Intervention Package |
| I-TEST branded HIVST packageAlso: Intervention ImplementationThe I-TEST branded HIVST package will include HIV self-testing (HIVST) kits, referral coupons, condoms, female or male hygiene products, and instructions on how to use the I-TEST photo verification App or USSD (Unstructured Supplementary Service Data) system to verify the HIVST results. Study participants will be referred to a youth-friendly health clinic for confirmatory HIV testing, STI testing (syphilis, gonorrhea, chlamydia, and hepatitis B), STI treatment and PrEP referral. | Behavioural | I-TEST Intervention Package |
| Follow-up testing and clinic assessmentsAlso: Post-ImplementationInformation to encourage routine retesting for HIV every 6 months and linkage to the youth-friendly clinic for confirmatory HIV testing, STI testing (syphilis, gonorrhea, chlamydia, and hepatitis B), STI treatment, and PrEP referral. Additionally, follow-up surveys will be administered to assess HIV testing, sexual behavior history, youth participation experience, and other related outcomes will be collected from enrolled participants. | Other | I-TEST Intervention Package |
Primary outcome
Uptake of HIV Self-testing
Time frame: Up to 24 months
The number of persons who tested with an HIV self-test. We will assess the number of persons who tested with an HIV self-test among the total number of participants in the study. The primary outcome will be ascertained using a photographic verification approach via a mobile application or a USSD (Unstructured Supplementary Service Data) system. We will also use self-reported data on HIVST results for those unable to use both systems accurately.
7 secondary outcomes
Uptake of Facility-Based HIV testing
Time frame: Up to 24 months
Sexually Transmitted Infection (STI) Testing
Time frame: Up to 24 months
Sexually Transmitted Infection (STI) Treatment
Time frame: Up to 24 months
PrEP Referral
Time frame: Up to 24 months
100% Condom Use
Time frame: Up to 24 months
Youth Engagement
Time frame: Up to 24 months
Cost effectiveness of the intervention
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- BackgroundWHO/TDR. (2018). Crowdsourcing in Health and Health Research: A Practical Guide (TDR/STRA/18.4). Retrieved from Geneva: https://www.who.int/tdr/publications/year/2018/crowdsourcing-practical-guide/en/
- Background: PubMed 32469971Iwelunmor J, Ezechi O, Obiezu-Umeh C, Gbaja-Biamila T, Nwaozuru U, Oladele D, Musa AZ, Idigbe I, Uzoaru F, Airhihenbuwa C, Muessig K, Conserve DF, Kapogiannis B, Tucker JD. The 4 youth by youth HIV self-testing crowdsourcing contest: A qualitative evaluation. PLoS One. 2020 May 29;15(5):e0233698. doi: 10.1371/journal.pone.0233698. eCollection 2020.
- Background: PubMed 33413246Obiezu-Umeh C, Gbajabiamila T, Ezechi O, Nwaozuru U, Ong JJ, Idigbe I, Oladele D, Musa AZ, Uzoaru F, Airhihenbuwa C, Tucker JD, Iwelunmor J. Young people's preferences for HIV self-testing services in Nigeria: a qualitative analysis. BMC Public Health. 2021 Jan 7;21(1):67. doi: 10.1186/s12889-020-10072-1.
- Background: PubMed 31881959Nwaozuru U, Iwelunmor J, Ong JJ, Salah S, Obiezu-Umeh C, Ezechi O, Tucker JD. Preferences for HIV testing services among young people in Nigeria. BMC Health Serv Res. 2019 Dec 27;19(1):1003. doi: 10.1186/s12913-019-4847-x.
- Derived from this study: PubMed 40262659Iwelunmor J, Obiezu-Umeh C, Gbaja-Biamila T, Oladele D, Nwaozuru U, Musa AZ, Abodunrin OR, Akinsolu FT, Ojo T, Olusanya O, Bamidele T, Ezeama N, Okeke C, Johnny I, Ekene M, Rahman N, Musari-Martins T, Ajibaye S, Lateef A, Ojo V, Babatunde Y, Airhihenbuwa CO, Muessig K, Rosenberg N, BeLue R, Xian H, Conserve DF, Zou Z, Ong JJ, Zhang L, Curley J, Nkengasong S, Mason S, Tang W, Bayus B, Ogedegbe G, Tucker JD, Ezechi O. The 4 youth by youth (4YBY) crowdsourced HIV prevention intervention: A stepped-wedge longitudinal trial on HIV self-testing uptake among adolescents and young people in Nigeria. Contemp Clin Trials. 2025 Jul;154:107919. doi: 10.1016/j.cct.2025.107919. Epub 2025 Apr 20.
- Derived from this study: PubMed 38687582Anikamadu O, Ezechi O, Engelhart A, Nwaozuru U, Obiezu-Umeh C, Ogunjemite P, Bale BI, Nwachukwu D, Gbaja-Biamila T, Oladele D, Musa AZ, Mason S, Ojo T, Tucker J, Iwelunmor J. Expanding Youth-Friendly HIV Self-Testing Services During the COVID-19 Pandemic: Qualitative Analysis of a Crowdsourcing Open Call in Nigeria. JMIR Form Res. 2024 Apr 30;8:e46945. doi: 10.2196/46945.
- Derived from this study: PubMed 34800699Iwelunmor J, Tucker JD, Obiezu-Umeh C, Gbaja-Biamila T, Oladele D, Nwaozuru U, Musa AZ, Airhihenbuwa CO, Muessig K, Rosenberg N, BeLue R, Xian H, Conserve DF, Ong JJ, Zhang L, Curley J, Nkengasong S, Mason S, Tang W, Bayus B, Ogedegbe G, Ezechi O. The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability: Study protocol in Nigeria. Contemp Clin Trials. 2022 Mar;114:106628. doi: 10.1016/j.cct.2021.106628. Epub 2021 Nov 17.
- 4 Youth by Youth WebsiteLink provided by the sponsor.
- SESH Crowdsourcing ClinicLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with Saint Louis University.
Related trials for HIV/AIDS
Enrolling by invitation
ORCHID: An Online Intervention for Persons With HIV (Miami)
HIV/AIDS, HPV Infection
Recruiting
Enhancing the Organizational Social Context to Improve Viral Suppression and Retention in HIV Care
HIV/AIDS
RecruitingPhase 1/2
SV2A & TSPO PET Imaging Measures to Reveal Mechanisms of HIV Neuropathogenesis During Antiretroviral Therapy
HIV Associated Neurocognitive Disorder, HIV Dementia
Recruiting
Peer-led Dynamic Choice HIV Prevention for Women: The Peer-led DCP Randomized Trial
HIV/AIDS, HIV/AIDS Prevention
Active, not recruitingPhase 2
Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer
AIDS-Related Anal Carcinoma, Anal Margin Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliet Iwelunmor, PhD principal investigator
St. Louis University
Oliver Ezechi, MD principal investigator
Nigerian Institute of Medical Research
Joseph Tucker, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual health information, I-TEST branded HIVST package and Follow-up testing and clinic assessments in people with HIV/AIDS and Sexually Transmitted Infections, run by Washington University School of Medicine at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of HIV Self-testing (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710784, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.