Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase

NCT ID: NCT04950153

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

558 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2024-12-31

Brief Summary

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Combination interventions with mHealth and Peer Navigation components will be evaluated in a randomized, stepped wedge trial among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study findings will demonstrate whether or not the combination interventions for HIV testing and linkage to care and for HIV treatment outcomes, which were found to be efficacious in our prior pilot UG3 trial, will remain efficacious if scaled as proposed in this UH3 trial, across multiple sites.

Detailed Description

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A randomized stepped wedge (cluster) trial will be conducted to investigate two combination interventions (each with mHealth + Peer Navigation components) among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study 1 (Testing and Linkage to Care) will test a combination intervention that targets HIV testing and linkage to care. Study 2 (Treatment Intervention) will test a combination intervention that targets HIV treatment outcomes (retention, adherence and viral suppression).

Conditions

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Adolescent HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Stepped wedge (cluster) randomized trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HIV Testing Intervention

Combination HIV testing and linkage to care intervention includes social media engagement and peer navigation

Group Type OTHER

Social Media Engagement

Intervention Type BEHAVIORAL

HIV testing outreach using social media platforms to promote HIV testing.

Testing Peer Navigation

Intervention Type BEHAVIORAL

Peer navigators will conduct HIV testing outreach and linkage to care to at-risk youth

HIV Treatment Intervention

Combination HIV treatment outcomes (retention, ART adherence and viral suppression) intervention includes SMS text messaging and peer navigation

Group Type OTHER

Peer navigation

Intervention Type BEHAVIORAL

Peer navigators will navigate youth with HIV to provide assistance and support to optimize adherence to antiretroviral treatment (ART)

SMS Text messaging

Intervention Type BEHAVIORAL

Short Message System (SMS) text messages to remind and encourage youth to adhere to their ART

Interventions

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Peer navigation

Peer navigators will navigate youth with HIV to provide assistance and support to optimize adherence to antiretroviral treatment (ART)

Intervention Type BEHAVIORAL

SMS Text messaging

Short Message System (SMS) text messages to remind and encourage youth to adhere to their ART

Intervention Type BEHAVIORAL

Social Media Engagement

HIV testing outreach using social media platforms to promote HIV testing.

Intervention Type BEHAVIORAL

Testing Peer Navigation

Peer navigators will conduct HIV testing outreach and linkage to care to at-risk youth

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Living with HIV infection
* Registered in the study clinics or their satellite clinics
* On antiretroviral therapy (ART) for at least 3 months
* Intention to remain a study clinic patient during the study observation and intervention period

Exclusion Criteria

* Inability to provide informed consent
* Youths who are 15 years old and not emancipated, who do not have parental consent
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Babafemi Taiwo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Babafemi Taiwo, MBBS

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Robert Garofalo, MD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert Lurie Childrens Hospital of Chicago

Locations

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University of Ibadan

Ibadan, , Nigeria

Site Status

Jos University Teaching Hospital

Jos, , Nigeria

Site Status

Lagos State University Teaching Hospital

Lagos, , Nigeria

Site Status

Lagos University Teaching Hospital

Lagos, , Nigeria

Site Status

Nigerian Institute of Medical Research (NIMR)

Lagos, , Nigeria

Site Status

Olabisi Onabanjo University Teaching Hospital

Sagamu, , Nigeria

Site Status

Countries

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Nigeria

References

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Kozhumam A, Singh R, Agbaji O, Adetunji A, Taiwo B, Omigbodun O, Kuti K, David A, Akanmu S, Adekambi F, Akinbami A, Oladeji B, Taiwo B, Kuhns LM, Okonkwor O, Berzins B, Johnson AK, Badru T, Janulis P, Adewumi OM, Cervantes M, Awolude O, Garofalo R, Ahonkhai AA, Hirschhorn LR. Attitudes toward scale-up of an Intensive Combination Approach to Rollback the Epidemic in Nigerian adolescents (iCARE) intervention for youth in Nigeria: results of a mixed methods early-implementation study. Implement Sci Commun. 2025 Jan 8;6(1):6. doi: 10.1186/s43058-024-00671-z.

Reference Type DERIVED
PMID: 39780298 (View on PubMed)

Taiwo BO, Kuhns LM, Omigbodun O, Awolude O, Kuti KM, Adetunji A, Berzins B, Janulis P, Akanmu S, Agbaji O, David AN, Akinbami A, Adekambi AF, Johnson AK, Okonkwor O, Oladeji BD, Cervantes M, Adewumi OM, Kapogiannis B, Garofalo R. A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol. PLoS One. 2023 Jul 7;18(7):e0274031. doi: 10.1371/journal.pone.0274031. eCollection 2023.

Reference Type DERIVED
PMID: 37418498 (View on PubMed)

Other Identifiers

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UH3HD096920

Identifier Type: NIH

Identifier Source: secondary_id

View Link

iCARE Nigeria UH3

Identifier Type: -

Identifier Source: org_study_id

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