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

NCT04950153 | Completed Results DMC

• 2 other identifiers: iCARE Nigeria UH3UH3HD096920
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 6

Brief Summary

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 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.

Conditions

Adolescent HIV Infection

Outcome Measures

Primary Outcomes (3)

• Proportion of Participants With Viral Load Suppression, (Plasma HIV-1 RNA <200 Copies/ml)

  We assessed the change in proportion of participants who were virally suppressed before and after exposure to 48 weeks of the iCARE intervention.

  Clusters randomized to 1 of 3 sequences, which determined timing of the intervention: Sequence 1 (intervention at visit 1=0 weeks(at baseline), 2 (intervention at visit 2: 24 weeks post baseline) or 3 (intervention at visit 3: 48 weeks post baseline)

• Proportion With Virologic Suppression (HIV-1 RNA<200 Copies mL)

  Proportion of participants with viral load suppression, defined as viral load (plasma HIV-1 RNA \<200 copies/ml); 24 Week Period

  24 Week Period

• Proportion With Viral Load Suppression (HIV RNA <200 Copies/ml)

  Proportion of participants with viral load suppression, defined as viral load (plasma HIV-1 RNA \<200 copies/ml); 48 Week Period

  48 Week Period

Secondary Outcomes (3)

• Proportion of Participants With Antiretrovial Adherence

  Clusters randomized to 1 of 3 sequences, which determined timing of the intervention: Sequences 1 (intervention at visit 1=0 weeks (at baseline), 2 (intervention at visit 2: 24 weeks post baseline) or 3 (intervention at visit 3: 48 weeks post baseline)

• Proportion of Participants With Antiretroviral Adherence

  24 Week period

• Proportion of Participants With Antiretroviral Adherence >=90%

  48 Week Period

Study Arms (3)

Sequence A (Cluster 1): HIV Treatment Intervention

OTHER

0 to 48 weeks intervention, 49-72 weeks post-intervention

Behavioral: Peer navigation; Behavioral: SMS Text messaging

Sequence B (Cluster 2): HIV Treatment Intervention

OTHER

0 to 24 weeks pre-intervention, 25 - 72 weeks intervention, 73 - 96 post intervention

Behavioral: Peer navigation; Behavioral: SMS Text messaging

Sequence C (Cluster 3): HIV Treatment Intervention

OTHER

0 to 48 weeks pre-intervention, 49 - 96 weeks intervention

Behavioral: Peer navigation; Behavioral: SMS Text messaging

Interventions

Peer navigation BEHAVIORAL

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

Sequence A (Cluster 1): HIV Treatment Intervention; Sequence B (Cluster 2): HIV Treatment Intervention; Sequence C (Cluster 3): HIV Treatment Intervention

SMS Text messaging BEHAVIORAL

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

Sequence A (Cluster 1): HIV Treatment Intervention; Sequence B (Cluster 2): HIV Treatment Intervention; Sequence C (Cluster 3): HIV Treatment Intervention

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Inability to provide informed consent
• Youths who are 15 years old and not emancipated, who do not have parental consent

Sponsors & Collaborators

• Northwestern University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (6)

University of Ibadan

Ibadan, Nigeria

Location

Jos University Teaching Hospital

Jos, Nigeria

Location

Lagos State University Teaching Hospital

Lagos, Nigeria

Location

Lagos University Teaching Hospital

Lagos, Nigeria

Location

Nigerian Institute of Medical Research (NIMR)

Lagos, Nigeria

Location

Olabisi Onabanjo University Teaching Hospital

Sagamu, Nigeria

Location

Related Publications (2)

• 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.

  PMID: 39780298 DERIVED

• 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.

  PMID: 37418498 DERIVED

Results Point of Contact

• Title: Lisa Kuhns
• Organization: Northwestern University

lkuhns@luriechildrens.org

312-227-7740

Study Officials

• Babafemi Taiwo, MBBS

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Robert Garofalo, MD

  Ann & Robert Lurie Childrens Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stepped wedge (cluster) randomized trial: There are three clusters, in which each cluster is exposed to a sequence: A (cluster 1), B (cluster 2), C (cluster 3). Each cluster is exposed to the intervention for two consecutive 24-week periods (total of 48 weeks)

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 6, 2021
• Study Start: April 15, 2021
• Primary Completion: August 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 21, 2026
• Results First Posted: April 21, 2026

Record last verified: 2026-04

Locations

NG (6)