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| ID | Type | Description | Link |
|---|---|---|---|
| UH3HD096920 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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 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.
A randomized stepped wedge (cluster) trial will be conducted to investigate a combination interventions (with mHealth + Peer Navigation components) among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. The Treatment Intervention will test a combination intervention that targets HIV treatment outcomes (retention, adherence and viral suppression).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A (Cluster 1): HIV Treatment Intervention | Other | 0 to 48 weeks intervention, 49-72 weeks post-intervention |
|
| Sequence B (Cluster 2): HIV Treatment Intervention | Other | 0 to 24 weeks pre-intervention, 25 - 72 weeks intervention, 73 - 96 post intervention |
|
| Sequence C (Cluster 3): HIV Treatment Intervention | Other | 0 to 48 weeks pre-intervention, 49 - 96 weeks intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer navigation | Behavioral | Peer navigators will navigate youth with HIV to provide assistance and support to optimize adherence to antiretroviral treatment (ART) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Antiretrovial Adherence | Number and proportion of participants with self-reported antiretroviral adherence based on 30-day recall reported on visual analogue scale, defined as >=90% | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Babafemi Taiwo, MBBS | Northwestern University | Principal Investigator |
| Robert Garofalo, MD | Ann & Robert Lurie Childrens Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ibadan | Ibadan | Nigeria | ||||
| Jos University Teaching Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39780298 | Derived | 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. | |
| 37418498 |
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We report herein results from a stepped wedge cluster-randomized trial (SW CRT). The SW-CRT involves randomization of clusters (of clinics) to different sequences that dictate the order (or timing) at which each cluster will switch to the intervention condition. In this SW CRT, there are three clusters/sequences: A (cluster 1), B (cluster 2), C (cluster 3) as defined below. Each cluster is exposed to the combination intervention for two consecutive 24-week periods (total of 48 weeks).
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A (Cluster 1): Implementation Start Week 0 | 0 to 48 weeks intervention, 49-72 weeks post-intervention |
| FG001 | Sequence B (Cluster 2): Implementation Start, Week 25 | 0 to 24 weeks pre-intervention, 25 - 72 weeks intervention, 73 - 96 post intervention |
| FG002 | Sequence C (Cluster 3: Implementation Start Week 49 | 0 to 48 weeks pre-intervention, 49 - 96 weeks intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 0 - 24 |
| |||||||||||||
| Week 25 - 48 |
| |||||||||||||
| Week 49 - 72 |
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| Week 72 - 96 |
|
Number of baseline participants in each cluster
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence A (Cluster 1) | Implementation start Week 0; 24 weeks of intervention, followed by 24 weeks of intervention, followed by 24 weeks of non-intervention observation, followed by 24 weeks of non-intervention observation |
| BG001 | Sequence B (Cluster 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age, continuous (years) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Baseline: Proportion with virologic suppression (HIV-1 RNA <200 copies/ml) | Posted | Count of Participants | Participants | 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) |
|
48 weeks
NOTE: Deaths and adverse events were monitored by cluster instead of assessed per intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sequence A (Cluster 1): HIV Treatment Intervention | 24 weeks of intervention, followed by 24 weeks of intervention, followed by 24 weeks of non-intervention observation, followed by 24 weeks of non-intervention observation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Immune system disorders | Non-systematic Assessment | Deaths were not related to study participation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Kuhns | Northwestern University | 312-227-7740 | lkuhns@luriechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2024 | Mar 4, 2025 | Prot_SAP_000.pdf |
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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)
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| SMS Text messaging | Behavioral | Short Message System (SMS) text messages to remind and encourage youth to adhere to their ART |
|
| Proportion of Participants With Antiretroviral Adherence | Number and proportion of participants with self-reported antiretroviral adherence based no 30-day recall reported on visual analogue scale, defined as >=90% | 24 Week period |
| Proportion of Participants With Antiretroviral Adherence >=90% | Number and proportion of participants with self-reported antiretroviral adherence based no 30-day recall reported on visual analogue scale, defined as >=90% | 48 Week Period |
| Jos |
| Nigeria |
| Lagos State University Teaching Hospital | Lagos | Nigeria |
| Lagos University Teaching Hospital | Lagos | Nigeria |
| Nigerian Institute of Medical Research (NIMR) | Lagos | Nigeria |
| Olabisi Onabanjo University Teaching Hospital | Sagamu | Nigeria |
| 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. |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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Implementation start Week 25; 24 weeks of non-intervention observation, followed by 24 weeks of intervention, followed by 24 weeks of intervention observation, followed by 24 weeks of non-intervention observation |
| BG002 | Sequence C (Cluster 3) | Implementation start Week 49: 24 weeks of non-intervention observation, followed by 24 weeks of non-intervention observation, followed by 24 weeks of intervention, followed by 24 weeks of intervention |
| BG003 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race (Black Africans) | Count of Participants | Participants | No |
|
| Region of Enrollment | Region of Enrollment: Nigeria | Number | participants |
|
| Proportion with virologic suppression (HIV-1 RNA <200 copies/ml) | Missing viral load data | Count of Participants | Participants |
|
| OG001 | Sequence B (Cluster 2): HIV Treatment Intervention | 24 weeks of non-intervention observation, followed by 24 weeks of intervention, followed by 24 weeks of intervention observation, followed by 24 weeks of non-intervention observation |
| OG002 | Sequence C (Cluster 3): HIV Treatment Intervention | 24 weeks of non-intervention observation, followed by 24 weeks of non-intervention observation, followed by 24 weeks of intervention, followed by 24 weeks of intervention |
|
|
| Primary | 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 virologic suppression (HIV-1 RNA<200 copies mL) after 24 Weeks of Intervention | Posted | Count of Participants | Participants | 24 Week Period |
|
|
|
| Primary | 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: Proportion with virologic suppression (HIV-1 RNA<200 copies mL) after 48 Weeks of Intervention | Posted | Count of Participants | Participants | 48 Week Period |
|
|
|
|
| Secondary | Proportion of Participants With Antiretrovial Adherence | Number and proportion of participants with self-reported antiretroviral adherence based on 30-day recall reported on visual analogue scale, defined as >=90% | Baseline: Proportion of participants with self-reported antiretroviral adherence >=90% | Posted | Count of Participants | Participants | 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) |
|
|
|
| Secondary | Proportion of Participants With Antiretroviral Adherence | Number and proportion of participants with self-reported antiretroviral adherence based no 30-day recall reported on visual analogue scale, defined as >=90% | 24 Week Period: Proportion of participants with self-reported antiretroviral adherence >=90% after 24 Weeks of Intervention | Posted | Count of Participants | Participants | 24 Week period |
|
|
|
| Secondary | Proportion of Participants With Antiretroviral Adherence >=90% | Number and proportion of participants with self-reported antiretroviral adherence based no 30-day recall reported on visual analogue scale, defined as >=90% | 48 Week Period: Proportion of participants with self-reported antiretroviral adherence >=90% after 48 Weeks of Intervention | Posted | Count of Participants | Participants | 48 Week Period |
|
|
|
|
| 1 |
| 60 |
| 1 |
| 60 |
| 0 |
| 60 |
| EG001 | Sequence B (Cluster 2): HIV Treatment Intervention | 24 weeks of non-intervention observation, followed by 24 weeks of intervention, followed by 24 weeks of intervention observation, followed by 24 weeks of non-intervention observation | 6 | 309 | 6 | 309 | 0 | 309 |
| EG002 | Sequence C (Cluster 3): HIV Treatment Intervention | 24 weeks of non-intervention observation, followed by 24 weeks of non-intervention observation, followed by 24 weeks of intervention, followed by 24 weeks of intervention | 5 | 172 | 5 | 172 | 0 | 172 |
|
| Hospitalization | Immune system disorders | Non-systematic Assessment | Hospitalization events were not related to study participation. |
|
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |