Trial Outcomes & Findings for Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase (NCT NCT04950153)

Last Updated: 2026-04-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

541 participants

Primary outcome timeframe

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)

Results posted on

2026-04-21

Participant Flow

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).

Unit of analysis: Clinics

Participant milestones

Participant milestones
Measure	Sequence A (Cluster 1): Implementation Start Week 0 0 to 48 weeks intervention, 49-72 weeks post-intervention	Sequence B (Cluster 2): Implementation Start, Week 25 0 to 24 weeks pre-intervention, 25 - 72 weeks intervention, 73 - 96 post intervention	Sequence C (Cluster 3: Implementation Start Week 49 0 to 48 weeks pre-intervention, 49 - 96 weeks intervention
Week 0 - 24 STARTED	60 1	309 3	172 2
Week 0 - 24 COMPLETED	59 1	302 3	168 2
Week 0 - 24 NOT COMPLETED	1 0	7 0	4 0
Week 25 - 48 STARTED	59 1	302 3	168 2
Week 25 - 48 COMPLETED	59 1	297 3	167 2
Week 25 - 48 NOT COMPLETED	0 0	5 0	1 0
Week 49 - 72 STARTED	0 0	297 3	167 2
Week 49 - 72 COMPLETED	0 0	294 3	167 2
Week 49 - 72 NOT COMPLETED	0 0	3 0	0 0
Week 72 - 96 STARTED	0 0	0 0	167 2
Week 72 - 96 COMPLETED	0 0	0 0	161 2
Week 72 - 96 NOT COMPLETED	0 0	0 0	6 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Missing viral load data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence A (Cluster 1) n=60 Participants 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	Sequence B (Cluster 2) n=309 Participants 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	Sequence C (Cluster 3) n=172 Participants 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	Total n=541 Participants Total of all reporting groups
Age, Continuous	18.85 years STANDARD_DEVIATION 2.4 • n=60 Participants	18.52 years STANDARD_DEVIATION 2.5 • n=309 Participants	18.26 years STANDARD_DEVIATION 2.3 • n=172 Participants	18.47 years STANDARD_DEVIATION 2.4 • n=541 Participants
Sex: Female, Male Female	41 Participants n=60 Participants	156 Participants n=309 Participants	95 Participants n=172 Participants	292 Participants n=541 Participants
Sex: Female, Male Male	19 Participants n=60 Participants	153 Participants n=309 Participants	77 Participants n=172 Participants	249 Participants n=541 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=60 Participants	0 Participants n=309 Participants	0 Participants n=172 Participants	0 Participants n=541 Participants
Race (NIH/OMB) Asian	0 Participants n=60 Participants	0 Participants n=309 Participants	0 Participants n=172 Participants	0 Participants n=541 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=60 Participants	0 Participants n=309 Participants	0 Participants n=172 Participants	0 Participants n=541 Participants
Race (NIH/OMB) Black or African American	60 Participants n=60 Participants	309 Participants n=309 Participants	172 Participants n=172 Participants	541 Participants n=541 Participants
Race (NIH/OMB) White	0 Participants n=60 Participants	0 Participants n=309 Participants	0 Participants n=172 Participants	0 Participants n=541 Participants
Race (NIH/OMB) More than one race	0 Participants n=60 Participants	0 Participants n=309 Participants	0 Participants n=172 Participants	0 Participants n=541 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=60 Participants	0 Participants n=309 Participants	0 Participants n=172 Participants	0 Participants n=541 Participants
Region of Enrollment Nigeria	60 participants n=60 Participants	309 participants n=309 Participants	172 participants n=172 Participants	541 participants n=541 Participants
Proportion with virologic suppression (HIV-1 RNA <200 copies/ml)	37 Participants n=59 Participants • Missing viral load data	182 Participants n=302 Participants • Missing viral load data	108 Participants n=167 Participants • Missing viral load data	327 Participants n=528 Participants • Missing viral load data

PRIMARY outcome

Timeframe: 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)

Population: Baseline: Proportion with virologic suppression (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.

Outcome measures

Outcome measures
Measure	Sequence B (Cluster 2): HIV Treatment Intervention n=302 Participants 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	Sequence C (Cluster 3): HIV Treatment Intervention n=167 Participants 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	Sequence A (Cluster 1): HIV Treatment Intervention n=59 Participants 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
Proportion of Participants With Viral Load Suppression, (Plasma HIV-1 RNA <200 Copies/ml)	182 Participants	108 Participants	37 Participants

PRIMARY outcome

Timeframe: 24 Week Period

Population: 24 Week Period: Proportion with virologic suppression (HIV-1 RNA\<200 copies mL) after 24 Weeks of Intervention

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

Outcome measures

Outcome measures
Measure	Sequence B (Cluster 2): HIV Treatment Intervention n=297 Participants 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	Sequence C (Cluster 3): HIV Treatment Intervention n=165 Participants 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	Sequence A (Cluster 1): HIV Treatment Intervention n=58 Participants 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
Proportion With Virologic Suppression (HIV-1 RNA<200 Copies mL)	193 Participants	109 Participants	41 Participants

PRIMARY outcome

Timeframe: 48 Week Period

Population: 48 Week Period: Proportion with virologic suppression (HIV-1 RNA\<200 copies mL) after 48 Weeks of Intervention

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

Outcome measures

Outcome measures
Measure	Sequence B (Cluster 2): HIV Treatment Intervention n=293 Participants 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	Sequence C (Cluster 3): HIV Treatment Intervention n=162 Participants 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	Sequence A (Cluster 1): HIV Treatment Intervention n=57 Participants 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
Proportion With Viral Load Suppression (HIV RNA <200 Copies/ml)	182 Participants	111 Participants	35 Participants

SECONDARY outcome

Timeframe: 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)

Population: Baseline: Proportion of participants with self-reported antiretroviral adherence \>=90%

Number and proportion of participants with self-reported antiretroviral adherence based on 30-day recall reported on visual analogue scale, defined as \>=90%

Outcome measures

Outcome measures
Measure	Sequence B (Cluster 2): HIV Treatment Intervention n=302 Participants 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	Sequence C (Cluster 3): HIV Treatment Intervention n=167 Participants 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	Sequence A (Cluster 1): HIV Treatment Intervention n=60 Participants 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
Proportion of Participants With Antiretrovial Adherence	149 Participants	133 Participants	28 Participants

SECONDARY outcome

Timeframe: 24 Week period

Population: 24 Week Period: Proportion of participants with self-reported antiretroviral adherence \>=90% after 24 Weeks of Intervention

Number and proportion of participants with self-reported antiretroviral adherence based no 30-day recall reported on visual analogue scale, defined as \>=90%

Outcome measures

Outcome measures
Measure	Sequence B (Cluster 2): HIV Treatment Intervention n=297 Participants 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	Sequence C (Cluster 3): HIV Treatment Intervention n=167 Participants 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	Sequence A (Cluster 1): HIV Treatment Intervention n=59 Participants 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
Proportion of Participants With Antiretroviral Adherence	191 Participants	144 Participants	43 Participants

SECONDARY outcome

Timeframe: 48 Week Period

Population: 48 Week Period: Proportion of participants with self-reported antiretroviral adherence \>=90% after 48 Weeks of Intervention

Number and proportion of participants with self-reported antiretroviral adherence based no 30-day recall reported on visual analogue scale, defined as \>=90%

Outcome measures

Outcome measures
Measure	Sequence B (Cluster 2): HIV Treatment Intervention n=294 Participants 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	Sequence C (Cluster 3): HIV Treatment Intervention n=162 Participants 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	Sequence A (Cluster 1): HIV Treatment Intervention n=59 Participants 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
Proportion of Participants With Antiretroviral Adherence >=90%	167 Participants	137 Participants	36 Participants

Adverse Events

Sequence A (Cluster 1): HIV Treatment Intervention

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Sequence B (Cluster 2): HIV Treatment Intervention

Serious events: 6 serious events

Other events: 0 other events

Deaths: 6 deaths

Sequence C (Cluster 3): HIV Treatment Intervention

Serious events: 5 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	Sequence A (Cluster 1): HIV Treatment Intervention n=60 participants at risk 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	Sequence B (Cluster 2): HIV Treatment Intervention n=309 participants at risk 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	Sequence C (Cluster 3): HIV Treatment Intervention n=172 participants at risk 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
Immune system disorders Death	1.7% 1/60 • Number of events 1 • 48 weeks NOTE: Deaths and adverse events were monitored by cluster instead of assessed per intervention.	1.9% 6/309 • Number of events 6 • 48 weeks NOTE: Deaths and adverse events were monitored by cluster instead of assessed per intervention.	2.9% 5/172 • Number of events 5 • 48 weeks NOTE: Deaths and adverse events were monitored by cluster instead of assessed per intervention.
Immune system disorders Hospitalization	1.7% 1/60 • Number of events 1 • 48 weeks NOTE: Deaths and adverse events were monitored by cluster instead of assessed per intervention.	0.32% 1/309 • Number of events 1 • 48 weeks NOTE: Deaths and adverse events were monitored by cluster instead of assessed per intervention.	0.00% 0/172 • 48 weeks NOTE: Deaths and adverse events were monitored by cluster instead of assessed per intervention.

Other adverse events

Adverse event data not reported

Additional Information

Lisa Kuhns

Northwestern University

Phone: 312-227-7740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place