Adolescent HIV InfectioniCARENCT04950153

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

A study testing Peer navigation and SMS Text messaging in people with Adolescent HIV Infection, run by Northwestern University at 6 sites in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 15 to 24 yearsHealthy volunteers can take part
Conditions the study is for: Adolescent HIV Infection
What is being tested?: Peer navigation and SMS Text messaging
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 541 participants
Where: 6 sitesNigeria
Study dates: 15 Apr 2021to 31 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 15 to 24 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Nigeria6 sites

University of Ibadan
Ibadan
Jos University Teaching Hospital
Jos
Lagos State University Teaching Hospital
Lagos
Lagos University Teaching Hospital
Lagos
Nigerian Institute of Medical Research (NIMR)
Lagos
Olabisi Onabanjo University Teaching Hospital
Sagamu

Other trials in Nigeria

About this study

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.

Read the detailed description

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).

Conditions: Adolescent HIV Infection
Being tested: Peer navigation, SMS Text messaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peer navigationBehavioural
Peer navigators will navigate youth with HIV to provide assistance and support to optimize adherence to antiretroviral treatment (ART)
SMS Text messagingBehavioural
Short Message System (SMS) text messages to remind and encourage youth to adhere to their ART

Study groups in NCT04950153
Study group	Role	What they receive
Sequence A (Cluster 1): HIV Treatment Intervention	Other	0 to 48 weeks intervention, 49-72 weeks post-intervention Receives: 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 Receives: 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 Receives: Behavioral: Peer navigation; Behavioral: SMS Text messaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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
Measured: 48 Week Period

Secondary outcomes (3)

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%
Measured: 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
Number and proportion of participants with self-reported antiretroviral adherence based no 30-day recall reported on visual analogue scale, defined as >=90%
Measured: 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%
Measured: 48 Week Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202131 Dec 2024

First posted6 Jul 2021
Study start15 Apr 2021
Primary completion30 Aug 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Adolescent HIV InfectionStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe 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: Randomised
Intervention model: Sequential
Model description: 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)
Masking: None (open label)
Enrolment: 541 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04950153
Sponsor's protocol ID: iCARE Nigeria UH3
Other IDs: UH3HD096920
Acronym: iCARE
Status last verified: Apr 2026
First submitted: 25 Jun 2021
Last updated: 21 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 39780298
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.
PubMed 37418498

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Recruiting
AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
Cervical Cancer, Kaposi Sarcoma
Recruiting
Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults
HIV
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse

All Adolescent HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase
ClinicalTrials.gov ID: NCT04950153
Acronym / sponsor ID: iCARE / iCARE Nigeria UH3
Conditions: Adolescent HIV Infection
Study type: Interventional
Recruitment status: Completed
Enrolment: 541 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 15 Apr 2021 (actual)
Primary completion: 30 Aug 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 6 Jul 2021 (actual)
Results: Posted 21 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: 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)

Arm	Type	Receives
Sequence A (Cluster 1): HIV Treatment Intervention	Other	Behavioral: Peer navigation, Behavioral: SMS Text messaging0 to 48 weeks intervention, 49-72 weeks post-intervention
Sequence B (Cluster 2): HIV Treatment Intervention	Other	Behavioral: Peer navigation, Behavioral: SMS Text messaging0 to 24 weeks pre-intervention, 25 - 72 weeks intervention, 73 - 96 post intervention
Sequence C (Cluster 3): HIV Treatment Intervention	Other	Behavioral: Peer navigation, Behavioral: SMS Text messaging0 to 48 weeks pre-intervention, 49 - 96 weeks intervention

Who may qualify

Ages: 15 to 24 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

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
Peer navigationPeer navigators will navigate youth with HIV to provide assistance and support to optimize adherence to antiretroviral treatment (ART)	Behavioural	Sequence A (Cluster 1): HIV Treatment Intervention, Sequence B (Cluster 2): HIV Treatment Intervention, Sequence C (Cluster 3): HIV Treatment Intervention
SMS Text messagingShort Message System (SMS) text messages to remind and encourage youth to adhere to their ART	Behavioural	Sequence A (Cluster 1): HIV Treatment Intervention, Sequence B (Cluster 2): HIV Treatment Intervention, Sequence C (Cluster 3): HIV Treatment Intervention

Primary outcome

Proportion of Participants With Viral Load Suppression, (Plasma HIV-1 RNA <200 Copies/ml)
Time frame: 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)
We assessed the change in proportion of participants who were virally suppressed before and after exposure to 48 weeks of the iCARE intervention.
Proportion With Virologic Suppression (HIV-1 RNA<200 Copies mL)
Time frame: 24 Week Period
Proportion of participants with viral load suppression, defined as viral load (plasma HIV-1 RNA <200 copies/ml); 24 Week Period
Proportion With Viral Load Suppression (HIV RNA <200 Copies/ml)
Time frame: 48 Week Period
Proportion of participants with viral load suppression, defined as viral load (plasma HIV-1 RNA <200 copies/ml); 48 Week Period

3 secondary outcomes

Proportion of Participants With Antiretrovial Adherence
Time frame: 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
Time frame: 24 Week period
Proportion of Participants With Antiretroviral Adherence >=90%
Time frame: 48 Week Period

Results and safety

Results posted to the registry on 21 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence A (Cluster 1): Implementation Start Week 0	60	59
Sequence B (Cluster 2): Implementation Start, Week 25	309	302
Sequence C (Cluster 3: Implementation Start Week 49	172	168

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

Time frame: 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). Count of participants. Unit: Participants

Measure	Sequence A (Cluster 1): HIV Treatment Intervention n = 59	Sequence B (Cluster 2): HIV Treatment Intervention n = 302	Sequence C (Cluster 3): HIV Treatment Intervention n = 167
Value	37	182	108

Population analysed: Baseline: Proportion with virologic suppression (HIV-1 RNA \<200 copies/ml)

Primary outcome: Proportion With Virologic Suppression (HIV-1 RNA<200 Copies mL)

Time frame: 24 Week Period. Count of participants. Unit: Participants

Measure	Sequence A (Cluster 1): HIV Treatment Intervention n = 58	Sequence B (Cluster 2): HIV Treatment Intervention n = 297	Sequence C (Cluster 3): HIV Treatment Intervention n = 165
Value	41	193	109

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

Primary outcome: Proportion With Viral Load Suppression (HIV RNA <200 Copies/ml)

Time frame: 48 Week Period. Count of participants. Unit: Participants

Measure	Sequence A (Cluster 1): Implementation Start Week 0 n = 57	Sequence B (Cluster 2): Implementation Start, Week 25 n = 293	Sequence C (Cluster 3: Implementation Start Week 49 n = 162
Value	35	182	111

Sequence A (Cluster 1): Implementation Start Week 0 vs Sequence B (Cluster 2): Implementation Start, Week 25 vs Sequence C (Cluster 3: Implementation Start Week 49: Odds Ratio (OR): 1.5, p <0.05, Regression, Logistic

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sequence A (Cluster 1): HIV Treatment Intervention	1 of 60 (1.7%)	0 of 60 (0%)	1 of 60
Sequence B (Cluster 2): HIV Treatment Intervention	6 of 309 (1.9%)	0 of 309 (0%)	6 of 309
Sequence C (Cluster 3): HIV Treatment Intervention	5 of 172 (2.9%)	0 of 172 (0%)	5 of 172

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39780298Kozhumam 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.
Derived from this study: PubMed 37418498Taiwo 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.

Related trials for Adolescent HIV Infection

RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection
Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Recruiting
AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
Cervical Cancer, Kaposi Sarcoma
Recruiting
Behavioral Activation and Risk Reduction for Stimulant Use Among Sexually Active Adolescents and Young Adults
HIV
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse

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.

Babafemi Taiwo, MBBS principal investigator

Northwestern University

Robert Garofalo, MD principal investigator

Ann & Robert Lurie Childrens Hospital of Chicago

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Peer navigation and SMS Text messaging in people with Adolescent HIV Infection, run by Northwestern University at 6 sites 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 4 inclusion and 2 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

Yes. Results are posted in the registry (first posted 21 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Proportion of Participants With Viral Load Suppression, (Plasma HIV-1 RNA <200 Copies/ml) (time frame: 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)). The study lists 3 primary outcomes in all. 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 NCT04950153, which also lists 2 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 21 Apr 2026.