N/A
Completed N=541
Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase
Adolescent HIV Infection
Source: ClinicalTrials.gov NCT04950153 ↗
Enrolled (actual)
541
Serious AEs
2.2%
Results posted
Apr 2026
Primary outcomePrimary: Proportion of Participants With Viral Load Suppression, (Plasma HIV-1 RNA <200 Copies/ml) — 37; 182; 108 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Viral Load Suppression, (Plasma HIV-1 RNA <200 Copies/ml) |
37; 182; 108 | — |
| PRIMARY Proportion With Virologic Suppression (HIV-1 RNA<200 Copies mL) |
41; 193; 109 | — |
| PRIMARY Proportion With Viral Load Suppression (HIV RNA <200 Copies/ml) |
35; 182; 111 | <0.05 sig |
| SECONDARY Proportion of Participants With Antiretrovial Adherence |
28; 149; 133 | — |
| SECONDARY Proportion of Participants With Antiretroviral Adherence |
43; 191; 144 | — |
| SECONDARY Proportion of Participants With Antiretroviral Adherence >=90% |
36; 167; 137 | <0.05 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04950153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.