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Completed

NCT Number: NCT04950153

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

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.

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Key information

Conditions

Adolescent HIV Infection

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ibadan, Ibadan, Nigeria

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peer navigation

Behavioral

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

SMS text messaging

Behavioral

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

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  1. 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)

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

  2. Proportion of Participants With Antiretroviral Adherence

    Time frame: 24 Week period

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

  3. Proportion of Participants With Antiretroviral Adherence >=90%

    Time frame: 48 Week Period

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Acronym: iCARE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2021
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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