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

Not Applicable

Active, not recruiting

• Conditions: Adolescent HIV Infection
• Interventions: Behavioral: Peer navigation; Behavioral: Social Media Engagement; Behavioral: SMS Text messaging; Behavioral: Testing Peer Navigation

• Registration Number: NCT04950153
• Lead Sponsor: Northwestern University

Brief 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 testing and linkage to care and 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.

Detailed Description

A randomized stepped wedge (cluster) trial will be conducted to investigate two combination interventions (each with mHealth + Peer Navigation components) among youth in Ibadan, Lagos, Sagamu, and Jos, Nigeria. Study 1 (Testing and Linkage to Care) will test a combination intervention that targets HIV testing and linkage to care. Study 2 (Treatment Intervention) will test a combination intervention that targets HIV treatment outcomes (retention, adherence and viral suppression).

Study Timeline

• Study Start: 2021-04-15
• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-07-06
• Primary Completion: 2024-08-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-15
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 558

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIV Treatment Intervention	SMS Text messaging	Combination HIV treatment outcomes (retention, ART adherence and viral suppression) intervention includes SMS text messaging and peer navigation
HIV Testing Intervention	Testing Peer Navigation	Combination HIV testing and linkage to care intervention includes social media engagement and peer navigation
HIV Treatment Intervention	Peer navigation	Combination HIV treatment outcomes (retention, ART adherence and viral suppression) intervention includes SMS text messaging and peer navigation
HIV Testing Intervention	Social Media Engagement	Combination HIV testing and linkage to care intervention includes social media engagement and peer navigation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Antiretrovial adherence measured by pharmacy drug pick-up	Week 48	Pharmacy drug pick-up (90% of days with medication)
Antiretroviral drug concentration	Week 48	Antiretroviral drug concentration in Dried Blood Spot sufficient for viral suppression
Retention in care	Week 48	Retention, defined as at least two care (non-study) visits in the prior 24-week period

Trial Locations

Locations (6)

Nigerian Institute of Medical Research (NIMR); 🇳🇬 Lagos, Nigeria

Lagos State University Teaching Hospital; 🇳🇬 Lagos, Nigeria

Olabisi Onabanjo University Teaching Hospital; 🇳🇬 Sagamu, Nigeria

University of Ibadan; 🇳🇬 Ibadan, Nigeria

Lagos University Teaching Hospital; 🇳🇬 Lagos, Nigeria

Jos University Teaching Hospital; 🇳🇬 Jos, Nigeria