Intensive Combination Approach to Rollback the Epidemic in Nigerian Adolescents: UH3 Phase
Overview
- Phase
- N/A
- Intervention
- Peer navigation
- Conditions
- Adolescent HIV Infection
- Sponsor
- Northwestern University
- Enrollment
- 541
- Locations
- 6
- Primary Endpoint
- VIral suppression
- Status
- Completed
- Last Updated
- 11 days ago
Overview
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 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 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).
Investigators
Babafemi Taiwo
Professor
Northwestern University
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
Arms & Interventions
Sequence A (Cluster 1): HIV Treatment Intervention
0 to 48 weeks intervention, 49-72 weeks post-intervention
Intervention: Peer navigation
Sequence A (Cluster 1): HIV Treatment Intervention
0 to 48 weeks intervention, 49-72 weeks post-intervention
Intervention: SMS Text messaging
Sequence B (Cluster 2): HIV Treatment Intervention
0 to 24 weeks pre-intervention, 25 - 72 weeks intervention, 73 - 96 post intervention
Intervention: Peer navigation
Sequence B (Cluster 2): HIV Treatment Intervention
0 to 24 weeks pre-intervention, 25 - 72 weeks intervention, 73 - 96 post intervention
Intervention: SMS Text messaging
Sequence C (Cluster 3): HIV Treatment Intervention
0 to 48 weeks pre-intervention, 49 - 96 weeks intervention
Intervention: Peer navigation
Sequence C (Cluster 3): HIV Treatment Intervention
0 to 48 weeks pre-intervention, 49 - 96 weeks intervention
Intervention: SMS Text messaging
Outcomes
Primary Outcomes
VIral suppression
Time Frame: Week 48
Proportion of participants with viral suppression, defined as viral load (plasma HIV-1 RNA) \<200 copies/ml
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
Secondary Outcomes
- Antiretrovial adherence measured by pharmacy drug pick-up(Week 48)
- Antiretroviral drug concentration(Week 48)
- Retention in care(Week 48)
- Proportion of Participants With Antiretrovial Adherence(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(24 Week period)
- Proportion of Participants With Antiretroviral Adherence >=90%(48 Week Period)