Adolescent HIV Infection
Conditions
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).
Interventions
BEHAVIORALPeer navigation
Peer navigators will navigate youth with HIV to provide assistance and support to optimize adherence to antiretroviral treatment (ART)
BEHAVIORALSMS Text messaging
Short Message System (SMS) text messages to remind and encourage youth to adhere to their ART
Sponsors
Northwestern University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
15 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Viral Load Suppression, (Plasma HIV-1 RNA <200 Copies/ml) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Number and proportion of participants with self-reported antiretroviral adherence based on 30-day recall reported on visual analogue scale, defined as \>=90% |
| Proportion of Participants With Antiretroviral Adherence | 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% |
| Proportion of Participants With Antiretroviral Adherence >=90% | 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% |
Countries
Nigeria
Contacts
PRINCIPAL_INVESTIGATORBabafemi Taiwo, MBBS
Northwestern University
PRINCIPAL_INVESTIGATORRobert Garofalo, MD
Ann & Robert Lurie Childrens Hospital of Chicago
Participant flow
Recruitment details
We report herein results from a stepped wedge cluster-randomized trial (SW CRT). The SW-CRT involves randomization of clusters (of clinics) to different sequences that dictate the order (or timing) at which each cluster will switch to the intervention condition. In this SW CRT, there are three clusters/sequences: A (cluster 1), B (cluster 2), C (cluster 3) as defined below. Each cluster is exposed to the combination intervention for two consecutive 24-week periods (total of 48 weeks).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 18.47 years STANDARD_DEVIATION 2.4 |
| Proportion with virologic suppression (HIV-1 RNA <200 copies/ml) | 37 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 541 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Nigeria | 172 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 60 | 6 / 309 | 5 / 172 |
| other Total, other adverse events | 0 / 60 | 0 / 309 | 0 / 172 |
| serious Total, serious adverse events | 1 / 60 | 6 / 309 | 5 / 172 |
Outcome results
None listed