Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART)

Study Overview
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Brief Summary
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The purpose of this study is to test an adaptive adherence intervention, which utilizes two mobile health (mHealth) intervention designs, in an effort to promote adherence to antiretroviral therapy (ART) and achieve and maintain viral load (VL) suppression in youth living with HIV (YLH) while increasing understanding of the context for wide-scale implementation of cell phone support (CPS) and text messaging support (SMS), with and without incentives.

Detailed Description
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The study will consist of two points of randomization. The first step involves randomization of participants to receive either CPS or SMS using a 1:1 allocation ratio. Both intervention conditions will receive 3 months of intervention (i.e., 12 weeks of CPS or SMS). The second step involves a stratified randomization in blocks with 8 possible intervention trajectories. Within each condition, participants are categorized into two groups - responders with VL<200 (Rsp) and non-responders with VL ≥200 (NRsp). Responders in the CPS condition will be randomly assigned to receive either 3 months of CPS tapered (CPS-T) intervention followed by standard care (SC) or only SC. Similarly, responders in the SMScondition will be randomly assigned to receive either 3 months of SMS tapered (SMS-T) intervention followed by SC or only SC. Non-responders in both CPS and SMS conditions will be randomly assigned to receive either 3 months of incentivized CPS (CPS-I) followed by 3 months of CPS-T and 3 months of SC or 3 months of incentivized SMS (SMS-I) followed by 3 months of SMS-T and 3 months of SC.

Official Title
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Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living With HIV Through Text Messaging and Cell Phone Support Embedded Within the Sequential Multiple Assignment Randomized Trial (SMART) Design

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: CPS
* Behavioral: SMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV diagnosis Viral load ≥ 200 copies/mL within 3 months prior to enrollment or self-reported adherence ≤ 80% ART medication regimen prescribed minimum of 3 months prior to eligibility VL or self-reported adherence Sole owner of device capable of sending/receiving calls and text messages Willingness to permit research team to communicate with their HIV care provider team Exclusion Criteria: Mental, physical, or emotional capacity prevents completion of protocol as written Inability to understand written/spoken English Concurrent participant in any adherence behavioral research intervention

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Multiple Assignment Randomized Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPS-Rsp-T<br>After 3 months of intervention, this group of CPS Rsp will receive 3 months of CPS-T intervention followed by SC. | Behavioral: CPS<br>* Assessment of participant's medication adherence and barrier problem solving via phone conversation<br>|
| Active Comparator: CPS-Rsp-SC<br>After 3 months of intervention, this group of CPS Rsp's intervention will discontinue and they'll receive SC only | Behavioral: CPS<br>* Assessment of participant's medication adherence and barrier problem solving via phone conversation<br>|
| Active Comparator: CPS-NRsp-I<br>After 3 months of intervention, this group of CPS NRsp will receive 3 months of CPS-I followed by 3 months of CPS-T and 3 months of SC. | Behavioral: CPS<br>* Assessment of participant's medication adherence and barrier problem solving via phone conversation<br>|
| Active Comparator: CPS-NRsp-SMS-I<br>After 3 months of intervention, this group of CPS NRsp will receive 3 months of SMS-I followed by 3 months of SMS-T and 3 months of SC | Behavioral: CPS<br>* Assessment of participant's medication adherence and barrier problem solving via phone conversation<br>|
| Active Comparator: SMS-Rsp-T<br>After 3 months of intervention, this group of SMS Rsp will receive 3 months of SMS tapered (SMS-T) intervention followed by SC. | Behavioral: SMS<br>* Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.<br>|
| Active Comparator: SMS-Rsp-SC<br>After 3 months of intervention, this group of SMS Rsp, intervention will discontinue and they'll receive SC only | Behavioral: SMS<br>* Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.<br>|
| Active Comparator: SMS-NRsp-CPS-I<br>After 3 months of intervention, this group of SMS NRsp will receive 3 months of CPS-I followed by 3 months CPS-T and 3 months SC | Behavioral: SMS<br>* Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.<br>|
| Active Comparator: SMS-NRsp-I<br>After 3 months of intervention, this group of SMS NRsp will receive 3 months of SMS-I followed by 3 months of SMS-T and 3 months of SC | Behavioral: SMS<br>* Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Load Comparison | Viral Load (VL) suppression rate will be compared between the CPS and SMS groups using an X2 test. Also the drop in VL will be compared between the two groups. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence Rate | Medication adherence rates will be compared between CPS and SMS groups, focusing on non-responders. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interventions, youth living with HIV, mHealth, ART adherence, adaptive intervention, cell phone, text messaging