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

Not Applicable

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
SMS-Rsp-SC	SMS	After 3 months of intervention, this group of SMS Rsp, intervention will discontinue and they'll receive SC only
SMS-NRsp-I	SMS	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
CPS-Rsp-SC	CPS	After 3 months of intervention, this group of CPS Rsp's intervention will discontinue and they'll receive SC only
CPS-NRsp-SMS-I	CPS	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
SMS-NRsp-CPS-I	SMS	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
CPS-Rsp-T	CPS	After 3 months of intervention, this group of CPS Rsp will receive 3 months of CPS-T intervention followed by SC.
CPS-NRsp-I	CPS	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.
SMS-Rsp-T	SMS	After 3 months of intervention, this group of SMS Rsp will receive 3 months of SMS tapered (SMS-T) intervention followed by SC.

Primary Outcome Measures

Name	Time	Method
Undetectable Viral Load	baseline, month 3, month 6, month 9, and month 12	Percent of participants that have an undetectable HIV Viral Load.
Medication Adherence Rate - 7 Day	baseline, month 3, month 6, month 9, and month 12	Self reported percentage of medication taken in the past 7 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.
Medication Adherence - 30 Days	baseline, month 3, month 6, month 9, and month 12	Self reported percentage of medication taken in the past 30 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.