Clinical trial NCT03535337: Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Interventions
youth living with HIV
mHealth
ART adherence
adaptive intervention
cell phone
text messaging
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: Hunter College of City University of New York
name: Wayne State University
First posted: 2018-05-24
Enrollment: 83
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multiple Assignment Randomized Trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Undetectable Viral Load
timeFrame: baseline, month 3, month 6, month 9, and month 12
measure: Medication Adherence Rate - 7 Day
timeFrame: baseline, month 3, month 6, month 9, and month 12
measure: Medication Adherence - 30 Days
timeFrame: baseline, month 3, month 6, month 9, and month 12
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The City University of New York
state: New York
Study officials:
References:
citation: Belzer ME, MacDonell KK, Ghosh S, Naar S, McAvoy-Banerjea J, Gurung S, Cain D, Fan CA, Parsons JT. Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living With HIV Through Text Message and Cell Phone Support With and Without Incentives: Protocol for a Sequential Multiple Assignment Randomized Trial (SMART). JMIR Res Protoc. 2018 Dec 20;7(12):e11183. doi: 10.2196/11183.