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

Florida State University83 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

CPSBEHAVIORAL

Assessment of participant's medication adherence and barrier problem solving via phone conversation

SMSBEHAVIORAL

Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.

Eligibility

Sex: ALLMin age: 15 YearsMax age: 24 Years

Medical Language ↔ Plain English

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

Locations (1)

The City University of New York

New York, New York, United States

Outcomes

Primary Outcomes

Undetectable Viral Load

Percent of participants that have an undetectable HIV Viral Load.

Time frame: baseline, month 3, month 6, month 9, and month 12

Medication Adherence Rate - 7 Day

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.

Time frame: baseline, month 3, month 6, month 9, and month 12

Medication Adherence - 30 Days

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.

Time frame: baseline, month 3, month 6, month 9, and month 12

Data from ClinicalTrials.gov

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