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

Sponsor

Florida State University (Other)

Overall Status

Completed

CT.gov ID

NCT03535337

Collaborator

Children's Hospital Los Angeles (Other), Hunter College of City University of New York (Other), Wayne State University (Other)

Enrollment

Location

Arms

44.9

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: CPS Behavioral: SMS	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

83 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Multiple Assignment Randomized TrialMultiple Assignment Randomized Trial

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

May 31, 2022

Actual Study Completion Date :

May 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Viral Load Comparison [3 months]
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.

Secondary Outcome Measures

Medication Adherence Rate [3 months]
Medication adherence rates will be compared between CPS and SMS groups, focusing on non-responders.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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