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

Florida State University

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: CPS; Behavioral: SMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03535337

ATN 144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 15 to 24 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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83 participants in 8 patient groups

CPS-Rsp-T

Active Comparator group

Description:

After 3 months of intervention, this group of CPS Rsp will receive 3 months of CPS-T intervention followed by SC.

Treatment:

Behavioral: CPS

CPS-Rsp-SC

Active Comparator group

Description:

After 3 months of intervention, this group of CPS Rsp's intervention will discontinue and they'll receive SC only

Treatment:

Behavioral: CPS

CPS-NRsp-I

Active Comparator group

Description:

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.

Treatment:

Behavioral: CPS

CPS-NRsp-SMS-I

Active Comparator group

Description:

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

Treatment:

Behavioral: CPS

SMS-Rsp-T

Active Comparator group

Description:

After 3 months of intervention, this group of SMS Rsp will receive 3 months of SMS tapered (SMS-T) intervention followed by SC.

Treatment:

Behavioral: SMS

SMS-Rsp-SC

Active Comparator group

Description:

After 3 months of intervention, this group of SMS Rsp, intervention will discontinue and they'll receive SC only

Treatment:

Behavioral: SMS

SMS-NRsp-CPS-I

Active Comparator group

Description:

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

Treatment:

Behavioral: SMS

SMS-NRsp-I

Active Comparator group

Description:

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

Treatment:

Behavioral: SMS