Clinical trial NCT02514356: SMS as an Incentive To Adhere (SITA) - An Intervention Communicating Social Norms by SMS to Improve ARV Adherence
Official title: A Small Randomized Controlled Trial Providing Weekly Information by SMS About Own and Group-level ARV Adherence to Patients in Two Clinics in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: behavioral economics
antiretroviral adherence
SMS
mobile health (mHealth)
Adolescents
Uganda
HIV
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: The AIDS Support Organization
First posted: 2015-08-03
Enrollment: 147
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study 'SMS as an Incentive To Adhere' (SITA) is to test two novel approaches of using SMS messages (provision of information about electronically measured own adherence, as well as in combination with group adherence level) to improve adherence to anitretroviral (ART) and pre-ART prophylaxis among youth age 15-24 at an HIV clinic in Uganda.

Detailed description: SITA addresses two behavioral biases observed in people living with HIV/AIDS (PLWHA). The growing field of behavioral economics (BE) suggests that people display behavioral biases (i.e. systematic decision making errors) that among patients can contribute to suboptimal adherence. Investigators observed two important such biases in our own work in Uganda: first, investigators found that patients to a large degree overestimate their own adherence, i.e. think that they adhere better than they actually do. Second, a patient's social environment matters: PLWHA clearly care about their peers and their peers' attitudes and behavior.

SITA is based on Social Cognitive Theory (SCT) and adapts two traditional interventions to mHealth. The first intervention is that of self-monitoring, i.e. providing participants with feedback about their adherence performance. Traditionally this involves clinic visits that take up provider and patient time and resources; SITA instead suggests providing objective, real-time information measured by electronic monitoring (Wisepill) devices sent to patients by weekly SMS. Such feedback builds self-efficacy, a key SCT concept and thereby may improve adherence. The second intervention is based on the SCT concept of social learning. Perceived group norms, and interventions that affect those perceptions, are a key influence on health behavior among youths, providing a substitute for direct learning. Investigators adapt this approach to a mHealth environment by providing PLWHA not only with their own adherence information but also that of a reference (peer) group.

SITA will use mixed methods research techniques and focus on knowledge transfer within a multidisciplinary team. In formative Phase 1 investigators will conduct qualitative focus groups with key stakeholders to elicit information about the use of wisepill devices, and acceptance, feasibility and locally appropriate adaptation of SITA. In Phase 2, investigators will implement a nine-months, three-arm (with 50-60 participants each) randomized controlled trial: youths in intervention group 1 will receive information about their wisepill-measured adherence level by weekly SMS. Intervention group 2 will in addition be sent the adherence level of a reference group that investigators hypothesize to exert normative influence. The control group will receive the usual standard of care. Throughout the study investigators will focus on capacity building and knowledge transfer to the Ugandan collaborators through workshops and mentoring.

Eligibility criteria: Inclusion Criteria:

* have been in HIV care at the clinic for at least three months
* are currently taking HIV-related medication (ART or co-trimoxazole)
* either own a phone or have regular access to one
* intend to stay at the clinic for the study period
* are not in boarding school (where phones are forbidden)

Exclusion Criteria:

* does not speak or understand either English or Luganda
* does not have the cognitive capacity to consent and/or understand the study procedures

Primary outcomes:
measure: Medication adherence rates using electronically monitored adherence (wise pill) data
timeFrame: 9 months after enrollment
Secondary outcomes:
measure: Self-reported adherence
timeFrame: 9 months after enrollment
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: The Aids Support Organization
Study officials:
affiliation: RAND
name: Sebastian Linnemayr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacCarthy S, Wagner Z, Mendoza-Graf A, Gutierrez CI, Samba C, Birungi J, Okoboi S, Linnemayr S. A randomized controlled trial study of the acceptability, feasibility, and preliminary impact of SITA (SMS as an Incentive To Adhere): a mobile technology-based intervention informed by behavioral economics to improve ART adherence among youth in Uganda. BMC Infect Dis. 2020 Feb 24;20(1):173. doi: 10.1186/s12879-020-4896-0.
citation: MacCarthy S, Saya U, Samba C, Birungi J, Okoboi S, Linnemayr S. "How am I going to live?": exploring barriers to ART adherence among adolescents and young adults living with HIV in Uganda. BMC Public Health. 2018 Oct 4;18(1):1158. doi: 10.1186/s12889-018-6048-7.