Overview

This trial is active, not recruiting.

Condition human immunodeficiency virus
Treatments own adherence, own and group level adherence
Sponsor RAND
Collaborator The AIDS Support Organization
Start date August 2015
End date December 2016
Trial size 147 participants
Trial identifier NCT02514356, 1R21MH107218-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Participants in this group receive a weekly message by SMS. They receive the intervention 'Behavioral: Own Adherence'.
own adherence
In this intervention group, participants receive weekly SMS messages informing them of their adherence that week as measured by the wise pill device used by the participant.
(Active Comparator)
Participants in this group receive a weekly message by SMS. They receive the intervention 'Behavioral: Own and Group Adherence'.
own and group level adherence
In this intervention group, participants receive weekly SMS messages informing them of their adherence that week as measured by the wise pill device used by the participant. In addition, in the same message they are informed of the adherence demonstrated by the other participants

Primary Outcomes

Measure
Medication adherence rates using electronically monitored adherence (wise pill) data
time frame: 9 months after enrollment

Secondary Outcomes

Measure
Self-reported adherence
time frame: 9 months after enrollment

Eligibility Criteria

Male or female participants from 15 years up to 24 years old.

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

Additional Information

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
Principal investigator Sebastian Linnemayr, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by RAND.