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SMS as an Incentive To Adhere (SITA) - An Intervention Communicating Social Norms by SMS to Improve ARV Adherence (SITA)

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Own adherence
Own and group level adherence
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Human Immunodeficiency Virus focused on measuring behavioral economics, antiretroviral adherence, SMS, mobile health (mHealth), Adolescents, Uganda, HIV

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Aids Support Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Own adherence

Own and group level adherence

Arm Description

Participants in this group receive a weekly message by SMS. They receive the intervention 'Behavioral: Own Adherence'.

Participants in this group receive a weekly message by SMS. They receive the intervention 'Behavioral: Own and Group Adherence'.

Outcomes

Primary Outcome Measures

Medication adherence rates using electronically monitored adherence (wise pill) data
Wisepill data will be collected continuously over the course of the 9-month study period (preceded by about one month of adherence measurement only to allow for solution of any wisepill-related problems) allowing us to investigate daily adherence and its timing. Wisepill data indicating the date and time when the participant opened their pill container (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the primary outcome variable of adherence (# of actual bottle openings / # of prescribed bottle openings).

Secondary Outcome Measures

Self-reported adherence
Survey will ask about self-reported adherence at baseline and month 9.

Full Information

First Posted
July 30, 2015
Last Updated
April 12, 2017
Sponsor
RAND
Collaborators
The AIDS Support Organization
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1. Study Identification

Unique Protocol Identification Number
NCT02514356
Brief Title
SMS as an Incentive To Adhere (SITA) - An Intervention Communicating Social Norms by SMS to Improve ARV Adherence
Acronym
SITA
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
March 7, 2017 (Actual)
Study Completion Date
March 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
The AIDS Support Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
behavioral economics, antiretroviral adherence, SMS, mobile health (mHealth), Adolescents, Uganda, HIV

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Own adherence
Arm Type
Active Comparator
Arm Description
Participants in this group receive a weekly message by SMS. They receive the intervention 'Behavioral: Own Adherence'.
Arm Title
Own and group level adherence
Arm Type
Active Comparator
Arm Description
Participants in this group receive a weekly message by SMS. They receive the intervention 'Behavioral: Own and Group Adherence'.
Intervention Type
Behavioral
Intervention Name(s)
Own adherence
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Own and group level adherence
Intervention Description
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 Outcome Measure Information:
Title
Medication adherence rates using electronically monitored adherence (wise pill) data
Description
Wisepill data will be collected continuously over the course of the 9-month study period (preceded by about one month of adherence measurement only to allow for solution of any wisepill-related problems) allowing us to investigate daily adherence and its timing. Wisepill data indicating the date and time when the participant opened their pill container (either one of the ART medications or prophylaxis if not on ART yet) will be used to calculate the primary outcome variable of adherence (# of actual bottle openings / # of prescribed bottle openings).
Time Frame
9 months after enrollment
Secondary Outcome Measure Information:
Title
Self-reported adherence
Description
Survey will ask about self-reported adherence at baseline and month 9.
Time Frame
9 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Linnemayr, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Aids Support Organization
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Citations:
PubMed Identifier
32093630
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.
Results Reference
derived
PubMed Identifier
30286746
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.
Results Reference
derived

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SMS as an Incentive To Adhere (SITA) - An Intervention Communicating Social Norms by SMS to Improve ARV Adherence

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