NCT02514356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2017

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

July 30, 2015

Last Update Submit

April 12, 2017

Conditions

Human Immunodeficiency Virus

Keywords

behavioral economicsantiretroviral adherenceSMSmobile health (mHealth)AdolescentsUgandaHIV

Outcome Measures

Primary Outcomes (1)

  • 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).

    9 months after enrollment

Secondary Outcomes (1)

  • Self-reported adherence

    9 months after enrollment

Study Arms (2)

Own adherence

ACTIVE COMPARATOR

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

Behavioral: Own adherence

Own and group level adherence

ACTIVE COMPARATOR

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

Behavioral: Own and group level adherence

Interventions

Own adherenceBEHAVIORAL

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.

Own adherence
Own and group level adherenceBEHAVIORAL

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

Own and group level adherence

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Aids Support Organization

Kampala, Uganda

Location

Related Publications (2)

  • 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.

    PMID: 32093630DERIVED

  • 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.

    PMID: 30286746DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Sebastian Linnemayr, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2015

First Posted

August 3, 2015

Study Start

August 1, 2015

Primary Completion

March 7, 2017

Study Completion

March 7, 2017

Last Updated

April 14, 2017

Record last verified: 2017-04

Locations

UG(1)