Supporting Adolescents to Adhere - an Intervention Using Airtime Rewards Allocated by a Prize Drawing
SATA
1 other identifier
interventional
216
1 country
1
Brief Summary
This study is an extension of Reminding Adolescents to Adhere (RATA) (Unique protocol ID: 1R01HD074925-01). Participants for SATA will be recruited during the RATA month 24 exit survey. Participants will be randomized 1:1:1 into either one of two intervention group (receiving the weekly messages and a chance to draw a prize at each clinic visit based on either a fixed adherence level of 90% or a self-chosen one of at least 80% as further detailed below) or the control group that receives the existing RATA intervention consisting of weekly motivational messages and the chance to get mobile airtime rewards conditional on responding. Doing so will allow the investigators to cleanly evaluate the impact of these additional adherence-based lotteries, and guarantees that those who have been in the control group receiving standard of care in the first 24 months of the RATA intervention will also receive an intervention for reasons of fairness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 14, 2016
CompletedFirst Posted
Study publicly available on registry
September 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedFebruary 19, 2018
February 1, 2018
1.5 years
September 14, 2016
February 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication adherence rates using electronically monitored adherence (MEMS cap) data
Medication Event Monitoring System (MEMS)-cap data will be collected continuously over the course of the 9-month study period allowing the study investigators to investigate daily adherence and its timing. MEMS caps data indicating the date and time when the participant opened their pill bottle (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 (3)
Fraction of clients displaying adherence of 90% or more
9 months after enrollment
Indicator for treatment interruptions of more than 48 hours
9 months after enrollment
Viral load assays
9 months after enrollment
Study Arms (3)
Own Adherence Group
EXPERIMENTALParticipant chooses their adherence level to be reached at next clinic visit (at least 80%, but can be higher). If they reach that percentage measured using the MEMS cap, they can participate in a lottery for an airtime reward of none, a small amount, and a larger amount. Participants also receive a weekly motivational message reminding them of their incentive to adhere. If they respond to the message they will receive airtime top-up.
Fixed Adherence Group
EXPERIMENTALParticipant is told to meet a pre-determined target of 90%. If they reach that percentage measured using the MEMS cap, they can participate in a lottery for an airtime reward of none, a small amount, and a larger amount. Participants also receive a weekly motivational message reminding them of their incentive to adhere. If they respond to the message they will receive airtime top-up.
Control Group
ACTIVE COMPARATORParticipants do not receive a lottery incentive conditional on adherence. Participants will however, continue to receive weekly messaging with airtime top-up contingent on response.
Interventions
Participant chooses their adherence level to be reached at next clinic visit (at least 80%, but can be higher). If they reach that percentage measured using the MEMS cap, they can participate in a lottery for an airtime reward of none, a small amount, and a larger amount. Participants also receive a weekly motivational message reminding them of their incentive to adhere. If they respond to the message they will receive airtime top-up.
Participant is told to meet a pre-determined target of 90%. If they reach that percentage measured using the MEMS cap, they can participate in a lottery for an airtime reward of none, a small amount, and a larger amount. Participants also receive a weekly motivational message reminding them of their incentive to adhere. If they respond to the message they will receive airtime top-up.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RANDlead
Study Sites (1)
Mildmay Uganda
Kampala, Uganda
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastian Linnemayr, PhD
RAND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2016
First Posted
September 29, 2016
Study Start
August 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
February 19, 2018
Record last verified: 2018-02