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Supporting Adolescents to Adhere - an Intervention Using Airtime Rewards Allocated by a Prize Drawing (SATA)

Primary Purpose

Human Immunodeficiency Virus

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Own Adherence Group
Fixed Adherence Group
Control Group
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus focused on measuring HIV, Antiretroviral (ARV), co-trimoxazole, SMS, Lottery incentive, mobile health, Uganda, Youth

Eligibility Criteria

16 Years - 25 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

Sites / Locations

  • Mildmay Uganda

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Own Adherence Group

Fixed Adherence Group

Control Group

Arm Description

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.

Participants do not receive a lottery incentive conditional on adherence. Participants will however, continue to receive weekly messaging with airtime top-up contingent on response.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Fraction of clients displaying adherence of 90% or more
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 secondary outcome measures of fraction of clients displaying adherence of 90% or more.
Indicator for treatment interruptions of more than 48 hours
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 secondary outcome measures of an indicator for treatment interruptions of more than 48 hours.
Viral load assays

Full Information

First Posted
September 14, 2016
Last Updated
February 15, 2018
Sponsor
RAND
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1. Study Identification

Unique Protocol Identification Number
NCT02918838
Brief Title
Supporting Adolescents to Adhere - an Intervention Using Airtime Rewards Allocated by a Prize Drawing
Acronym
SATA
Official Title
Supporting Adolescents to Adhere - an Intervention Using Airtime Rewards Allocated by a Prize Drawing
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
February 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
For Group 1 (lottery reward with fixed target): Study coordinators check participant's MEMS extraction for last month's adherence. Study coordinators then tell participants of the participants' adherence in the last month. Participants are also informed that during the next clinic visit, if they adhere at least 90 percent they have a chance to enter into a game where they have a chance of winning mobile airtime, by drawing into a bag and picking a card associated with their airtime winnings. If they do not have 90% adherence, they will not receive the airtime award game, but there will be another chance the next time they come for their scheduled clinic visit during the study period. For Group 2 (lottery award with own target): Study coordinators check participant's MEMS extraction for last month's adherence. They inform participants of their adherence in the last month. In order to be eligible for an airtime reward game, during their next clinic visit they must reach their own target goal. The target adherence goal must be greater than 80%. Participants may, for example, choose 80%, 85%, 90%, 95%, or 100%. Again, if they meet or exceed this target they have a chance to draw into a bag to win mobile airtime. If they do not have meet this self-imposed target adherence, they will not be eligible to play the airtime award game, but there will be another chance the next time they come for their scheduled clinic visit during the study period. During each clinic visit, participants will have their MEMS extracted and study coordinators will check for average adherence between that day and the last clinic visit. For those who have met the target, coordinators will initiate the lottery, complete the drawing procedure, or send them the airtime reward without drawing (depending on which group). Every Sunday, study investigators will send treatment participants a motivational message to remind them about the reward. Within each of the two intervention groups, study investigators will randomly send the message either in a loss-frame or a gain-frame, i.e. an intervention participant (in either group) will some weeks receive a message telling them to keep up motivation (as a code-word for adherence) to win a prize, and some weeks telling them to make sure not to lose their chance to win a prize.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
HIV, Antiretroviral (ARV), co-trimoxazole, SMS, Lottery incentive, mobile health, Uganda, Youth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Own Adherence Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Fixed Adherence Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants do not receive a lottery incentive conditional on adherence. Participants will however, continue to receive weekly messaging with airtime top-up contingent on response.
Intervention Type
Behavioral
Intervention Name(s)
Own Adherence Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fixed Adherence Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Primary Outcome Measure Information:
Title
Medication adherence rates using electronically monitored adherence (MEMS cap) data
Description
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).
Time Frame
9 months after enrollment
Secondary Outcome Measure Information:
Title
Fraction of clients displaying adherence of 90% or more
Description
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 secondary outcome measures of fraction of clients displaying adherence of 90% or more.
Time Frame
9 months after enrollment
Title
Indicator for treatment interruptions of more than 48 hours
Description
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 secondary outcome measures of an indicator for treatment interruptions of more than 48 hours.
Time Frame
9 months after enrollment
Title
Viral load assays
Time Frame
9 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 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
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
Mildmay Uganda
City
Kampala
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Supporting Adolescents to Adhere - an Intervention Using Airtime Rewards Allocated by a Prize Drawing

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