Clinical trial NCT02918838: Supporting Adolescents to Adhere - an Intervention Using Airtime Rewards Allocated by a Prize Drawing
Official title: Supporting Adolescents to Adhere - an Intervention Using Airtime Rewards Allocated by a Prize Drawing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Keywords: HIV
Antiretroviral (ARV)
co-trimoxazole
SMS
Lottery incentive
mobile health
Uganda
Youth
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 216
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Medication adherence rates using electronically monitored adherence (MEMS cap) data
timeFrame: 9 months after enrollment
Secondary outcomes:
measure: Fraction of clients displaying adherence of 90% or more
timeFrame: 9 months after enrollment
measure: Indicator for treatment interruptions of more than 48 hours
timeFrame: 9 months after enrollment
measure: Viral load assays
timeFrame: 9 months after enrollment
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mildmay Uganda
Study officials:
affiliation: RAND
name: Sebastian Linnemayr, PhD
role: PRINCIPAL_INVESTIGATOR
References: