Demographic characteristics of participants are shown in Table 2. All participants had similar baseline adherence levels. Compared with the control group, participants in the two treatment arms were more likely to be male and have English as their first language. They also had a higher monthly income.
Table 2. Balance between Groups at Baseline
|
Control
|
T1
|
T2
|
N
|
53
|
35
|
49
|
Baseline Adherence
|
0.81
|
0.79
|
0.79
|
Male
|
0.17
|
0.26
|
0.20
|
English Preferred Language
|
0.51
|
0.66
|
0.63
|
Can Read Newspaper
|
0.85
|
0.83
|
0.88
|
Completed Secondary Education
|
0.66
|
0.63
|
0.73
|
Currently Employed
|
0.51
|
0.43
|
0.45
|
Monthly Income (USD)
|
5.86
|
9.10
|
9.42
|
Has Bank Account
|
0.15
|
0.40
|
0.27
|
Notes: T1 = Received text messages with their own adherence information only, T2 = Received text messages with their own adherence as well as the adherence information of their peers
|
Acceptability Results
Intervention coherence – Do participants understand SITA? Qualitative data showed that participants understood the intervention protocols. They viewed SITA as an intervention to improve their adherence and emphasized the helpful role of Wisepill and receipt of adherence information.
Affective attitude – How do participants feel about SITA? Both quantitative and qualitative data show partiicpants had positive attitudes about SITA. In the follow-up survey data, 96.6% of participants reported that they would remain in the intervention if they had the choice (95.3% in the T1 group and 97.8% in T2), and 84.2% said there was nothing about SITA that they did not like (86.0% in T1 and 82.6% in T2). In the FGs, many participants in T2 reflected on enjoying the competition with their peers that was brough about by receiving information on peer adherence, while only one person from T1 mentioned liking the competition it caused from voluntarily sharing adherence information with peers. Further, several participants from both T1 and T2 felt that SITA boosted their morale and prompted them to take their ART medication.
Self-efficacy – Are participants able to perform the SITA activities? The intervention has two key components: use of the Wisepill device and use of the mobile phone to which SMS were delivered.
With respect to the Wisepill devise, the quantitiatve data shows that it recorded an 88% median level of adherence for participants, suggesting that most people used the Wisepill device to store their medication. Aditionally the survey showed that participants were generally very fond of the Wisepill device: more than half of participants reported that Wisepill was the part of the study they liked the most. The FGs found that many participants said their least favorite part of the study was having to give the device back. Further, participants in both treatment arms said that the Wisepill device was easy to move with and that the device itself helped as a reminder to take their medication. In the FGs, participants reported experiencing some challenges with the device–e.g., difficultly charging it; however, overall they appreciated its benefits. Anecdotal evidence from study staff noted some challenges in receiving Wisepill devices (e.g., fees required upon receipt at the airport) and preparing the devices for distribution (e.g., packaging the device along with the required cables, batteries, and plugs).
The second key protocol component was use of the mobile phone to which text messages were delivered. The quantitative data reveal exposure to the text messages was high, suggesting strong usage. Specifically, 75% of participants reported reading the messages every week, and 85% said they read them most weeks. Of note, wrong individual adherence information was sent on 82 occasions. Staff notes suggest that the errors were due to technological difficulties with SIM cards when trying to register them with the Ugandan phone service provider. In the FGs, participants reported that receiving inaccurate information undercut their desire to further improve their adherence. The study team subsequently resolved this problem in cooperation with the cell service provider.
Perceived effectiveness – Did participants think SITA was effective? Both the quantitative and qualitative data show that participants also thought SITA was effective. In the follow-up survey, 97.7% reported benefiting from being part of the SITA program (95.4% in the T1 group and 100% in the T2 group), and all participants reported that other youth at the clinic would benefit from being part of SITA. The FGs revealed that SITA consistently helped participants to take their medications on time. Further, participants noted that SITA’s impact extended beyond the specific act of taking their medication: in many ways, the program improved their overall outlook on life and generated renewed focus on their health.
Representative qualitative quotes that support the key findings on acceptability are shown in Table 3.
Table 3. Acceptability Results
|
Acceptability Component
|
Quotes
|
Intervention Coherence
|
"If […] you have the device, it helps you remember to take your drugs on time and also keeps drugs safe and helps to inspire you with the messages." (Treatment Group 1)
|
Affective Attitude
|
Enjoying the Competition: "I would not love to lose SITA because it really changes a lot of people’s lives, and it has really changed my life because if I compare, sincerely speaking, my life now with the life backward or before SITA, it was really miserable in that I didn’t have anything to push me. But now with this project, there was competition, I was competing with the rest of my colleagues. I always wanted good marks from SITA, so it really encouraged me with all my friends. It really changed our lives. It was very wonderful." (Treatment Group 1)
|
Increased Morale: "When you have the wise pill device, it comes to your mind that someone will know whether you took drugs or not so it was always boosting morale." (Treatment Group 2)
|
Helpful Reminders: “[SITA] was so good generally especially to us who used not to take our drugs well so it reminded us so much (Treatment Group 1)
|
Self-Efficacy
|
Use of Wisepill Device: "You can easily move with it without anyone knowing what you are carrying and it’s only you that knows. One can easily mistake it for a power bank and not mind about it. It was very good especially making it easy to move with it rather than moving with medication containers while making noise." (Treatment Group 2)
|
Use of SMS Messages: "I was eager to see the message because I very much wanted to see my percentage. Whenever, I saw my percentage for example like 30% or 50%, I would ask myself why it is 50%. I would ask myself, [and] it seemed here I skipped some minutes, so I am going to start to have to be punctual because poor adherence denied me a chance of the right percentage." (Treatment Group 1)
|
Perceived Effectiveness
|
Taking medication on time: “According to me, [Wisepill] is good because I used to take my drugs on a daily basis but not on time. It used to motivate me and I would say, let me take drugs on time so that I score good marks because someone is monitoring me, so it always reminded me to take drugs on time. That was its merit." (Treatment Group 1)
|
Improved their overall quality of life: "It made me happy because before they gave it to me, I [thought] that even if I take the medication at the time I want, so long as I take, but for me it taught me that I have to take it on time... It made me set an alarm in my phone. If it rings I just know that I am missing something. In other words, it changed my life." (Treatment Group 1)
|
Feasibility Results
Scientific assessments – Is SITA safe and standardized, and does it use valid measures? Study safety was established through the ethics approval processes at the RAND Corporation, TASO, and the Uganda National Council for Science and Technology. In addition, the study protocol was published in the clinical trials registry (ClinicalTrials.gov Identifier: NCT02514356 [22]). All measures of adherence are established using the electronic medication monitoring system Wisepill.
Process assessment – What is the recruitment process and are study procedures followed? Figure 1 (CONSORT Flow Diagram) demonstrates that the eligibility criteria were feasible and not too narrow. Specifically, the quantitative data show that, of the 229 individuals approached, 32 were ineligible, most often because they did not have a working phone or did not meet the age requirement; 18 declined to participate in the study because they were not interested, or they provided no explanation. Staff notes also highlight that participants were concerned about potential disclosure of their HIV status (e.g., as a result of receiving calls from study staff associated with TASO, a known HIV service provider in the area). Despite these issues, target numbers were readily achieved. Of those recruited for the study, 24 failed to reach sufficient adherence in the pre-baseline period to warrant further study participation. Attrition was low, with only 8 (5 in control group, 3 in T2, and 0 in T1) of 155 participants lost to follow-up (5.16%).
Preliminary Impact Results
The average effect over the entire 36 weeks was relatively small and statistically insignificant for both intervention groups. Adherence was 81.1% in the control group, 76.5% in T1 group, and 82.5% in the T2 group. After controlling for baseline adherence, the T1 group had 3.8 percentage point lower adherence than the control group (95% CI -9.9, 2.3) and the T2 group had 2.4 percentage points higher adherence than the control group (95% CI -3.0, 7.9). However, the average effect masks an increasing treatment effect over time for T2. To demonstrate this, Figure 2A shows trends in adherence for the different study arms (smoothed using locally weighted scatterplot smoothing) over the 36 weeks and Figure 2B shows treatment effects in each of the four 9-week intervals. Over the course of the study, adherence in the control group and in the T1 (own adherence information) group steadily dropped off. The control group began at over 80% adherence but fell to about 70% by the end of the study. The T1 group decreased from around 84% to 74%. In the T2 group, adherence increased initially and the subsequent drop off was less stark than in the other two groups. Adherence in the T2 group remained between 80% and 85% for the duration of the study. Figure 2B shows a 3 percentage point increase in adherence in the initial 9-weeks that grows to 9 percentage points by the last 9-weeks of the study. We find negative treatment effects for T1 in 3 of the 4 intervals.
Because this is a pilot study, our sample size is not large enough to give us sufficient power to detect statistically significant effects. However, the direction and magnitude of the treatment effects for T2 are promising; the T1 intervention shows no signs of impact. In other words, giving adolescents information about their own adherence (T1) does not appear to improve adherence, but giving them information about their own adherence relative to their peers (T2) shows promise for increasing adherence.