Needs and contents of a customized digital tool for retention in care among breast- feeding and pregnant women living with HIV in Kilimanjaro

doi:10.21203/rs.3.rs-2120648/v1

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Research Article

Needs and contents of a customized digital tool for retention in care among breast- feeding and pregnant women living with HIV in Kilimanjaro

https://doi.org/10.21203/rs.3.rs-2120648/v1

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Background: Retention in care and adherence to medication among pregnant and breastfeeding women living with HIV (PBWLH) are crucial for prevention of mother-to-child transmission (PMTCT) of HIV. Due to the comprehensive coverage of mobile phones, digital tools, including the use of internet-enabled medication dispensers and short message service (SMS), have been described as potential interventions to improve adherence. Therefore, the study’s main objective was to understand the needs and contents of a customized digital tool for retention in care and medication adherence among PBWLH.

Method: A mixed-methods study was conducted from September 2021 to March 2022 at five health facilities in Kilimanjaro region. Pregnant and breastfeeding receiving PMTCT services were included in a survey using a semi-structured questionnaire. Among the interviewed, twenty breastfeeding participants were purposively selected, trained, and enrolled to use an internet-enabled medication dispenser for one month. They received different types of SMS reminders for four weeks and feedback on their adherence patterns from a nurse counsellor after one month using an adherence graph from Wisepill. Later, exit interview and an in-depth interview (IDI) were conducted to explore needs and content. We did descriptive analyses for quantitative data and thematic content analyses for qualitative data.

Results: Among 142 women interviewed, 42(29.5%) were pregnant, and 100 (70.5%) were breastfeeding. A majority of 136(95%) had access to mobile phones and used SMS daily. Ninety-six percent were interested in receiving reminder messages. Nearly 86(61%) preferred to be reminded daily before medication intake time. Showing adherence graphs during tailored feedback sessions was highly appreciated. Qualitative findings revealed more insights into the content of reminders and educational SMS. Most people prefer neutral SMS which does not contain the word “medication”. Health educational SMS contents preferred breastfeeding, opportunistic diseases, nutrition, and entrepreneurship education. Overall, SMSs were regarded as helpful in reminding clients of medication time and medication dispenser provided them with privacy and safe storage for their medication.

Conclusion: This study helps to construct useful content for future digital adherence tools to support the health of pregnant and breastfeeding women living with HIV. Digital tools seem to be highly needed.

Antiretroviral therapy (ART)

HIV/PMTCT

Retention

Digital Adherence Tools (DAT)

Real Time Medication Monitoring (RTMM)

HIV/AIDS is still a major cause of death globally. About 38 million people globally were living with HIV in 2020 (1). More than half of the world's population affected by HIV lives in Sub-Saharan Africa (2). In Tanzania, nearly 1.7 million were said to be diagnosed with HIV in 2019 (1). From 2010 to 2019, the number of people living with HIV in the country increased from 1.3 million to 1.9 million (1). Despite the implementation of option B + in 2014, 8,600 children aged 0–14 were newly infected with HIV through mother-to-child transmission during delivery or breastfeeding in 2019 (1).

Over 90% of new infections among infants and young children occur through mother-to-child transmission, which is during pregnancy, labour and breastfeeding (3). In absence of interventions, during breastfeeding 5–20% of infants are at risk of getting HIV (1). Without antiretroviral treatment, the risk of mother-to-child infection is 15–45% in Sub-Saharan Africa (4). The WHO guideline recommends that regardless of the immunity (CD4 count) of the pregnant woman living with HIV, she should immediately receive ARVs and continue lifelong treatment (5). A systematic review of cohort studies done in East Africa shows that the average prevalence of mother to child transmission is 7.68% (6). Among pregnant women living with HIV in Tanzania, the percentage enrolled in prevention of mother-to-child transmission (PMTCT) services reached 92% in 2019 (1).

Being on lifelong ART treatment involves high levels of adherence to treatment and retention in care. However, poor retention rates among pregnant and breastfeeding women remain a challenge contributing towards the mother to child HIV infection rate of 11% in 2019, which is higher than the global target of 5% (1). Retention in care is a requirement for adherence to treatment as visiting a clinic is needed for medication dispensing (7). Adherence to treatment is among the most important factors for success of the UNAIDS “start free-stay free-AIDS free” framework. Adherence can be measured and monitored directly through measuring drug levels in serum. As this method is expensive, indirect measures can be used such as self-reported adherence, pharmacy refill counts and medication monitoring through digital adherence tools (7). A systematic review, which was done for Africa, including 35 articles showed that retention in care after the first appointment was estimated to be 74.5% at 12 months after ART initiation (8). A cohort study done in Tanzania shows that among women living with HIV during the postpartum period, the lost to follow up was about 69.5% (9).

Adherence to ARTs during pregnancy, labour and breastfeeding contributes largely in reducing the risk of transmission to the child from 35–2% in low middle-income countries (10). Various factors have been identified as barriers for women to adhere to ART or be retained in care such as lack of correct information on how to use ARTs, low awareness on HIV infection and mother to child prevention of HIV, stigma, disclosure to a spouse, regime fatigue, physical and depressive symptoms and lack of social support (11). Lack of social support has been linked to poor adherence and low retention in care (8, 12). All these factors increase the possibility of developing drug resistance, treatment failure and contribute to failure in viral load suppression and increase rate of HIV transmission to the child (13). Several studies have been done to improve adherence investigating interventions such as reminder cues, counselling, extensive education, and clinical care retention (14, 15), but still there is lack of effective evidence on effective intervention to improve retention to care (16).

Several review studies have shown a positive effect of SMS on retention in care and adherence to treatment, though all recommend that more robust intervention studies are needed (14, 15, 17–19). Most studies on the use of SMS in PLHIV in SSA are conducted in Kenya. There is one trial that sends weekly messages asking, ‘How are you?’ to pregnant women, in Western Kenya (20). Another study sends weekly motivational and educational SMS and visit reminders (21). The intervention used on their trial was designed through formative research in which results showed that SMS may improve outcomes. Messages should be customized according to the context and users have different needs considering the contents of SMS (22). Another study in Kenya, which sent SMS informed by constructs of the Health-Belief-Model showed a significant effect on maternal postpartum clinic attendance (23). This intervention was also informed through qualitative research and has led to the trial (24).

The penetration of mobile phones in Tanzania was 89% in 2021. Additionally, 32 billion SMS were sent in the last quarter of 2021 (25). Using the common way of communication through SMS at an affordable price of nearly 54 Tanzania shillings (0.02$) has high potential for disease management. However, optimization of existing and previously investigated strategies is needed. In Tanzanian previous pilot studies, it was found that using digital adherence tools (DATs) including SMS for reminding about medication intake among adults in Moshi, Tanzania was feasible (26, 27). Furthermore, a trial has successfully been implemented using a DAT (Wisepill) combined with SMS reminders. It showed a positive effect of both the DAT and SMS on adherence to treatment among participants with viral load below 1000 copies/ml. Furthermore, the proportion of participants reaching 90% was higher among the intervention groups (28).

Results of a mixed method study among participants of the same trial have shown that real time medication monitoring is highly acceptable and has potential to improve adherence (29). Despite these positive results, the authors also encountered with concerns about unwanted disclosure and stigma due to the contents of SMS asking directly if medication was taken (30). These could be overcome by using more neutral messages, (colour) symbols, multimedia SMS or a joke as a code for reminding people to take their pill. In addition, technical challenges have been reported such as limited network availability, limited access to electricity and problems with battery life resulting in SMS not being sent. Given the high coverage of mobile technology in the country, digital health tools are feasible to be implemented. However, based on the previous studies done, we believe there is a need for a formative study to understand better about the contents of digital tools which may help to improve adherence to medications. Therefore, this study aims to understand the needs and contents of a customized digital tools among pregnant and breastfeeding women living with HIV. We will explore contents for short message service texts to take medication and contents for reminder short messages to facilitate clinic attendance. Furthermore, we will investigate educational needs in order to design messages based and identify barriers in using digital tools.

Study design

This was a parallel formative mixed methods study, including both quantitative and qualitative data collection methods. We conducted a survey among pregnant and breastfeeding women. A selection of women was then using a digital adherence tool (DAT) for a month followed by feedback from a nurse counsellor on their adherence to medication patterns. After this, we conducted in-depth interviews (IDI) among Breastfeeding women. We obtained ethical clearance from the local institutional review board which is Kilimanjaro Christian Medical College Research Ethics and Review Committee (CRERC) and the National Medical Research Institute (NIMR) of Tanzania. We followed Good Clinical Practice (GCP) guidelines in all study procedures.

Study area

This study was conducted in Kilimanjaro region located in the Northern part of Tanzania. We conducted the study in five HIV care clinics including care and treatment centres (CTC), antenatal care (ANC) and PMTCT clinics in Kilimanjaro, Tanzania. Participants were recruited from Kilimanjaro Christian Medical Centre (KCMC), Pasua health centre, Mawenzi regional hospital and Majengo health centre all located in Moshi urban. We also involved a peripheral site, which was Kibosho hospital.

Study population and inclusion and exclusion criteria

This study involved pregnant and breastfeeding women living with HIV in Kilimanjaro region. Data collection took place from September 2021-March 2022.

Inclusion criteria: Pregnant and breastfeeding women who are HIV-positive: pregnant women were only included in the survey and breastfeeding women were included in both survey and digital adherence tools study; Attending Care and Treatment Centres (CTC) or postnatal clinics in Kilimanjaro; Age between 18–50 years. Breastfeeding women willing to use digital tools; Pregnant or breastfeeding women willing to sign and able to understand the informed consent.

Exclusion criteria: Admitted to hospital, participating in other trials related to adherence and retention into care.

Sample size calculation

To our knowledge, there is no information on how many participants experience barriers for using Digital Adherence Tools (DAT). Selecting the arbitrary percentage of 50% experiencing barriers to using a DAT with standard error of 0.05 and power of 80% (estimation of single proportion sample calculation), we needed 142 pregnant and breastfeeding women.

Intervention (DAT and Tailored feedback)

The Wisepill device (RT2000 dispenser) is a pocket-sized dispenser designed by the Wisepill company. It contains a global SIM card that communicates through cellular networks to synchronize with the Wisepill Cloud service each time the device is opened. At any point that the device is opened, the exact opening time, it's identification number, and technical information of the battery and signal strength are recorded in the database. We registered the user’s agreed intake time on the Wisepill Web Server. Whenever a participant forgets to take medication at the prescribed time, a reminder SMS is sent to their mobile phones. The health care workers and researchers can monitor medication intakes through access provided to online adherence reports and graphs generated.

After one month, participants received feedback on adherence reports. In the first part of the feedback session, consciousness was being generated by providing tailored feedback on adherence performance. They were firstly asked how they felt about their medication intake behaviour. This was followed by showing a graph to the participant, so he or she could understand where adherence could be improved. In addition, nurses gave basic education on the importance of adherence. After this phase in the session, participants considered changing their drug taking behaviour. The possible pros and cons of changing behaviour and barriers to improving were discussed. Nurses offered possible solutions, such as “cues” in daily life to be coupled with medication intake. The third phase of the feedback session consists of the participant taking making decisions concerning their behaviour. An adherence goal for the next clinic visit was set by the nurse and participant together (goal setting). We used a modified stage of change model developed by Prochaska et al (31).

Study Procedures

Eligible individuals were asked to participate in the study by signing an informed consent form. After participants completed their clinic visits with health care workers, they were brought to a private room where research assistants interviewed them. A thoroughly informed consent procedure was used whereby the aim of the study was explained using a patient information sheet. After informed consent was filled, a semi-structured questionnaire was administered face to face to breastfeeding and pregnant women as part of the survey.

A sub-sample of 20 participants was selected from the study participants, considering variability in demographic characteristics including rural or urban, facilities, clinic adherence patterns, and viral load to ensure heterogeneity in to use of digital tools. Another thoroughly informed consent procedure was done before enrolment in the DAT study. Participants used the device for a period of one month to understand the mechanism of operation of the device. In the first week, participants received a basic medication reminder SMS in Swahili, “Habari ndugu, muda wako wa kumeza dawa umekaribia unakumbushwa kumeza dawa zako kwa wakati kama ulivyoelekezwa na wataalamu wa afya”, which in English means “Hello dear, your time to take medications is near, you are reminded to take your medications as instructed by the health care professionals”, half an hour before usual time of intake. A second reminder was sent one hour after the agreed usual time of intake in case there was no signal of the box being opened. These types of SMS were derived from our previous REMIND study (28). More neutral SMS reminders were sent in the next three weeks, which did not mention the word medication. We decided not to use the word medication as the word could lead to unwanted disclosure of the HIV status to others who might, by accident read the SMS. Over time, messages became more neutral; for instance, in the second week, we used SMS such as “you are reminded to drink” (unakumbushwa kunywa) or “your time to use is near” (muda wako unakaribia) and in the third week were “Your health is important” (afya yako ni muhimu) or “Remember to care about your health” (kumbuka kulinda afya yako), and in the fourth week were “Health!” (Afya) or “Use!” (tumia) or “Value health” (thamini afya). After one month, study nurses shared and discussed adherence reports generated by the device giving each participant tailored feedback on their adherence reports during clinic visits. Exit-interviews and in-depth interviews followed this to understand the context of adherence to treatment, use of the digital tools, contents and experience of DAT and SMS in breastfeeding women. Exit-interviews and IDI were done in Kiswahili by trained research assistants who were not part of care of the participant.

Theoretical framework

In order to understand needs, contents and barriers, we felt it would be best explained through the two theoretical frameworks. Figure 1 outlines how the theoretical framework construct helped to understand the needs, contents and barriers of using digital tools.

The content of the interview guide for IDI was informed by the Health Belief Model (HBM) (32) and Theoretical Framework of Acceptability (TFA) (33). We also used findings of prior research done in Kenya on developing contents for the mHealth intervention to promote postpartum retention in preventing mother to child HIV transmission with the use of the HBM (23). We used six domains of the HBM: perceived severity prompted participants’ perceptions of the disadvantage of using DAT and how it affected their timetable; Perceived susceptibility explored participants’ perceptions of the risk associated with the use of DAT; Perceived benefits explored participants’ beliefs about the reasons why they should use DAT and perception of the potential benefits of using DAT in taking medications; Perceived barriers explored on perceived difficulties in using DAT and we further probed on how difficult it was to open and close the device; Self-efficacy explored on participants’ confidence in using DAT and to what extent participants think (s)he is able to use DAT; For Cues to action, we asked the participants specific questions concerning the kind of SMS that would potentially help women to adhere to medication and clinic visits including content, timing and frequency of SMS. All seven domains of TFA were being explored: Affective attitude explored how participants feel about DAT and tailored feedback; Perceived effectiveness explored how participants think DAT improves their medication adherence; Ethicality explored how DAT preserves cultural values and appropriateness of the content; Intervention coherence explored how participants understand how DAT works; Self-efficacy explored on participants’ confidence in using DAT and to what extent participants think (s)he is able to use DAT; Perceived burden explored difficulties in using intervention and Opportunity cost investigated whether participants gave up something of value, or to what extent the intervention cost them in terms of financial or time cost.

Data collection tools

Survey with semi-structured questionnaires

For the survey, we used a semi-structured questionnaire using electronic data capture, RedCap (Research Electronic Data Capture). In the survey, we collected demographics, treatment-related data, medication and clinic adherence, use of mobile phones and network availability, barriers to using DAT, stigma and depression related to HIV.

Exit Interviews

Trained research assistants conducted exit interviews after participants completed one month of using DAT. Interviews were done face to face. A semi-structured questionnaire was used which was based on previous studies (29) and included all emerging issues during formative study. Closed questions were first asked to understand participants’ perceptions, followed by open-ended questions for each item to allow further explanation. Data were entered in real-time using RedCap.

IDI

The topic guide focused on the experience in using mobile phones, phone access, SMS use, network connectivity, barriers to using digital tools, needed content for reminder SMS, needs for educational SMS, needed content of tailored feedback on adherence patterns during clinic visits and preference in time, psychosocial factors (stigma, disclosure and social support), medication adherence and usage of graphs which were generated by the digital tools. The interviews were conducted in the hospital clinic in a private doctor’s room. The interviews lasted approximately 40 to 90 minutes. The topic guides were adapted during the study in an iterative process. Interviews were transcribed verbatim and translated to English.

All collected data were stored pseudonymously using patient identifier codes.

Data Analysis

We used descriptive analysis to summarize the participants characteristics, preference and use of mobile phones.

In order to answer the objectives regarding needs and contents of SMS for reminding and education and content for tailored feedback on adherence patterns, we conducted thematic content analysis of data from in-depth interviews and focus group discussions and descriptive analysis from survey and follow up interviews.

Themes were developed from reading and re-reading of transcripts. Memos were developed based on the first six interviews by RAM, KWK and from there a preliminary codebook was developed. Translated transcripts and field notes were uploaded into NVivo software for data organization and the codebook was imported as well. Data was organized according to codes from where themes were derived. We discussed the listed themes and agreement was met on common subthemes. A coding framework was developed based on the themes. Themes were discussed with other research assistants who were in data collection together with other social scientists to ensure reliability and validity of the coded data together with compliance of the framework.

To answer objectives on the barriers of using digital tools we conducted thematic content analysis from in-depth interviews and focus group discussions as above. Descriptive analysis was done using data from survey and follow up interviews.

Participants characteristics

A total of 142 women were interviewed in the survey. Among those, 42 (30%) were pregnant women and 100 (70%) were breastfeeding women. Mean age was 31.3 (SD 6.3) and ranged from 19 to 45 years. One hundred and two women (72%) had either primary or secondary education. Most women included were seeking health services from Pasua Health Centre. One hundred and thirty-four (95.7%) owned a mobile phone, 85 (60%) had a basic feature phone and 49 (35%) owned a smartphone. The details of the participants are shown in Table 1 below.

Table 1

Demographic characteristics of 142 participants
Variable	Category	Frequency	Percentage
Participants
	Breastfeeding	100	70%
	Pregnant	42	30%
Level of education
	None	1	0.7%
	Primary	51	36%
	Secondary	51	36%
	Tertiary	39	27%
Inclusion site
	KCMC referral hospital	39	28%
	Majengo health centre	41	32%
	Pasua health centre	45	39%
	Mawenzi regional hospital	14	10%
	Kibosho hospital	3	2.10%
Own mobile phone		134	95.7%
	Phone which have no access to Internet	85	60%
	Phone which access to Internet	49	35%
	Others	8	6%

More than 90% of participants use and read SMS in their daily life. Among 142 participants, 23 (15%) reported to ever have skipped medications. Among 23 participants who skipped medications, 13 (56.5%) reported that they forgot. Only 64 (46%) were having people to remind them taking medications. Among 42 pregnant women, 10 (24%) did not have knowledge on how to protect their child from HIV infection. The details about the mobile phone use have been shown on the Table 2 below.

Table 2

**Mobile phone use**
Variable	Frequency	Percentage
Use and read SMS	134	96%
Good experience with SMS	129	90.8%
Participants who reported ever skipped taking medications	23	15%
Forgetting among people who skip medications	13	56.5%
Willing to be reminded for those who skipped	20	95%
Having people to remind them taking medication	65	46%

All 20 breastfeeding women who used the device for one month participated in an IDI. Characteristics of these 20 interviewees are shown in Table 3 below. There is considerable variability in demographic characteristics and adherence rates.

Table 3

Demographic and adherence characteristics of participants of in-depth interview
No	Age of Breastfeeding women (years)	Religion	Marital status	Age of Child (month)	Adherence DAT	Medication time	Regimen	Problems
1	34	Christian	Married	3	96%	21:00	TDF + 3TC + DTG
2	30	Christian	Single	3	100%	21:00	TDF + 3TC + DTG
3	29	Christian	Married	5.5	100%	20:00	TDF + 3TC + DTG
4	37	Christian	Single mother	9.5	96%	20:00	ATV/r + ABC + 3TC
5	28	Christian	Married	9	96%	21:00	TDF + 3TC + DTG
6	24	Christian	Single	2	90%	20:00	TDF + 3TC + DTG
7	28	Muslim	Married	9	96.70%	22:00	TDF + 3TC + DTG
8	32	Christian	Single	6	70%	18:00	TDF + 3TC + DTG
9	45	Christian	Married	8	100%	20:00	TDF + 3TC + DTG
10	41	Muslim	Married		100%	19:00	TDF + 3TC + DTG
11	31	Muslim	Married	5	100%	21:00	TDF + 3TC + DTG
12	30	Muslim	Single	6	96.50%	19:00	TDF + 3TC + DTG
13	25	Muslim	Married	7	NIL	22:00	TDF + 3TC + DTG	Device was not communicating
14	38	Christian	Single	6	79.80%	21:00	TDF + 3TC + DTG
15	30	Christian	Single	11	100%	21:00	TDF + 3TC + DTG
16	33	Muslim	Married	11	100%	21:00	TDF + 3TC + DTG
17	23	Christian	Single	18	100%	21:00	TDF + 3TC + DTG
18	30	Christian	Single	4	NIL	21:00	TDF + 3TC + DTG	Device was not communicating
19	23	Christian	Married	5	100%	21:30	TDF + 3TC + DTG
20	36	Christian	Married	8	100%	20:00	TDF + 3TC + DTG

We present results based on the two models and we categorized results in three major themes. Two categories of themes were: (i) themes related to needs of DAT and (ii) themes related to barriers in using DAT and (iii) themes related to content of DAT.

Themes related to needs

Perceived benefits

From the IDI, the majority of participants explained that using the DAT helped them with taking medications on time. Even before they receive SMS, just seeing the device triggers them to remember to take medications. Participants explained they were busy taking care of the family and therefore easily forget the time for medications. Device also gave them privacy while taking medications because the device does not make a sound when taking out the pill like the usual medication containers. The DAT provided social support as participants felt like they are not alone.

“because it reminds me, you find that mothers, like we, are very busy. But, when you see the message, ohoo, you say ‘let me count some few minutes. It reminds you that its time.” 45 years married woman

“Firstly, the device stores well the medications. Secondly, you get motivation of taking medications because you know that you have something (device) and third, it is not easy for someone to recognize it even if someone sees it…” 32 years single woman

“This device does not make sound while using it. If you just take the pills out of the usual medication containers, the person in the second room will hear, it does ‘karakaka’ 30 years single woman

Perceived effectiveness

From the survey, we found that most women (105 (78%)) were interested to receive reminder SMS to support them in adherence to medications. In the follow up interviews, 19 (95%) said they received SMS on time and they did not have difficulties in receiving SMS. Participants agreed that the interventions made them to take their medications on time every day. Out of 20 participants, 18 (90%) mentioned the SMS made them to take their medications on time hence improve their adherence. Through IDI, we found that participants perceived that DAT helped improved taking medication on time. A 32 years-old woman explained that after receiving the device, she had never missed or exceeded time for medications. She becomes more conscious with the time to take medications. “After receiving the device, I have never exceeded the time for medication, when it is 09 o'clock or even before it reaches 09 o'clock, sometimes when it is 08:30 after the message I waited about 15 minutes then I took medications.”

Another one explained that:

“SMS reminders helped a lot because they made me to take medications on time or they would remind me to take my pills when I forgot” 28 years married woman

“I think it has made me to take my medication on time. Because I never miss a pill but it's just I don’t take them on time, few times I take them correctly on time” 34 years married woman

“Another thing, it makes me not forgetful, since I keep remembering that there is a device that I have to open to take my drugs” 23 years single woman

Affective Attitude

In the follow-up interviews, 19(95%) participants reported to have good or very good experience with receiving reminder SMS and they thought the device was good. Twenty women (100%) said it has good appearance. Ninety five percent reported that the way the graphs displayed their adherence level was either good or very good. IDI participants felt good and happy using DAT, both device and SMS together. The majority of participants were satisfied with the graphs showing the adherence status, especially the percentage indicated their adherence. Participants elaborated that they wished to continue using the DAT even for the rest of their lives and others suggested that this intervention should be used by all people living with HIV.

“Actually, the way it’s working, I see it is good, that is, I love it very much, very, very much” 34 years married woman

“…. we would like to be given (DAT) to all the people with this problem.” 31 years married woman

“It would be nice to receive reminder message, because most people right now use the phone. So, if someone got a reminder text that you had to take your medication at certain time, it would be very helpful, because someone would know if I didn't take the medication they will know (health care people).” 31 years married woman

Ethicality

From the survey, 128 (93%) participants were comfortable receiving reminder SMS and 105(78%) were ready to receive reminder SMS and using the device. Even, 96 (69%) participants were willing to pay to receive medication reminder SMS. In the follow up interviews, 18 (90%) of participants said it was appropriate to receive reminder SMS. IDI Participants did not have concerns or ethical issues with using DAT or receiving tailored feedback from the nurse. Most of them explained it was appropriate receiving reminders and they were comfortable using the device in front of their family members. Furthermore, the device protected their privacy because it was not easy for someone to know if they are using medications since the device almost looks like a phone. For participants who shared their phones with their husband or children, they did not report any domestic disputes or unwanted disclosure caused by reminder SMS. There was no issue which was raised that concerned religion or culture from participants.

“The device is acceptable, because you are at peace when you are with it, as you can bring it with you when you go out or travel with it without someone else noticing what you have” 23 years married woman

“I share my phone with my child. Even though my child knows this problem and I have no problem with it and he also keep my secret”. 37 years single woman

“…it's not easy to know what is inside the device” 32 years single woman

Intervention coherence

From the follow up interviews, 17 (85%) participants did not experience difficulties in opening of device and 18 (90%) did not have any issue with refilling medications to the device. Some of the participants in the IDI understood how the intervention works, but others had understood only that the device was for storing medication and it has no link to the reminders message which they receive. Though the majority of participants understood at the end of the intervention, after receiving the one-month feedback, how the device generated the adherence graph. Also, all of them understood how to open and refill the device.

“…. I don’t know, I just know it’s a thing to store medications” 45 years married woman

“… for this device, when I open it, it turns on the lights. It sends information that I took the medications, so those who are my nurses or who are following me about my health, will really know what instructions that they were teaching or telling me, I follow them” 31 years married woman

“It is this way, I open and take the cartridge out, I take my pills and then I close it and return it inside” 23 years married woman

Opportunity costs

There were no participants interviewed during the survey, exit or IDI mentioned that they had incurred any cost in terms of finance or time during the study period.

Self-efficacy

Participants were confident in using the DAT as required and were able to use the intervention. IDI participants explained that it was easy for them to understand the SMS which they received.

“I felt good using the device because I told to myself, they gave it to me because they think I was capable of using it” 29 years married woman

“…. it didn't last even a few seconds because after I received the SMS I knew it’s for my health.” 29 years married woman

Themes related to barriers

Perceived burden

In the survey, 31 (22%) reported to experience network challenges and in the follow-up interviews, 3(15%) experienced network challenges during the study period. For IDI participants, the mostly perceived barrier identified was to receive more than one SMS, which was due to network challenges. They explain that they took medications on time and yet they receive the second reminder SMS stating that they did not take medications. One participant reported not to receive the reminder SMS twice. Also, there were participants described that in the beginning, opening of devices was a challenge. However, after some time they did understand and it was even easy to refill and take pills from the Wisepill device.

“About two times, I noticed I didn’t receive SMS” 30 years single women

“I felt bad the first time before getting the advice because you can find I took medications on time and then I receive SMS that you haven’t taken on time, that’s where it confused me” 25 years married woman

“I normally receive reminder SMS although I have already taken [pills]” 30 years single woman

Perceived susceptibility

In the survey, 27(20%) of women reported to share their phone and 15 (56%) share their phone with their husband. In follow up interviews, no participant reported that the intervention caused any unwanted disclosure of their HIV status. Although, IDI participants perceived that they were having a risk of unwanted disclosure when someone uses their phone or for those who were sharing their phone with family or friends. Using a feature phone made them susceptible to unwanted disclosure. This is because those phones have no password. Participants noted unwanted disclosure to be a consequence of using SMS reminders which contain the word “dawa” or “medications”. They said that if someone saw the reminder message with the word ‘medicines’, they will start to ask questions and start to follow up with them on why they are taking medications or what is the medications for. This may create stigmatization and women may start to lose confidence that they are not normal people.

“…Eeeh medicine… someone might ask what medicine you are taking?...... For me, a solution is that the word medicines should be removed, because someone will know that” – 29 years old married woman

“The issue of the message is good. But the challenge was at the very beginning when I was used to be reminded with the message to take “medication”. Now it made me worried to think where I left my phone on the table, while I am outside or am taking bath” − 29 years old married woman

Perceived severity

In follow-up interviews, 18(90%) participants reported to have no concern about being watched or monitored all time by healthcare providers. Perceived severity explained during the IDI was a fear created that there were being watched by someone.

“These people are watching me, my child refused to give me medicine from the device. He said ‘mother, they will see me there’, my husband also said ‘you will use yourself that device because they will see us, we will not touch your device’” – 28 years married woman

No participants reported to have difficulties in carrying the device around with them. In fact, they were happy to travel with it because no one could notice what is inside.

“But this device, even if you place it in your wallet, you can go anywhere but it’s difficult for someone to know.” 29 years married woman

Themes related to content

Cues to action

The majority of IDI participants identified that they wished to receive reminder message for medication and clinical attendance, and also educational message. Participants felt cared for and satisfied after receiving feedback on how they have taken their medications.

“….. I feel like education which is related to HIV is important to me, because I didn’t even know how to give medication to my child, which I was given for 42 days after I gave birth.” 30 years single woman

“I also bought Septrin without knowing its function, I was just following the instruction which was given to me by the health provider.” 30 years single woman

“Mmmm…my opinion is that there should be a system people would be sent a reminder message to CTC members. This would help our fellows to remember the time that I must take medications, as there was our neighbour who died because he stayed three months without taking medications.” 31 years married woman

“I would have liked feedback to continue the same way as I sit with the nurse and talk about health,” 30 years single woman

Participants’ recommendation on the content of the message content

IDI participants preferred neutral messages and which do not directly mention words like ‘medications’ or ‘drink’ or ‘swallow’. Furthermore, they mention that reminder SMS should be short at least and not very open or obvious that anyone could understand what its meaning.

“There is a message which has irritated me, is the one of “use medication on time”, that word “medication” …., 30 years single woman

“I would choose SMS that even when someone else get to see it he/she will not understand the meaning of that SMS”. 30 years single woman

“For me, the solution is the word medicines to be removed, because someone might know that am taking medication.” 29 years married woman

Several participants suggested other reminders which they preferred such as

… they should probably be, “remember to eat fruit for your health” …. “eat fruit”, “drink water”, “remember to drink water” 33 years married woman

Considering educational topics, women suggested they want education about business, breastfeeding, taking medication, mental health issues, nutrition, sexual issues and other opportunistic disease.

“I would like to know for example a mother with such a disease, how long she should breastfeed”. 33 years married woman

“Why do they say that a child is at danger of getting infected after a year while they grow tooth after six months?” 30 years single woman

“I would like to receive education about taking medications because it will help me remember well and I will know very well if I don't take medications I will get this and this, I will be like this” 45 years married woman

“Education should be about, how to avoid overthinking” 30 years single woman

“Other education to receive I think it should be about food/nutrition meaning balanced diet for other people like us, when I say other people it does not mean I am not among of them aa– no but it is only that for me I do really care about my health.” 23 years single woman

Women suggested on the frequency for clinic visit reminders to be least it monthly, a day before their appointment day.

“Then you (research team) can also take note of maybe the person's clinics visit dates and call her maybe the day before visit to remind” 29 years married woman

Also, women preferred educational messages that should be sent may be each week.

“Interviewer: And what about educative ones, after how long should they be sent?” “Responder: I think educational message should be sent after a week” 30 years single woman

In the survey, more women suggested wanting to receive reminder SMS for their medications daily 82 (58%) same for IDI results also women suggested to receive reminders daily.

“For me I like to receive the reminders every day” 30 years single woman

This mixed method study describes the needs and content of customized digital tools for retention in care and medication adherence among breastfeeding women living with HIV. The use of theoretical frameworks helped to understand needs, content and barriers of DAT and constructs from TFA and HBM were identified as themes within this data.

Overall findings were that majority of participants described that using the DAT triggered them to take medications on time. Also, we found that the device was highly needed as most of women said that taking medication out of the device was comfortable, easy and they wished to continue using the device. Furthermore, the use of device was found to be ethical because of its good appearance, size and the fact that it does not make a sound when taking out the pills compared to the usual medication containers. The effectiveness of DAT on sending SMS was perceived to be high as majority of participants pointed out that SMS reminders were received daily and on time, and more surprisingly we found having device at home motivated them to take medications. In addition, our results illustrate that the majority of women were able to understand how DAT works.

Despite of the positive findings, few participants reported concerns such as that the device did not capture the opening signal of the device due to poor network availability and led them to have low adherence graphs and receive the second reminder telling them they did not take their medication. Another issue was the word “dawa” or “medication” in the reminder SMS content, which was described as a potential for unwanted disclosure. In line with this, those who had a simple feature phone described that the SMS content which contains the word “medication” made them susceptible to unwanted disclosure as those phones have no security features as smartphones. Moreover, during the discussion with participants we found there was a fear in use as they feel as they are being monitored. Though, during the exit interviews, more than 90% of participants reported to have no concern about being monitored all time.

Participants reported to prefer SMS which were more neutral so that even if someone else reads the SMS from their phone, they will not understand that she is reminded to take medications. Neutral messages are those which do not mention words like ‘medication’ or ‘drink’ or ‘swallow’. Also, they mention that neutral SMS gave them self-confidence and having an advantage of being reminded. However, we saw that 20% of women shared their mobile phone with relatives, husband and their children. Despite of that, no one reported that the intervention caused unwanted disclosure. Though, during in-depth interviews, participants explained that the first week SMS placed them at risk for unwanted disclosure. Our findings also support studies which were done in Kenya and South Africa among HIV infected women showing that neutral text message content provides confidentiality, minimize fear and provide self-confidence to women (23, 34).

Educational messages preferred by women were about entrepreneurship, breastfeeding, advantage of taking medication, consequences of not taking medication, mental health issues, nutrition, sexual issues and other opportunistic disease. Interestingly, our findings showed that participants preferred to receive reminder SMS daily, which is different to the study which was done among women in South Africa who preferred to receive weekly SMS (34). Also, a Cochrane review, which included clinical trials from Kenya, reported that receiving weekly messages improved adherence to ART medication compared to daily messaging (35).

In similar studies among people living with HIV done in Kenya and Tanzania, a high level of satisfaction on using digital technology interventions was found (29, 36). In our previous study, which was done in Kilimanjaro using the same RTMM device, participants reported that the device was easy to use and feasible (26, 37). A meta-analysis which was done to design better ART medications, showed that those who receive reminder SMS were more likely to adhere to medication compared to those who are not receiving reminders (38).

We found that 15% of women reported to skip medication and more than half mentioned it was due to forgetting. From in-depth interviews, they explained that sometimes they were busy with other activities, therefore, receiving a reminder helped them to remember. Forgetting is a complex multi-faceted phenomenon (39). Studies suggest that sending reminder SMS helps against forgetting (40). Regarding tailored feedback, most women were happy to receive feedback and were mostly satisfied when they were shown adherence graphs generated by the RTMM device. During feedback sessions, women were able to have time to receive education from health care provider.

There are several limitations of our study, Firstly, the sample size for participants who used DAT is small, as this was a formative study in which we selected a small number of participants to use DAT for one month. The aim of our study was to gain insight and develop SMS content for future trials and not to generalize study findings. Secondly, participants used the device for only one month which is a short period of time therefore using the digital tools for a longer period of time might give different results on acceptability, though doing formative study is the innovative step to explore feasibility of the study.

The major strength of our study is the use of mixed methods, which helped to provide quantification and insights leading to better understanding of the needed content of digital adherence tools among breastfeeding women. Also, triangulation of the data from different data sources helped to strengthen our study. These important findings will help to design better tools to improve adherence to ART among pregnant and breastfeeding women so as to prevent mother-to-child transmission. Another strength is the use of two theoretical frameworks that offered inclusive insights in study participants’ perceptions on the needs and contents for digital adherence tools which can be considered for future interventions.

Our mixed methods study helps with the construction of useful contents for future digital adherence tools to support the health of pregnant and breastfeeding women living with HIV. Digital tools seem to be highly needed. However, the content and feedback should be tailored to the needs of pregnant and breastfeeding women living with HIV. From each construct, we found digital tools are highly needed as most women were satisfied with the intervention. However, participants reported few challenges such as network availability, issues related to fear of being monitored and the use of particular words in SMS leading to unwanted disclosure. Future research using digital tools should address these issues before implementation. These findings also create ways for customization of the digital tool in preparation of a clinical trial to evaluate effectiveness on improving retention to care among pregnant and breastfeeding women living with HIV.

AIDS, Acquired Immunodeficiency Syndrome; ANC, Antenatal Care; ART, Antiretroviral Therapy; CTC, Care and Treatment Centre; CRERC, College Research and Review Committee; DAT, Digital Adherence Tool; GCP, Good Clinical Practice; HBM, Health Believe Model; HCW, Health Care Workers; HIV, Human Immunodeficiency Virus; IDI, In-depth Interviews; KCMC, Kilimanjaro Christian Medical Centre; KCRI, Kilimanjaro Clinical Research Institute; NIMR, The National Institute for Medical Research; PBWLH, Pregnant and Breastfeeding Women Living with HIV; PLHIV, People living with HIV; PMTCT, Prevention of Mother to Child Transmission of HIV; RTMM, Real Time Medication Monitoring; SMS, Short Message Service; SSA, Sub-Saharan Africa; TFA, Theoretical Framework of Acceptability; UNAIDS, The Joint United Nations Programme on HIV/AIDS

Acknowledgements

We thank the women who participated in this research. We thank the administration of the health facilities, Kilimanjaro Christian Medical Centre (KCMC), Pasua health centre, Mawenzi regional hospital and Majengo health centre to allow us to conduct this study in their facilities. We also thank the research assistants in recruiting participants and collecting data. Lastly, we thank the European and Developing Countries Clinical Trials Partnership (EDCTP) for financial support to conduct the study through the TMA2818 grant.

Funding

The European and Developing Countries Clinical Trials Partnership (EDCTP) supported this study. The funder had no role in design of the study, execution, analysis or interpretation of data.

Availability of data and material

All data generated and analyzed during this study are included in this article

Authors contributions

RM: Wrote the main manuscript text and analysis. KN, AM: Involved in qualitative analysis. LM, BM: Involved in quantitative analysis, HM, AD: Contributed in proposal designing and drafting manuscript, MSB: Is a principal investigator of the study and she was involved in study design and review of the manuscript. All authors read and approved the final manuscript.

Competing interests

The authors have no competing interest to declare

Consent for publication

Not applicable

Ethics approval and consent to participate

We obtained ethical clearance from the local institutional review board which is Kilimanjaro Christian Medical College Research Ethics and Review Committee (CRERC) No.2519 and the National Medical Research Institute of Tanzania (NatHRERC) with reference number of NIMR/HQ/R.8a/Vol. IX/3825. We followed Good Clinical Practice (GCP) guidelines in all study procedures including informed consent. All study methods were carried out in accordance with guidelines and regulations of Tanzania ethical review boards. All interventions done in the protocol were approved by both local and national ethical review boards. We obtained informed consent from all participants.

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No competing interests reported.

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Needs and contents of a customized digital tool for retention in care among breast- feeding and pregnant women living with HIV in Kilimanjaro

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