There were 195 community member participants in total, of whom 104 were located in Kenya and the remaining 91 in South Africa. In depth interviews with five female participants with a history of PTB were conducted in each country; the remaining 3 per country participated in the focus group discussions. There were 9 males in South Africa, and 1 male in Kenya, who participated in the FGDs, who reported that they had a partner who had a history of PTB. The information from the IDIs with women with a history of PTB demonstrated sampling to redundancy, as no new information was described.

There were 142 female and 53 male community member participants (who participated in FGDs—8 female groups and 4 male groups in South Africa; and 12 female and 2 male groups in Kenya). Demographics between the two countries were similar with regard to age, parity, urban or rural location (Table 1). A greater proportion of Kenyan community member participants were employed and living with a partner in comparison to South Africa. The majority of Kenyan community member participants reported primary school as their highest education level as compared to South African community member participants, who were more likely to have completed secondary school. In both countries, the majority of community members were within 5 km of a healthcare facility and the most common mode of transportation was by foot with some variation between countries. The vast majority owned their own cellphone.

Table 1 Demographics of participants

A total of eight healthcare providers in each country were recruited for participation. These healthcare providers were selected from facilities within which the community members were based. Provider types included those in managerial positions, physicians, nurses, and counselors or community health workers. In both countries, half of the providers were nurses, with 13 years average experience in Kenya and seven years in South Africa. The average age of the providers was similar between the two countries (41 years in Kenya and 44 years in South Africa) and the majority of respondents were women (five in Kenya and seven in South Africa). There were five health systems experts interviewed in each country; in total, half were women, and the average work tenure was 6 years.

Qualitative results are presented according to thematic areas which emerged from the data and address the aims of the manuscript, to describe overall perspectives on the ideal form and use of a device, including (1) factors promoting acceptability of an intravaginal device; (2) specific challenges with the introduction and use of a device; and (3) design preferences.

Factors promoting acceptability of an intravaginal device

Of note, throughout the manuscript the use of the term “acceptability” refers to willingness or openness to the device either with regard to information or use.

Previous experience with preterm birth

Women who had previously experienced PTB were essentially unanimous in favor of a device that could detect a high-risk of going into preterm labor or that could potentially give them other information about the health of the fetus.

“What would make me want to use it is that I would like it to tell me if there is [a] problem appearing.” (Female participant with history of PTB, South Africa)

Other female respondents were generally positive but expressed more reservations than their counterparts with a prior history of PTB about both self-insertion as well as the concept of an intravaginal device. Concerns included insertion practice, hygiene and comfort, as described below. Healthcare providers also stated that they anticipated acceptance of such a device among women with prior PTB experience:

“[E]specially for mothers who’ve had...previous preterm deliveries. It will be so helpful because that way they are able to know when they can run to the facility.” (Healthcare provider, Kenya).

Male partner support

The majority of male partners interviewed responded positively to the concept of an intravaginal device. Partners stated that they were supportive of a device that could potentially be beneficial to the mother and baby:

“I think I would like her to use it [intravaginal preterm birth detection device]; it’s best for her to insert it at a certain stage so that it can protect her…. To avoid problems of the baby being born before time.” (Male community member, South Africa).

Some male partners expressed some concerns for the baby regarding safety and hygiene if using an intravaginal device.

Experience with intravaginal devices

Community members, providers, and health systems experts pointed to prior use of intravaginal devices as evidence for the acceptability of an intravaginal device to detect risk of PTB. Although not specifically asked about previous experience with intravaginal devices, participants spontaneously described these experiences. Pregnant participants who had previously used either the female condom, the menstrual cup, an intrauterine device (IUD), or the Dapivirine ring stated that they would be comfortable using another type of intravaginal device even during pregnancy. Health systems experts reported that prior success with the female condom suggested that with an adequate educational campaign, an intravaginal device for use during pregnancy could be successful:

“[M]any of the things we have done that use the vagina have been a challenge, but they have been used. Like now female condoms is an issue, […] but they are still used, …so we need to give them cultural advice and tell them exactly what their benefits are.” (Health systems expert, South Africa).

Perceived usefulness

Potential users, healthcare providers, and health systems experts at all sites expressed openness to an intravaginal device, as long as it had been proven to be of benefit and provide useful information about potential risk of PTB. Pregnant women without a history of PTB stated that they would be interested in using such a device as long as safety and efficacy had been demonstrated. Pregnant women also pointed to a timely alert as a potential benefit.

“Maybe it tells you that something is happening in your womb you have to go to the clinic and check, than getting things late… it is going to be the one that encourages you to go and get help.” (Pregnant community member, South Africa).

Similarly, healthcare providers stated that if the device could accurately alert patients to cervical changes it could encourage them to seek care early and potentially improve preterm birth outcomes.

“I would say that if this technology will come in, it will be of great importance to our clients…they don’t need to worry even at home. They know when the problem will…in case of any problem it will be signaled to their phone then they can be…they can come to the hospital immediately for intervention.” (Healthcare provider, Kenya).

Specific challenges identifiedDiscomfort with vaginal touching and device insertion

Some interviewees expressed reluctance about device acceptability due to discomfort with vaginal touching and device insertion. This hesitation although cited by some female participants, was more frequently cited by providers and male community members. Respondents noted that different cultural beliefs could discourage vaginal touching and pointed to poor uptake of the female condom and low acceptance of vaginal examinations for Pap smears as evidence for potential reluctance among patients.

“You see again in African setup you know if there’s anything going inside [intravaginally]… that system is not very welcome.[…], but having said that when you look at like we have not been able to market very well to uh, the, the, the female condom to prevent HIV infection.” (Health systems expert, South Africa)

“The concern that I see it’s very invasive, [….] So, they don’t like coming to the clinic and we are doing them PVs [pelvic examinations]. So, they know that no, this time I have to do the PV and so on and so on; it’s very invasive for them unless, unless it is a different woman, it’s a woman who have experienced this pre-term labor and can do anything to prevent it. Those women maybe, those women who won’t mind taking it off and on.” (Healthcare provider, Kenya).

Device positioning, comfort, hygiene, and impact on sexual activity

Participants in both IDIs as well as FGDs, identified several potential challenges to the insertion of an intravaginal device. Potential users voiced concerns regarding pain or discomfort associated with either insertion or wearing of the device. For example:

“What can scare you is the first time is that how is it going to be inserted and how is it going to be removed? I think that is what can be scary, that pain.” (Pregnant community member, South Africa).

Concerns over harming the cervix or disrupting the pregnancy were also expressed.

“Because there are some body parts you should not touch and you can touch them during insertion and cause harm or hurt the cervix.” (Pregnant community member without preterm birth experience, Kenya).

The question of hygiene regarding device storage and cleaning was also raised. Some participants suggested that the device be left in place to avoid potential challenges of unhygienic conditions.

“That is a place [referring to vagina] that requires high levels of hygiene. It [device] is better just inserted and left there because constant insertion and removal and disturbing the cervix might hurt her and she gets other side effects.” (Male partner, Kenya).

Female participants also expressed concern regarding the impact the device might have on sexual activity. Some stated that they worried the device might be felt by their partner and that this might contribute to domestic discord.

“If you cannot feel it when you are having sex with my partner it can stay inside there is no problem, but if he is going to feel it and he is going to ask me a lot of things, […] that I will not be able to respond to them and end up having a fight.” (Pregnant community member, Kenya)

Need for buy-in, training, and support among providers

In addition to some of the technical considerations mentioned above, both providers and health systems experts cited potential challenges to the implementation of a preterm birth diagnostic device in health facilities. Health systems experts in both Kenya and South Africa pointed to the need for buy-in on the part of providers ranging from physicians, to nurses, to community health workers, in order to facilitate device introduction, use and success. The need for training was also articulated:

“And nurses must go… must have in-service training just to assess if they’re still updated or if there are new developments or some new equipment. But what is extremely important is to have the equipment, have the spares and know where these things need to be repaired.” (Health systems expert, South Africa).

Stakeholders also pointed to the challenge of providing on-going technical support to providers in their individual clinical settings.

Cell phones and Bluetooth/wireless technology

Respondents were concerned about the reliability of cell phones as a device to receive messages, as cell phones break or get lost, and network unreliability may cause delays in messages being received. Concerns were also raised that not all people have access to smart/android phones.

Healthcare providers had concerns about safety of Bluetooth technology and community members’ questions related to lack of understanding of how Bluetooth works.

“[A]nd because we don’t know the side effect and using the wireless technology, so it’s still risky to that foetus, you don’t know in the long-term how it might affect that foetus, who might be born at term.” (Healthcare provider, South Africa).

Country-specific health systems and regulatory processes

Multiple health systems and regulatory challenges were identified by health systems experts in both Kenya and South Africa. Due to the fact that the regulatory environment is continually changing, these challenges would need to be explored in more detail if/when device implementation was considered.

Design preferencesPreference for provider-inserted device

Participants were asked their preferences regarding whom they thought would be best to insert an intravaginal PTB risk detection device, when given the choices of self-insertion, placement by healthcare providers, or by a trained non-healthcare provider such as a male partner. All healthcare providers in both locations agreed that a health professional would be the best person to insert the device, citing hygienic reasons and knowledge of vaginal anatomy. Similarly, women with a history of PTB preferred a healthcare professional due to concern for discomfort.

“To me, I see that it’s a doctor or person who is trained to insert that device. […] No, I wouldn’t like to self-insert. […] Because the time I insert it and maybe if I feel the pain and I will then stop […] and end up not inserting it.” (Female participant with history of PTB, South Africa).

Among focus group participants, the majority of both males and females preferred a healthcare professional to insert the device, and reasons cited were concerns over incorrect placement or the possibility of triggering preterm labor. Participants also felt that if a professional were to place the device, this would present an opportunity for increased monitoring.

“If I visit the doctor and they use a device like this to check and they can advise me about my problem so the device is not bad; I think it is good.” (Pregnant community member, Kenya).

Very few respondents in either location reported a preference for self-insertion and only a couple preferred a male partner to insert the device. Respondents cited lack of anatomical knowledge among non-healthcare professionals as well as the physical difficulty of self-insertion among pregnant women as barriers to insertion.

“Because there are some body parts you should not touch and you can touch them during insertion and cause harm or hurt the cervix.” (Pregnant community member, Kenya)

“I think it must be health professionals, which can be people from the clinic or the doctor because they are the people trained to work with the inside of the person. If I were to say she must insert it herself maybe it will not be fixed to the position.” (Male community member, South Africa)

Material, size, color, and shape preferences

The majority of respondents from both Kenya and South Africa felt that a soft, pliable device made from material similar to the FemCap (a reusable barrier contraceptive made of flexible silicone fitted over the cervix) and would promote ease and comfort for the user. A few respondents from both countries recommended that a range of sizes be available.

“[My] suggestion is, if it is made, we are not the same, we don’t wear same underwear, so as women, if the sizes say in certain age people usually wear the size so on and so on, it must not be one size.” (Male respondent, South Africa).

Preference for device color was discussed—in both Kenya and South Africa, color was important, as healthcare providers felt it should be visible during physical exams.

“It should have its own unique color. […] I think like it can even be green, blue so that at least if… it will be removed …by the time the pregnancy is at term, you are able …to see fast then come with it.” (Healthcare provider, Kenya).

Various device shapes were described and drawn—including a ring, cup, triangle, and oblong (see Fig. 1). Only South African respondents described that the device design should take into consideration factors to facilitate ease of insertion and removal—some community males and females suggested that it could be pen- or “thermometer”-shaped, and some women suggested a string/handle to facilitate removal:

“I mean, it is better if it is a pen like, you see, so that it can be able to be inserted like this and maybe there must be something that is string like, so that it is easy that when you have inserted it you hold this string and take it out” (Pregnant community member, South Africa).

Fig. 1

Examples of design preferences