Background
Prevention of mother-to-child HIV transmission has greatly reduced the number of children born with HIV, but in 2020, there were still 150,000 cases of perinatal transmission globally; despite greater availability of pediatric treatments, 37% of HIV-exposed infants are not tested in the first 2 months of life [
1]. Mortality for untreated infants is high, with almost 50% succumbing to the disease before age two, with the highest risk occurring around 10 weeks of age [
2]. Innovations in testing technologies and improved service delivery are urgently needed to address this gap.
Early infant diagnosis at age 6-8 weeks is recommended by the World Health Organization (WHO) and has been scaled up in many countries [
3]. Where 6-week testing programs are strong, the WHO more recently recommended considering the addition of birth testing (BT) to the existing testing algorithm [
4]. Because disease progression can be rapid among untreated infants, especially preterm or low birth weight infants, identifying infections immediately after birth and initiating a treatment regimen can greatly improve survival for the most at-risk infants [
5].
Due to the need for virologic testing and lengthy laboratory processing procedures for infant blood samples, the turnaround times for conventional BT can be slow, reducing the clinical effectiveness of testing. Nonetheless, successful BT pilots and programs have been introduced in many countries in Southern Africa, including Eswatini, Malawi, Mozambique, South Africa, Zambia, and other countries [
6,
7], although studies in each recorded challenges and delays, with some specifically noting the need for rapid on-site tests [
8‐
11]. The introduction of point-of-care (POC) testing, which allows for on-site processing of blood tests, instead of sending samples to reference laboratories, provides the possibility to offer BT and receive results within hours or days, rather than weeks or months. Previous studies have shown that POC is feasible at birth [
12,
13]; offering birth testing with POC with rapid availability of test results allows most mothers to know the result before discharge after delivery. Infants who are identified as HIV-positive can be enrolled in the HIV program per protocol and initiated on treatment as soon as possible.
Previous studies have shown that POC testing at age 6-8 weeks can reduce median turnaround time from sample collection to results from 55 to 0 days [
14]. Building on the existing POC early infant diagnosis program in Zimbabwe, the Ministry of Health and Child Care worked with the Elizabeth Glaser Pediatric AIDS Foundation, with funding from Unitaid, to offer HIV testing at birth to every HIV-exposed infant born at or presenting to 10 hospitals throughout the country [
15]. Studies around the time of data collection found an HIV prevalence among adults to range between 10 and 18% [
16]; despite the high coverage of ART among pregnant women (92%), the prevalence of maternal-to-child transmission is still relatively high (8%) [
17]. National data from Zimbabwe suggest that the proportion of HIV-exposed infants receiving a 6-8 week HIV test was 56% [
18].
Implementation of BT and the use of POC tests requires both health care workers and mothers to find such testing acceptable [
19]. Previous studies in Kenya and Eswatini found POC BT to be highly acceptable to mothers, as the reduction in waiting time for test results greatly reduced anxiety and fear. In these previous studies, although many families noted feeling concern about infant pain or fragility, this was noted as a concern but not strongly enough as to prevent acceptance of the test. POC BT was also found to be acceptable to health workers, although they also expressed concerns about health system capacity, workload of staff, sustainability of the program, and post-test engagement of patients in care [
20,
21]. Due to the limited number of countries with point-of-care birth testing programs, and even fewer with POC BT offered in a routine health care setting, there is little previous qualitative evidence about its use and acceptability.
Following the introduction of POC BT in Zimbabwe, we carried out a qualitative study on the acceptability of POC BT among health care workers and mothers. This is one of the first studies to assess POC BT in a routine setting. This study was aimed at understanding the views of mothers and health care workers on POC birth testing in Zimbabwe, with the goal of understanding the necessary inputs for a successful POC birth testing program. It was part of a larger study of POC birth testing which also included quantitative data collection in the same 10 sites [
14].
Methods
Study hospitals (n = 10) were selected based on high volumes of births to HIV-infected women, and co-located maternities with an existing POC testing platform on site. Every infant born to an HIV-infected mother at or presenting with 72 h of birth to one of the 10 hospitals was eligible for testing. None of the hospitals previously had on-site laboratory testing, but all sites had the ability to send samples to the national reference lab for testing, if desired. Once POC was implemented, the use of non-POC was generally used only to resolve discrepant test results.
Qualitative participants were selected from the pool of mothers who were offered such a test, as well as health care workers in the same hospitals who were involved with BT. Most of the health care workers had experience with laboratory-based testing and could speak comparatively about the two types of tests after POC was introduced. Mothers may have had previous experiences with laboratory-based testing if they had given birth previously after receiving their HIV diagnosis; however, many mothers did not have this previous experience and therefore were not comparing but rather describing the experience of getting POC birth testing for their infant.
Recruitment for qualitative interviews took place over approximately a one-month period at each site. The maximum number and type of qualitative respondents was purposively chosen to include a range of stakeholders, namely health care workers and mothers, with potentially divergent experiences or views (See Table
1). Daily debriefings were held by members of the study team to determine if thematic saturation had been reached and no new themes were arising from interview participants.
Table 1
Maximum sample sizes for qualitative study participants
Study facilities | 10 health facilities | 10 health facilities with high numbers of HIV exposed infants identified per month were purposively selected to participate in the study |
Heath care workers | Up to 30 health workers | Up to 3 health care workers at each facility |
Health managers (lab or facility managers) | Up to 10 managers | Up to 10 managers across facilities |
Mothers of HIV exposed infants | Up to 40 women | Up to 4 women per facility |
Participants were approached to participate and consented by study staff and invited to participate regardless of their acceptance of testing or receipt of test result. Participants were informed that participation was fully voluntary and asked to provide written informed consent before beginning interviews. Interviews were held in private locations within the hospital facilities. Interviews were conducted by research assistants that were trained in study protocol procedures, conducting qualitative interviews, and human subject ethics, and who were supervised throughout the data collection process. Participants were given $5 to cover travel costs; health care workers were given $4 and a snack as a token of appreciation for their time.
Interviews were guided by pre-developed and pre-tested semi-structured field guides (See
Supplemental Files). Interviews were held in English, Shona, or Ndebele, by multi-lingual study staff, depending on comfort and capacity of the interviewee. Interviews lasted between 40 min and 1.5 h and were audio recorded with permission of participants. Audio recordings were transcribed verbatim by multi-lingual research assistants familiar with the project. Inadvertent disclosure of names or other potentially-identifying information by respondents was redacted during transcription. Shona and Ndebele transcripts were translated into English. Study team members reviewed a selection of transcripts to ensure quality.
Analysis was guided by a phenomenological approach, which focuses on the commonality of lived experiences within particular groups. Data were uploaded into and analyzed using MaxQDA software version 12.0. General codes developed a priori based on previous knowledge of the topic and study objectives were used in the preliminary analysis of transcripts after reading each for familiarity. More detailed codes were developed during the analysis process, as nuance emerged, and further themes were identified from the data. Thematic analysis and constant comparison methods were utilized to identify and categorize each theme, according to the type of respondent [
22]. Subthemes were organized into each theme and reviewed by multiple members of the study team before being finalized. Changes to theme and subtheme organization were noted and recorded. Illustrative quotes were selected to represent each theme.
Our study team included medical doctors, epidemiologists, public health researchers, and policymakers, all with experience in the study and provision of maternal and pediatric HIV care, especially in under-resourced settings. We began this study with prior research knowledge, as well as anecdotal and experiential knowledge, that in many contexts there are very long delays for infant HIV results, which leads to delays in treatment initiation and poor outcomes for infected children. Most team members had experience related to early infant diagnosis, both with and without POC; some had experience in research or care related to birth testing, including the involvement in a similar introduction of POC BT and study in Eswatini.
Discussion
Mothers and health care workers were overwhelmingly accepting of POC BT, even as concerns about the program were noted, especially around the need for improved information to patients. Mothers noted ongoing structural challenges with health systems, such as the lack of private space in hospitals in which to discuss tests and results, and noted the need for introducing the topic of birth testing and point-of-care both to a wider audience in the community, and at appointments prior to delivery. Mothers also worried about the age and fragility of newborns to have a blood draw; however, no respondents believed this outweighed the need and benefit of having the test. Further, most mothers were grateful to receive test results sooner in order to act sooner to prevent transmission in the postpartum period or initiate treatment as soon as possible.
Health care workers equally saw a benefit of being able to provide test results quickly, especially as they previously had challenges contacting patients after discharge. Health care workers agreed with the need to raise correct information and awareness about BT generally in the community, but also noted the need to ensure consistent supplies of equipment (namely, cartridges) before scaling up programs, in order to ensure that every patient offered a test was actually able to receive one and get results in the promised timely way. Considering the benefits, mothers and health care workers, including in-charge nurses, were in favor of continuing, expanding, and promoting POC programs, including offering BT.
Findings from this study suggest that, while scaling up POC BT programs, attention should be paid to the health system aspects that are necessary for its success: specifically, ensuring private areas for patient testing and discussion, ensuring sufficient numbers of trained staff to run tests, strengthening forecasting and supply chain systems for testing equipment, and improving the provision of information to patients. As much as possible, health care workers should include discussions about birth testing and point-of-care options in antenatal care visits and allowing mothers time (both antenatally and postnatally) to ask questions about the test and be reassured about its safety and minimal pain and invasiveness, especially for newborns.
In other studies, both with POC and not, BT has been found to be generally acceptable among mothers and HCWs [
23,
24]. Similar to this study, other studies have found parental concern about pricking newborns [
23,
24], but in general BT was considered to be in the best interest of the child and the benefits seen to outweigh the concerns. Similar to this study, a study in Kenya reported that POC BT can improve newborn care and reduce parental anxiety [
25]. The same study also found concerns that a HIV-positive result at birth would impact parent-infant bonding and negatively impact care [
25], but this was not raised by participants in the present study.
Compared to conventional birth testing, POC birth testing offers a unique opportunity to ensure that infants are tested and lab results returned more quickly. A recent study from Zambia which evaluated a conventional BT pilot, reported a median turnaround time of 53 days [
11]; a pilot study of POC BT in Eswatini found a median turnaround time of 13 days [
12]. Thus, even with intensive support to conventional systems, POC BT is likely to significantly improve turnaround times in most settings. For women delivering in health facilities, most will be able to receive the result before being discharged from the facility.
One of the main challenges, regardless of testing method, is ensuring that infants who test HIV-positive are linked to care in order to begin treatment. The conventional testing study in Zambia found that only a third of infants diagnosed with HIV were linked to care [
11], but the POC BT study in Eswatini found 84% of infants testing positive were initiated on treatment [
12]. A qualitative study on birth testing in Lesotho found that treatment acceptance did not appear to be different between mothers learning their child was infected at birth versus other time points [
24], and it is likely that linkage to care depends more on availability of treatment services or clinics and interoperability of medical record systems than parental acceptance. Other studies have found that mothers are very motivated to ensure their child receives the necessary treatments after being diagnosed with HIV [
12].
One of the initial concerns raised with BT was whether parents would return in the 6-8 week window period for the follow-up test as recommended once they had already received a birth test. Quantitative data from the same study as presented here found a 46% return for subsequent testing within 8 weeks after an initial POC negative birth test [
26]. The conventional testing study in Eswatini found that return rates for the follow-up appointment dropped from 78 to 74% after the introduction of BT [
23], but the POC birth testing study in Eswatini found a 91% return rate for infants at 6-8 weeks who tested negative at birth [
12]. A POC birth testing study in Kenya also found that 92% returned at the six-week follow-up period [
27]. Thus, it appears feasible to encourage and achieve high levels of follow up testing for those testing negative at birth, given proper guidance and information. Qualitative research may be helpful to identify the barriers still outstanding for those who did not return for follow up testing.
On the health system side, this study identified the challenge of adequate staff and supplies, which has been reported elsewhere in the literature [
25]. Challenges with stockouts, broken machines, expensive cartridges, and electrical blackouts remain persistent barriers to sustainable implementation. A study in Kenya comparing piloting POC machines against conventional lab-based processing found higher rates of missed testing opportunities, largely due to machine/stock outs and invalid results [
27]. Thus, introducing new diagnostic options must be accompanied by standardized systems for forecasting and ordering supplies. Findings also emphasize that, despite the recognition of the importance of education, privacy, and community awareness, these activities are often not implemented well, if at all.
This study provides important insight into the experiences with POC BT but has some limitations. As this was not a longitudinal or comparative study, participants were not asked to directly compare laboratory-based to POC testing, nor birth testing directly to early infant (6-week) HIV testing. Health care workers spoke frequently about the advantages of POC over laboratory-based testing, as many had experience in both. Most mothers in the study only had the experience of POC BT, unless they had other children who were tested, most likely receiving conventional testing at 6 weeks, and possibly at different clinics under different circumstances. As it was possible to have a conventional BT or a 6-week POC test, the experiences of POC and BT together may be conflated. Although efforts were made to include a selection of participants from across multiple regions in the country, the selected facilities were only hospital level, and patients at other types of medical facilities (where the program might expand to) may be different. Further, future research would benefit from interviews with ministerial-level policymakers and administrators about potential challenges at the national or regional level. Lastly, because acceptance of BT was so high, we were unable to interview mothers who refused testing, and this minority of mothers may have differing views than the mothers who accepted testing. This is an important group, as they are the most vulnerable to not only poor clinical outcomes, but also social isolation; future studies may need different, targeted methods to gain perspectives from these families.
Because BT is so new, and POC BT even newer, this study provides important information about its acceptability among various stakeholders. Unlike previous pilot studies, this study’s strengths included collecting data at 10 hospitals in a wide range of regions, providing further confidence in the near-universality of acceptability, which echoes findings about POC in general. The study also provides one of the first analyses of acceptability of birth testing in a routine (non-study) setting, and as offered to every exposed dyad, rather than only those considered at highest risk of mother-to-child transmission. While there is consensus around the need to offer HIV testing as early as possible to those exposed, the long-term clinical advantage of early testing and treatment will need to be examined separately.
As POC BT is introduced in a country or region, the specific needs of the mothers and health care workers should be taken into consideration, as there may be differences in the experiences and concerns across countries. Future research should also seek to understand the views of the general community on HIV and birth testing and to identify the best strategies for raising community awareness and providing accurate information about new diagnostic options. Programs will need to implement strategies to improve linkage to care for infected infants as well as follow-up for subsequent testing for infants initially testing negative [
28], as well as ensure consistent availability of supplies. As POC BT becomes available in lower-volume clinics and health facilities, further implementation research will be needed about how to ensure its optimal use and effectiveness.
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