Prevalence and correlates of pregnancy self-testing among pregnant women attending antenatal care in western Kenya.

In sub-Saharan Africa little is known about how often women use pregnancy self-tests or characteristics of these women despite evidence that pregnancy self-testing is associated with early antenatal care (ANC) initiation. Understanding the characteristics of women who use pregnancy self-tests can facilitate more targeted efforts to improve pregnancy testing experiences and entry into the ANC pathway. We conducted a cross-sectional survey among pregnant women enrolling in a pre-exposure prophylaxis (PrEP) implementation study to determine the prevalence and factors associated with pregnancy self-testing among women in western Kenya. Overall, in our study population, 17% of women obtained a pregnancy self-test from a pharmacy. Pregnancy test use was higher among employed women, women with secondary and college-level educated partners, and women who spent 30 minutes or less traveling to the maternal and child health (MCH) clinic. The most reported reasons for non-use of pregnancy self-tests included not thinking it was necessary, lack of knowledge, and money to pay for the test. Future research should focus on understanding the knowledge and attitudes of women toward pregnancy self-testing as well as developing community-based models to improve access to pregnancy testing and ANC.

Introduction

The World Health Organization (WHO) recommends that pregnant women should initiate the first antenatal care (ANC) visit in the first trimester of pregnancy because early ANC access is central to identifying pregnancy complications and managing pre-existing conditions [1]. However, in western Kenya, less than 20% of pregnant women are estimated to present for ANC in the first trimester [2]. Barriers to early initiation of ANC due to uncertainty of pregnancy status during the first trimester can potentially be addressed by improving access to pregnancy testing [3, 4]. However, little is known about how often women use pregnancy self-tests or the characteristics of these women. Understanding the characteristics of women who use pregnancy self-tests can facilitate more targeted efforts to improve pregnancy testing experiences and entry into the ANC pathway. In this study, our primary objective was to determine the prevalence of pregnancy self-testing and associated factors among pregnant women attending maternal and child health (MCH) clinics in western Kenya. In a secondary objective, we evaluated whether pregnancy self-testing was associated with early ANC initiation among pregnant women.

Methods

Study design

From December 2018 to July 2019, we collected data as part of a baseline survey among pregnant women enrolling in the PrEP Implementation for Mothers in Antenatal Care (PrIMA) study. PrIMA is a cluster randomized trial (NCT03070600) that compares facility-based approaches for delivering oral pre-exposure prophylaxis (PrEP) in pregnancy. Briefly, between January 2018 and July 2019, study participants were recruited from women presenting for ANC in 20 public health facilities in Homabay and Siaya counties in western Kenya. In this region, approximately more than 95% of pregnant women receive antenatal care from a skilled provider [2]. Health facilities eligible for inclusion in the PrIMA study were located in counties with an HIV prevalence of at least 20%, had more than 350 HIV-negative clients receiving ANC annually, and provided postnatal care services, including infant immunizations. Women were eligible for enrollment if they were: (1) pregnant, (2) HIV negative (based on test results abstracted from the MCH card), (3) not currently using PrEP, (4) ≥ 15 years of age, (5) TB negative and (6) planned to receive postnatal and infant care at the enrollment facility. Participants were recruited for the study while waiting to access ANC services at any ANC visit and at any gestational age. The study team administered the enrollment questionnaire in English, Kiswahili, or the local language, Dholuo (see S1 Appendix). Participants answered questions on socio-demographics, medical and pregnancy history, and partner characteristics. Additional details on the PrIMA study protocol are described elsewhere [5].

Study variables

We analyzed two dependent variables: “obtained pregnancy self-test from pharmacy” and “early ANC initiation.” If a woman reported using a pregnancy test on her own to confirm her pregnancy and obtained the pregnancy test from the pharmacy, we categorized her as having obtained a pregnancy self-test from the pharmacy. We defined “early ANC initiation” as starting ANC during the first trimester of pregnancy (gestational age less than 13 weeks). We analyzed variables that we hypothesized from the literature would be associated with pregnancy self-test use and early ANC: socio-demographics (age, partner status, number of years in school, partner’s education level, and history of prior pregnancy), accessibility (travel time to the health facility), affordability (women’s employment status) and women’s knowledge or attitudes (history of pregnancy or delivery complications) [3, 4, 6–9]. We analyzed “obtained pregnancy self-test from pharmacy” as an independent variable when evaluating factors associated with early ANC initiation [3, 4]. We categorized age into three groups: 15–19 years, 20–24 years, and > 25 years. We included three different age groups because adolescents and young women face unique challenges in pregnancy and are likely to have different health-seeking behaviors [10]. We defined and categorized partner status into two groups: having a partner (including a married partner) or not having a partner in the last three months at the time of the survey. The number of years in school was categorized into three groups (8 years, 9–12 years, and >12 years), reflecting the number of years that individuals have typically spent in school at primary, secondary, and college levels in the region. We categorized the partner’s education level into four groups: primary school and below (no formal schooling or having attended or completed primary school), secondary school (having attended or completed secondary school), and college (having attended or completed college). We defined history of prior pregnancy as a woman reporting that she had previously been pregnant. Women reported estimated travel time to the health facility in minutes which we categorized into two groups (≤ 30 minutes versus > 30 minutes) based on the median travel time. Women were categorized as employed if they reported currently having regular employment. Women had a history of prior pregnancy or delivery complications if they indicated that they had the following problems during her last pregnancy: late pregnancy bleeding, miscarriage, fetal miscarriage, high blood pressure, laceration, hemorrhage, obstructed labor, premature birth (<37 weeks), spontaneous fetal death (< 20 weeks) or stillbirth. All variables were self-reported.

Statistical analysis

We conducted a descriptive analysis of the independent (age, partner status, history of prior pregnancy, employment status, and the number of years in school) and dependent variables (obtained pregnancy self-test from pharmacy and early ANC initiation). We examined the sources of pregnancy self-tests and the reasons for non-use of pregnancy self-tests among pregnant women. We conducted bivariate logistic regression analyses to examine the associations between the independent variables and each of the two dependent variables. In the multivariable logistic regression analysis, we excluded age and number of years in school because they were strongly correlated with a history of prior pregnancy and partner’s education level, respectively (Cramer’s V > 0.30, p <0.05) [11]. To maintain the sample size, we excluded history of pregnancy or delivery complications because we could only determine this variable among women who had previously been pregnant. We included women who reported not having a partner as a separate category under the partner’s education level. We used the Mantel-Haenszel test of homogeneity to identify potential modifiers of the relationship between obtaining a pregnancy self-test from a pharmacy and early ANC initiation. The relationship differed significantly by partner’s education level; therefore, we stratified the analysis by this variable. Given that we conducted a secondary analysis of data from an existing cluster randomized trial, we adjusted for the 20 facility clusters using a robust method of standard errors. Overall, 93% of records had complete data. Missingness ranged from 0.6% to 4.6% across all variables. Statistical analyses were performed using R software (R-Studio Version 1.1.456) and STATA 16.1 (College Station, TX).

Ethics

The Kenyatta National Hospital (P73/02/2017) and the University of Washington (STUDY00000438) institutional review boards approved this study. All participants provided written informed consent to participate in the study.

Results

Socio-demographic characteristics

From December 10th, 2018, to July 31st, 2019, 1128 women enrolled in the PrIMA study and completed the baseline survey. We excluded six records where the participants reported presenting for ANC earlier than the trimester in which they confirmed their pregnancy. Overall, this analysis included 1122 pregnant women between the ages of 15–43 years with a median age of 24 years (interquartile range [IQR]: 21–28 years). At the time of the survey, the majority of women were married or had partners (92%), had previously been pregnant (78%), were employed (87%), and had completed up to 12 years of school (84%).

Prevalence and correlates of pregnancy self-testing

Table 1 summarizes the characteristics of pregnant women who confirmed their pregnancy with or without obtaining a pregnancy self-test from a pharmacy. Seventeen percent of women reported obtaining a pregnancy self-test from a pharmacy to confirm their pregnancy. An additional 5% of women reported using a pregnancy self-test and obtained their kits from a public health facility (n = 36), a private health facility (n = 17), and other sources including community health workers, school, and home (n = 4). Of the 846 respondents who did not use a self-test: 85% confirmed their pregnancies at a public health facility, 8% at a private health facility, and 7% used other means. Among women who reported using other means to confirm their pregnancies: 43 stated that they did not confirm their pregnancies or knew they were pregnant based on physical signs of pregnancy, including missed periods, fatigue, nausea, and abdominal growth, eight went to traditional birth attendants, community health workers or a midwife and two went to an unspecified health facility. The most frequent reasons for non-use of pregnancy self-tests included: not thinking it was necessary (58%), lack of knowledge on self-tests (25%), and lack of money to pay for a self-test (11%).

Table 1

Characteristics of pregnant women who confirmed their pregnancy with or without obtaining a pregnancy self-test from a pharmacy.

Variables	Obtained a pregnancy self-test from the pharmacy N = 187 *		Did not obtain a pregnancy self-test from the pharmacy N = 903 *
	N	(%)	N	(%)	p-value
Maternal age
15–19	18	(10)	131	(15)	0.193
20–24	76	(42)	352	(41)
≥25	86	(48)	382	(44)
Number of years in school
≤ 8	43	(23)	397	(44)	<0.001
9–12	79	(43)	388	(43)
> 12	63	(34)	108	(12)
History of prior pregnancy
Yes	134	(72)	716	(79)	0.02
No	53	(28)	186	(21)
Partner status
Have a partner or married	171	(92)	824	(92)	0.937
No partner	15	(8)	74	(8)
Currently employed
Yes	46	(25)	92	(10)	<0.001
No	139	(75)	800	(90)
Travel time to the health facility (minutes)
≤30	140	(76)	524	(59)	<0.001
>30	45	(24)	369	(41)
Partner’s education level
Primary school and below	20	(12)	310	(38)	<0.001
Secondary school	71	(42)	341	(41)
College	80	(47)	173	(21)
History of pregnancy or delivery complications
Yes	13	(10)	68	(10)	0.9
No	117	(90)	637	(90)
Timing of presentation for ANC
1st trimester	80	(43)	292	(32)	0.009
2nd trimester	98	(52)	528	(59)
3rd trimester	9	(5)	82	(9)

*The number of respondents for each variable may vary due to missing responses.

Table 2 shows the univariate and multivariable logistic regression results for correlates of pregnancy self-test use. In the univariate analysis, women who obtained a pregnancy self-test from the pharmacy were more likely to be pregnant for the first time, employed, more educated (9–12 years or > 25 years vs. ≤ 8 years), spend 30 minutes or less traveling to the health facility, and have more educated partners (secondary school or college vs. primary school or below). In the multivariable analysis, women who obtained a pregnancy self-test from the pharmacy were more likely to be employed, spend 30 minutes or less traveling to the health facility, and have more educated partners (secondary school or college vs. primary school or below). Obtaining a pregnancy self-test from the pharmacy was not associated with a history of a prior pregnancy.

Table 2

Univariate and multivariable logistic regression examining the variables associated with obtaining a pregnancy self-test from a pharmacy.

Variables	Univariate Model		Multivariable Model
	OR (95% CI)	p-value	OR (95% CI)	p-value
Partner status
Have a partner or married	1.02 (0.46, 2.26)	0.954	-	-
No partner	Reference group		-	-
History of prior pregnancy
Yes	Reference group		Reference group
No	1.52 (1.13, 2.06)	0.006	1.22 (0.87, 1.70)	0.251
Age
15–19	0.61 (0.35, 1.07)	0.087	-	-
20–24	0.96 (0.59, 1.55)	0.87	-	-
≥25	Reference group
Currently employed
Yes	2.88 (2.08, 3.97)	<0.0001	2.01 (1.31, 3.08)	0.001
No	Reference group		Reference group
Number of years in school
≤ 8 years	Reference group
9–12 years	1.87 (1.30, 2.71)	0.001	-	-
> 12 years	5.39 (2.74, 10.57)	<0.0001	-	-
Travel time to health facility(minutes)
≤30	2.19 (1.40, 3.42)	0.001	1.81 (1.19, 2.73)	0.005
>30	Reference group		Reference group
Partner’s education level
Primary school and below	Reference group		Reference group
Secondary school	3.22 (1.66, 6.27)	0.001	3.11 (1.63, 5.93)	0.001
College	7.17 (3.92, 13.11)	<0.0001	6.11 (3.40, 10.96)	<0.0001
No partner	-	-	2.71 (1.22, 6.00)	0.014
History of pregnancy or delivery complications
Yes	1.04 (0.67, 1.62)	0.859	-	-
No	Reference group		-	-

Prevalence and correlates of early antenatal care initiation

Approximately 65% of women confirmed their pregnancy in the first trimester. However, only 35% of the women initiated ANC early–in the first 13 weeks of pregnancy. Fifty-eight percent of the women started ANC during the second trimester, and 8% during the third trimester.

Table 3 shows the univariate logistic regression results for correlates of early ANC initiation. In the univariate analysis, women who initiated ANC early were more likely to have obtained a pregnancy self-test from a pharmacy, be pregnant for the first time, be employed, and have a more educated partner (college vs. primary school or below). Table 4 shows the multivariable logistic regression results stratified by partner education level. Early ANC initiation was more likely among women with college-educated partners if the women obtained a pregnancy self-test from a pharmacy (OR: 1.94, 95% CI: 1.12, 3.35). However, early initiation among women with partners who had at least a primary level education was less likely if the women obtained a pregnancy self-test from a pharmacy (OR:0.25, 95% CI: 0.068, 0.92). Among women with partners who had at least a primary or secondary level education, early ANC initiation remained more likely if women were pregnant for the first time.

Table 3

Univariate logistic regression examining the variables associated with early ANC initiation.

Variables	OR (95% CI)	p-value
Obtained pregnancy self-test from pharmacy
Yes	1.56 (1.12, 2.17)	0.008
No	Reference group
Partner status
Have a partner or married	0.67 (0.42, 1.09)	0.105
No partner	Reference group
History of prior pregnancy
Yes	Reference group
No	1.55 (1.12, 2.13)	0.008
Age
15–19	0.95 (0.65, 1.38)	0.791
20–24	1.24 (0.98, 1.57)	0.079
≥25	Reference group
Currently employed
Yes	1.33 (1.01, 1.75)	0.043
No	Reference group
Number of years in school
≤ 8years	Reference group
9–12 years	1.23 (0.97, 1.55)	0.091
> 12 years	1.52 (0.96, 2.41)	0.077
Travel time to health facility(minutes)
≤30	0.80 (0.55, 1.16)	0.239
>30	Reference group
Partner’s education level
Primary school and below	Reference group
Secondary school	1.30 (1.00, 1.68)	0.054
College	2.04 (1.56, 2.67)	<0.0001
No partner	-	-
History of pregnancy or delivery complications
Yes	1.35 (0.77, 2.37)	0.300
No	Reference group

Table 4

Logistic regression examining the variables associated with early ANC initiation and stratified by partner’s education level.

	Partner’s education level
Variables	Primary school and below (N = 327)		Secondary school (N = 406)		College (N = 247)
	OR (95% CI)	p-value	OR (95% CI)	p-value	OR (95% CI)	p-value
Obtained pregnancy self-test from pharmacy
Yes	0.25 (0.068, 0.92)	0.036	0.92 (0.57, 1.50)	0.749	1.94 (1.12, 3.35)	0.018
No	Reference group
History of prior pregnancy
Yes	Reference group
No	2.36 (1.23, 4.51)	0.009	2.04 (1.12, 3.71)	0.019	0.89 (0.54, 1.48)	0.654
Currently employed
Yes	2.03 (0.76, 5.44)	0.157	1.11 (0.57, 2.16)	0.752	0.95 (0.47, 1.89)	0.879
No	Reference group
Travel time to health facility(minutes)
≤30	1.20 (0.88, 1.63)	0.251	0.95 (0.55, 1.64)	0.858	1.19 (0.59, 2.39)	0.621
>30	Reference group

Discussion

In this study, we investigated the prevalence and correlates of pregnancy self-testing among pregnant women attending MCH clinics in western Kenya. Overall, the prevalence of pregnancy self-testing in the study population was low, with 23% of women reporting having used a pregnancy self-test to confirm their pregnancy and 17% of women having obtained a pregnancy self-test from a pharmacy to confirm their pregnancy. We report a slightly lower prevalence of pregnancy self-test use than a 2006 South African study in which 27% of ANC clients obtained a pregnancy self-test from a private pharmacy [4]. Interestingly, most women who did not use a pregnancy self-test either did not think it was necessary or did not know that they could use one. Further studies are needed to understand women’s knowledge and attitudes toward pregnancy self-testing.

In this study population, employment, education level, partner’s education level, and travel time to health facility were the strongest correlates of pregnancy self-testing. Employed women may have greater autonomy in deciding how to spend financial resources than women who are not employed. Women who are more educated are more likely to have increased knowledge and familiarity with obtaining and using pregnancy tests [9]. Women with more educated partners might be likely to experience positive reinforcement of pregnancy testing behaviors and have the financial resources for pregnancy self-tests [12]. Finally, women who reported shorter travel times might be more likely to afford pregnancy self-tests or live in urban areas with better access to pregnancy self-tests [13]. Our findings are consistent with studies conducted in the United States that demonstrate increased rates of pregnancy self-test use among women of higher socioeconomic status [9].

In this study population, we found that 35% of women reported initiating ANC in the first trimester of pregnancy. This proportion is higher compared to findings reported for sub-Saharan Africa (24.9%) in a 2017 systematic review [14] and for the greater study region (<20%) in the 2014 Kenya Demographic and Health Survey [2]. In the univariate analysis, we found that women who initiated ANC in the first trimester were more likely to obtain a pregnancy self-test from the pharmacy, have no history of prior pregnancy, be employed, and have a college-level educated partner. Interestingly, in the stratified analysis, we found that partner education level modified the association between obtaining a pregnancy self-test from the pharmacy and early ANC initiation. In cases where partners had a college-level education, women were twice as likely to initiate ANC early if they obtained a pregnancy self-test from a pharmacy. However, in cases where partners had a primary school education or below, women were less likely to start ANC early if they obtained a pregnancy self-test from a pharmacy. Prior studies show that a partner’s education level is an essential determinant of women’s health-seeking behavior [15, 16]. When partners are more educated, women are likely to live in households of higher socioeconomic status and able to forgo the opportunity costs of initiating ANC early [12].

To our knowledge this is one of the few studies to evaluate whether pregnancy testing is associated with early ANC initiation. One study in Ethiopia found that women who recognized their pregnancy using a urine test were more likely to initiate ANC early than women who used other means such as missed periods [17, 18]. A prior study in South Africa found that women who independently decided to obtain a urine pregnancy test from a private pharmacy initiated ANC 3.6 weeks earlier in their pregnancy [4]. However, neither of these studies adjusted for partner +*-education level; a recent systematic review from sub-Saharan Africa shows that studies did not evaluate the relationship between partner education and early ANC initiation [7]. Our study shows that pregnancy testing is an important prerequisite to initiating ANC early, particularly among women with highly educated partners. Strategies that increase knowledge and understanding of ANC and its benefits, bring care closer to the community, or provide financial and social support are important components to realizing the full benefits of pregnancy testing. For example, community-based models of care that combine the delivery of free pregnancy tests and home-based counseling could be a promising strategy for improving early ANC initiation [19, 20]. Exploring opportunities to engage community pharmacies, which are known to be frequently accessed [21] and sell pregnancy tests [22], could also expand the options available to women for early pregnancy recognition and referral to ANC [23].

Our study has some limitations. Although we were able to recruit over 1000 study participants from 20 clinics in western Kenya, the majority of the participants came from rural areas therefore some aspects of our findings may not generalize to other settings. Secondly, participants self-reported when they confirmed their pregnancy and when they first presented for antenatal care. It is therefore possible that some women may not accurately recall their pregnancy history leading to over- or underestimation of study outcomes. Thirdly, because our sample comprised women attending ANC as part of a PrEP implementation trial in public-sector MCH clinics, our findings may not be representative of all ANC attendees who use pregnancy self-tests in this setting. Finally, given that we conducted a cross-sectional analysis of enrollment data from an implementation trial, we were unable to assess additional independent variables such as knowledge and attitudes toward pregnancy self-testing and ANC [4].

Conclusions

In conclusion, this study confirms that pregnancy testing plays a beneficial role in facilitating early ANC initiation. However, we found modest overall use of pregnancy self-tests among women attending ANC in western Kenya. Most women either did not see the utility of pregnancy self-testing or did not know about pregnancy self-tests. Further research is needed to understand women’s attitudes, knowledge, and motivations toward pregnancy self-testing and how it informs decision-making around ANC attendance. To create value for women in the ANC pathway, we need to explore strategies to adapt existing community-based models that include pregnancy testing, antenatal counseling, and timely referral for care.

Demographic and pregnancy history questionnaire.

(PDF)

Click here for additional data file.

1 Feb 2021

PONE-D-20-39327

Prevalence and correlates of pregnancy self-testing among pregnant women attending antenatal care in western Kenya

PLOS ONE

Dear Dr. Mugambi,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

There is potential for selection bias (also called collider bias or Berksonian bias) in this study, and this may have led to spurious associations. If the socio-demographic characteristics of women who attended the clinics and participated in the PrIMA trial are different from those who did not attend the clinics and participated in the trial, then assessing the socio-demographic variables in multivariable regression introduces Berksonian bias.  This is because the study is conditioned on attending the clinic and participating in the trial. The socio-demographic characteristics may influence clinic attendance and trial participation. Moreover, women  who self-test are more likely to attend ANC.  Thus, clinic attendance is a “collider” and given that the study is conditioned on this, the result is the bias I have mentioned above.

The authors have not provided sufficient background information to judge whether this bias indeed affected/or did not affect this study. What is the coverage of ANC in the study area? Women were eligible for recruitment during which ANC visit? (The first ANC visit or any ANC visit?).  Of the women attending ANC, what proportion participated in the trial? What proportion  of women in the study area attend ANC in the included health facilities?

The study methodology is scanty. The authors should refer to the STROBE checklist for reporting cross-sectional studies STROBE Statement: Available checklists (strobe-statement.org).

These are major concerns that threaten the validity of this study and it is important to address them adequately before a decision can be made on this manuscript.

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Reviewer #2: Partly

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: No

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Reviewer #2: No

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Reviewer #1: 1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript is technically sound as it addresses an area of public health interest-pregnancy self testing. However while the conclusion on main outcome is in tandem with data, the conclusion on correlates seems to be based on exploratory data(line 186/187) where the author explored reasons for not self testing for pregnancy instead of correlates assessed in regression

2.Has the statistical analysis been performed appropriately and rigorously?

Yes, appropriate technique applied ie logistic regression and confounders controlled for. To add more rigour to the analysis and show the reliability of the prevalence estimates reported, please add 95% CIs to these prevalence estimates

3. Have the authors made all data underlying the findings in their manuscript fully available?

Data available on request and contacts provided

4. Is the manuscript presented in an intelligible fashion and written in standard English?

Standard English has been used. The following revisions are necessary

-Line 10 is not clear

-To improve logical flow, results on outcomes(ie the prevalence estimates) should be removed from the section on sociodemographics and brought down to the respective sections where the correlates are being presented

Reviewer #2: 1. Line 41- variables that were hypothesized should be based on previous studies in similar context. References should be provided.

2. Statistical analysis- What was the criteria of including a variable in the multi-variable analysis after conducting the univariate ? Was multi-collinearity assessed. Provide results for the same.

3. Was the travel time self-reported ? discuss its limitations. Further travel time and the location of the health facility are likely be highly correlated and infer the same thing

4. Ethics- provide the study protocols review numbers also in this section

5. Summarise the missing responses in the data and reflect on how it might have affected the analysis

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Reviewer #1: No

Reviewer #2: No

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17 Sep 2021

Response to Reviewers

Re: Prevalence and correlates of pregnancy self-testing among pregnant women attending antenatal care in western Kenya (. PONE-D-20-39327)

Editor comments

There is potential for selection bias (also called collider bias or Bersanian bias) in this study, and this may have led to spurious associations. If the socio-demographic characteristics of women who attended the clinics and participated in the PrIMA trial are different from those who did not attend the clinics and participated in the trial, then assessing the socio-demographic variables in multivariable regression introduces Berksonian bias. This is because the study is conditioned on attending the clinic and participating in the trial. The socio-demographic characteristics may influence clinic attendance and trial participation. Moreover, women who self-test are more likely to attend ANC. Thus, clinic attendance is a “collider” and given that the study is conditioned on this, the result is the bias I have mentioned above.

Response: We appreciate the reviewer's comments that the characteristics of the women who attended ANC and enrolled in the PrIMA study could be different from the women who did not participate in ANC and were not enrolled. We have accounted for this potential bias in the discussion section. We include the following sentence: "Thirdly, because our sample comprised women attending ANC as part of a PrEP implementation trial in public-sector MCH clinics, our findings may not be representative of all ANC attendees who use pregnancy self-tests in this setting." [Please see revised manuscript page 16 lines 64 - 66]

PrIMA was intentionally designed to represent the underlying population of HIV-negative ANC clients in Homa Bay and Siaya counties by enrolling women attending any ANC visit at any gestational age. Additionally, prior studies show that only 2.6% of pregnant women in the region of PrIMA implementation did not present for ANC during pregnancy, indicating a high frequency of ANC attendance. Therefore, our study population is likely representative of the general population of pregnant women in this setting.

Additionally, we expanded on the process of facility and participant selection in our revised submissions. Our newly added sentence reads, “ Briefly, between January 2018 and July 2019, study participants were recruited from women presenting for ANC in 20 public health facilities in Homabay and Siaya counties in western Kenya. In this region, approximately more than 95% of pregnant women receive antenatal care from a skilled provider[2]. Health facilities eligible for inclusion in the PrIMA study were located in counties with an HIV prevalence of at least 20%, had more than 350 HIV-negative clients receiving ANC annually, and provided postnatal care services, including infant immunizations. Women were eligible for enrollment if they were: (1) pregnant, (2) HIV negative (based on test results abstracted from the MCH card), (3) not currently using PrEP, (4) ≥ 15 years of age, (5) TB negative and (6) planned to receive postnatal and infant care at the enrollment facility. Participants were recruited for the study while waiting to access ANC services any ANC visit and at any gestational age”. [Please see revised manuscript pages 3 – 4 lines 18 – 28].

The authors have not provided sufficient background information to judge whether this bias indeed affected/or did not affect this study. What is the coverage of ANC in the study area? Women were eligible for recruitment during which ANC visit? (The first ANC visit or any ANC visit?). Of the women attending ANC, what proportion participated in the trial? What proportion of women in the study area attend ANC in the included health facilities?

Response: We appreciate the reviewers comment and have described the study background in more detail [please see revised manuscript pages 3-4 as well as the previous response]. As we described above, we have added this selection bias as a potential limitation in the discussion section. Findings from the 2014 KDHS reported that 96.6% of pregnant women in Nyanza region (where PrIMA was conducted) received antenatal care from a skilled provider (doctor, nurse or midwife). As described above, PrIMA was intentionally designed to represent the underlying population of HIV-negative ANC clients by enrolling women attending any ANC visit at any gestational age. Additionally, of the 9,915 HIV-negative women who received ANC at the health facilities, 8,391 women were screened for the study and thus we screened a high proportion of the overall HIV-negative ANC population.

The study methodology is scanty. The authors should refer to the STROBE checklist for reporting cross-sectional studies STROBE Statement: Available checklists (strobe-statement.org).

Response: We appreciate the reviewers comments and have carefully revised the methods section and modified the non-compliant parts according to the STROBE checklist for reporting cross-sectional studies. These changes are reflected in the revised manuscript on pages 3 – 6.

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Partly

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: No

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: No

4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1:

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript is technically sound as it addresses an area of public health interest-pregnancy self-testing. However, while the conclusion on main outcome is in tandem with data, the conclusion on correlates seems to be based on exploratory data (line 186/187) where the author explored reasons for not self-testing for pregnancy instead of correlates assessed in regression

Response: We appreciate the reviewer considers our manuscript technically sound. In response to the reviewers comment about the conclusion we have updated this section to read: “ However, we found modest overall use of pregnancy self-tests among women attending ANC in western Kenya. Women who were employed, more educated, had more educated partners, and took a shorter time traveling to the health facility were more likely to use pregnancy self-tests. Most women either did not see the utility of pregnancy self-testing or did not know about pregnancy self-tests.” [Please see revised manuscript page 17, lines 72 – 76].

2. Has the statistical analysis been performed appropriately and rigorously?

Yes, appropriate technique applied i.e. logistic regression and confounders controlled for. To add more rigour to the analysis and show the reliability of the prevalence estimates reported, please add 95% CIs to these prevalence estimates

Response: We have reviewed the manuscript and included the 95% CIs to the odds ratios and key prevalence estimates.

3. Have the authors made all data underlying the findings in their manuscript fully available?

Data available on request and contacts provided

Response: We have provided a limited and anonymized data set to a GitHub page, which can be accessed at the following URL (https://github.com/jcdettin/PrIMA-PregnancySelftesting).

4. Is the manuscript presented in an intelligible fashion and written in standard English?

Standard English has been used. The following revisions are necessary

-Line 10 is not clear

-To improve logical flow, results on outcomes (i.e. the prevalence estimates) should be removed from the section on sociodemographic and brought down to the respective sections where the correlates are being presented

Response: We agree with the reviewer and following changes have been made:

Line 10, which was previously stated as: “Understanding the characteristics of women who use pregnancy self-tests is important to facilitate early access to ANC and to preventive interventions in pregnancy” has been restated as follows: “Understanding the characteristics of women who use pregnancy self-tests can facilitate more targeted efforts to improve pregnancy testing experiences and entry into the ANC pathway” [see lines 9 – 11 on page 3]

The pregnancy related characteristics in the results section have been moved to their respective subheadings under “Prevalence and correlates of early antenatal care initiation” on page 11.

Reviewer #2:

Line 41- variables that were hypothesized should be based on previous studies in similar context. References should be provided.

Response: We agree with the reviewer and have provided references on page 4 line 46.

2. Statistical analysis- What was the criteria of including a variable in the multi-variable analysis after conducting the univariate? Was multi-collinearity assessed. Provide results for the same.

Response: We appreciate the reviewers comments. Key inclusion criteria described in the methods section are as follows [Please see revised manuscript pages 4 – 5]:

We analyzed variables that we hypothesized from the literature would be associated with pregnancy self-test use and early ANC.

Multicollinearity was assessed using Cramer’s V. We excluded age and number of years in school because they were strongly correlated with a history of prior pregnancy and partner’s education level, respectively (Cramer’s V > 0.30, p <0.05).

Age and history of prior pregnancy, Cramer’s V = 0.47

Number of years in school and partner’s education level, Cramer’s V = 0.35

To maintain the sample size, we excluded history of pregnancy or delivery complications because we could only determine this variable among women who had previously been pregnant.

We included women who reported not having a partner as a separate category under the partner’s education level.

We used the Mantel-Haenszel test of homogeneity to identify potential modifiers of the relationship between obtaining a pregnancy self-test from a pharmacy and early ANC initiation. The relationship differed significantly by partner’s education level; therefore, we stratified the analysis by this variable

Given that we conducted a secondary analysis of data from an existing cluster randomized trial, we adjusted for the 20 facility clusters using a robust method of standard errors.

3. Was the travel time self-reported? discuss its limitations. Further travel time and the location of the health facility are likely be highly correlated and infer the same thing

Response: Travel time to health facility was a self-reported variable and was captured by the question ‘How long does it take you to travel to clinic? (number of minutes)’. Travel time to health facility is dependent on the mode of transport to the health facility (walking, motor vehicle either personal or public or Boda-boda (bicycle or motorcycle taxis)). In the PrIMA study, the travel time question did not account for the various modes of transport.

We initially included location of health facility (urban/rural) as a variable to account for the 20 different facilities that were included in the study. We have now revised our approach and adjusted for the 20 health facility clusters using a robust methods of standard errors.

4. Ethics- provide the study protocols review numbers also in this section

Response: The study was approved by the institutional review boards at the Kenyatta National Hospital (P73/02/2017) and the University of Washington (STUDY00000438). We have also included the review numbers in the manuscript.

5. Summarise the missing responses in the data and reflect on how it might have affected the analysis

Response: We have summarized the missing responses by study variable:

Study variable Number missing % missing

Early ANC initiation 12 1.1

Obtained pregnancy self-test at pharmacy 32 2.9

Maternal age 52 4.6

Partner status 11 1

Travel time to health facility 18 1.6

Currently employed 19 1.7

Number of years in school 20 1.8

Partner’s education level 10 0.9

History of prior pregnancy 29 2.6

Overall, 93% of records had complete data. Missingness ranged from 0.6% to 4.6% across all variables. Therefore it is highly unlikely that missing data had a substantial impact on our findings.

6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

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Response: We have carefully revised our manuscript and modified the non-compliant parts according to the PLOS ONE style requirements.

2. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information.

Response: The study was approved by the institutional review boards at the Kenyatta National Hospital (P73/02/2017). and the University of Washington (STUDY00000438). All participants provided written informed consent to participate in the study. The study recruited pregnant women who were 15 years and older. Pregnant women (or women who have ever been pregnant) who are <18 years are considered ‘emancipated minors’ and are legally able to consent themselves for medical research.

3. Please include additional information regarding the survey or questionnaire used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed a questionnaire as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information. If the original language is written in non-Latin characters, for example Amharic, Chinese, or Korean, please use a file format that ensures these characters are visible.

Response: We have included a sample of the questionnaire used in the study as a supplementary file.

4. Please state whether you validated the questionnaire prior to testing on study participants. Please provide details regarding the validation group within the methods section.

Response: We did not pilot test the questionnaire prior to using it for the study. However, most of the pregnancy history questions are asked as part of standard sociodemographic, pregnancy and postnatal care questions in the Demographic and Health Surveys (DHS) program, which is implemented by ICF International. A DHS model questionnaire can be accessed at: https://dhsprogram.com/pubs/pdf/DHSQ7/DHS7-Womans-QRE-EN-17Dec2018-DHSQ7.pdf.

5. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions.

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Response: We have provided a minimal anonymized data set. We have addressed prompts a and b in our revised cover letter.

Submitted filename: PLoS ONE_Response to Reviewers_7192021.docx

Click here for additional data file.

1 Oct 2021

Prevalence and correlates of pregnancy self-testing among pregnant women attending antenatal care in western Kenya

PONE-D-20-39327R1

Dear Dr. Mugambi,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: (No Response)

Reviewer #2: (No Response)

**********

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Reviewer #1: No

Reviewer #2: No

3 Nov 2021

PONE-D-20-39327R1

Prevalence and correlates of pregnancy self-testing among pregnant women attending antenatal care in western Kenya

Dear Dr. Mugambi:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

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