Patient costs for prevention of mother-to-child HIV transmission and antiretroviral therapy services in public health facilities in Zimbabwe.

Zimbabwe has made large strides in addressing HIV. To ensure a continued robust response, a clear understanding of costs associated with its HIV program is critical. We conducted a cross-sectional evaluation in 2017 to estimate the annual average patient cost for accessing Prevention of Mother-To-Child Transmission (PMTCT) services (through antenatal care) and Antiretroviral Treatment (ART) services in Zimbabwe. Twenty sites representing different types of public health facilities in Zimbabwe were included. Data on patient costs were collected through in-person interviews with 414 ART and 424 PMTCT adult patients and through telephone interviews with 38 ART and 47 PMTCT adult patients who had missed their last appointment. The mean and median annual patient costs were examined overall and by service type for all participants and for those who paid any cost. Potential patient costs related to time lost were calculated by multiplying the total time to access services (travel time, waiting time, and clinic visit duration) by potential earnings (US$75 per month assuming 8 hours per day and 5 days per week). Mean annual patient costs for accessing services for the participants was US$20.00 [standard deviation (SD) = US$80.42, median = US$6.00, range = US$0.00-US$12,18.00] for PMTCT and US$18.73 (SD = US$58.54, median = US$8.00, range = US$0.00-US$ 908.00) for ART patients. The mean annual direct medical costs for PMTCT and ART were US$9.78 (SD = US$78.58, median = US$0.00, range = US$0.00-US$ 90) and US$7.49 (SD = US$60.00, median = US$0.00) while mean annual direct non-medical cost for US$10.23 (SD = US$17.35, median = US$4.00) and US$11.23 (SD = US$25.22, median = US$6.00, range = US$0.00-US$ 360.00). The PMTCT and ART costs per visit based on time lost were US$3.53 (US$1.13 to US$8.69) and US$3.43 (US$1.14 to US$8.53), respectively. The mean annual patient costs per person for PMTCT and ART in this evaluation will impact household income since PMTCT and ART services in Zimbabwe are supposed to be free.

Introduction

Access to prevention of mother-to-child transmission of HIV (PMTCT) and antiretroviral therapy (ART) services has been greatly expanded in Zimbabwe. In 2015, there were an estimated 1.4 million people living with HIV (PLHIV) in Zimbabwe, including 68,000 pregnant women [1]. By the end of December 2015, a total of 1,560 sites were offering ART services to 879,271 individuals, translating to about 63% of the total estimated number of PLHIV in the country [2].

The rise in treatment costs for individuals and families with chronic health conditions can impose a significant financial burden among even those with health insurance [3]. One review found that catastrophic health expenditures and impoverishment were highest for persons living with HIV receiving ART in Sub-Saharan African countries [4]. In Zimbabwe, even though HIV treatment is provided free of charge at public facilities, treatment of opportunistic infections and access to other diagnostic services may not be covered or available, forcing patients to seek care at private facilities resulting in expenses for patients.

To ensure a continued robust HIV response in Zimbabwe and to achieve HIV elimination, a clear understanding of program and patient costs associated with HIV are critical. Patient costs also include transport costs incurred when going to access services and earnings the patient did not receive while visiting the health facility. Against this background we evaluated both service provider and patient costs associated with receiving HIV services in Zimbabwe. In this paper we focus on the patient costs.

Methods

Ethical approval

The evaluation protocol received human subjects approval from the Medical Research Council of Zimbabwe and the Columbia University Institutional Review Board. The protocol was also reviewed in accordance with the United States Centers for Disease Control and Prevention (CDC) and determined to be a non-research, program evaluation.

Facilities

This evaluation included health facilities with both PMTCT services through antenatal care (ANC) and an ART clinic. In Zimbabwe these are different points of services and pregnant women with HIV receive ART in ANC until they are 24 months postpartum. Other adults with HIV receive HIV-related services through the ART clinic. Of the 1,560 PMTCT/ART co-located health facilities in Zimbabwe at the time of the evaluation, we eliminated 565 those that were for-profit, served closed populations such as uniformed forces and miners, or had less than 12 months of experience providing comprehensive PMTCT/ART services at the start of data collection. Additionally, facilities were excluded if they were experiencing difficulties with program implementation as determined by members of the project team or if they had low patient volumes (<20 ART patients), as these facilities were generally not representative. Of the 995 remaining facilities, 20 were selected using stratified random sampling. Eligible facilities were first categorized by service delivery level (primary, secondary, tertiary, or quaternary) then categorized by geographic area (northern and southern regions). One health facility was then randomly selected from each facility level within each geographic area.

Participants

Data were collected from September to November 2017. At each site, we selected a cross-sectional convenience sample among adult patients (aged ≥18 years) receiving either outpatient PMTCT services in ANC (pregnant women and postpartum women with HIV) or ART services (ART and pre-ART patients) at the facility on the day of data collection and for whom the date of encounter was not the first visit at the facility. Individuals were not eligible for participation if they were aged less than 18 years of age; not enrolled in the PMTCT or ART programs at the site; newly registered PMTCT or ART patients (to ensure that individuals in the sample have had experience with PMTCT or ART services in the facility); did not speak English, Shona, or Ndebele; or did not provide consent. Because HIV-related services are different for pregnant and postpartum women than for other PLHIV likely resulting in different costs to both the clients and the program and their age and sex structure differ, we evaluated them separately from other adults receiving HIV services. Clinical staff referred potential participants to project staff for eligibility screening. Because participants enrolled on-site may visit the facility more frequently, resulting in overestimation of patient costs (since more frequent facility visits entail higher costs), the evaluation also included phone interviews for adult ART or PMTCT patients who had at least one prior appointment at the facility and had missed their most recent appointment. Health facility staff used clinic records to identify potential participants for the phone interviews and obtained verbal consent to provide contact information to project staff.

After eligibility was confirmed, participants were enrolled in person or via telephone and provided informed oral consent. For informed oral consent, interviewers read the consent form to eligible, potential participants in the language of their preference. Potential participants were provided the opportunity to ask any questions. The consent form covered all procedures, potential risks and benefits, and who to contact to report complaints or concerns. After potential participants clearly indicated that they understood the content of the informed consent form, they provided verbal consent by repeating the consenting statement. Those not willing to take part, would read a refusal statement. The interviewer signed an attestation that consent was provided. Those that were enrolled in person were provided a copy of the consent form. Patients were enrolled sequentially until sample size targets were met for each facility was reached. Across all facilities, the target sample sizes were 547 (420 on-site and 127 phone) PMTCT participants and 767 ART (460 on-site and 87 phone) participants. Patient-level data were collected during in-person and telephone interviews using structured questionnaires on tablets. Information collected included demographics and the amount of money (in US dollars, the official currency of Zimbabwe at the time of the evaluation) and time spent (e.g., for transportation, registration, medications, and laboratory testing) in the last 6 months to receive ART or PMTCT services.

Cost estimates

We estimated the costs using micro-costing from patient level data using the patient level questionnaire where they reported direct medical, non-medical and indirect costs incurred from health-related visits over a six-month period prior to enrolment in the study. Direct medical costs referred to costs incurred for consultation, medication, diagnostic and monitoring tests while non-medical costs were related to travel, accommodation and other costs associated with the health-related visits. Indirect costs included opportunity costs associated with travel time and time spent in the health facility. The source of income was provided by participants in the questionnaire while the hourly rate was estimated by looking at the prevailing wage of that occupation as provided in the literature (see Table 1). We calculated the opportunity cost in three ways: 1) we used actual income estimates for those participants who received a wage from actual work and not passive or no income at all; 2) We allocated 1 to all the participants who had a passive income or not receiving an income at all and 3) we varied the income to the sectoral minimal rate and the maximum casual wage rate. This income was given at 2016 rates. The currency used was 2016 United States Dollars at the December 2016 average exchange rate of 1 US Dollar: 13.38 South African Rands (ZAR) [5] where applicable. No discount rate was applied. Costs were stratified by the type of service the clients were receiving i.e. ART or PMTCT.

Table 1

Source and type of income.

Type of income	Amount	Source
Wage work	$0,56	Crush J & Chikanda A. (2016). Zimbabwe’s Exodus: Crisis, migration, survival. Chapter 13:, Migrant Remittances and Household Survival in Zimbabwe. Accessed from: http://samponline.org/wp-content/uploads/2016/10/Zimbabwes-Exodus-Chapter-13.pdf
Casual Work	$0,53
Remittance-money	$0,56
Remittance-goods	$0,53
Sale of farm products	$0,53
Formal business	$0,52
Informal business	$ 0,54
Pension	$0,53; $ 0,33; $0,23	Crush J & Chikanda A. (2016). Zimbabwe’s Exodus: Crisis, migration, survival. Chapter 13:, Migrant Remittances and Household Survival in Zimbabwe. Accessed from:http://samponline.org/wp-content/uploads/2016/10/Zimbabwes-Exodus-Chapter-13.pdfInternational Labour Office. (2012). Zimbabwe: Report to the Government: Actuarial Study on the National Pension Scheme / International Labour Office, Social Security Department.—Geneva: ILO, 2012 xiii. 51 p. accessed from: https://www.social-protection.org/gimi/RessourcePDF.action;jsessionid=LgRIIVvrJnZVnwRkjlz-4lLmwYfUuprHig5OiBn-J5OKslpvjBAv!474614842?id=31528Social Security Administration. (2017). Social Security Programs Throughout the World: Africa, 2017, Zimbabwe. Accessed from: https://www.ssa.gov/policy/docs/progdesc/ssptw/2016-2017/africa/zimbabwe.html
Gifts	$0,52	Crush J & Chikanda A. (2016). Zimbabwe’s Exodus: Crisis, migration, survival. Chapter 13:, Migrant Remittances and Household Survival in Zimbabwe. Accessed from: http://samponline.org/wp-content/uploads/2016/10/Zimbabwes-Exodus-Chapter-13.pdf
Private Wage	$2,95	Labour and Economic Development Research Institute of Zimbabwe (LEDRIZ). (2016) USAID Strategic Economic Research And Analysis–Zimbabwe (SERA) Program Wage Structure And Labour Costs In Zimbabwe: An Analysis Of Flexibility, Competitiveness And Equity. Accessed from https://www.ilo.org/wcmsp5/groups/public/—africa/—ro-abidjan/—sro-harare/documents/genericdocument/wcms_470742.pdf
Public Wage	$3,73
Municipal Wage	$4,54
Parastatal Wage	$4,43
NGOs Wage	$5,19
Daily general worker (unskilled)	$0,64	DCLA. (2016). 3.3 Zimbabwe Manual Labor Costs, Accessed from https://dlca.logcluster.org/display/public/DLCA/3.3+Zimbabwe+Manual+Labor+Costs 2015
Daily general worker (skilled)	$1,58
Skilled labour	$3,14
Catering	$1,15
Mining	$1,41
Harare municipal undertaking	$1,17
Property Income	$69,00 (monthly wage)	ZIMSTAT. (2013) Poverty Income Consumption and Expenditure Survey 2011/12 Report. Accessed from https://www.zw.undp.org/content/zimbabwe/en/home/library/poverty/poverty-income-consumption-and-expenditure-and-survey-2011-12.html
Minimal sectoral ncome	$0,42; $0,41	WageIndicator 2021 - ALREI.org - Minimum Wages And Collective Bargaining In Zimbabwe Compiled By Naome Chakanya, Ledriz, September 2016 Accessed from https://alrei.org/education/minimum-wages-and-collective-bargaining-in-zimbabwe-compiled-by-naome-chakanya-ledriz-september- Zhangazha Wongai. Farm Workers are Suffering! [Internet]. Mywage.org/Zimbabwe, Wage Indicator Foundation . 2018 [cited 2018 Oct 5]. Available from: https://mywage.org/zimbabwe/main/salary/minimum-wage-1/farm-workers-are-suffering

Statistical analysis

Analysis was conducted using Stata MP 15 (StataCorp, College Station, TX) [6]. Mean annual patient costs were calculated, which included direct payments by patients for HIV-related consumables and services and transportation costs related to obtaining those consumables and services. We also separately calculated patient costs related to income that individuals could have received if they had not visited the clinic.

The mean and median patient annual cost was calculated separately for PMTCT and ART for all participants regardless of services received and whether they paid for any services. The same calculations were repeated for participants who paid some cost. The patient costs for specific services associated with PMTCT and ART were also calculated among those who accessed that specific service or consumable. Standard deviations (SD) were calculated. For the individual services costs, we multiplied the amount of money spent by the patient by the number of times the patient accessed the service or consumable in the six months before the interview; this cost was doubled to obtain annual costs. At the time of the evaluation, most patients had an appointment every three months and differentiated service delivery models such as multi-month scripting had not been widely implemented.

Potential patient costs related to time lost were calculated by measuring the total time spent (including travel time, waiting time, and time receiving services) to access services reported by patients and multiplying that by the amount of money the patient could have earned. To determine the income we initially calculated hourly wages from available sources based on their primary sources of income, given that the income was not passive and then assumed a minimum monthly sectoral wage of US$75.00 for all patients [7] and a maximum casual rate of skilled workers of US$3.14 per hour [8]. For the latter calculations, we converted all the passive income and non-working responses to $1 to avoid dividing by 0 [9]. We assumed 22 days per month and an 8-hour workday. Zimbabwe does not have a minimum wage so US$75.00 was used as that was the wage that was proposed as the Zimbabwe 2018 farm workers minimum wage and discounted to 2016 dollars [10].

Results

We interviewed 923 patients: 424 onsite PMTCT participants, 47 offsite PMTCT participants, 414 onsite ART participants, and 38 offsite ART participants. Due to active programs to return patients to care, sample size goals were met for onsite participants, but not for offsite participants, so all analyses combined the two groups.

Almost all PMTCT participants [467 of 471 (99%)] and ART participants [441 of 452 (98%)] reported that they were receiving ART. Most ART participants were women (63%). Mean ages of the respondents for PMTCT and ART participants were 30 years (SD, 7; range, 18–45 years) and 43 years (SD, 12; range, 18–73 years), respectively. Most participants in both groups had either some level of secondary education or had completed secondary education (Table 2).

Table 2

Self-reported demographic characteristics for participants at the 20 participating facilities, Zimbabwe, 2017.

Variable	PMTCT N (%)	ART N (%)
Number of patients	471	452
Location of interview
On-site	424 (90%)	414 (92%)
Off-site	47 (10%)	38 (8%)
Receiving ART
Yes	467 (99%)	441 (98%)
No	4 (1%)	11 (2%)
Gender
Male	N/A	166 (37%)
Female	471 (100%)	286 (63%)
PMTCT status
Pregnant	102 (22%)	3*
Breastfeeding	354 (78%)	3**
Mean age (years) (SD)	30 (7)	43 (12)
Age range (years)	18–45	18–73
Education
No education	3 (1%)	13 (35%)
Some primary	39 (8%)	47 (10%)
Completed primary	83 (18%)	80 (18%)
Some secondary	178 (38%)	122 (27%)
Completed secondary	140 (30%)	142 (31%)
Any tertiary	28 (6%)	44 (10%)
Refused to answer	0 (0%)	4 (1)
Employment status
Farming or livestock keeping or fishing	61 (13%)	71 (16%)
Paid employee (Government or Private)	69 (15%)	121 (27%)
Self-employed	88 (19%)	106 (23%)
Not working	66 (14%)	61 (13%)
Home maker/housewife/house chores	165 (35%)	47 (10%)
Student	3 (1%)	7 (2%)
Other	19 (4%)	35 (8%)
Refused to answer	0 (0%)	4 (1%)

*In the ART sample, there were 3 patients who reported being pregnant and were awaiting transfer to PMTCT and one patient who did not know her pregnancy status.

**3 patients in ART were still breastfeeding due to prolonged breastfeeding.

N/A: Not Applicable

SD: Standard Deviation

Among all participants (regardless if they paid any costs), mean annual patient costs were US$20.00 (SD = US$80.42) per PMTCT patient (median = US$6.00, range = US$0.00–US$1218.00) and US$19.31 (SD, US$65.18) per ART patient (median = US$8.00, range = US$0.00–US$908.00). Among those who paid any cost (651 of 923 or 71%) mean annual patient costs were US$28.90 (SD = US$95.37) per PMTCT patient (median = US$12.00, range = US$1.00–US$1218.00) and US$26.86 (SD = US$75.56) per ART patient (median = US$12.00, range = US$1.00–US$908.00).

We also estimated participant annual costs incurred as part of accessing specific PMTCT services (Table 3) or ART services (Table 4) at any health facility and these included transport, antiretroviral drugs (ARV), initial appointments, routine appointment, CD4 tests, in-patient stays, and drugs other than ARV among participants who accessed that specific service or consumable. The highest annual cost among PMTCT participants was for in-patient stays (US$216.36, n = 11), followed by other HIV treatment costs not listed above, such as full blood count and erythrocyte sedimentation rate testing (US$42.00, n = 1) and other government facility costs (US$27.66, n = 40). Mean annual costs for transportation to health facilities for PMTCT participants was US$10.49, n = 459. All other mean annual costs were

Table 3

Estimated participant annual costs for receiving PMTCT services among participants who incurred costs associated with that service or consumable, Zimbabwe 2017*.

Item/Service	Number of participants reporting receiving the service	Mean (US$)	Min (US$)	Max (US$)
Transport	459	$10.49	$0.00	$160.00
ARVs	465	$0.03	$0.00	$12.00
Initial registration appointment	23	$6.09	$0.00	$24.00
Routine appointment	60	$7.93	$2.00	$32.00
Emergency appointment	5	$7.20	$2.00	$18.00
CD4 tests	4	$4.00	$4.00	$4.00
Viral load tests	0
X-rays	3	$6.67	$0.00	$20.00
Inpatient stays	11	$216.36	$24.00	$1200.00
Other costs	1	$42.00	$42.00	$42.00
Other HIV-related drugs or supplies	27	$8.63	$0.00	$30.00
Other government facility	40	$27.66	$0.00	$1040.00
Other private clinic	10	$8.60	$0.00	$80.00
Traditional healer	9	$0.00	$0.00	$0.00
Pharmacy	11	$5.32	$0.00	$30.00
Costs at other facilities	8	$0.00	$0.00	$0.00

*Reported costs for each service were multiplied by the number of times a patient utilized the service over 6 months and then that was doubled to reflect annual costs.

Table 4

Estimated participant annual costs for receiving ART services among participants who incurred cost associated with that service or consumable, Zimbabwe 2017*.

Service	Number of participants reporting receiving the service	Mean (US$)	Min	Max
Transport	438	$11.62	$0.00	$360.00
ARVs	439	$0.17	$0.00	$72.00
Initial registration appointment	42	$5.48	$0.00	$20.00
Routine appointment	44	$6.70	$0.80	$12.00
Emergency appointment	7	$7.00	$1.00	$18.00
CD4 tests	6	$57.33	$4.00	$288.00
Viral load tests	1	$24.00	$24.00	$24.00
X-rays	13	$38.15	$0.00	$100.00
Inpatient stays	7	$67.71	$0.00	$200.00
Other costs	4	$13.50	$4.00	$26.00
Other HIV-related drugs or supplies	17	$8.29	$2.00	$24.00
Other government facility	37	$3.78	$0.00	$70.00
Other private clinic	17	$58.59	$0.00	$900.00
Traditional healer	14	$0.00	$0.00	$0.00
Pharmacy	14	$5.00	$0.00	$40.00
Costs at other facilities	14	$0.00	$0.00	$0.00

*Reported costs for each service were multiplied by the number of times a patient utilized the service over 6 months and then that was doubled to reflect annual costs.

The mean round-trip travel time per visit, including time waiting for transport, reported by PMTCT participants was 1 hour and 5 minutes (range, 2 minutes–8 hours 15 minutes). Mean waiting times at the facility to see a clinician were 44 minutes (range, 0–7 hours) for PMTCT participants with an appointment and 1 hour 1 minute (range, 0–5 hours) for those without an appointment. Average time spent seeing a clinician was 13 minutes (range, 0–2 hours). The mean time (including traveling and waiting time at the facility) for a PMTCT visit was 3 hours 11 minutes (range, 0–18 hours 45 minutes). For ART participants, the mean travel time was 1 hour 4 minutes (range, 0–10 hours). Mean waiting times to see a clinician were 47 minutes (range, 0–5 hours 15 minutes) for ART participants with an appointment and 53 minutes (range, 0–5 hours) for those without an appointment. The mean time spent seeing a clinician was 11 minutes (range, 0–2 hours 30 minutes). The mean total time (including traveling and waiting time and time spent with the clinician) for an ART visit was 3 hours 17 minutes (range, 0–21 hours 2 minutes).

Regarding the indirect costs, mean potential patient costs related to total time lost during travel, waiting and clinician contact multiplied by the estimated participants’ income for ART and PMTCT patients were US$3.43 and US$3.53 per visit (see Table 5). Based on a minimum sectoral wage of US$74 and the high skilled average wage of US$3.14 per hour; the mean indirect cost for ART and PMTCT ranged from US$1.11 to US$8.53 for ART patients and US$1.13 to US$8.69 for PMTCT patients respectively.

Table 5

Estimated average monthly income and disaggregation of costs by type of income.

Program	Monthly income			Direct Medical Costs			Direct non-medical costs			Total Medical costs			Indirect Costs (Opportunity costs using estimated income)
	Mean	Median	Standard deviation	Mean	Median	Standard deviation	Mean	Median	Standard deviation	Mean	Median	Standard deviation	Mean	Median	Standard deviation
PMTCT	$201.02	$275.00	$111.66	$9.78	$0.00	$78.58	$10.23	$1400	$17.35	$20.00	$6.00	$80.42	$3.53	$4.14	$25.83
ART	$193.06	$275.00	$119.82	$7.49	$0.00	$60.00	$11.23	$6.00	$25.22	$18.73	$8.00	$58.54	$3.43	$4.20	$17.50
Total	$197.13	$275.00	$115.73	$8.66	$0.00	$66.49	$10.71	$6.00	$21.56	$19.38	$8.00	$70.52	$3.48	$3.48	$4.17

Discussion

The overall mean annual patient costs per person for PMTCT (US$20.00) and ART (US$19.31) in this evaluation. While these costs are at least 2% of the minimum sectoral wage (US$75), they are 79% and 76% of Zimbabwe’s own allocated health expenditure per capita budget of US$25.45 [11], reflecting that the cost of PMTCT and ART services in Zimbabwe can barely be covered under the budget. However, per unit costs for certain services showed high values when restricted to those who accessed a certain service. Without a general improvement of the socio-economic conditions in communities with the highest risk of HIV, HIV elimination will be challenging [12]. Financial barriers hinder access to health services in low- and middle-income countries [12, 13] and are usually related to out-of-pocket expenses and the impact on household budgets [14]. The World Health Organization [15] states that when people suffer financial hardship due to out-of-pocket expenses, universal health coverage cannot be achieved.

Although ART and PMTCT services and their associated diagnostics are offered free of charge within the public sector in Zimbabwe, access to such services is still a challenge in a country that has experienced myriad of economic hardships over the past decade. We found that patients are still incurring costs. Among PMTCT patients who had costs associated inpatient admissions, the costs were large (mean = $216.36, range = $24.00–$1200.00, n = 11). Although PMTCT visits are monthly at the beginning of the pregnancy, the number of visits tends to decrease during the postnatal period, contributing to reduced mean transport costs. Although the potential patient costs related to time lost per visit ranged between US$1.10 to more than US$8 for either PMTCT and ART patients, this adds on average, a 1% burden of a monthly wage [10]. Although seemingly a small amount, prolonged absenteeism from one’s economic activities while seeking HIV-related care can result in loss of earnings which adds to the financial woes to an already financially overburdened populace.

This evaluation had several limitations. The analysis did not include all indirect costs (i.e., productivity losses) associated with HIV-related morbidity and mortality. This evaluation also did not include information from patients regarding the services they did not receive due to financial constraints. This evaluation also primarily focused on costs incurred by patients who received services from publicly funded facilities and therefore did not estimate costs for patients solely receiving services at private, for-profit clinics. In addition, the patient costs for receiving PMTCT and ART services were self-reported and may not be entirely accurate. As a result, there is likely to be recall bias. The study sample may also not be representative of all PMTCT and ART patients in Zimbabwe.

Future studies should evaluate the impacts of incurred costs on the ability of patients to access care and how DSD models could help address these issues. As new policies and guidelines are implemented, public health leaders should consider patient expenses as a potential barrier to accessing care.

(DTA)

Click here for additional data file.

23 Mar 2021

PONE-D-21-04638

Patient costs for prevention of mother-to-child HIV transmission and antiretroviral therapy services in public health facilities in Zimbabwe

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b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories.

We will update your Data Availability statement on your behalf to reflect the information you provide.

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7. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Comments to the Author

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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

**********

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

Reviewer #1: Yes

Reviewer #2: Yes

**********

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

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Reviewer #1: Yes

Reviewer #2: No

**********

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

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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: The authers have used standard costing methodology, though need more explanations, to estimate costs associated with seeking and receiving PMCT and ART care in Zimbabwe. Costs were summarized using means and medians and ranges appropriately described.

English is good and clear and manuscript is well presented

Reviewer #2: This is a nice study with contact with a considerable sample of ART and PMTCT cohort in Zimbabwe. It demonstrates a cost to individuals to access "free" health care services.

There are a few areas where perhaps more clarification can be made to outline procedures for those unfamiliar with clinical processes in Zimbabwe. The site selection process that removed poorly functioning clinics poses some potential bias as clients at those sites likely occur much more cost if the clinic is not run well, and its unclear the size of those poorly functioning clinics to know if they represent a large part of the national cohort, as it represents some percentage of the 565 excluded clinics - 1/3 of all sites in the country.

If included in the questions to clients, often in addition to wages lost many clients lose employment opportunities due to the recurrent absences they need to incur to attend ART appointments. Were clients asked if they have lost jobs due to recurrent absences?

Additionally the authors discuss client visits with "appointments" versus "without appointment" visits and its unclear if in Zimbabwe these "appointments" are for a certain day or if they are given a time slot within the day which may affect the amount of time spent at the facility. For example, are clients given an appointment on 5 April or 5 April at 1400.

Further details of the selection process for phone interview will be helpful as clinic staff identified clients eligible for phone interview had to include only those who had phones and it's not clear what percentage of the ART/PMTCT cohort in Zimbabwe has a phone available for followup. It seems unusual that the authors could not find enough clients who missed even one appointment so perhaps they couldn't find enough who also had a phone?

The authors report, "The data underlying the results presented in the study are available from Zimbabwe

Ministry of Health and Child Care." I am not sure if that qualifies as readily available and defer to the editors.

**********

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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.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Submitted filename: Plos One review comments .docx

Click here for additional data file.

11 May 2021

ICAP at Columbia University, Zimbabwe Country Office

107 King George

Avondale

Harare

Zimbabwe

Editorial Office

PLOS ONE

Re: Edits/Response to Reviewers for “Patient costs for prevention of mother-to-child HIV transmission and antiretroviral therapy services in public health facilities in Zimbabwe”

Dear Editor

We appreciate the opportunity to resubmit our work to your journal. We would like to thank you for helpful comments and suggestions. The manuscript has been modified accordingly, with, revisions in tracked changes. Responses to the reviewers’ suggestions are given below, in bold font.

Editor’s Comment

Please review comments below and address. Please note PLOS ONE data policy. For the third party data not owned by the authors, PLOS ONE requires that the authors provide all information necessary (e.g. URLs, contact information, dataset titles, etc) for other researchers to access the same data used to present the findings of their study and to confirm that they accessed the data in the same manner they expect future researchers to do so, and did not receive special privileges from the third party. It is not sufficient to note that data is available with the Zimbabwe Ministry of Health. Further, if the data are owned by the authors, PLOS ONE requires the data to be made available unless there are specific legal or ethical considerations for doing so.

Response: We have provided the details in the online submission manager of how data can be accessed. i.e. “Data are available from the MoHCC, as STATA Format named PACE Study Patient Data. Contact Dr Brian Moyo , Epidemiologist at the Zimbabwe Ministry of Health’s AIDS and TB Unit, e-mail- moyobk1@gmail.com. Phone +263 774021723..”

Comment 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

Response: The manuscript has been revised to match the PLOS ONE’s style requirements.

Comment 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 how verbal consent was documented and witnessed.

We have elaborated in the manuscript on page 6-7 on the details of participant consent. Briefly, to obtain informed oral consent, interviewers read the consent form to eligible potential participants in the language that was preferable to the individual and provided them the opportunity to ask any questions. The consent form covered all procedures, potential risks and benefits, and who to contact to report complaints or concerns. After potential participants indicated that they clearly understood the content of the informed consent form, they provided verbal consent by repeating the consenting statement. Those not willing to take part, would read a refusal statement. The interviewer signed an attestation that consent was provided. Those that were enrolled in person were provided a copy of the consent form.

Comment 3. In your Methods section, please provide additional information about the participant recruitment method and the demographic details of your participants. Please ensure you have provided sufficient details to replicate the analyses such as:

a) the recruitment date range (month and year),

The recruitment date ranged from September-November 2017 as written in the first sentence on page 6.

b) a description of any inclusion/exclusion criteria that were applied to participant recruitment,

The inclusion and exclusion criteria is now reflected on page 6. Briefly, at each site, we selected a cross-sectional convenience sample among adult patients (aged ≥18 years) receiving either outpatient PMTCT services in ANC (pregnant women and postpartum women with HIV) or ART services (ART and pre-ART patients) at the facility on the day of data collection and for whom the date of encounter was not the first visit at the facility. Exclusion criteria used included individuals who were not enrolled in the PMTCT or ART programs at the site, individuals aged less than 18 years of age, individuals who were newly registered PMTCT or ART patients in the health facility to ensure that individuals in the sample have had experience with PMTCT or ART services in the facility, individuals who do not consent to be interviewed in English, Shona, or Ndebele.

c) a table of relevant demographic details,

Table 1 on page 9 already includes the demographics details.

d) a statement as to whether your sample can be considered representative of a larger population,

We have added in the limitations section on page 16 that “This study sample may not be representative of all PMTCT and ART patients in Zimbabwe”.

e) a description of how participants were recruited, and

This is already described in the Facilities and Participants subsections on page 5 and 6.

f) descriptions of where participants were recruited and where the research took place.

This is already described in the Facilities and Participants subsections on page 5 and 6.

Comment 4. 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. Moreover, please include more details on how the questionnaire was pre-tested, and whether it was validated.

The evaluation made use of a standard patient questionnaire developed by CDC, which they used in other countries where they have supported similar studies. It was adapted to the local context and translated to Shona and Ndebele languages.

Comment 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.

Data can be accessed in writing, from the MOHCC Epidemiologist Dr Brian Moyo, who is based at MOHCC AIDS and TB Programme office at 2nd floor Mkwati Building in Harare, via the following e-mail, moyobk1@gmail.com. Phone +263 774021723. Data are available from the MoHCC, as STATA Format named PACE Study Patient Data

Comment 6. In your revised cover letter, please address the following prompts:

a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent.

Upon release of the final report, third-party researchers may e-mail one of the MOHCC PIs listed in the protocol to gain access to the processed data. Permission given to any third party shall be communicated in writing, stating the terms and conditions that need to be observed by the party when using the data, they would have been given access to.

Data can be accessed in writing, from the MOHCC Epidemiologist Dr Brian Moyo, who is based at MOHCC AIDS and TB Programme office at 2nd floor Mkwati Building in Harare, via the following e-mail, moyobk1@gmail.com. Phone +263 774021723.

Comment 7. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories.

Ministry of Health and Child Care will provide data upon request and as mentioned above, we have provided the details in the online submission manager of how data can be accessed. i.e. “Data are available from the MoHCC, as STATA Format named PACE Study Patient Data. Contact Dr Brian Moyo, moyobk1@gmail.com. Phone +263 774021723.

Comment 8. PLOS requires an ORCID iD for the corresponding author in Editorial Manager on papers submitted after December 6th, 2016. Please ensure that you have an ORCID iD and that it is validated in Editorial Manager. To do this, go to ‘Update my Information’ (in the upper left-hand corner of the main menu), and click on the Fetch/Validate link next to the ORCID field. This will take you to the ORCID site and allow you to create a new iD or authenticate a pre-existing iD in Editorial Manager. Please see the following video for instructions on linking an ORCID iD to your Editorial Manager account: https://www.youtube.com/watch?v=_xcclfuvtxQ

The ORCID iD for the first author is https://orcid.org/0000-0001-6512-2832. The paper will be linked to the first author ORCID iD when re-submitting the revised version.

Comment 9. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Our reference list have been revised to match the expected standards.

All authors concur with the re-submission. This work has neither been published nor is it simultaneously being considered for publication elsewhere. Neither I, nor any of my co-authors, have any conflicting interests.

We look forward to hearing from you regarding whether or not these revisions have improved the manuscript such that the revised version can be published in PLOS ONE.

Yours sincerely,

Innocent Chingombe

Submitted filename: Responses to Reviewers.docx

Click here for additional data file.

10 Jun 2021

PONE-D-21-04638R1

Patient costs for prevention of mother-to-child HIV transmission and antiretroviral therapy services in public health facilities in Zimbabwe

PLOS ONE

Dear Dr. Chingombe,

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.

ACADEMIC EDITOR:

We have been trying to contact you to address comments made by reviewers. Please make sure to respond to all comments in a point-by-point manner in your response letter.  Comments from reviewer 1 are attached and comments from Reviewer 1 and 2 are below.

Please submit your revised manuscript by Jul 24 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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We look forward to receiving your revised manuscript.

Kind regards,

Saeed Ahmed

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Review comments from first round of reviews:

Reviewer #1: The authers have used standard costing methodology, though need more explanations, to estimate costs associated with seeking and receiving PMCT and ART care in Zimbabwe. Costs were summarized using means and medians and ranges appropriately described.

English is good and clear and manuscript is well presented

Reviewer #2: This is a nice study with contact with a considerable sample of ART and PMTCT cohort in Zimbabwe. It demonstrates a cost to individuals to access "free" health care services.

There are a few areas where perhaps more clarification can be made to outline procedures for those unfamiliar with clinical processes in Zimbabwe. The site selection process that removed poorly functioning clinics poses some potential bias as clients at those sites likely occur much more cost if the clinic is not run well, and its unclear the size of those poorly functioning clinics to know if they represent a large part of the national cohort, as it represents some percentage of the 565 excluded clinics - 1/3 of all sites in the country.

If included in the questions to clients, often in addition to wages lost many clients lose employment opportunities due to the recurrent absences they need to incur to attend ART appointments. Were clients asked if they have lost jobs due to recurrent absences?

Additionally the authors discuss client visits with "appointments" versus "without appointment" visits and its unclear if in Zimbabwe these "appointments" are for a certain day or if they are given a time slot within the day which may affect the amount of time spent at the facility. For example, are clients given an appointment on 5 April or 5 April at 1400.

Further details of the selection process for phone interview will be helpful as clinic staff identified clients eligible for phone interview had to include only those who had phones and it's not clear what percentage of the ART/PMTCT cohort in Zimbabwe has a phone available for followup. It seems unusual that the authors could not find enough clients who missed even one appointment so perhaps they couldn't find enough who also had a phone?

The authors report, "The data underlying the results presented in the study are available from Zimbabwe

Ministry of Health and Child Care." I am not sure if that qualifies as readily available and defer to the editors.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

[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.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

1 Jul 2021

Editorial Office

PLOS ONE

Re: Edits/Response to Reviewers for “Patient costs for prevention of mother-to-child HIV transmission and antiretroviral therapy services in public health facilities in Zimbabwe”

Dear Editor

We appreciate the opportunity to resubmit our work to your journal. We would like to thank you for helpful comments and suggestions. The manuscript has been modified accordingly, with, revisions in tracked changes. We had missed some comments and have now responded to the reviewers’ suggestions as detailed below, in bold italicised font.

Reviewer #1:

The authors objectives were to estimate costs associated with seeking and receiving PMCT and ART treatment from a household perspective. This is an interesting paper for programmers and policy makers providing care for people living with HIV and AIDs.

Thank you

Comment 1: The authors should be explicit about the costing approach used and describe it in more detail. It appears a bottom up or micro costing methodology was used but there is no reference to this

We have added the section with a description on the methodology on page 8 of the revised manuscript

Comment 2: What are the implication of using potential earnings to input for lost time? If unemployment is high in Zimbabwe implying not much opportunity costs for the time loss, this would bias the cost estimates upwards. The Authors must critically comment about this. A sensitivity analysis would have been in order to explore uncertainty surrounding such assumptions.

We aligned the income based on the information on income sources provided by the participants. We drew the income information from several sources. As part of the sensitivity analysis, we measured minimal wage and maximum casual wage rate. As the economic crises progresses in Zimbabwe; the health system has to advance to accommodate the need to earn money by patients.

Comment 3: Please present summary table of the costs, by the standard cost categories i.e. medical, non-medical and indirect costs etc(Refer to Drummond). Present these separately for PMCT and ART. By comparing the two, you could gain some insight if PMCT cost profile is markedly different from ART profile, which may be useful. For example, PMCT women are generally not very sick and may walk to and from ANC compared to ART patients who are often sick, have others accompanying them and my use different and more costly modes of transport. And in view of this, can author explain why the mean time to care for PMCT and ART are not substantially different, I would expect this given the explanation above.

We have presented these in the table. The cost difference between the groups was very small. With an ART profile-people are being put into treatment earlier especially since we didn’t look at first visits. We also focussed on refill visits to the specific service centres versus outpatient visits in an emergency situation. We did account for such visits but they were not the primary focus and were not reported as frequently.

Comment 4: The costs are described as low (page 13) begging the question compared to what?

We have compared to the household monthly income and health sector budget per capita.

Comment 5: It would be useful to express the annual costs a share of total annual household income or expenditure on health, this would give an idea about burden which can be compared with other available data published in the literature.

Comment 6: Limitation section should include re-call biased, as patients are likely to accurately report costs for recent than relatively more distant events or illness episodes. One can do quick robust checks to test this premise and report on findings

This has been added

Comment 7: Selection bias is another limitation, as only individuals seeking care in facilities were interviewed, so results can not be generalised to the general populations. The author can use Heckman models to estimate their costs and control for this bias.

We tried to obtain information from those who did not attend visits but the sample size was not large enough

Reviewer #2:

This is a nice study with contact with a considerable sample of ART and PMTCT cohort in Zimbabwe. It demonstrates a cost to individuals to access "free" health care services.

Thank you

Comment 1: There are a few areas where perhaps more clarification can be made to outline procedures for those unfamiliar with clinical processes in Zimbabwe. The site selection process that removed poorly functioning clinics poses some potential bias as clients at those sites likely occur much more cost if the clinic is not run well, and its unclear the size of those poorly functioning clinics to know if they represent a large part of the national cohort, as it represents some percentage of the 565 excluded clinics - 1/3 of all sites in the country.

More clarifications have been added to the methodology

Comment 2: If included in the questions to clients, often in addition to wages lost many clients lose employment opportunities due to the recurrent absences they need to incur to attend ART appointments. Were clients asked if they have lost jobs due to recurrent absences?

We have included further clarifications on these calculations, see page 8

Comment 3: Additionally the authors discuss client visits with "appointments" versus "without appointment" visits and its unclear if in Zimbabwe these "appointments" are for a certain day or if they are given a time slot within the day which may affect the amount of time spent at the facility. For example, are clients given an appointment on 5 April or 5 April at 1400.

Appointments are per day and do not drill down to the time

Comment 4: Further details of the selection process for phone interview will be helpful as clinic staff identified clients eligible for phone interview had to include only those who had phones and it's not clear what percentage of the ART/PMTCT cohort in Zimbabwe has a phone available for followup. It seems unusual that the authors could not find enough clients who missed even one appointment so perhaps they couldn't find enough who also had a phone?

This is described on page 7 of the manuscript. Because participants enrolled on-site may visit the facility more frequently, resulting in overestimation of patient costs (since more frequent facility visits entail higher costs), the evaluation also included phone interviews for adult ART or PMTCT patients who had at least one prior appointment at the facility and had missed their most recent appointment

Comment 5: The authors report, "The data underlying the results presented in the study are available from Zimbabwe Ministry of Health and Child Care." I am not sure if that qualifies as readily available and defer to the editors.

We uploaded all the required data

All authors concur with the re-submission. This work has neither been published nor is it simultaneously being considered for publication elsewhere. Neither I, nor any of my co-authors, have any conflicting interests.

We look forward to hearing from you regarding whether or not these revisions have improved the manuscript such that the revised version can be published in PLOS ONE.

Yours sincerely,

Innocent Chingombe

Submitted filename: Responses to Reviewers 16 June 2021-1.docx

Click here for additional data file.

4 Aug 2021

Patient costs for prevention of mother-to-child HIV transmission and antiretroviral therapy services in public health facilities in Zimbabwe

PONE-D-21-04638R2

Dear Dr. Chingombe,

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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Kind regards,

Saeed Ahmed

Academic Editor

PLOS ONE

9 Aug 2021

PONE-D-21-04638R2

Patient costs for prevention of mother-to-child HIV transmission and antiretroviral therapy services in public health facilities in Zimbabwe

Dear Dr. Chingombe:

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.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

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on behalf of

Dr. Saeed Ahmed

Academic Editor

PLOS ONE