Keywords

HIV; ART; Option B+; Adherence; Pregnant women; Ethiopia

Introduction

Since the start of the epidemic, about 78 million people have become infected with HIV while 35 million people have died from AIDS-related illnesses [1]. In 2013 there were 35 million people living with HIV. Sub-Saharan Africa shared about 24.7 million of the world HIV positive people and 58% of them were women [2]. In 2015, 77% (69-86%) of pregnant women living with HIV had access to antiretroviral medicines to prevent transmission of HIV to their babies [1]. Anti-retroviral therapy has made a significant reduction in morbidity and mortality related to HIV/AIDS [3]. Since 2010, new infection of HIV was declined by 50% due to applications of Option A, Option B, and Option B+ protocols [4].

According to option A, pregnant women start ART prophylaxis as early as 14 weeks of gestation and as soon as possible thereafter during pregnancy and labor, and the infant continuing to take prophylaxis throughout breastfeeding. Under option B, the women start ARV during pregnancy and continuing to take it throughout breastfeeding. On the other hand, the third approach, option B+, recommend the use of lifelong ARV drugs for all pregnant women regardless of their CD42 count [5,6]. Option B+ was first conceived and implemented in Malawi in 2011 [7]. In 2013, Ethiopian government launched implementation of option B+ with aims to eliminate new HIV infection to children in 2015 and to keeps the mother alive [8]. Since its implementation, the number of women on ART is increasing in Ethiopia [9].

Even though ART decrease morbidity and mortality related to HIV/AIDS, it cannot be fully realized without addressing barriers related to retention in care and medication adherence [3]. Nonadherence to HAART is associated with an increased tendency to vertical transmission of HIV, the progression of mothers HIV to AIDS, raised a number of orphaned children, economic impact and potential development of drug-resistant virus [10-13]. So retention in care is a determinant factor to bring desired effect [14]. There are several anticipated fear related option B+ adherences; Option B+ doesn‘t consider the CD4 status and recommends all pregnant including women who feel healthy to initiate lifelong ART which can affect their adherence [15]. Moreover, option B+ recommends initiation of lifelong ART without considering gestational age which increases the probability of non-adherence due to long-time exposure to treatment [16].

Though several studies assessed ART adherence levels and factors affecting adherence in different regions of Ethiopia, to the best of investigator’s knowledge there is no study conducted on Option B+ ART adherence issues among HIV positive pregnant women in Oromia regional state. So, this study is aimed to assess the level of ART adherence and factors affecting it among pregnant women on option B+ PMTCT program in East Shawa zone of Oromia regional state, Ethiopia.

Materials and Methods

Study area and study period

This study was conducted in public health facilities (hospitals and health centers) of East Shawa zone, one of the twenty-zones in Oromia regional state. The zone has four public hospitals (Adama Referral Hospital, Bishoftu General Hospital, Welenchit district hospital and Batu district Hospital) and seventy health centers. All of the public hospitals and sixty-one of the health centers in this zone provide PMTCT services. The study was conducted in all the four public hospitals and eighteen health centers. The study was conducted from January to March 2017.

Study design

A health facility based cross-sectional study design was implemented to assess the level of adherence to option B+ treatment and associated factors among pregnant women on PMTCT follow up at selected public health facilities of East Shawa zone.

Population

The source population was all pregnant women on PMTCT follow up at public health facilities of East Shawa Zone. The study population was pregnant women on PMTCT follow up at the selected public health facilities of East Shawa Zone.

Inclusion and exclusion criteria

Inclusion criteria: Pregnant women who were on PMTCT follow up for at least one month at the selected public health facilities of East Shawa zone were included in the study.

Exclusion criteria: Pregnant women who were on PMTCT follow up but who was critically ill and unable to communicate during data collection period were excluded from the study.

Sample size

Sample size (n) was determined based on a single population proportion formula with the following assumptions; the level of confidence (α) was taken to be 0.05 (Z (1-α/2)=1.96); the margin of error was taken as 0.05. For the first specific objective, based on the study conducted at public hospitals of Tigray regional state, the levels of option B+ ART adherence was 87.1% [17]. For a second specific objective, based on a study conducted in Addis Ababa HIV disclosure status was 77.2% [18]. ccordingly, the calculated sample size was 172 and 304 respectively with 5% consideration for non-responses. Finally, the maximum sample size was taken (304).

Sampling procedure

Public Healthcare facilities in East Shawa zone that which provides ART services were classified as public hospitals and health centers. All of the public hospitals in the zone were included in the study. Since the zone has sixty-one public health centers that provide option B+ PMTCT services, it was economically difficult to include all of them. As a result, each health center was considered as similar to their administration and quality of service they provide. Finally, 30% of the health centers were randomly selected by simple random sampling technique to get an adequate sample for the study. A specific sample size was allocated to each health facility using proportion-to-size allocation. To select 304 pregnant women, the first women in each public health facilities were randomly selected by simple random sampling technique.

Data collection and instruments

To collect data from pregnant women; the intervieweradministered questionnaire was used. There was one data collector for each selected health facilities. The qualification of data collectors was a Bachelor of Science in Nursing. They were recruited based on their competence and data collection experience. In addition, they were not working at the selected public health facilities in which the study was conducted. Moreover, one supervisor for each hospital and one supervisor for every three health facilities were recruited. They provided with training on the data collection method by principal investigator before data collection go-ahead.

Measurements

There is no standard tool to measure the level of adherence. But this study applied adherence measurement questions adapted from South Africa experiences, which was designed to measure adherence in the resource-constrained setting to collect data for outcome variables [19]. Another study conducted in Tigray regional state, Ethiopia, has also used the same tool to measure the level of adherence in the study area [17].

Ethical considerations

Ethical clearance was secured from Research Ethics Committee (REC) of the School of Public Health as mandated by Addis Ababa University. Letter of permission was obtained from Oromia Regional Health Bureau, zonal health, and district officials. Informed consent was obtained from all pregnant women prior to proceeding data collection from them. This was done after the clear description of the objectives of the study and of its procedures. Then, each respondent was asked to check whether the information provided for the purpose of the study has been adequately understood or not. Confidentiality of the information obtained from each participant was maintained.

Data entry, processing, and statistical analysis

Data were checked for completeness, inconsistencies, cleaned, coded. The collected data was entered into EpiData 3.1 (EpiData Association, Odense, Denmark) and then exported to SPSS version 21.0 for statistical analysis.

Descriptive statistics were used to summarize the data. Bivariate logistic regression was used to find an association of each independent variable with the dependent variable. Variable with P-value of <0.25 were considered for multivariate logistic regression to control the effect of the confounders. Then, the significance level was set at P<0.05.

Operational definitions

Good adherence: A woman was considered good adherence if she responded ‘No’ to all (four) questions prepared to assess the adherence level. These questions are:

1) Do you sometimes find it difficult to remember to take your medication?

2) When you feel better, do you sometimes take a break from your medication?

3) Many patients have trouble with taking their ARV doses as prescribed; did you miss any ARV doses in the last 3 days?

4) Sometimes if you feel worse when you take the medicine, do you stop taking it? [17,19].

Poor adherence: A woman was considered as poor adherence if she responded ‘Yes’ to at least one of the above questions [17,19].

Results

Socio-demographic characteristics of respondents

A total of 304 respondents were planned to be interviewed. However, about 293 pregnant women on option B+ ART drug at public health facilities in East Shawa Zone were interviewed regarding their ART drugs adherence. The overall response rate was 96.4%.

Concerning the age category of respondents 95 (32.4%) of them belong to the age group of 30 to 34 while 85 (29%) of them belong to the age group 25-29. The mean age ± SD of the participants was 29.2 ± 4.6. Two hundred and twenty-five (76.8%) of the respondents were urban residents. Majority of the study participants were Ethiopian orthodox Christianity followers which accounted for 202 (68.9%) of the respondents followed by protestant 55 (18.8%). Concerning the educational status, one hundred and fifty-three (52.2%) of the respondents have a primary education while 83 (28.3%) of them can‘t read and write (Table 1).

Table 1: Socio-demographic characteristics of pregnant women on option B+ ART drugs at East Shawa Zone, Oromia, Ethiopia January to March 2017.

Two hundred and forty-nine (85%) participants were married, and 27 (9.2%) of the respondents divorced while widowed constituted 10 (3.6%) of the respondents. Regarding their occupation, more than half 161 (54.9%) of the respondents were housewives. Three-fourths of the respondents 223 (76.1%) were living with their husbands/partners while 25 (8.5%) of them live alone at the time of the study.

ART adherence level and health care system related characteristics of respondents

Majority of the respondents 184 (62.8%) were attending their ART follow up at health centers. Two hundred and twenty-six (77.1%) of the study participants spent less than an hour walking on foot to reach healthcare facilities for their follow up. Regarding time of their HIV status diagnosis, the majority of the study participants 180 (61.4%) knew their HIV status before being pregnant. More than half of the respondents, 158 (53.9), started their ART drugs during the second trimester (13-28 weeks) of their current pregnancy.

Concerning pregnancy type, 213 (72.7%) of the participants had intended pregnancy. With regard to disclosure status, 249 (83.3%) of the respondents disclosed their HIV status to their husbands/partners and/or family and/or friends and/or other significant persons. Majority of the respondents 204 (69.6%) received financial and social support from partner, family, relatives, governmental or non-governmental organizations meanwhile 173 (59%) of the respondents participated in HIV positive mother to mother discussion about ART adherence. Sixty-five (22.2%) participant developed ART side effect during the current pregnancy. The overall adherence level to antiretroviral medication was 82.6%, which was achieved by 552 study participants (Table 2).

Table 2: HIV, ART, and health care system related characteristics of pregnant women on option B+ ART drugs at East Shawa Zone, Oromia, Ethiopia January to March 2017.

Predictors of option B+ ART adherences using bivariate and multivariate logistic regression

FBEducational status was significantly associated with adherence status. Women who had the educational status at primary school level were 4.5 more likely to have good adherence than those who were unable to read and write, [AOR 4.54 (95% CI; 1.72-11.95)]. The analysis also leveled that Antiretroviral drug adherence was strongly associated with drug side effect. Accordingly, women who developed drug side effect during current pregnancy were 76% less likely to have good adherence than their counterparts, [AOR 0.24 (95% CI; 0.1-0.6)] (Table 3).

Table 3: Bivariate and multivariate analysis result for factors associated with ART drug adherence among option B+ pregnant women in public health facilities of East Shawa Zone, Ethiopia, 2017.

Respondents who were counseled on health benefit of treatment for mother and fetus were nearly three times more likely to be adherent than those who were not counseled, [AOR 2.9 (95% CI; 1.27-6.63)]. Moreover, ART adherence has a strong association with fear of stigma and discrimination. Those who didn‘t report fear of stigma and discrimination were about sixteen times more likely to have good adherence than those who reported fear of stigma and discrimination in the current pregnancy, [AOR 15.79 (95% CI; 4.64-53.67)].

The study also showed that respondents who received social and financial support from partner, family, friends, relatives, government or non-governmental organizations were 2.76 times more likely to have good adherence than those who didn‘t receive support, [AOR 2.76 (95%CI; 1.17-6.51)]. Furthermore, respondents who had a poor relationship with health care providers were 78% less likely to be good adherent than those who reported having a good relationship, [AOR 0.22 (95% CI; 0.08-0.62)] (Table 3).

Discussion

In this study, good adherence was achieved by 242 respondents, which accounts 82.2% of the study participant. This level of adherence is similar to the study conducted in Chongwe district of Zambia (82.5%) and Kisumu, Kenya (82%) [20,21]. On the hand the overall adherence level of this study is less than the result reported by the study conducted in Tigray regional state of Ethiopia (87.1%), South Wollo Zone of Amhara regional state of Ethiopia (87.9%), the study in Western Kenya (89%), the study conducted in Bwaila Hospital, Malawi [16,22,23]. The study conducted in Tigray regional state of Ethiopia used similar tool with our study to assess the level of adherence. However, the discrepancy might be due to; the study conducted in Tigray regional state used data from public hospitals only, but our study used hospitals and health centers. The women on follow up at primary health care facilities are less adherent to ART medications than those on follow up at hospitals [24].

In this study, educational status was strongly associated with ART adherence. The respondent who had the educational status at primary school level were 4.5 times more likely to have good adherence than those unable to read and write, AOR 4.54 (95% CI; 1.72-11.95). Similarly, educational status was strongly associated with adherence status in the previous study by Kristen in Tanzania, Boateng in Ghana and Ayuo in Western Kenya [16,25,26]. This might be due to better educated have access to information and are more likely to make better-informed decisions.

The study conducted in Zambia reported that; women attended follow up at referral health facilities were more likely to be poor adherent than those on follow up at rural health centers (20). In contrary, a study conducted in Addis Ababa, Ethiopia, shows that the women on follow up at primary health care facilities are less likely to continue their follow up than those on follow up at hospitals [25]. However, in this study type of health care facilities has no statistically significant association with ART drug adherence both in bivariate and multivariate analysis, COR 1.92 (95%CI; 0.97-3.79) vs. AOR 1.21 (95% CI; 0.50-2.95).

Social and financial support from partner, family, friends, governmental and non-governmental organization were associated with medication adherence. Those received supports were 2.76 times more likely to have good adherence than those didn’t have support from others, AOR 2.76 (1.17-6.51). This study finding is in line with the result reported by the study conducted in Nigeria [27]. This might be due to the usual benefit of social and financial support for moral encouragement and healthcare assistance through transportation and reminders [3].

Women lived with a partner were six times more likely to be adherent than those lived alone, AOR 6.1 (95% CI; 1.22-30.4). Moreover, those who lived with extended family were nearly five times more likely to be adherent to their ART drug than those lived alone with AOR of 4.98 (95% CI; 0.81-30.68). The study in Ukraine agree with our finding; poor adherence during pregnancy was more commonly reported among women living with their extended family and women not living with a partner [28]. HIV status disclosure to partner, family, friend, and significant others had a statistically significant association with ART adherence [25,27,28-30]. Our study agreed with these studies. Respondents who disclosed their HIV status to others were 2.6 times more likely to have good adherence than those who didn’t disclose their status, AOR 2.61 (95% CI; 1.01-6.71).

Good relationships with their health care provider enabled patients to have better information about the importance of adhering to their ART medications [31-33]. Similarly, in our study, the respondent who reported a poor relationship with health care provider were 78% less likely to be good adherent than their counterparts, AOR 0.22 (95% CI; 0.08-0.62).

Adherence to option B+ was strongly associated with drug side effect. The respondents who self-reported experience of drug side effect in current pregnancy was 76% less likely to have good adherence than who didn’t develop drug side effect, AOR 0.24 (95% CI; 0.1-0.6). The previous study in Ukraine also reported similar finding on association of drug side effect and ART adherence [28]. Moreover, fear of stigma and discrimination determine the adherence status in our study. Those who didn’t report fear of stigma and discrimination were nearly 16 times more likely to have good adherence than those reported it. Our finding is consistent with previous studies conducted in India, Tanzania, and Nigeria [27,34,35].

Proper counseling on health benefit of the ART treatment for mother and fetus were significantly associated with medication adherence. Our study shows that; women who counseled on health benefit of treatment for mother and fetus were 2.9 times more likely to be good adherent than their counterparts, AOR 2.9 (95% CI; 1.27-6.63).

The major limitation of this study was considered as a method by which adherence was evaluated, based on self-report, thus the adherence estimate might be affected by some recall bias which might have a tendency to overestimate adherence level. However, the investigators believe as this effect was minimized by data quality control strategies like frequent supervision of data collectors and informing the respondents about the aim of the study and the role of their participation in detail.

Conclusion and Recommendations

Majority of the respondents were adherent to their ART drug regimen. However, nearly one-fifth of the respondents did not adhere to their drugs. The finding of this study depicts that fear of stigma and discrimination and drug side effects effect negatively affect ART drug adherence of pregnant women while appropriate counseling on health benefit of ART for fetus and mothers, social and financial support, patient-health care provider relationship, disclosure status and educational status positively affect ART adherence. Based on the result of the present study, investigators recommend collaborative work between the patient, family, healthcare provider, a governmental and non-governmental organization to enhance ART medication adherence during pregnancy.

Acknowledgements

We express our deepest gratitude to the management of selected hospitals for facilitating the carrying out of the study. Finally, our special respect goes to all respondents and data collectors in this study.

References

1. United Nations Programme on HIV and AIDS (2016) How AIDS changed everything?
2. United Nations Programme on HIV and AIDS (2014) Global Fact sheet HIV/AIDS.
3. Holtzman CW, Brady AK, Yehia RB (2015) Retention in care and medication adherence: Current challenges to antiretroviral therapy success. Dep Heal Hum Serv 75: 445-454.
4. United Nations Programme on HIV and AIDS (2015) The gap report: Beginning of the end of the AIDS Epidemic. J Int AIDS Soc.
5. World Health Organization (2010) Antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: Recommendations for a public health approach. WHO Press. Geneva, Switzerland.
6. World Health Organization (2012) Use of antiretroviral drugs for treating pregnant women and preventing HIV infection in infants: A Programmatic update. Geneva, Switzerland.
7. United Nations Children's Fund (2012) Options B and B+: Key considerations for countries to implement equity focused-approach.
8. FDRE/MOH (2013) National comprehensive PMTCT/MNCH/RH training package reference manual.
9. FDRE/MOH (2014) Country Progress Report on the HIV. Addis Ababa, Ethiopia.
10. Bhatti AB, Usman M, Kandi V (2016) Current scenario of HIV / AIDS, treatment options, and major challenges with compliance to antiretroviral therapy the infection. Cureus 8: 1-12.
11. Paredes R, Marconi VC, Lockman S, Abrams EJ, Kuhn L (2013) Impact of antiretroviral drugs in pregnant women and their children in Africa: HIV resistance and treatment outcomes. J Infect Dis 207: 93-100.
12. Kalichman SC, Washington C, Grebler T, Hoyt G, Welles B, et al. (2015) Medication adherence and health outcomes of people living with HIV who are food insecure and prescribed antiretrovirals that should be taken with food. Infect Dis Ther 2: 1.
13. Stover J, Korenromp EL, Blakley M, Komatsu R, Viisainen K (2011) Long-term costs and health impact of continued global fund support for antiretroviral therapy. PLoS One 6: e21048.
14. Kieffer MP, Mattingly M, Giphart A, Chouraya C, Walakira M, et al. (2014) Lessons learned from early implementation of option B + : The Elizabeth Glaser Pediatric AIDS Foundation Experience in 11 African Countries. Journals AIDS 67: 188-194.
15. Kim MH, Zhou A, Mazenga A, Ahmed S, Markham C, et al. (2016) Why did i stop ? Barriers and facilitators to uptake and adherence to ART in Option B+ HIV Care in Lilongwe, Malawi. PLoS One 11: 1-16.
16. Ayuo P, Musick B, Liu H, Braitstein P, Nyandiko W, et al. (2013) Frequency and factors associated with adherence to and completion of combination antiretroviral therapy for prevention of mother to child transmission in western Kenya. J Int AIDS Soc 16: Pp 17994.
17. Ebuy H, Yebyo H, Alemayehu M (2015) International Journal of Infectious Diseases Level of adherence and predictors of adherence to the Option B+ PMTCT programme in Tigray, northern Ethiopia. Int J Infect Dis [Internet]. International Society for Infectious Diseases 33: 123-129.
18. https://www.jiasociety.org/content/14/1/50
19. Steel G, Joshi MP (2007) Development of a multi-method tool to measure ART adherence in resource-constrained settings : The South Africa Experience. Management Sciences for Health, 4301 North Fairfax Drive, Suite 400. Arlington, VA 22203 USA: Rational Pharmaceutical Management Plus Program Center for Pharmaceutical Management.
20. https://dx.doi.org/10.1186/s12884-015-0697-7
21. Thomas TK, Masaba R, Borkowf CB, Ndivo R, Zeh C, et al. (2011) Triple-antiretroviral prophylaxis to prevent mother-to-child HIV transmission through breastfeeding-The Kisumu Breastfeeding Study, Kenya: A clinical trial. PLoS medicine 29: e1001015.
22. Tweya H (2014) Loss to follow-up among women in Option B+ PMTCT programme in Lilongwe, Malawi: Understanding outcomes and reasons. J Int AIDS Soc.
23. https://doi.org/10.4178/epih.e2016043
24. Mitiku I, Arefayne M, Mesfin Y, Gizaw M (2016) Factors associated with loss to follow‐up among women in Option B+ PMTCT programme in northeast Ethiopia: A retrospective cohort study. Journal of the International AIDS Society.
25. Kirsten I, Sewangi J, Kunz A, Dugange F, Ziske J, et al. (2011) Adherence to combination prophylaxis for prevention of mother-to-child-transmission of HIV in Tanzania. PLoS One.
26. Boateng D, Kwapong GD, Agyei-baffour P (2013) Knowledge, perception about antiretroviral therapy ( ART ) and prevention of mother to child transmission (PMTCT) and adherence to ART among HIV positive women in the Ashanti Region, Ghana : A cross-sectional study. BMC Women's Health [Internet]. BMC Women’s Health.
27. Ekama SO, Herbertson EC, Addeh EJ, Onwujekwe DI, Tayo F, et al. (2013) Pattern and determinants of antiretroviral drug adherence among Nigerian pregnant women. J Pregnancy.
28. Bailey H, Thorne C, Malyuta R, Townsend CL, Semenenko I, et al. (2014) Adherence to antiretroviral therapy during pregnancy and the first year postpartum among HIV-positive women in Ukraine. BMC Public Health 14: 1-11.
29. Igwegbe AO, Ugboaja JO, Nwajiaku LA (2010) Prevalence and determinants of non-adherence to antiretroviral therapy among HIV- positive pregnant women in Nnewi, Nigeria. Int J Med Med Sci 2: 238-45.
30. Awiti OU, Mia AE (2011) Reasoning and deciding PMTCT-adherence during pregnancy among women living with HIV in Kenya. Cult Health Sex 13: 829-40.
31. Mbirimtengerenji ND, Jere G, Lengu S, Maluwa A (2013) Factors that influence anti-retroviral therapy adherence among women in Lilongwe Urban Health. World J AIDS 3: 16-25.
32. Lewis MP, Colbert A, Erlen J, Meyers M (2006) A qualitative study of persons who are 100% adherent to antiretroviral therapy. AIDS Care 18: 140-148.
33. Starks H, Simoni J, Zhao H (2008) Conceptualizing antiretroviral adherence in Beijing, China. AIDS Care 20: 607-614.
34. Ngarina M, Popenoe R, Kilewo C, Biberfeld G, Ekstrom AM (2013) Reasons for poor adherence to antiretroviral therapy postnatally in HIV-1 infected women treated for their own health : experiences from the Mitra Plus study in Tanzania. BMC Public Health 13: 1-9.
35. Rahangdale L, Banandur P, Sreenvivas A, Turan JM, Washington R, et al. (2010) Stigma as experienced by women accessing prevention of parent to child transmission of HIV services in Karnataka, India. AIDS Care 22: 836-842.