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EVALUATION OF HORMONAL CONTRACEPTIVE EFFECTIVENESS AMONG WOMEN IN GASABO DISTRICT

BY
CLAUDINE UWAMARIYA
BPHARM/2014/76994

A research project submitted in partial fulfillment of the requirement for the bachelor of pharmacy degree from Mount Kenya University.

APRIL 2018
DECLARATION
INVESTIGATOR
I declare that this is my original work and has not been presented for award of any degree in any university.

Student Name: UWAMARIYA Claudine

Sign ____________________ Date _____________

SUPERVISOR
This research project has been submitted with my approval as the Mount Kenya University Supervisor.

Supervisor Name: Dr. TWAHIRWA Epaphrodite

Sign ____________________ Date _____________

Dedication

I dedicate this work to:
Almighty God Jehovah
My husband BUREGEYA Jeanvier
My mother NYIRASAFALI Marie Claire
My mother- in- low NZABAMWITA Agnes
My brothers and sisters
My friends and classmates
For moral and financial support toward the accomplishment of the project.

Acknowledgment

Firstly, I thank the Almighty God Jehovah for His everlasting love and grace to me along this life journey. I owe a recognition to my beloved husband, my parents, brothers, sisters and my grandmother in low for the moral, financial and intellectual support given to me along my academic journey.
Special thanks to my supervisor Dr. Epaphrodite TWAHIRWA who was overseeing the piloting and supporting in the preparation and follow up of this research project through all its stages. His detailed and constructive feedback, comments and advice were invaluable.
I extend my sincere gratitude to the government of Rwanda through the Mount Kenya University and the department of pharmacy for the knowledge, skills, and advice provided to us through daily academic activities.
I finally owe the deepest thanks to my friends and classmates for help during my studies without their prayers, encouragement, and motivation, I could never have persevered to this brilliant outcome.
May Almighty God bless you all!

Table of content
Contents
DECLARATION 2
Dedication 3
Acknowledgment 4
Table of content 5
ABSTRACT 9
ACRONYMS AND ABBREVIATIONS 10
CHAPTER I: GENERAL INTRODUCTION 11
1.1. Background of the study 11
1.2. Problem statement 12
1.3. Study Objectives 12
1.3.1. Broad Objective 12
1.3.2. Specific objectives 13
1.4. Research questions 13
1.5. The significance of the study 13
CHAPTER II: LITERATURE REVIEW 14
2.1. Introduction 14
2.2. Review of past studies 15
2.2.1. Some types of hormonal contraceptive methods 15
2.2.1.1. Combined oral pills 15
2.2.1.2. Progestin-only pills 15
2.2.1.3. Implants 16
2.2.1.4. Monthly injectable contraceptives 16
2.3. Prevalence of hormonal contraceptive use, failure, and discontinuation 17
2.3.1. Prevalence of hormonal contraceptive use 17
2.3.2. Contraceptive failure 18
2.3.2.1. Overall Method-Specific Contraceptive Failure Rates (Medians) 18
2.3.2.2. Sub-regional Method-Specific Contraceptive Failure Rates (Pooled Estimates) 19
2.4. Effect of concomitant drugs on hormonal contraceptives 22
2.5. Lack of adherence to hormonal oral contraceptives 23
2.6. Recommendation for missed pills 24
2.7. Discontinuation reasons of hormonal contraceptive methods 24
2.8 Conceptual framework 24
2.8.1 Explanation of conceptual framework 24
CHAPTER III: METHODOLOGY 27
3.1. Study design 27
3.2. Study population and site 27
3.3. Sampling method and Sample size 28
3.4. Data collection process 29
3.5. Enrolment criteria 29
3.5.1. Inclusion criteria 29
3.5.2. Exclusion criteria 29
3.6. Data collection tool 29
3.7. Data entry and data analysis 30
3.8. Ethical considerations 30
CHAPTER IV: RESULTS AND DISCUSSION 31
4.1. Social and Demographic data 31
4.2 Distribution of respondents based on health center 33
4.3. Percentage of hormonal contraceptive methods failure 33
4.4 Reasons of hormonal contraceptive failure among women in Gasabo District 34
4.4.1 Adherence of oral pills’ users 34
4.4.2 Concomitant drugs were being taken prior to the failure 35
4.5. The rate of hormonal contraceptive methods discontinuation 37
4.6. Reasons for methods discontinuation 39
4.7. Study limitations 41
CHAPTER V: CONCLUSION 42
5.1. Conclusion 42
5.2. Recommendations 42
References 43
References 43

LIST OF TABLES

Table.4.1 Distribution of respondents by age 29
Table4.2 Percentage of participants based on health center 31
Table 4.3 Percentage of hormonal contraceptive methods failure among women in Gasabo district 31
Table 4.4.1 Percentage of women reported to miss a number of oral pills in a month 33
Table 4.4.2 Frequency of women failed while using the interacting concomitant drug 34
Table 5: Percentage of women discontinued hormonal contraceptive methods 36
Table 6 Percentage of women and methods discontinuation reasons 38

List of figures

Contents v
FIGURE 1: CONCEPTUAL FRAMEWORK xxvi
FIGURE 2: PERCENTAGE OF RESPONDENTS BASED ON AGE xxxii

ABSTRACT
Background: The failure and discontinuation of contraceptive methods are considered to raise the levels of unintended births and induced abortion. However, we mainly aimed to evaluate the effectiveness of hormonal contraceptives methods among women in Gasabo district.
Methodology: A descriptive quantitative study using a structured-interview method was used to collect data at three health facilities which are Gihogwe, Kabuye and Nyacyonga health center. SPSS was used to compute the data in form tables and figures.
Results: When hormonal contraceptive methods are ranked by effectiveness among women in Gasabo district, the implant and combined oral pills have the lowest failure rate, 11.3%, and 14.2% respectively, followed by Depo-Provera with 17.0% and progestin-only pills 25.0%. In general, the average failure among women with these methods above was 16.0%. However, 30.0% of oral pills’ users reported to miss more than three pills a month and 10 out of 25 women failed during the period of contraception were on Efavirenz. Nevertheless, all methods have been discontinued at a different rate, but Depo-Provera was at the high rate of 60.2% (53), which is 8.5, 4.8 and 3.1 times the rate of combined oral pills, progestin-only pills and implant respectively. And yet, 61.7% (21 out of 34) and 72.2% (13 out of 18) discontinued Depo-Provera because of side effects and failure method respectively.
Conclusion: The levels of contraceptive failure and discontinuation rates vary widely by the method, as well as by way of individual use. Co-administration of enzyme-inducing drugs, especially efavirenz with hormonal contraceptive methods was more likely to results in failure. Yet, the lack of adherence has been found probably to contribute to the failure occurred among women.
However, side effects and failure of methods were the main reasons for high discontinuation rate of Depo-Provera among women in Gasabo district.

ACRONYMS AND ABBREVIATIONS

ART: Antiretroviral therapy
COP: Combined oral pills
CPN: Consultation pre-natal
DHS: Demographic health survey
DMPA: Depot medroxyprogesterone acetate
IUD: Intra-uterine device
OC: Oral contraceptive
PMTCT: Prevention of mother-to-child transmission
POP: Progestin-only pills
UK: United Kingdom
US: United State
VCT: Vaccination
WHO: World health organization

CHAPTER I: GENERAL INTRODUCTION
1.1. Background of the study
Contraception allows women, and couples, to determine if and when to have children; and it plays a pivotal role in population control, poverty reduction, and human development (KATHLEEN McNAMEE MB BS, 2013). But when the fail, they result in unintended births which in turn lead to grave consequences for the health and well-being of women and families, particularly in low- and middle-income countries where maternal mortality is high and abortions are often unsafe (SARAH.E.K., 2011).

According to some studies, none adherence is one of the reasons for contraceptive failure and it depends on the methods used. For example, more efficacy was found with male and female sterilization and the long-acting reversible contraceptives, while hormonal contraceptives requiring more frequency of administration and consequently more adherence (James Trussell, P. , 2013). Other studies suggest that demographic and Socioeconomic Characteristics have also an impact on the contraceptive failure rate. Subregional factors have been observed and some studies also suggested that as a greater proportion of women begin using contraceptives, a greater proportion of women are likely to experience unintended pregnancies via failure (Singh, 2014). In some situation, drug interactions is another reason for contraceptive failure (Shaver, 2002).

Many studies show that contraceptive prevalence continues to increase and that the proportion of unintended pregnancies that result from failure is likely to increase concomitantly, thus, there is a need for more research on the correct use of these contraceptives in order to avoid failure and its consequence. More research is needed in developing countries, where in contrast with developed countries, little is known about contraceptives failure and its consequences (Black, 2010,2002).

This study aims to fill this gap, by evaluating hormonal contraceptive effectiveness in Rwanda, focusing on Gasabo district. Indeed, according to studies, contraceptive prevalence has increased markedly in Rwanda, yet few studies exist about their effectiveness, hence there is an urgent need to fill the gap (SURVEY, 2014-2015).

1.2. Problem statement
Contraceptive methods are highly effective methods of reversible contraception in controlling births(Black A. ,., 1995,2014). But their failure and discontinuations contribute considerably to lead to grave consequences for the health and well-being of women and families, particularly in low- and middle-income countries like Rwanda where maternal mortality is high and abortions are often unsafe.
As the failure rate is very high for such kind of contraceptive, research on this failure rate is needed to improve their effectiveness. There is very a small number of research about these rates in developing countries, as most information available comes only from Demographic and Health Survey (DHS) data. This study contributes to fill the gap by evaluating the rate failure in one Rwandese district.

1.3. Study Objectives
1.3.1. Broad Objective
This study is mainly aimed to evaluate the effectiveness of hormonal contraceptives methods among women in Gasabo district.
1.3.2. Specific objectives
This research project is specifically aimed:
1.To determine the failure rate of hormonal contraceptives methods among women in Gasabo district.
2.To identify the reasons for discontinuing hormonal contraceptive.
1.4. Research questions

1.What is the failure rate of hormonal contraceptive methods among women in Gasabo district?
2.What are the reasons for discontinuing of hormonal contraceptive?

1.5. The significance of the study

This study is mainly intending to evaluate the effectiveness of hormonal contraceptive methods among women in Gasabo district, Kigali city. Thus, I assess the failure, discontinuation rates of the hormonal contraceptive methods and associated reasons among users. Therefore, methods users and health care providers, from this district as well as the whole country will earn the information on hormonal contraception in order to reduce both their failure and discontinuation rates. And yet, the decision-makers will gain the way of overcoming the challenges of the family planning in Rwanda. ?

CHAPTER II: LITERATURE REVIEW

2.1. Introduction
The literature on contraceptive failure is expanding rapidly. The review of recent literature reveals that many studies carried on this topic focused on the determine women’s knowledge of contraceptive effectiveness, the Global Contraceptive Failure rates including the rate of unintended pregnancies due to the failure, the rate of method-related failures and user-related failures.
Many of the studies highlighted also many undesirable consequences of contraceptive failures and concluded that detailed information on the issue is critical to inform improvements in the provision of contraceptive information, supplies, and services, which can help women and couples to use methods correctly and consistently.
Despite this increasing interest in contraceptive failure research, there is still a gap between its correlates, especially in developing countries. Moreover, much of what is known about these
rates in developing countries come from Demographic and Health Survey (DHS) data. Some authors have highlighted that DHS surveys were likely to be underestimated, hence the need for more accurate research. The literature below reviews the recent studies on the contraceptive failure rates in developed and developing countries and identifies the gaps to be filled in the present and future studies. A brief description of some types of hormonal contraceptive methods given at the beginning of the section.

2.2. Review of past studies

2.2.1. Some types of hormonal contraceptive methods
Hormonal contraceptives, which include birth control pills, injections and implants all use hormones to control births(Jones, 2012), (Black, A., 2004),(Cathy Solter ; International, 1999).
2.2.1.1. Combined oral pills
This method is 99.7% effective with perfect use. This means that if 100 women use it correctly for one year when no pill-taking mistakes are made, less than one will become pregnant (Stewart, M., Chaar, B. ; Bateson, D, 2014). But with typical or ‘real life’ use it is less effective with up to 9 women in every 100 becoming pregnant in a year (Black, A., 2004) (Black A. , Combined hormonal contraception. Can. Contracept. Consens, 2004) (Gajria, 2012). The combined oral contraceptive pill is the most commonly used contraceptive method in the United States and Australia.
Women rapidly adopted the pill as it allowed the reliable separation of sex and reproduction and gave them the opportunity to plan when to have children. Since then it has been further developed to ensure good efficacy while minimizing the adverse effects (Stewart, 2015),(Winner, B. et al, 2012).
Because the pill requires daily compliance, failure rates calculated on the basis of “perfect use” differ from real-world failure rates calculated on the basis of typical use. Annual failure rates with typical use of oral contraceptive pills are estimated at 9% for the general population, 13% for teenagers. The US National Survey of Family Growth estimates that 9% of women using oral contraceptive pills will have an unintended pregnancy within the first year (Winner, Effectiveness of long-acting reversible contraception, 2012). However, the combined oral contraceptive pill is not recommended during lactation as it may affect breast milk volume (Stewart, M. ; Black, K, 2015).
2.2.1.2. Progestin-only pills

Progestin-only pills (POPs) contain a very small amount of only one kind of hormone, progestin. They contain one-half to one-tenth as much progestin as COPs. They do not contain estrogen(Cathy Solter ; International P. , 1999). Therefore, they do not cause many of the side effects or concerns more commonly associated with the estrogens in combined oral contraceptives. Progestin does not suppress production of milk in breastfeeding mothers and has no documented side effects on the baby, which makes the POPs an ideal contraceptive for breastfeeding women(Achwal., 2000). Theoretically, for breastfeeding women, POPs are very effective as commonly used with 1 pregnancy per 100 women in the first year of perfect use. For non-breastfeeding women, POPs are less effective as commonly used since as many as 9 to 12 pregnancies per 100 women may occur in the first year of use (Isaac Achwal., 2000).

2.2.1.3. Implants

The implant is more than 99.9% effective method of preventing a pregnancy. This means that less than one woman in every hundred using this method of contraception for a year would become pregnant (Gajria, 2012). It acts by suppressing the secretion of pituitary gonadotropins which, in turn, prevents follicular maturation producing long-term anovulation in the reproductive-aged woman. It also suppresses the Leydig cell function in the male, this means that it suppresses endogenous testosterone product(Cathy Solter ; International, P. Module 4, 1999). Although long-acting reversible methods are initially costlier than different other methods, several studies have found long-acting and permanent methods to be much more cost-effective than short-acting hormonal or barrier methods (Health, RWANDA ;, 2012).

2.2.1.4. Monthly injectable contraceptives

More than twice as many women are using injectable contraceptives today a decade ago, and the numbers keep growing. Women choose injectable because they are highly effective, long-acting, reversible, and private(Jejeebhoy, 2012). The estrogen component of a combined hormonal contraceptive may build up the endometrium and therefore regulate bleeding patterns while progestin-only contraceptives may produce a thin endometrium that can bleed irregularly and unpredictably. This makes it more convenient than progestin-only injectable, because of the negative effects of progestin-only injectable which include disruption in bleeding patterns as well as the long duration of contraception (Gallo, 2008),(Cathy Solter ; International, P, 1999),(Jejeebhoy, 2012).

The studies indicated that when an estrogen such as estradiol cypionate added to the long-acting progestin such as depot medroxyprogesterone acetate, bleeding cycles are more regular than they are with injectable progestin-only methods. Combination injectable contraceptives are given on a monthly basis, which is more convenient for some women than the daily oral contraception regimen. They work mainly by preventing ovulation by suppressing LH surge from the pituitary gland, and also thicken the cervical mucus, making it a barrier to sperm transport, thus blocking fertilization (Gallo M. F., 2008). Nevertheless, Combination injectable contraceptives are comparable in effectiveness to Norplant implants(Winner B. e., 2012). And also in 2010, according to data from US National Survey of Family Growth, the probability of failure within 3, 6 and12 months of combined injectable contraceptives in the United States are 2, 3.2 and 6.7 percent respectively(Kost, 2010).

2.3. Prevalence of hormonal contraceptive use, failure, and discontinuation

2.3.1. Prevalence of hormonal contraceptive use
With about two in three married couples using a method of family planning in 2009. In 2011, WHO indicated that the most commonly used contraceptive method also differed by country: 67.1% used the pill in Zimbabwe, 65.6% injectable in Ethiopia (Bradley, 2011). In Kenya, modern contraceptive use among currently married women has increased from about 27% in 1993 to 39% in 2009(Alaii, 2012). According to Sarah in 2011, the percentages of induced abortions that resulted from contraceptive failure are even higher, at 36-65 percent in the US. This implies that between one and two out of every three induced abortions result from failed contraceptive use(Bradley, 2011).
Globally, by estimation 33 million unintended pregnancies reported to occur among women known to use a contraceptive method(Staveteig, S., Rebecca, W., Mallick, L. ; ICF, 2015). In one survey conducted in some developing countries, on average, within the first year of use, 9% of women discontinue using implants and 32% discontinue injectable(Staveteig, 2015). Yet, the discontinuation of subdermal implants ranges from 10% to 13% at one year to 28% at two years. For injectable, U.S. insurance claims shows that nearly 60% of new users did not have a second injection at three months. In Brazil, 64% of injectable users discontinued in the first 12 months, with 27% related to side effects (Halpern, V., Lm, L., Da, G. ; Mf, G, 2011).
The contraceptive prevalence rate fell after the 1994 genocide, from 13% in 1992 to only 4% in 2000 (Solo, J, 2008). According to Demographic and Health Surveys, the contraceptive prevalence rate has tripled, from 10% of currently married women aged between 15 and 49 years in 2005 to 36% in 2007. In 2008, MOH reported that the average number of new users per health facility grew from about 18 in 2006, when performance-based financing (PBF) was started, to 60 by 2008(Emmart, 2010). From January 2006 to December 2007, there was an increase in contraceptive prevalence from 3.89% to 10.63%. These dramatic changes have been seen at health facilities level. At the Gasabo Health Center, located in Kigali, there has been close to a doubling in family planning clients from 2006 to 2007 i.e. from 1,312 to 2,234. KimironkoHealth Center, also in Kigali, had 7,217 client visits for family planning in 2007, almost 64% of which were for Depo Provera. A rural facility, Kabarondo Health Center, had a similar method mix among its 1,541 clients in 2007 where 1,178 Depo Provera users, 202 taking oral contraceptives, 134 implants users (Solo, J, 2008).
2.3.2. Contraceptive failure

There are an estimated 85 million unintended pregnancies every year, 86% of which occur in low- and middle-income countries (Sedgh G, 2014). Estimates across a range of low- and middle-income countries suggest that approximately one out of every three unintended pregnancies was conceived while using contraception (Bradley, 2011)(Singh, 2014). As contraceptive prevalence continues to increase, the proportion of unintended pregnancies that result from failure is likely to increase concomitantly.

2.3.2.1. Overall Method-Specific Contraceptive Failure Rates (Medians)

As expected, modern contraceptive methods with the least room for user error had the lowest median failure rates and the lowest variability in these rates. The overall 12-month median failure rate for every 100 episodes of method use was 0.6 for implants (with a median of 95% confidence intervals for all included countries, hereafter, median 95% confidence interval, of 0.0–2.4), 1.4 for IUDs (0.0–2.4) and 1.7 for injectable (0.6–2.9). The rate for implants in Benin was an outlier at 3.7, but was based on fewer than 250 unweighted episodes of contraceptive use, and should be interpreted with caution. Injectable failure rates in Paraguay, Bolivia, Dominican Republic and Brazil were also unexpectedly high, at 13.6, 8.3, 8.2 and 8.0, respectively.(Chelsea B. Polis, 2016) However, these estimates are based on somewhat older data, it is possible that one-month injectable was available in at least some LAC countries, and the 12-month injectable failure rate estimates in both Benin and Bolivia were based on fewer than 250 unweighted episodes. Oral contraceptive pills had higher failure rates than implants, IUDs, and injectable. The median 12-month failure rate for every 100 episodes of method use was 5.5 (median 95% CI, 3.5–7.3) for oral contraceptive pills. The rate for oral contraceptive pills in Kazakhstan was an outlier at 15.3; that country also had some of the highest failure rates for other methods, including IUDs.(Chelsea B. Polis, 2016)

2.3.2.2. Sub-regional Method-Specific Contraceptive Failure Rates (Pooled Estimates)

For each method, we calculated sub-regional failure rates at various durations of use (12, 24 and 36 months) by pooling country data. As previously noted, these findings should be interpreted as averages across populations in the countries analyzed and cannot be considered representative of the subregion (given uneven distribution of populations as well as incomplete representation of countries in a given sub-region)(Chelsea B. Polis, 2016). Also, there are concerns about the quality of calendar data in certain subregions, particularly Western Africa, so these estimates should be interpreted with caution. We did not conduct formal significance testing, but the confidence intervals shown provide an informal sense of whether differences in estimates between methods or other subgroups are likely to be statistically significant.(Chelsea B. Polis, 2016)

Implants
Across subregions, the 12-month, failure rates for implants ranged from 0.2 to 1.3 per 100 episodes of use. The lowest was seen in LAC, whereas the highest was seen in Northern Africa and West Asia. Failure rates across subregions ranged from 0.2 to 2.1 at both 24 months and 36 months.

Intrauterine Devices
Across subregions, the 12-month, failure rates for the IUD ranged from 0.9 to 2.2 per 100 episodes of use. The lowest was seen in Western Africa (but should be interpreted with particular caution) and Southern Asia, whereas the highest was seen in LAC. Failure rates across subregions ranged from 0.9 to 4.4 at 24 months and from 2.7 to 7.9 at 36 months, with particularly high values seen in Eastern Africa at these time points.
Injectable
Across subregions, the 12-month failure rates for injectable ranged from 0.9 to 4.2 per 100 episodes of use. The lowest was seen in Southeast Asia, whereas the highest was seen in LAC. Unexpectedly, failure rates for injectable and IUDs were not dissimilar. Failure rates across subregions ranged from 2.0 to 6.6 at 24 months and from 2.8 to 9.5 at 36 months.
Oral Contraceptive Pills
Across subregions, the 12-month failure rates for oral contraceptive pills ranged from 3.6 to 8.5 per 100 episodes of use. The lowest was seen in Western Africa (but should be interpreted with particular caution), whereas the highest was seen in Eastern Europe and Central Asia, and in Northern Africa and Western Asia. Failure rates across subregions ranged from 6.6 to 13.9 at 24 months and from 9.7 to 18.4 at 36 months.

2.4. Effect of concomitant drugs on hormonal contraceptives

Potential drug interactions should be considered when prescribing any medication for women of reproductive age. Drug interactions may result from alterations in pharmacodynamics or pharmacokinetics. Pharmacodynamical interactions occur when one drug directly influences the action of another by synergy or antagonism; while pharmacokinetic interactions occur during the processes of drug absorption, distribution, metabolism or elimination. Bioavailability is the amount of hormone available to have a clinical effect. Bioavailability of contraceptive hormones depends primarily on absorption including secondary absorption via the enterohepatic circulation and metabolism (Guidance, F, 2005).
Some antibiotics are more likely than others to make birth control pills less effective. Antibiotics, such as rifampin speeds up the metabolism of the pill 17,37. Rifampin and rifabutin have shown to reduce both ethinylestradiol and progesterone(Guidance, F, 2005). Although the risk of penicillin and tetracycline classes is less than with rifampin, they make birth control pill less effective. Women are advised to check with pharmacist or prescriber in order to prevent the risk of getting pregnancies(Shaver K. P., 2002).
Antifungal like fluconazole has been shown to have no alterations in ethinylestradiol or progestogens, but griseofulvin is known to be a potent liver enzyme-inducer and pregnancies are documented (Shaver K. P., 2002),(Guidance, F, 2005). Pregnancies have also been reported following concomitant use of COP and a wide range of antimicrobial agents, including penicillin, tetracycline, which are not enzyme inducers(Unit, C. E., 2012).
However, the co-administration of combined oral contraceptives with ART regimens containing efavirenz in HIV-infected women might be complicated by drug interaction. It has been known that efavirenz is an inducer of hepatic cytochrome P450 (CYP) 3A4 and uridine-diphosphate glucuronosyl transferase that involve in metabolic pathways of ethinylestradiol. Though the specific enzymes involved in progestin metabolism have not been well-defined, (CYP) 3A4 and uridine-diphosphate glucuronosyl transferase might play a role. Therefore, as result of drug interactions, exposure to combined oral contraceptives components could be adversely affected when co-administered with this anti-retroviral drug, not only affecting menstrual patterns but potentially impacting ovulation suppression and hence contraceptives efficacy(Sevinsky, H. et al., 2011).
On the other hand, the metabolism of estrogen and progestogen is increased by anti-epileptics that induce cytochrome P450. Anti-epileptics may be strong inducers like carbamazepine and phenytoin or weaker inducers like topiramate. There is a lack of good quality evidence on the effect of liver enzyme-inducing anti-epileptics on the efficacy of hormonal contraception. Available evidence suggests that the magnitude of any effect on contraceptive efficacy depends on the dose of hormones and route of administration. The efficacy of the progestogen-only injectable, depot medroxyprogesterone acetate, is not reduced(WHO, 2010).
2.5. Lack of adherence to hormonal oral contraceptives
A woman’s adherence to her hormonal contraceptive regimen is a major determinant of its effectiveness, as well as the correct and consistent use of any contraceptive method, is essential to its effectiveness, but adherence may vary significantly by the contraceptive method. Hormonal contraceptives are nearly 100% effective with perfect use; however, typical failure rates in the range of 3% to 9% reflect the fact that adherence with daily, weekly, monthly, or even tri-monthly regimens is a problem.
Up to 60% of COPs users report irregular pills use, including missing pills or starting new pill packages late North American studies have found that approximately 50% of women take one pill every day6 but that the percentage of women missing at least three pills a month can vary from 10% to 51%. (Guilbert, E. & Foy, S., 2008)
Numerous studies have shown high rates of inconsistent or incorrect hormonal contraceptive use. In contrast to the commonly held belief that adherence will improve with time, a study of COPs users found that in the first three months of COPs use, women’s compliance did not improve and they actually became less consistent at taking their pills over time. Therefore, Women who frequently miss pills are unable to return reliably for DMPA (Depot medroxyprogesterone acetate) injections every three months should consider alternative methods of contraception that are less compliance demanding. Insofar as women may be more likely to consistently use a method they have chosen than one they have been assigned, the compliance rates may be higher, and failure rates lower(Winner, B. et al, 2012).

2.6. Recommendation for missed pills
In the 2004 Canadian Contraception Consensus, the Society of Obstetricians and Gynecologists of Canada provided instructions for COP users in the event of missed pills. These stated that a woman may miss one pill; however, if two or more pills were missed in the first or second week of the pack, then back-up contraception should be used for seven days, and emergency contraceptive should be considered. When two or more pills were missed in the third week, a new pack of pills should be started immediately. If three or more pills were missed at any time, the woman should start a new pack immediately, consider emergency contraceptive, and use a backup method. No differentiation was made between different types of pills(Guilbert, E. ; Foy, S., 2008).
2.7. Discontinuation reasons of hormonal contraceptive methods
The use of synthetic progesterone, progestin, in all long-acting reversible contraceptives is associated with breast pain, weight gain, bloating, and acne or greasy skin. Changes in menstruation can also occur with LARCs. Some injectable such as Depo Provera and implants can cause both irregular bleeding and amenorrhea. Hence, discontinuation of a method occurs when there is method failure and when a woman no longer has a need for contraception. However, when a woman is dissatisfied with her method or cannot access or afford the method, it can result in method discontinuation. Nevertheless, it is important to examine how often and why women discontinue these methods, particularly in low-income countries(Staveteig, S., Rebecca, W., Mallick, L. ; ICF, 2015).
2.8 Conceptual framework

2.8.1 Explanation of conceptual framework
The conceptual framework explains how the independent variables relate to medication outcome. It points out the stream of influences that determine the medication adherence outcomes in contraceptive users. Intervention in any of the independent variables has the ability to change the medication adherence; These include knowledge, concomitant drugs, side effect of the medication which are usually high in contraceptive users. Improper control of side effect and poor knowledge in contraceptive users can lead to poor medication adherence. The intervention variables are those identified variables that could affect the relationship between the independent and dependent variables but will be taken into consideration during the course of this research.

The interrelationship of variables: the independent variables and intervention variables are interrelated in influencing dependent variable (medication adherence outcome). The educational level could play a major role in both good or poor medication adherence, it could improve the patient’s knowledge of using contraceptives. Therapeutic relationship between a patient and a healthcare provider have a positive impact on medication adherence.

FIGURE 1: CONCEPTUAL FRAMEWORK

CHAPTER III: METHODOLOGY
In this chapter, I outline the research methodology and procedures that were used to collect and analyze data. This includes methods and data source, study population and site, sampling method and sample size, data collection process, enrolment criteria, data collection tool, data entry and analysis and ethical considerations.
3.1. Study design
A descriptive quantitative study in which I have used a structured-interview method to collect data. Hence in our study, women were interviewed using a questionnaire of structured questions. However, at a health facility, I have been working with the women who are in VCT, CPN and PMTCT programs.
3.2. Study population and site
The study involved women aged between 15 and 49 years old from Gihogwe, Kabuye and Nyacyonga health centers located in Gasabo district.
3.3. Sampling method and Sample size
In this district, 54.2% of women are on any contraceptive method in 91000 women aged from 15 years old. However, among them, 9.7% are on oral pills, 24.4% and 6.4% are on injectable and implant respectively 39,40. This implies that 19629 women are on these hormonal contraceptive methods in this district. Yet, the sample size was calculated using Yamane formula with the confidence interval of 90% and the margin error of 0.1, one hundred women were needed to participate in the study as the formula as shown below, but 156 participants consented to participate in the research. This number was reached by using a stratified method at health facilities where I selected women from VCT, CPN and PMTCT programs.
Yamane formula is defined as:

Where, n= sample size, N= population and e= margin error
Calculations
First our e2= (0.1)2=0.01, then

3.4. Data collection process
The data collection process took three weeks to comply with the availability of participants. At each health facility, I spent three days for data collection, every morning I took twenty minutes of explaining the purpose and procedure of the study in order to help them to participate with confidence, trust and to avoid the repetition of data. Yet, both interviewer and woman used a provided questionnaire and secured room for an interview. Each woman interviewed alone in that room.
3.5. Enrolment criteria
3.5.1. Inclusion criteria
1. This study has considered all women aged between 15 to 49 years old
2. She should be either used or using one of the hormonal contraceptive methods, indeed combined oral pills, progestin-only pills, implant or monthly injectable contraceptives methods.
3.5.2. Exclusion criteria

However, this research didn’t consider:
1. Women who never used one of four hormonal contraceptive methods, indeed, combined oral pills, progestin-only pills, implant or monthly injectable contraceptive methods.
2. Women aged below 15 or above of 49 years old

3.6. Data collection tool

During data collection process I used a questionnaire of closed and open-ended question to facilitate the interview. Hence, our questionnaire was constructed by adopting from the study of 2015 that was conducted by S. Sarah in 19 developing countries including Rwanda, where he developed his tool from demographic health survey (DHS) questionnaire of WHO 16. Yet, the participation of women helped to know the failure, discontinuation rate and the associated reasons of combined oral pills, progestin-only pills, implants and monthly injectable contraceptive in Gasabo district. The questionnaires were translated from English into Kinyarwanda.
3.7. Data entry and data analysis
During this period of data entry and analysis, I have used statistical package for social science (SPSS) in order to statistically enter and analyze data easily and correctly. This is a software helped to relate our quantitative data of different variables and obtain the results and present them in form of tables and charts.

3.8. Ethical considerations
As this research was conducted in health facilities, I had a recommendation letter from the Mount Kenya University through School of Pharmacy to the Mayor of Gasabo district. After being recommended, I got the written permission from the Mayor of Gasabo district through the department of health and sanitation. However, at a health facility, I used a provided room to interview the participant alone and the questionnaires were coded. Hence, this was to keep the confidentiality of information.

CHAPTER IV: RESULTS AND DISCUSSION
The results obtained from this study are interesting and provide an insight into the effectiveness of hormonal contraceptive methods among women in Gasabo district. However, by focusing on failure, adherence of oral pills’ users, use of enzyme-inducing drugs, discontinuation and related reasons of hormonal methods give a rise on how hormonal contraception is effective among women in this district.
According to H. Fu, the proportion of unintended pregnancies that are due to contraceptive failure is directly linked to the proportion of the population using contraception (Fu, 1995). Therefore, as the modern contraceptive methods especially hormonal contraceptive methods are prevalent in our country, but with different challenges (RWANDA & Health. Family planning strategic plan 2012–2016, 2012), it is reasonable to assess their failure and discontinuation among women in Gasabo district as they have been documented in our country.

4.1. Social and Demographic data

Table.4.1 Distribution of respondents by age

Frequency Percent Valid Percent Cumulative Percent
Valid < 20 years of old 8 8.0 8.0 8.0
20-29 years old 42 42.0 42.0 50.0
30-39 years old 36 36.0 36.0 86.0
40-49 years old 14 14.0 14.0 100.0
Total 100 100.0 100.0

FIGURE 2: PERCENTAGE OF RESPONDENTS BASED ON AGE

4.2 Distribution of respondents based on health center
Table4.2 Percentage of participants based on health center

Health center frequency Percent
Kabuye health center
Gihogwe health center
Nyacyonga health center 53
51
52 34.0%
32.7%
33.3%
Total 156 100%

4.3. Percentage of hormonal contraceptive methods failure
As I was interested to determine the failure rate of hormonal contraceptive methods, it has been determined based on the total users of each contraceptive methods as shown in the table below.
Table 4.3 Percentage of hormonal contraceptive methods failure among women in Gasabo district
Methods Total users Birth controlled Pregnant Induced abortion Percentage of failure
Combined oral pills 14 12 2 0 14.2% (2)
Progestin only pills 16 12 2 2 25.0% (4)
Depo-Provera 82 68 12 2 17.0% (14)
CMIC 0 0 0 0 0
Implant 44 39 2 3 11.3% (5)

From the Table 2, progestin-only pills have considered a high rate of failure than combined oral pills, implant and Depo-Provera. 25.0% of progestin-only pills (POP) users have failed during the period of use. This indicates that POPs are less effective among women compared to COPs, Depo-Provera and an implant.
Therefore, in Gasabo district, the hormonal contraceptive methods are failing at high rate. And also, the progestin-only pills (POPs) are less effective in Gasabo, as it has shown a higher rate compared to combined oral pills (COPs), Depo-Provera and implant respectively.
4.4 Reasons of hormonal contraceptive failure among women in Gasabo District
4.4.1 Adherence of oral pills’ users
Here, was interested to assess the adherence of oral pills’ users by approximating the number of pills missed a month. The Table 3 shows the percentage of women missed according to the pills missed in a month.

Table 4.4.1 Percentage of women reported to miss a number of oral pills in a month

No of pills missed Frequency Percent
Between 1 and 3 pills 6 20%
More than 3 pills 9 30%
No pills missed 15 50%
Total 30 100%

According to Vera Halpern in 2011 “…several types of hormonal contraceptives depend on adherence to the regimen, which is often called ‘compliance’ in the medical literature. Repetitive and correct use by the woman is critical for successful use of the combined oral contraceptives, progestin-only pills…”(Halpern, V., Lm, L., Da, G. & Mf, G, 2011). In Table 3, 30% of pills’ users reported missing more than 3 pills a month. This percentage shows that among pills users, there is a lack of adherence. It is also comparatively higher than the findings of 2004 Canadian contraception study where 22% miss 2 or more pills per cycle (Black A. ). As 2006 Canadian Contraception Study indicated that the typical failure rates in the range of 3% to 9%, it is the fact of lack of adherence on daily, weekly, monthly, or trimonthly regimens(Guilbert, E. ; Foy, S., 2008) 14. Therefore, as women do not adhere to oral pills, probably their lack of adherence has contributed to the failure occurred among women in Gasabo district. Thus, the measures should be taken to improve the adherence among pills’ users.
4.4.2 Concomitant drugs were being taken prior to the failure
Of course, there are some classes of drug known to interact with hormonal contraceptive methods, like antiretroviral, antiepileptic drugs and some antibiotics(Sevinsky, H. et al., 2011),(Health, RWANDA &, 2012). Hence, here we identified the interacting concomitants drugs which were being taken by women prior to the time of experiencing the failure of methods.

Table 4.4.2 Frequency of women failed while using the interacting concomitant drug

Concomitant drugs Outcome of failure Frequency Percentage of failure
Pregnant Induced abortion
Amoxycillin 3 0 3 12%
Efavirenz 9 1 10 40%
Nevirapine 1 1 2 8%
Total 13 2 15 100%

From the Table 4, 10 out of 15 women whose methods failed during the period of contraception were on Efavirenz, anti-retroviral drug. This showed that probably the use of efavirenz has contributed to the failure occurred among women. However, it has been indicated that efavirenz is known as an inducer of hepatic cytochrome P450 (CYP) 3A4 and uridine-diphosphate glucuronosyl transferase which both involved in the metabolism of ethinylestradiol;
then as result of drug interactions, contraceptive efficacy could be affected when is associated with efavirenz(Sevinsky, H. et al., 2011).
Hence, women who are using hormonal contraceptive methods and antiretroviral drugs are advised additional or alternative contraceptive methods which are more effective (McGough, P, 2012). According to Faculty of Sexual and Reproductive Healthcare in 2011, the enzyme-inducing drugs increase the metabolism of estrogens and progestogens, which may, in turn, reduce the contraceptive efficacy of combined hormonal contraceptives. Women using enzyme-inducing drugs should ideally switch to a method that is unaffected by intra-uterine methods(McGough, P, 2012).
And it has been advised that when prescribing medication for women who are on hormonal contraception drug interactions should be considered to avoid the risk of contraceptive failure(Unit, C. E., 2012). Therefore, women with both efavirenz and hormonal contraceptive showed a high rate of failure in this district. Hence, should be assisted in selecting their birth control methods to more effective and convenient to reduce the failure of contraceptive methods among them.

4.5. The rate of hormonal contraceptive methods discontinuation
As in this study, I was intended also to determine the discontinuation rate of hormonal contraceptive methods among women, it has been determined based on the women who abandoned and changed one of the methods presented in Table 5.

Table 5: Percentage of women discontinued hormonal contraceptive methods
Methods

Continued the methods
No answer is given
Discontinuation Frequency
Percentage of discontinuation

Changed the methods Stopped the method
Combined oral pills

7
0
6
1
7
7.9%
Progestin-only pills

4
1
10
1
11
12.6%
Depo-Provera
28

1
43
10
53

60.2%
Implant
26
1
11
6
17
19.3%

Total
65
3
70
18
88
100%

From the Table 5, 60.2% (53) of women discontinued the methods, have reported discontinuing Depo-Provera which is a progestin-only monthly contraceptive. When I compare the discontinuation rate of Depo-Provera to the rate of COPs, POPs, and implant respectively. The discontinuation rate of Depo-Provera is 8.5, 4.8 and 3.1 times the rate of COPs, POPs implant respectively. This shows that women are discontinuing this method at a high rate compared to other hormonal contraceptive methods.
However, this rate is comparatively higher than the discontinuation rate reported in 2010, wherein Rwanda, among women aged between 15 and 49 years old, around 30% and 45 % discontinued the injectable after 24 months and 36 months of use respectively because of method-related reasons(Staveteig, S., Rebecca, W., Mallick, L. & ICF, 2015). Therefore, Depo-Provera is the most hormonal contraceptive method which has discontinued at a high rate among women in Gasabo district compared to the rates of COPs, POPs, and implant respectively.

4.6. Reasons for methods discontinuation
However, I identified the reasons behind the discontinuation rate found in Gasabo district. Thus, Table 6 roll out all possible reasons reported by the women discontinued the hormonal contraceptive methods.

Table 6 Percentage of women and methods discontinuation reasons

Methods

Fear of side effect

Failure of their methods

Inconvenient to use
Reasons
Access and cost

Religious beliefs

Total discontinuation

Wanted to become pregnant
Wanted a more effective method

Combined oral pills 3 0 0 2 1 1 0 7
Progestin only pills 3 3 1 2 0 0 2 11
Depo-Provera 21 13 2 8 5 1 3 53
Implant 7 2 1 3 3 0 1 17
Total 34 18 4 15 9 2 6 88

From Table 6, 34 out of 88 women who discontinued contraceptive methods, have reported the fear of side effects as the reason for discontinuing the hormonal contraceptive methods in Gasabo district. However, 61.7% (21 out of 34) of women reported the side effects have discontinued Depo-Provera. Yet, this is comparatively higher than other. S. Sarah’ findings, where he indicated that in 2010, 45.1% discontinued injectable because of fear of side effects in Rwanda, and also in 2013, 54.4% have discontinued injectable because of fear of side effects in Liberia(Staveteig, 2015). Therefore, this shows that the fear of side effects is the most prevalent reason for discontinuing hormonal contraceptive methods, mostly monthly injectable contraceptive methods among women in Gasabo district.
Nevertheless, 72.2% (13 out of 18) of women discontinued their methods because of failure of the methods, have discontinued the Depo-Provera. This is comparatively higher than 5.4% of women discontinued the injectable in 2010 because of method failure in Rwanda(Staveteig, 2015). Hence, this indicates that the failure of the contraceptive method has also highly contributed to the discontinuation rate occurred in Gasabo district. Therefore, side effects and failure of hormonal contraceptive methods are the main reasons which are behind the high discontinuation rate of Depo-Provera among women in Gasabo district. These reasons have seemed to have much power among women who discontinued the contraceptive methods.

4.7. Study limitations
During the study, I have missed the records of failure and discontinuation at the health center. The records would have been used in the study, but from this, I required to use the data from the interview.

CHAPTER V: CONCLUSION
5.1. Conclusion
This study revealed that the effectiveness of hormonal contraceptive methods differs from methods among women. In Gasabo district, hormonal contraceptive methods are failing at high rate. Yet, the progestin-only pills were shown to be less effective than combined oral pills, implant, and Depo-Provera respectively among women. However, it has been shown that probably the lack of adherence among oral pills users have contributed to a failure occurred in Gasabo. This seemed to take the measure of improving the adherence among women.
Nevertheless, I cannot confirm that the use of interacting concomitant drugs influenced the failure, but there have been shown a high rate of failure among women who were on efavirenz. From this, I have seen that the women used both efavirenz and contraceptive methods were likely to experience the failure of hormonal contraceptive methods. Consequently, Women with interacting concomitant drugs were advised to use the long-acting reversible methods which are more effective methods to avoid the interactions.
However, the discontinuation rate of Depo-Provera was comparatively higher than the one of combined oral pills, progestin-only pills, and implant. Among different reasons reported to be the reasons of discontinuation, the side effects and the failure of the methods were found to contribute to the higher discontinuation rate of Depo-Provera in Gasabo district, as well as an implant, progestin-only and combined oral pills.
5.2. Recommendations
Apart from this study, further studies on current prevalence use of hormonal contraceptive methods and the effect of efavirenz on hormonal contraceptive methods are needed. Yet, measures are needed to improve the adherence of oral pills’ users, and to reduce the failure and discontinuation rates of hormonal contraception among women in Gasabo district.

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