EVALUATION OF HORMONAL CONTRACEPTIVE EFFECTIVENESS AMONG WOMEN IN GASABO DISTRICT BY CLAUDINE UWAMARIYA BPHARM/2014/76994 A research project proposal submitted in partial fulfillment of the requirement for the bachelor of pharmacy degree from Mount Kenya University

EVALUATION OF HORMONAL CONTRACEPTIVE EFFECTIVENESS AMONG WOMEN IN GASABO DISTRICT

BY
CLAUDINE UWAMARIYA
BPHARM/2014/76994

A research project proposal 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 _____________

TABLE OF CONTENTS
Contents
DECLARATION 3
TABLE OF CONTENTS 4
TABLE OF FIGURES 6
ABSTRACT 7
ACRONYMS AND ABBREVIATIONS 8
DEFINITIONS OF KEY TERMS 9
CHAPTER I: GENERAL INTRODUCTION 10
1.1. Background of the study 10
1.2. Problem statement 11
1.3. Study Objectives 11
1.3.1. Broad Objective 11
1.3.2. Specific objectives 11
1.4. Research questions 11
1.5. The significance of the study 11
CHAPTER II: LITERATURE REVIEW 13
2.1. Introduction 13
2.2. Review of past studies 13
2.2.1. Some types of hormonal contraceptive methods 13
2.3. Prevalence of hormonal contraceptive use, failure, and discontinuation 16
2.3.1. Prevalence of hormonal contraceptive use 16
2.3.2. Contraceptive failure 17
2.4Effect of concomitant drugs on hormonal contraceptives 19
2.5 Lack of adherence to hormonal oral contraceptives 20
2.6 Recommendation for missed pills 21
2.7 Discontinuation reasons of hormonal contraceptive methods 21
2.8 Conceptual framework 22
2.8.1 Explanation of conceptual framework 22
2.9. Summary 23
CHAPTER III: METHODOLOGY 24
3.1 Introduction 24
3.2. Study design 24
3.3. Study population and site 24
3.4. Sampling method and Sample size 24
3.5. Data collection process 24
3.6. Enrolment criteria 25
3.6.1. Inclusion criteria 25
3.6.2. Exclusion criteria 25
3.7. Data collection tool 25
3.8. Data entry and data analysis 25
3.9. Ethical considerations 26
References 28
References 28
APPENDICES 30
APENDEX I: CONSENT FORM 30
DECLARATION FOR THE CONSENT 31
APPENDEX II: QUESTIONNAIRE 32
APPENDEX III: RESEARCH PROJECT WORK DESIGN 33

TABLE OF FIGURES

FIGURE 1: CONCEPTUAL FRAMEWORK 22

ABSTRACT
Background: The failure and discontinuation of contraceptive methods are considered to raise the levels of unintended births and induced abortion. The aim of this study is to evaluate the effectiveness of hormonal contraceptives methods among women in Gasabo district.

Objective: The objective of this research project is to determine the failure rate of hormonal contraceptives methods among women in Gasabo district and to identify the reasons for discontinuing hormonal contraceptive.
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 charts.
Expected outcomes: the success of this study will participate in the increasing awareness about hormonal contraceptive effectiveness and also help in reducing the failure and rate of discontinuation among women.

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

DEFINITIONS OF KEY TERMS
1.Combined oral pills contraceptive pills: which contain low dose of estrogen and progesterone which work mainly by stopping ovulation, this means that it acts by preventing a woman’s ovaries from releasing an egg each month, are the most popular method of contraception among female adolescents (Black A. , 2004) (Gajria, 2012).
2.Combined injectable contraceptives: are contraceptive injectable which contain two hormones, a progestin and an estrogen, combined injectable contraceptives were developed to address troublesome side effects of progestin-only formulations (Gallo M. F., 2008).
3.The implant: is a small, flexible rod which is inserted under the skin of the inner upper arm. It slowly releases a progestogen hormone to prevent pregnancy for up to 5 years (Gajria, 2012).
4.Progestin-only pills: are contraceptive pills which contain a very small amount of only one kind of hormone, progestin (Cathy Solter ; International, P. Module 4, 1999).
5.Depo-Provera: is contraceptive injectable which contain only one kind of hormone, progestin (Gallo M. F., 2008).

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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 low efficacy was found with 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 in some studies and some other 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 interaction 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 are very a small number of studies 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 failure?
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, we 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. This chapter reviews all these studies and it starts by presenting the types of contraceptive hormonal currently in use.
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; 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 . 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 Leyding 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

In 2009, it was reported in a study that about two in three married couples were using a method of family planning (Alaii, 2012). 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 20. 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).
According to Demographic and Health Surveys in Rwanda, 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. Kimironko Health 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.

2.4Effect 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 the metabolism of the pill (Shaver K. P., 2002)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. In so far 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

2.9. Summary
Literature review shows an increasing interest in contraceptive failure research. It is obvious that despite this interest, 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.
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.

CHAPTER III: METHODOLOGY

3.1 Introduction
In this chapter, the research methodology is outlined including 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.
3.2. Study design
This is a descriptive quantitative study in which a structured-interview method to collect data will be used. In this study, women will be interviewed using a questionnaire of structured questions. At health facility, during the interview, staff from VCT, CPN and PMTCT programs will contribute during data collection.
3.3. Study population and site

The study will involve women aged between 15 and 49 years old from Gihogwe, Kabuye and Nyacyonga health centers located in Gasabo district.
3.4. Sampling method and Sample size

Stratified random sampling method will be used in study, and the sample size will be calculated using Yamane formula with the confidence interval of 90% and the margin error of 0.1.

Yamane formula is defined as:

Where, n= sample size, N= population and e= margin error
3.5. Data collection process

The data collection process took three weeks to comply with the availability of participants. At each health facility, three days were spent for data collection, every morning we 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.
3.6. Enrolment criteria

3.6.1. 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.
3.6.2. 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
3.7. Data collection tool

During data collection process, a questionnaire of closed and open-ended question will be used to facilitate the interview. Hence this will help women 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.
3.8. Data entry and data analysis

During this period of data entry and analysis, we 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.
3.9. Ethical considerations

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

References
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APPENDICES

APENDEX I: CONSENT FORM

Dear Respondent,
I am by name of UWAMARIYA Claudine a student in Mount Kenya University, college of health sciences, school of pharmacy. I am conducting a study entitled “Evaluation of hormonal contraceptive effectiveness among women in Gasabo district, case study Kabuye, Gihogwe,Nyacyonga health facilities “The objective of this research project is to determine the failure rate of hormonal contraceptives methods among women in Gasabo district and to identify the reasons for discontinuing hormonal contraceptive” Therefore I am soliciting your support in this project and implore you to participate in it. Please, respond to the questions by giving honest and accurate answers as they will contribute to the success of this study by increasing awareness about hormonal contraceptive effectiveness and also help in reducing the failure and rate of discontinuation, I hereby assure you that all the information that will be provided to these questions will be treated confidentially.
DECLARATION FOR THE CONSENT

I……………………………………………. (full name) hereby give consent to participate in the study to be conducted by UWAMARIYA Claudine, I agree that this purpose of the study has been described to me in a language that I understand and I will voluntarily agree to participate in the study, I understand that information I will provide will be for this research purpose only . Also I understand that my identity will not be disclosed and the consent I am going to give will be kept confidential.

Participant signature: ……………….

Researcher signature: ……………….

Date…………….

APPENDEX II: QUESTIONNAIRE
Health center name: Kabuye Gihogwe Nyacyonga

1. Age (in years) :