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Study Protocol

An interventional study to assess knowledge, attitude, and practices among rural men (aged 18-45) about contraception and family planning in Wardha, Maharashtra

[version 1; peer review: awaiting peer review]
PUBLISHED 23 Apr 2024
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Introduction

In India, Sustainable Development Goals (SDG) have placed high priority on Maternal and Child Health (MCH) and Family Planning (FP). According to various studies, female contraceptives have been widely accepted and over-reliant by men. In addition, men’s attitudes towards contraception and FP say a lot about gender disparity. Power disparities and gender-restrictive norms have also endured, making it difficult for married women to fulfill their unmet needs. Spouses may find it difficult to openly communicate their need for contraception and their preferences for reproduction if their husbands have a low gender equality mindset.

Aim and objectives

This study aimed to examine the prevalence and behaviors related to contraception as well as the level of knowledge about family planning (FP) among men in rural areas. It aimed to ascertain the attitude towards the limited participation of rural men in FP. Additionally, the study aimed to identify any associated health issues in females resulting from the absence of adequate family planning measures.

Methods

This interventional study will be conducted in a rural area of the Wardha district. It includes rural married men (aged 18-45) and a pre-test and post-test study will be conducted to attempt door-to-door visits and local working areas.

Study implications

This intervention-focused research methodology seeks to evaluate the understanding and behaviors related to contraception and family planning (FP) among rural men. The goal was to assess the effectiveness of a comprehensive FP education program in influencing knowledge, attitudes, and contraceptive utilization among men in rural communities.

Keywords

Contraception, Family planning, Birth control, maternal health, child health,

Introduction

Sustainable Development Goal (SDG) 3 places high priority on maternal, fetal, and child health, which cannot be achieved without Family Planning (FP).1 While female contraception methods have been widely available, accepted, and over-relied for decades, the development and acceptance of male contraception options have been slower.2 However, India had the highest number of abortions, especially in the first trimester.3 According to the National Health Family Survey-5 (NHFS-5) (2019-21), for all currently married women aged 15–49 years, the contraceptive prevalence rate (CPR) is 67%.4 In the five years before the survey, 50% of women who began using a contraceptive technique quit using it in less than 12 months. The main reason for quitting was the desire to become pregnant (11% of the cases). One in five unwanted pregnancies, India's high infant death rates, and premature and underweight babies are caused by the lack of support for the use of spacing contraceptives. This also affects maternal health, as it does es not allow more time for the mother's body to heal and be ready for the following pregnancy.5 Social norms that support early and high fertility and prioritize male children are major factors driving limited contraceptive usage rates in rural India.6 In India and worldwide, male dominance over female partners, especially in the context of intimate partner violence (IPV), can prevent the adoption of contraception and increase the likelihood of contraceptive inefficacy.2

It is widely recognized that men’s overall attitudes and understanding regarding optimal family sizes, gender preferences of children, ideal childbearing intervals, and contraceptive techniques have a significant impact on women's choices and beliefs.7 However, more than one-third of males think that men should not be concerned about contraception because it is a women's responsibility.8 More than 50% of women who do not receive FP live in India, out of an estimated 153 million women worldwide.2 According to 20% of men, women who use contraception may develop tendencies toward prostitution. Men in scheduled tribes, Sikh and Christian, men with little to no formal education, or rural men and men in the two quintiles of lowest income hear fewer family planning messages.4 Currently, 9.4% of married women have unmet family planning needs overall.9

Currently, male sterilization (age 15-49) using modern methods is only 0.2% in India. Family planning strategies can help control fertility by ensuring the optimal timing and spacing of pregnancies. Infant, child, and maternal mortality rates all increase with declining fertility. The use of contraception is crucial in reducing maternal mortality, a significant safeguard for women to prevent unwanted pregnancies, thereby reducing the likelihood of unsafe abortions7; it also offers economic development, educational advances, and women empowerment.1

The PICO format for this interventional study is mentioned below in Table 1:

Table 1. PICO format.

PopulationInterventionComparisonOutcome
Rural married men of reproductive ageHealth education and awareness.Comparison between Pre-test knowledge and practices and post-test knowledgeTo determine the prevalence and practices of contraception and knowledge about FP among rural men

Birth control for men

Temporary male contraceptives: Condoms, hormones and injections.

Condoms: Condoms are not the most effective form of contraception, but offer some protection against STDs.10

Hormonal Male contraceptives

Action: Testosterone functions as a male contraceptive by inhibiting the release of LH and FSH through negative feedback at the pituitary and hypothalamus. The testis lacks the signals required for endogenous steroidogenesis and spermatogenesis when there are extremely low circulating levels of LH and FSH.

Efficiency: Oral testosterone administration is ineffective since the liver breaks down oral testosterone so quickly. Consequently, long-acting testosterone esters are injected intramuscularly once a week, and have been used in the majority of male hormonal contraceptive treatments.10

Injections: Long-acting testosterone esters involves injections of testosterone undecanoate (TU) (1000 mg) and testosterone enanthate (TE) (200 mg).10

Permanent male contraceptive

Vasectomy: Vasectomy is a costly procedure and was irreversible. Sometimes reversal is possible, but the success rate is approximately 75% if the procedure is performed within 3 years, 55% if it is performed between 3 and 8 years, and 35% if it is performed between 9 and 19 years.11

Definitions

Male contraception: Use of birth control by men to lessen or avoid the possibility of pregnancy during intercourse.

Contraceptive Prevalence Rate (CPR): Percentage of women using any type of contraception.

Modern Contraception: Injectable contraceptives, intrauterine devices (IUDs/PPIUDs), pills, implants, male and female condoms, diaphragms, foam/jelly, standard days, lactational amenorrhea, emergency contraception, and male and female sterilization.

Spacing: An interval of time between the births of the children.

Rationale

The most recent National Family Health Survey-5 (2019-2021) reveals that female sterilization continues to be on the rise, especially in urban India. One in ten males use condoms in India, while nearly four in ten women undergo sterilization to avoid pregnancy. This suggests that cultural and religious beliefs, lack of sex education, and awareness and family planning may have affected the acceptance or rejection of male contraceptive methods. This study emphasizes the significance of contraception in FP and reproductive health. It examines attitudes towards male contraception from different demographics and explores the perspectives of men, women, healthcare professionals, religious leaders, and policymakers. It also explores concerns regarding safety, side effects, effectiveness, and potential long-term consequences.

Aim

This study aimed to assess the prevalence and practice of contraception and knowledge of FP among rural men.

Objectives

  • Primary Objective: To determine the prevalence and practices of contraception and knowledge of FP among rural men.

  • Secondary objective:

    • 1. To determine the attitude towards acute non-involvement of rural men in FP.

    • 2. To identify the associated comorbidities on female health due to lack of FP.

Methods

Study design

This is an interventional study that includes a pre-post study design.

Study setting

This study will be undertaken in the Deoli village of Wardha district in Maharashtra.

Study duration

The intervention study is expected to span a period of 7-8 months, including recruitment, intervention implementation, and data collection.

Study population

The target population for this intervention study will be married rural men of reproductive age (18-45 years) residing in a village.

Inclusion criteria

  • 1. The present study will include married rural men of reproductive age (18-45 years).

  • 2. Those who give consent for the study.

Exclusion criteria

  • 1. Those who are below the age of 18 years and above 45 years.

  • 2. Married women.

  • 3. Unmarried men and women.

  • 4. Those who are divorced or separated, neither are sexually active nor have any family.

  • 5. Those who do not give consent for the study.

  • 6. If a specific residence remains inaccessible upon the initial visit, eligible participants cannot be contacted, even after two more attempts.

Sample size

The sample was calculated based on the NFHS report of 2019-21. The sample size was calculated using the formula:

N=4PQd2

P= Prevalence= 67

Q= 100-p=33

d= margin of error=5%

Therefore

N=4PQd2

N =4×67×33/25

N= 340

Hence, sample size 340 yield with 5% margin of error and prevalence = 67%

Sampling method

This study includes convenient sampling method.

Variables

Sociodemographic variables:

For example: Name, age, sex, education, type of family, religion, occupation, marital status

Study variables:

Prevalence of male contraception practice in rural adults of reproductive age group.

Assessing the knowledge about contraception and family planning in rural adult.

Any disorders related to reproductive health.

Data tool

The data will be collected by the tool kobocollect. KoboToolbox, Version V7.

Data collection procedure

Data collection will include three stages: a baseline survey, an intervention, and an endline survey.

  • The first stage will collect sociodemographic data such as age, gender, family type, and socioeconomic study. A pre-tested study questionnaire will be employed to determine the extent of knowledge and practices of male contraception and family planning before the intervention.

  • The second stage of intervention will be implemented.

  • In the third stage, we will see the impact of the study to determine what knowledge and practice they acquire from the intervention. This is also known as the post-test.

Data will be collected through semi-structured interviews conducted before and after the intervention.

Validated questionnaires will be used to assess knowledge, attitudes, and contraceptive use.

Data quality will be ensured through rigorous training of interviewers and regular monitoring of the data collection processes.

Bias

Selection Bias

Ethical considerations

The study was approved by the Institutional Ethical Committee of DMIHER (DU), Ref. DMIHER (DU)/IEC/2023/34, dated: 20/12/2023.

Consent: All participants will be asked to provide informed consent in writing, before being included in the study, Written consent will be in the local language (Marathi) for the better understanding & clarity of the rural people. Measures will be taken to minimize any potential harm or risks to participants, such as referrals for medical consultation if needed.

Confidentiality: Strict measures will be maintained to ensure privacy and confidentiality throughout the study. All the participants’ data will be protected by password and 2-step verification in the questionnaire toolbox.

Data analysis plan

The data collected in the kobo toolbox will be imported into Microsoft Excel and they will be examined using the statistical program R Statistical software (https://www.r-project.org/) Version 4.2.3. The gathered data will be analyzed using suitable statistical techniques such as chi-square tests, t-tests, and regression analysis. Hypotheses related to the impact of the intervention on knowledge, attitude, and contraceptive use will be tested. Significance levels are set at p<0.05, and effect sizes will be determined using the appropriate measures.

Study status

This study has not yet been conducted. IEC approval was obtained for the study.

Expected outcomes

Level of awareness, knowledge, and utilization of contraception and FP. It will also expose the misconceptions, attitudes, and beliefs of men regarding non-involvement in FP. The measurement of participants’ satisfaction with the FP services they have assessed so far can improve the quality of care, privacy, and counselling.

Discussion

According to Kwawukume et al., the majority of the 200 male respondents had heard of FP. Nearly half of the participants were informed and used the FP services. Couples who disapproved of FP methods cited a variety of factors, such as societal beliefs, side effects such as missed or delayed menses, and difficulty in becoming pregnant after stopping FP use. Couples knew a lot about modern methods of contraception, but their use was low because of their sociocultural beliefs and perceived side effects.12

A study by Vishwakarma and Shekhar stated that women whose husbands had moderate and low gender attitudes were more likely to conceal their use of contraception. The number of living children, women's education, wealth index, and place of residence were also found to be substantially correlated with CCU (Covert Contraceptive Use).13

Iván Mejía-Guevara et al. found a negative correlation between men's attitudes and women’s contraceptive use. Men who think that contraception is a woman's domain were linked to a 12% decrease in the likelihood of using contraception. After considering only contemporary techniques or removing female sterilization, similar correlations persisted or strengthened.14

Kathpalia stated that in the history of contraception, the discovery of Emergency Contraception (EC) was a significant turning point. Nevertheless, there was low awareness of the EC. Not only patients, but also healthcare providers do not have sufficient or accurate information. If EC is used regularly and appropriately, unwanted pregnancies can be prevented due to unprotected sexual activity.15

Implication of the study

This interventional research methodology aims to assess the knowledge and practices of contraception and FP among rural men and to evaluate the impact of a comprehensive FP education program on knowledge and attitudes and contraceptive use among men in rural communities.

The results of this study could provide insights for future interventions and policies designed to enhance family planning, with the ultimate goal of improving reproductive health outcomes for both individuals and communities.

Limitations

There are two potential limitations of this intervention study:

First, depending on self-reported data, there is the possibility of recall bias or social desirability bias. To address this limitation, attempts will be made to build rapport with the participants and maintain confidentiality during the data collection process.

Second is derived from the various studies, as the interviews exclusively involves men, it is also challenging to determine whether women privately used FP without their partner's consent. Despite this constraint, research findings can be assessed and applied at the local level, serving as a valuable planning tool for programs.

Dissemination

This study protocol will be presented at conferences and seminars and will be published in an indexed journal.

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Kumar D and Ingole DA. An interventional study to assess knowledge, attitude, and practices among rural men (aged 18-45) about contraception and family planning in Wardha, Maharashtra [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:325 (https://doi.org/10.12688/f1000research.147563.1)
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Comments on this article Comments (0)

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VERSION 1 PUBLISHED 23 Apr 2024
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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