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Effectiveness of peer-led education intervention on contraceptive use, unmet need and demand among secondary school adolescents in Gedeo Zone, South Ethiopia. A study protocol for cluster randomized controlled trial
School-based interventions are believed to increase contraceptive use and demand among adolescents. However, there is limited evidence on the effectiveness of peer education in promoting contraceptive use, unmet needs, and demand among adolescents aged 15–19 years.
Objective
The purpose of this study protocol will be to evaluate the effect of a peer-led educational intervention on increasing contraceptive use and demand among high school students in the Gedeo Zone of southern Ethiopia.
Methods
A single-blind randomized controlled trial will be conducted in 6 randomly selected secondary schools in the Gedeo zone of southern Ethiopia. Two hundred twenty-four participants will be selected and randomly assigned to two groups: an intervention group and a control group. A peer-led educational intervention will be administered to the intervention group for six months. Pre-tested and validated questionnaires will be used to measure contraceptive use, unmet need and contraceptive demand. Generalized estimating equation (GEE) will be used to test the effectiveness of the interventions by examining whether there is any significant difference in contraceptive use, unmet needs, and contraceptive demands between the intervention and control groups.
Trial registration
This trail was registered under Clinical Trials.gov with identifier number PACTR202109586981531.
Universal access to sexual and reproductive health services and rights, including the use of contraceptives, is a priority global agenda for sustainable development by 2030.
Adolescent pregnancy and childbirth is a major global health problem, particularly in low-income and resource-limited countries. In resource-poor countries, 1 in 5 young girls become pregnant before the age of 18. Young women between the ages of 15 and 19 give birth to 16 million children every year.
As a result, adolescents pregnancy is one of the major causes of maternal death, pregnancy-related complications, preterm birth, low birth weight, and intimate partner violence.
Gynecology: Maternal-Perinatal Morbidity and Mortality Associated with Adolescent Pregnancy in Latin America: Cross-Sectional Study. 192. 2005: 342-349
Factors Associated with Modern Contraceptive Use Among Women with No Fertility Intention in Sub-saharan Africa: Evidence from Cross-Sectional Surveys of 29 Countries. 6. 2021: 1-13
However, currently, many adolescent girls in developing countries are actively involved in unprotected sexual practices, and one third of them do not use modern contraception, even if they do not intend to become pregnant.
However, gender norms that idealize girls' sexual ignorance undermine young people's access to information and services and their ability to engage in sexual activities.
In addition, both young married and unmarried women have the highest unmet needs compared to older women. Globally, 19% of young married people have unmet needs and 15% of married women aged 20–49.
The importance of reproductive health education in schools has been recognized on the sustainable development agenda (SDG) agenda to enable all students to acquire the necessary knowledge and skills in this area.
The information is usually given to adolescents. However, it is communicated in an authoritative, judgmental or inappropriate manner to adolescent values, attitudes and lifestyles.
Adolescents are often embarrassed to talk about sex with their parents and cannot express their reproductive desires because of difficulties in communicating with their sexual partners.
A study conducted in four sub-Saharan African countries concluded that facility- or provider-based improvements alone were not sufficient to increase contraceptive use.
Supporting youth access and use of contraceptives through effective programs can accelerate progress towards national family planning goals and the SDGs.
Peer intervention approaches are the best way to communicate information about sexually transmitted diseases, including contraceptive use, to adolescents.
Therefore, this study will evaluate the effects of peer-led educational interventions on contraceptive use, unmet needs, and demands among sexually active high school students in the Gedeo Zone of southern Ethiopia.
2. Method and materials
2.1 Setting and period
The study will be conducted in Gedeo Zone, southern Ethiopia, 362 km from Addis Ababa. Dilla is the administrative center of the Zone. The districts in Gedeo Zone are Bule, Gedeb, Kuchare, Wonago, Yirgafafe, Hadida Gubata, Rape, and Chorso. In the Gedeo Zone, there are three hospitals, 35 health centers, and 146 health Posts. The total population of the area is 1,193,162, of which 351,983 are adolescents.
Magnitude and associated factors for attitude and practice toward covid-19 and its prevention among the residents of gedeo zone, southern Ethiopia: a community-based cross-sectional study.
Furthermore, there are 29 secondary schools, two private schools, one religious school, and 26 public schools (both Junior and Senior). There are a total of 34,445 secondary school students in the Gedeo Zone. The current study included only six of the nine senior public secondary schools in the Gedeo Zone. The study will be conducted for six months.
2.2 Trail design
A cluster-randomized controlled trial with a single-blind, 1:1 allocation ratio will be conducted to evaluate the effect of peer-led educational intervention on improving contraceptive use, unmet needs, and demand among sexually active high school students (Table 1).
Table 1Standard protocol items: Recommendations for interventional trials (SPIRIT).
Outcomes
Allocation -t1
Study period
Baseline (t0)
Intervention (6 months) (t1)
Close-out
End line at month 6 (t2)
Enrollment
Allocation
X
Eligibility screen
X
Informed consent
X
Interventions
Intervention Group
x
x
Control Group
x
x
Assessments
Background
x
x
Awareness
x
x
Knowledge
x
x
Attitude towards contraceptive
x
x
Perceived Social norm on modern contractive
x
x
Perceived behavioral control towards contraceptive
Study participants for this intervention will be 224 adolescent girls between the ages of 15 and 19 attending senior secondary school in the Gedeo Zone of southern Ethiopia. Clusters will be public secondary schools in Gedeo Zone, Southern Ethiopia. The study protocol will be described according to the SPIRIT (Standard Protocol Items Recommendations for Intervention Trials) checklist.
A cluster randomized controlled design will be used to avoid contamination between groups.
3. Eligibility criteria
3.1 Inclusion and exclusion criteria
In a senior public secondary school in the Gedeo Zone, biology and chemistry teachers, selected peer educators, and randomly selected sexually active students will participate in this study. However, among study participants, those who are unwilling to participate in the study, those who became seriously ill during the intervention, and those who refused to continue the intervention will be excluded from the study.
3.2 Peer educator and teachers selection process
Four responsible and communicative students will be selected as peer educators for each section in the intervention school. In addition, two biology and chemistry teachers will be recruited for each school. The peer educators' primary role will be to facilitate peer education, and the teacher's role will be to ensure that the peer education activities progress according to schedule.
3.3 The training of peer educators
Selected teachers from each school and Peer educators will receive a standard training program. Peer educators and teachers will attend the training session. The peer educators will receive ten days of training. The format of the training will include intensive teaching, group discussions, and knowledge competition. The training topics will be divided into four parts: a general introduction to reproductive health, knowledge and skills needed to become a peer educator, knowledge of modern methods of contraception and practical demonstration. The external team will provide extensive training to all trainees, including field training outside the training area. Before conducting the interactive training sessions, the trainers must pass written and oral exams.
3.4 Intervention procedure
Before the start of the intervention, an invitation letter will be given to selected participants of adolescent girls aged 18–19 years and sent to parents/guardians of adolescents aged 15–17 years. In this study, Peer educators will disseminate information about modern contraception to their peers through various methods, such as school clubs.
By participating in peer-to-peer training, Peer educators implemented intervention activities using knowledge and skills gained from their training practice. In addition, peer education interventions will be supported by a booklet, flipcharts and posters. Interventions will be performed once a week for 1 h and lasted at least six months. The content focuses on developing a general introduction to the female and male reproductive organs, sexual negotiation skills and knowledge about the consequences of pregnancy, contraception and unwanted pregnancies. The teacher will not participate in the classroom during the actual intervention activity.
Peer educators will apply informal approaches, relied on participatory learning methods, and facilitated the discussions. The activities involved during the intervention include group discussion, poems, question-and-answer competitions, drama, and role play. Attendee lists will be collected for each session to check who attended and who did not. Students must attend at least 80% of the sessions for eligibility criteria. The interventions' organization, content, and delivery will be standardized across the experimental schools. The control group will receive the same educational interventions at the end of the study.
3.5 Intervention fidelity
Following standard guidelines for peer education programs, researchers developed criteria for evaluating the reliability of the intervention.
The checklist will be used to assess intervention content, peer-to- peer education, and intervention acceptance. The effectiveness of the intervention will be confirmed by recommendation to experts from two academic centers in reproductive health and health education and promotion. We also held two expert meetings with selected students, health professionals and other experts to develop materials such as posters, flipcharts, and booklet to support the implementation process of peer education. To compensate for differences, equal numbers of eligible student participants will be recruited into the intervention and control groups. In addition, to standardize the interventions within the intervention group, each student received an equivalent session of the intervention package. Finally, Peer educator knowledge and skills will be assessed through pre- and post-training tests.
4. Outcome measurements
4.1 Primary outcomes
Contraceptive Use: Defined as the use of any one of the modern contraceptive methods during and after the intervention period (At the time of end line data survey).
Unmet need for contraceptive: Defined as the proportion of sexually active respondents who do not want to become pregnant and intend to use contraceptive but who fail to do so after intervention delivered. The minimum time frame of assessment was six months after the initiation of intervention.
Contraceptive Demand: Defined as proportion of sexually active respondents who were currently used contraception and or those exposed to unmet need for contraceptive. The minimum time frame of assessment was six months after the initiation intervention.
4.2 Sample size determination and sampling
The sample size will be determined using G-Power statistical software version 3.1.5 and assumes an estimated prevalence (P1) of 57% of modern contraceptive use among high school students,
and an estimated increase of 10% of post-intervention contraceptive use assuming 67% (P2) with a 95% confidence interval, 80% power and design effect 2, and by adding 15% non-response rate, the final sample size is 1698. However, in both arms, only 224 participants who are currently sexually active students will be included in the analysis. The study will include 273 sections from six schools, with 81 sections from grade nine, 76 from grade ten, 64 from grade eleven, and 52 from grade twelve. Using their lists or identification numbers, the number of study participants in each school and class will be determined and allocated in proportion to population size.
4.3 Randomization
After the first stage of baseline data collection, schools will be randomly assigned to either an intervention or a control group. Accordingly, six schools (clusters) will be randomly selected from 9 secondary schools (clusters) in Gedeo Zone, and three intervention groups and three control groups will be selected. The study arm associated with each randomization number will be completed before randomization and wrapped until all enrolled participants complete all baseline assessments. Then simple randomization will be performed with an allocation ratio of 1:1. The randomizer will inform the study group whether the study group will be assigned to an intervention or control group. Concealment of assignments from study participants will not be performed because the intervention is a training program, and neither the school nor the trainer could be blinded to the research arm. The method will be stayed the same since the beginning of the process. The study will be considered the Consolidated Standards of Reporting Trials (CONSORT) as a guide for study randomization (Fig. 1).
Fig. 1Consort flow diagram: Effectiveness of peer led education interventions in generating contraceptive utilization and demand among adolescents in Gedeo Zone, South Ethiopia.
Sexual and reproductive health communication and awareness of contraceptive methods among secondary school female students, northern Ethiopia: a cross-sectional study.
Most of the questions are closed-ended, and some are open-ended. Before the data collection, a pre-test will be conduct in a location other than the research site. To avoid confidentiality and pooled responses, students will be separated from each other, and contact is not possible while completing the survey. Twelve female university student and three midwives will participate in the data collection process.
4.5 Data quality control
An experienced translator translated the questionnaire from English to the local language and back to English for consistency. Both data collectors and supervisors will attend a two-day training session on study objectives, survey completeness, and a daily data quality review. The investigators of the study will be responsible for the entire activity. All completed questionnaires at all levels of data management will be reviewed and checked for completeness, inconsistencies, and other errors. Cronbach's alpha greater than 0.7 is used to assess the instrument's reliability.
4.6 Data processing and analysis
Data will be entered into Epi info version 7.2 software and exported to SPSS version 23 for analysis. Descriptive summaries such as frequency and proportion will be drawn. Group differences will be investigated using a chi-square test for categorical variables. Pre- and post-intervention differences between the peer-education intervention and control groups will be measured for contraceptive use, unmet need, and demand. We compared the difference in outcome change between intervention and control groups using generalized estimating equations (GEEs) with binary logit functions. GEE was used to adjust for correlations between clustered data and within-subject observations. The effects of unstructured covariance matrices and potentially confounding socio-demographic variables, time, treatment, and time-to-treatment interventions will be accounted for model fitting. The interaction between time and treatment will evaluate the effectiveness of the intervention. Odds ratios and 95% confidence intervals will be calculated. A statistically significant P value of 0.05 will be considered.
5. Study timeline
Activities related to protocol development, pre-testing and finalizing questionnaires, and hiring and training of all study staff will be carried out in the first month. Screening and recruitment of study subjects for the intervention will be completed in 1–2 months and assigned group randomization using ENA for SMART software to one of the arms. The total duration of data collection will be completed in six months. All data entry and cleaning will be carried out in an ongoing fashion. Data analysis will be conducted in one month. The finding of this intervention will be analyzed and disseminated through journal articles, policy reports, and presentations at national, regional, and international conferences and meetings.
Trial status
Out of nine senior secondary schools in Gedeo Zone, six senior secondary schools will be randomly selected. A Cluster Randomized Controlled Trial will be delivered to the target population in selected schools.
Data safety monitoring plan (DSMP)
We assume that there is no risk of interference. The validity and integrity of the data will be ensured through an appropriate research design; furthermore, the use of previously tested and validated tools for data collection and quality assurance will be performed.
Disclosure statement
None of the authors have any competing interest.
Ethics and consent
The Institutional Review Board of Jimma University will granted the ethical clearance with the reference number IHRPG995/November 20, 2020. Written informed consent will be obtained from a parent and/or legal guardian for study participation after providing detailed information on study objectives, benefits. The procedure used in this study will adhered to the principles of the Helsinki Declaration.
This work is supported by Jimma University and Dilla University Research grant
Paper context
In developing countries, many adolescent girls actively engage in unprotected sexual intercourse, and most do not use modern contraception, even if they do not have a plan for pregnancy. Peer-led intervention approaches best convey information to adolescents on contraceptive use. Our study will test whether school-based peer education intervention effectively improves contraceptive use, unmet needs, and demand among sexually active female students.
Author contributions
YA was involved in the conception, design, and wrote the draft of the paper. ZB and GT were involved in the design and wrote the draft of the paper. All authors were involved in report writing and interpretation; reviewed the study and drafts of the manuscript, read and approved the final manuscript, and agreed to the submission.
Declaration of competing interest
None of the authors have any competing interest.
Acknowledgments
The authors would like to acknowledge the Institute of Health, Jimma University, and Dilla University for funding the study.
References
Kuruvilla S.
et al.
The Global strategy for women’s, children’s and adolescents’ health (2016–2030): a roadmap based on evidence and country experience.
Gynecology: Maternal-Perinatal Morbidity and Mortality Associated with Adolescent Pregnancy in Latin America: Cross-Sectional Study. 192. 2005: 342-349 (2)
Factors Associated with Modern Contraceptive Use Among Women with No Fertility Intention in Sub-saharan Africa: Evidence from Cross-Sectional Surveys of 29 Countries. 6. 2021: 1-13 (1)
Magnitude and associated factors for attitude and practice toward covid-19 and its prevention among the residents of gedeo zone, southern Ethiopia: a community-based cross-sectional study.
Sexual and reproductive health communication and awareness of contraceptive methods among secondary school female students, northern Ethiopia: a cross-sectional study.
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