Article Text

Protocol
Study protocol for a type-II hybrid effectiveness-implementation trial to reach teenagers using mobile money shops to reduce unintended pregnancies in Uganda
  1. Makiko Komasawa1,2,
  2. Miho Sato3,
  3. Robert Ssekitoleko4,
  4. Peter Waiswa5,6,
  5. Sheba Gitta7,8,
  6. Josephine Nabugoomu9,
  7. Sumihisa Honda10,
  8. Kiyoko Saito1,
  9. Myo Nyein Aung2
  1. 1Ogata Sadako Research Institute for Peace and Development, Japan International Cooperation Agency, Shinjuku-ku, Japan
  2. 2Department of Global Health Research, Juntendo University, Bunkyo-ku, Japan
  3. 3School of Tropical Medicine and Global Health, Nagasaki University, Nagasaki, Japan
  4. 4Department of Physiology, Makerere University, Kampala, Uganda
  5. 5School of Public Health, Makerere University, Kampala, Uganda
  6. 6Busoga Health Forum, Jinja, Uganda
  7. 7School of Public Health, Uganda and Busoga Health Forum, Jinja, Uganda
  8. 8Makerere University, Kampala, Uganda
  9. 9World Alliance for Lung and Intensive Care Medicine, Kampala, Uganda
  10. 10Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan
  1. Correspondence to Dr Makiko Komasawa; mkomasa{at}juntendo.ac.jp

Abstract

Introduction Unintended teenage pregnancies have become a global public health challenge, particularly in sub-Saharan Africa. There is a notably high prevalence of unintended pregnancies among unmarried teenagers in Uganda. This study will develop an intervention programme using mobile money shops (vendors) as a platform to deliver sexual and reproductive health and rights (SRHR) services to teenagers and assess its effectiveness and scalability in Uganda.

Methods and analyses This hybrid study comprises two integral components: an intervention study to assess the effectiveness of vendor-mediated intervention and implementation research to evaluate the implementation process. 30 vendors will be recruited for both intervention and control arms in 2 municipalities in Eastern Uganda, which have a high unintended pregnancy prevalence rate among unmarried teens aged 15–19 years. A preintervention and postintervention repeated survey involving 600 participants for each arm will be conducted over 4 months. The primary outcome is the rate of condom users among teenage vendor users. The secondary outcomes include the rate of preference for receiving SRHR services at vendors and knowledge regarding SRHR. A difference-in-differences analysis will be used to determine the effectiveness of the intervention. The Bowen model will be employed to evaluate the implementation design.

Ethics and dissemination Ethical approval was obtained from the Ethics Review Committee of Uganda Christen University and JICA Ogata Sadako Research Institute for Peace and Development in Japan. The findings will be widely disseminated. This study was registered with the University Hospital Medical Information Network in Japan (UMIN000053332) on 12 January 2024.

Trial registration number UMIN000053332.

  • Adolescent
  • Clinical Trial
  • Health Services Accessibility
  • PUBLIC HEALTH
  • Social Support
  • GYNAECOLOGY
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STRENGTHS AND LIMITATIONS OF THIS STUDY

  • The effectiveness-implementation hybrid study design enables us to assess both the impact of the noble intervention and the acceptability of its intervention simultaneously.

  • Triangulation using both quantitative and qualitative methods enhances the interpretation of the study findings.

  • Given the nature of customers' utilisation of mobile money shops, randomising intervention allocation was not feasible; therefore, this non-randomised design was less definitive than a randomised design.

Introduction

Every year, an estimated 21 million girls aged 15–19 become pregnant in low-income and middle-income countries (LMICs), approximately half of which are unintended as of 2019.1 These populations have substantial unmet needs regarding sexual and reproductive health and rights (SRHR) services compared with all women of reproductive age who want to avoid pregnancy (43% vs 24%).2 Teenage pregnancies tend to lead to dangerous abortions and an increased risk of complications.1 3 Decreased unintended pregnancy could reduce maternal mortality and child mortality rates by 60% and 57%, respectively.4 It has also been noted that early pregnancy affects girls’ education and income-earning potential, which thus causes a poverty spiral that can last generations.5 6 The WHO has emphasised the important role of sexual education, and the promotion and distribution of contraceptives in preventing unintended pregnancies.3 The Second Lancet Commission on Adolescent Health and Wellbeing series in 2020 emphasised the need for innovative and scalable multisectoral approaches to encourage the use of modern contraceptives.6 Expanding such opportunities through youth-friendly services is crucial to address adolescents’ specific needs and well-being.2 6 7

Numerous interventions have been implemented in adolescent SRHR services since the declaration of the International Conference on Population and Development in 1994.8 The majority of intervention studies on family planning have been carried out in schools, primary care facilities and with community stakeholders.9–11 Several studies have pointed out that many programmes targeted married populations and are unlikely to reach younger, unmarried populations. They were also limited in quantity and spread and have not been widely adopted. Consequently, many of them were unsustainable and ineffective for large investment.9–12 Several studies mentioned the need for innovative research with robust designs, including studies examining implementation process and considering cost-effectiveness to guide decision-makers on sustainability and scalability.7 10 11 13 The Lancet series raised concerns that innovations for youth SRHR promotion had stagnated for almost two decades and the Sustainable Development Goals 2030 are off-track.14 15 The series urgently called for global community action to change the situation.

Approximately 70%–80% of women with unmet needs to prevent unintended pregnancy through modern contraception live in sub-Saharan Africa.16 17 Uganda is one of the countries facing such challenges.18 Uganda’s population is young, with those under 18 years old accounting for 52.6% of the total.19 The average age of first marriage for adult women (25–49 years) in Uganda was 18.7 years old while the average age of first sexual intercourse was 16.9 years, which means that many girls have had sexual experience before marriage.20 The contraceptive prevalence rate for modern methods (mCPR) among women of reproductive age who do not want to become pregnant is low at 32%.20 In addition, the rate of correct knowledge of SRHR was approximately 50%, with a notably low rate among men in particular.20 The number of public and non-profit health facilities with youth-friendly programmes is limited. Consequently, about 25% of girls aged 15–19 years in Uganda became pregnant, and almost all teen mothers (97%) dropped out of school.21 22 Although the government has issued a series of national guidelines on SRHR for the young population since 2006, substantial changes have not yet been noted.22–27 It is possibly because the health sector budget has remained low, accounting for 7% of the total budget in 2018/2019, which was far lower than the Abuja Declaration of 15%, and trends in the last decade have shown a downward slope.19 The Ugandan government is not expected to increase its budget for SRHR programmes in the near future. The government called for innovative approaches to mobilise multiple sectors, including the private sector, to reach underserved teens who are at a high risk of unintended pregnancies.25

The Busoga region in Eastern Uganda faces severe economic challenges and struggles with limited accessibility to health information and services. Only one-third of the women in the region can access SRHR services, including family planning. According to the National Health Information Management System 2, approximately 20% of mothers are teenagers; some 55 teenage girls give birth every day, amounting to approximately 18 000 girls annually in the Busoga region. In addition, during the COVID-19 pandemic period, mCPR decreased by 25% among all women, leading to a 48% increase in unsafe abortions among girls in the region, as reported by the Busoga Health Forum. Several previous studies have identified the factors associated with such situations, including the early initiation of sexual activities, a lack of knowledge about SRHR, social and religious beliefs, deteriorating household finances, an increase in gender-based violence, and engaging in sexual intercourse in exchange for money or material goods.21 28–30

Regarding mobile phone users, 63% of the total population were active users in early 2023, thus indicating a significant acceleration over the past decade.31 The number of registered mobile phone customers increased by 1.3-fold, from 19 634 in 2015 to 26 691 in 2019. Concurrently, the volume of mobile transactions surged 4.1-fold from 693 million transactions in 2015 to 2.8 billion in 2019.19 Young people regularly access services at mobile money shops (vendors), such as money transfers, airtime/data purchases and deposits, according to our preliminary preparation study in May 202332 (online supplemental material S1). These vendors are ubiquitous in every corner of the country.

We applied the Capability, Opportunity, Motivation, Behaviour (COM-B) model to analyse the current situations.33 34 The model states that continuous behaviour change requires the expansion of each of the three components; capability, opportunity and motivation. Capability includes knowledge, skills and physical capability. Opportunity relates to external factors, both physical opportunity (eg, time, location and resources) and social opportunity (eg, cultural norms and social cues). Motivation includes recognition, attitude and feeling. Our preparation study showed that sexually active teenagers in Busoga recognised the importance of contraception in avoiding unintended pregnancies. In short, teenagers in Busoga are motivated to prevent unwanted pregnancies but lack the capability (knowledge) and opportunity (easy access to contraceptives, social influences around them).

Given these considerations, we plan to conduct the intervention study using vendors as a platform to deliver information on SRHR, condoms and referral services to teenagers and assess its effectiveness using parallel groups in Uganda.

Aim, objectives and hypotheses

The primary objective of this study is to evaluate using vendors to reach teenagers who are sexually active and increase the use of condoms in Busoga region, Uganda. In addition, we aim to evaluate the acceptability and scalability of the intervention within the broader context of Uganda. Our hypothesis is that vendors can serve as an effective platform for delivering SRHR services and ultimately reducing unintended pregnancies among teenagers in Uganda.

Methods

Study design

This type-II hybrid effectiveness-implementation study consists of two components35:

  1. Prospective intervention study.

  2. Implementation research.

This hybrid design enables us to simultaneously evaluate both the impact of the developed intervention and the implementation process on the feasibility and acceptability.36–38 The intervention prospective study will recruit the same teenagers aged 15–19 at pre–post intervention periods to assess the effectiveness of the intervention. As vendor customers frequently use multiple shops for their convenience, thus a randomised control trial is not feasible in this study. To design the vendor-based SRHR intervention for teenagers, we referred to the drug-shop-based intervention in Tanzania.39 40 Figure 1 shows the flow chart of the hybrid study. The detailed study components are shown in table 1.

Table 1

Study components

Figure 1

Flow chart of the hybrid study. Four geographical areas (North, East, Central and West), Busoga region (Study region), Iganga municipality (intervention site) and Bugiri municipality (control site). FGDs, focus group discussions; IEC, information, education and communication; KIIs, key informant interviews.

Setting

The study will be conducted in the Busoga region, which is located in Eastern Uganda, approximately 80 km from Kampala, the capital of Uganda (figure 2). The Busoga region was once the territory of the former Kingdom of Busoga and still has social welfare functions operating outside of the official governmental structure. Jinja is the former capital of the Kingdom and has remained its political, economic and cultural centre. Uganda’s administrative system is divided into six levels: district, constituency, county/municipality, subcounty/town council, parish/ward and local council.19 As of December 2023, there are 11 districts and 4 municipalities in the Busoga region: Jinja, Iganga, Kamuli and Bugiri.

Figure 2

Map of the study sites.

In this study, we included the Iganga and Bugiri municipalities. The reasons for excluding Jinga and Kamuli were as follows: Jinja, due to its large size and high degree of urbanisation and Kamuli, which has received special SRHR support from its Swedish partner since April 2023. The population of Iganga municipality is 55 263, and that of Bugiri is 28 747, whose teenage population (10–17 years) accounted for 20.9% and 19.3%, respectively, in 2022.19 Iganga has 11 parishes and Bugiri has four. Both Iganga and Bugiri municipalities are located along the national highway connecting to Kenya and Rwanda. The distance between the centres of the two municipalities is approximately 35 km, with an estimated 50 min drive.

Study population

Selection of vendors

Based on the results of the feasibility study and the methodology of the reference study in Tanzania,39 40 it was determined that 30 vendors would be sufficient to reach 600 participants, as it was anticipated that the number of daily teen users at each vendor would range from 20 to 80. Through field observations, it was also decided to divide Iganga into six blocks and Bugiri into four blocks according to the nature of the areas (rg, commercial, governmental and residential areas; the presence of hospitals, health centres, schools, etc). Considering the geographical distribution and population, it was deemed reasonable to select 5–8 vendors from each block, for a total of 30 vendors.

The inclusion criteria of the vendors are 30 years old and under who tend to be teen-friendly age bracket, self-owned, full-time business, more than 1 year of operation experience and willingness to participate in this study. The exclusion criteria are vendors who plan to move outside the municipality within 6 months and are located in public health facility catchment areas. In addition, locations near schools or health facilities will be taken into consideration to match the intervention and control arms.

In the formative phase, the vendor survey compiled a list of potential target vendors. From the eligible vendors in the list, the target vendors will be purposely selected in each block. Through the field observations, we found that there were four major types of vendors: standalone (one person in a kiosk-type box), mixed (serving other services, such as selling daily necessities or fruits, or hair salon), verandah (stationed in front of a building or house) and umbrella (an independent setting, just with a table under an umbrella). To ensure customer privacy and the intervention commodity stock, we set the order of preference for vendor selection as (1) stand-alone, (2) mixed, (3) verandah and (4) umbrella. If there are more than the required number of qualified vendors in one block, the order of priority for the criteria is as follows: (1) type of vendor, (2) longest in business and third, (3) largest number of teenage customers.

Prospective intervention study

We applied a non-randomised clinical trial design since vendor customers cannot be assigned to specific shops because they use several shops for their own convenience. The term ‘teenager’ typically refers to individuals aged 13–19. In our study, we specifically concentrated on those aged 15–19, as this age group is at the onset of sexual behaviour, lacks information about SRHR, has low access to contraceptives and commonly possess personal mobile phones based on the preparatory study. The inclusion criteria are as follows: unmarried teenagers aged 15–19 years, both school students and out-of-school teenagers, living in the target municipalities. If they are aged 15–17 years, they must agree to obtain consent to participate from their parents/guardians and be able to provide their telephone numbers. The exclusion criteria are planning to move outside the municipality within 6 months, before the completion of the endline survey.

The intervention and control arms will each include 600 teens. We assumed that 70% of unmarried teens aged 15–19 years were currently sexually active but did not want to become pregnant, and the rate of modern contraceptive use was 30% among teens 15–19 years in the intervention arms at baseline, based on available statistics and previous studies.20 41 42 We expected that the rate of modern contraceptive use would increase by 10% though the intervention, based on existing statistics and other relevant studies.20 41 43 44 The following formula was applied to compare the two arms: the minimum required sample size was 355. Considering the prevalence of the currently non-sexual active population (required sample size: 507) and the drop-out rate (assumed to be 15%) at the endline, the sample size was increased to 600 for both the intervention and control arms. Thus, the minimum sample size was 600 in each arm in the baseline survey. A trial study on teens (26 participants) showed that 84.6% of teenagers used vendors more than once per week, and 65.4% selected vendors because they were nearest to their homes. These results support adherence rates of more than 85.0% for the same vendor usage.

m=minimum sample size required

p1: % of intervention group

p2: % of control group

α=0.05 (two sided)

Zα=1.96

Zβ=0.84

Embedded Image

The study may include a large number of teens aged 15–17 years, parental/guardian consent is required for these age groups. There is some concern that obtaining such consent may be a hurdle and result in some selection bias. To address this concern, we plan to dispatch a highly experienced and skilled researcher to the home of expected participants under 17 years old of age at a later date to provide a detailed explanation of the parents/guardians and emphasise the significance of this study. To retain the teen participants in the endline survey, we will use social networking services (such as WhatApp, Facebook or Instagram) to connect with them.

For triangulation, we will conduct key informant interviews (KIIs) with teens and local adult stakeholders (eg, district health office managers, public health workers, teachers, religious leaders and teen parents) as well as focus group discussions (FGDs) with vendors in both baseline and endline surveys. The KIIs at baseline aim to grasp the situation of teens and the perception of the stakeholders regarding teens’ knowledge and attitudes concerning sexual behaviour, contraceptive use and issues surrounding it, as well as opinions on the utilisation of vendors. The FGDs with vendors will confirm the vendors’ business operating status, perceptions of teen SRHR situations and opinions of the intervention programme. Based on a previous study, we determined that saturation could be reached with a minimum of 12 interviews for each target.45

Implementation research

To evaluate the acceptability and scalability of the intervention process, we will employ the Bowen’s model with eight areas of focus (ie, acceptability, demand, implementation, practicality, adaptation, integration, expansion and limited efficacy) (see details in the Measures section). Data from the baseline and endline surveys with teens, the KIIs with stakeholders and the FGDs with vendors, and monitoring information from the implementation organisation (Busoga Health Forum) will be used for the analysis.

Tool development

We developed a structured questionnaire by reviewing the existing literature with instruments on the knowledge and practice of SRHR among adolescents and teenagers in LMICs. We complied with questions from the Demographic and Health Survey in Uganda20 and other studies conducted mainly in sub-Saharan countries.41–43 46–48 Questions included basic sociodemographic characteristics, SRHR knowledge and perceptions, sexual behaviour, and vendor usage (online supplemental material S2). The questionnaire was developed in English and translated into the local language.

We will use information, education and communication (IEC) materials from the resource authorised by the Ministry of Health. IEC materials cover pregnancy and contraceptives for teens, proper condom usage, and strategies for preventing sexually transmitted diseases.

Intervention

The intervention will be implemented between May and August 2024. The intervention vendors will provide three services: (1) IEC materials related to SRHR, (2) condoms and (3) referral of teens who disclose a healthcare need to appropriate health facilities (eg, a public district hospital, public health centers, Non-Governmental Organization [NGO] clinics or private clinics).

Prior to the intervention, the vendors will receive a 2-day training session by the research team to provide an outline of the study, the role of the vendors, basic knowledge of SRHR and communication skills for dealing with teens in the field of SRHR. The session will be audiorecorded for fidelity monitoring.

During the intervention, the vendors are responsible for keeping records of the total number of customers, teen customers and the number of services provided, using the daily monitoring sheet. The research team will perform weekly supervision to monitor vendors’ activities, observe teen customers’ acceptance, collect data and procure the necessary commodities. In the mid-term, the intervention vendors will be invited to the workshop to share their activities and discuss teenagers’ attitudes towards the services and any challenges they face. As we will apply an intention-to-treat principle, the selected vendors and teenagers will not be replaced during the intervention period.

Following the intervention, a wrap-up workshop will be conducted with intervention vendors to share comprehensive results, assess acceptability and explore scalability. Employing the stepped-wedge design to ensure equity for both arms, the control vendors will receive an identical package of services to what the intervention arm received on completion of the endline survey.

Study procedures

Prospective intervention study

The prospective intervention study will be conducted at the baseline and endline points to assess intervention effectiveness over 4 months. Repeated data collection should be performed in the same teens each time. A structured questionnaire will be administered through face-to-face interviews by trained and skilled data collectors with either public health or social study backgrounds in their respective local languages. Data collectors will recruit teen participants from selected vendor sites. The data collector will observe customers from a short distance away from the target and approach, if possible, eligible customers after finishing their business with the vendor. The data collector will verify their criteria, and if they meet these criteria, the data collector will proceed with the consent procedure. For teens aged 18–19 years, the data collectors can immediately commence the interview after obtaining the written consent. In the case of teens aged 15–17 years, the data collectors are required to verify the possibility of obtaining parental/guardian consent and the provision of their respective phone numbers. The data collectors will make an appointment with the teens and their parents/guardians and place it on the list. Experienced senior researchers will visit their residence on the appointed date and time to see the parents and obtain consent, and then begin the teens’ interviews. Recruitment will be the first come-first served. It is assumed that the entire recruitment procedure takes less than 10 min for teens aged 18–19 years and approximately 15 min for teens aged 15–17 years. The interviews with the structured questionnaire take around 30–45 min per person.

Implementation research

With selected 30 vendors in the 2 arms, meetings will be conducted at the beginning, mid-term and end. During the intervention period, the research team will supervise the intervention vendors weekly to monitor their performance, teens’ and resident reactions, and commodity availability. Condoms will be provided through the Ministry of Health procurement channels. The research team will distribute condoms, IEC materials and monitoring tools to the participating vendors during the intervention period. The schedule of enrolment, intervention and assessments of the study is shown in figure 3.

Figure 3

Schedule of enrolment, intervention and assessments of this study. FGDs, focus group discussions; IEC, information, education and communication; KIIs, key informant interviews.

Measures

Prospective intervention study

The primary outcome is the rate of condom users among study participants and those who are sexually active. The secondary outcomes include the number of recipients of SRHR information at vendors, the number of recipients of condoms at vendors, the number of referrals to appropriate health facilities and knowledge of contraception and fertile period. The number of service provisions will be collected by the vendors. The knowledge of teens will be collected by the structured questionnaire. Questions related to teens’ knowledge of contraceptives and a women’s fertile period were adapted from DHS 201620 and from the Nigeria study.41

Implementation research

The primary outcome for implementation research is the rate of acceptance of SRHR service by vendors. Based on Bowen’s model,49 50 we set eight areas of focus (ie, acceptability, demand, implementation, practicality, adaptation, integration, expansion and limited efficacy). Data and information will be collected through monitoring, supervision, the KIIs and the two rounds of teen surveys, as described in table 2.49 50

Table 2

Outcome indicators for Bowen model questions

Analysis plan

Prospective intervention study

To assess the effectiveness of the intervention, we will conduct baseline and endline surveys of teen customers at the vendors of both the intervention and control arms. We will use difference-in-differences (DID) analysis to assess the effectiveness of the model by comparing the two arms.44 In this analysis, the basic characteristics of the participants will first be compared between the two arms at the baseline and endline. A DID analysis will be conducted using the primary outcome indicator between the two arms. To obtain an accurate rate of contraceptive use among needy teens, we first need to identify sexually active teens who require contraception to prevent unintended pregnancy. Then, a logistic regression analysis (reference is ‘no use’) will be performed to examine the factors associated with contraceptive use at the endpoint.51 Statistical significance will be set at p<0.05. The STATA software program V.18 (STATACorp, TX, USA) will be used for all statistical analyses.

Implementation research

For the Bowen model, we will analyse the indicators shown in table 2 using quantitative data from the teen surveys and qualitative data from the KIIs, FGD and other observations by vendors and researchers, referring to previous studies.49 52 All qualitative data will be audiorecorded and transcribed. The interview data will be analysed using a general inductive approach.53 The transcripts will be read repeatedly by two researchers until they have fully familiarised themselves with the contents, and codes and themes will be extracted independently using the NVivo software program, V.1.6.1 (QSR International, MA, USA). A study team with field researchers will discuss and finalise abstract themes and subthemes. The study team will analyse the indicators set by the study design.

Patient and public involvement

This study focuses on teenagers. We conducted trial studies with 16 teenagers from two target municipalities to develop teen questionnaire. In addition, to finalise the vendor questionnaire, we performed a feasibility study with four vendors in Jinja, 2 FGDs and 17 vendor trial using the draft questionnaire in Iganga and Bugiri. The involvement of teens and vendors in the actual field gave us insight into the reality of teens and vendors and imbued us with confidence in the feasibility of our study design and tools. In addition, we developed a local advisory group to obtain input on method development, communications, intervention and interpretation of the findings.

Ethics and dissemination

Ethics and informed consent

Ethical approval was obtained from the Ethics Review Committee of Uganda Christen University (UCUREC-2023-710) and the Ethics Review Committee of the JICA Ogata Sadako Research Institute for Peace and Development in Japan (JICA Ogata RI, reference: JICA (DI) 202312220002). Following the instructions of the Uganda ethics committee, written informed consent will be obtained from all study participants, including teens aged 15–17 and their parents/guardians (online supplemental material S3). The consent process has also been documented. Study participants will be informed of all risks and protections and will be able to withdraw from the study at any time for any reason. All data will be collected by application-installed device and be anonymised by a data management specialist and only assigned researchers will be accessible at JICA Ogata RI during data analysis phase. After the analysis, the data will be stored at JICA Ogata RI under password protection for 5 years after study completion.

Benefit and risks

This intervention package is non-invasive. Thus, participants will not be exposed to marked risks. Participation in this study will improve their knowledge of SRHR and contraceptive use. The vendors in the intervention arm will receive essential information on SRHR, necessary commodities and links with healthcare facilities in the community during the intervention, whereas the vendors in the control arm will receive the package after the endline survey.

Confidentiality of information

We will take concrete steps to ensure privacy in the interviews, strict management of the personal information collected and anonymisation. Quantitative data collection will be conducted using portable devices, with data promptly stored on a personal computer not connected to the outside world by a data management specialist with experience in data management under the supervision of a field coordinator with research experience in information protection measures. When the data are sent to JICA Ogata RI, the field coordinator ensures that the data are non-personally identifiable and will be submitted to password-protected files. Qualitative data will be transcribed by two staff members from the audio data, and the researcher who conducted the interviews will verify the quality of contents.

Dissemination of study findings

We aspire to disseminate the results of our study to a broader audience. Initially, the study findings will present to community stakeholders and the local leaders in the two municipalities. Subsequently, the results will be shared with policy-makers at various levels, from the municipality, the district and to central levels. Dissemination meetings will be organised, with invitations extending from the local to the central levels at the end of the study. In addition, we will publish the report at both JICA Ogata RI and Busoga Health Forum. The findings will also be disseminated through scientific meetings and papers that encompass both the baseline and endline survey results. A local advisory committee was established to enhance communication with local authorities, and periodic meetings will be held. Furthermore, approximately twice a year, we will meet with the Reproductive Health Department at the Ministry of Health to update the progress and findings of this study.

Ethics statements

Patient consent for publication

Acknowledgments

We would like to express our gratitude to the Ministry of Health for their invaluable support. Our heartfelt thanks also go to all the research members of the Busoga Health Forum, whose efforts facilitated the establishment of this study, including the development of a network involving various stakeholders and healthcare facilities, as well as the execution of preparatory field research.

References

Supplementary materials

Footnotes

  • Contributors MK, MS, RS, JN, SG, KS and MNA were involved in the development of the conception and study design. SH provided technical advice on the overall methodology, including the sampling. MK was involved in drafting the manuscript. PW supervised the study and was involved in critical revision of the manuscript for important intellectual content. MS, RS and MNA provided technical comments on the manuscript draft. MK was responsible for the fund acquisition. All authors were involved in the final approval of the manuscript and the decision to submit the manuscript for publication. The authorship eligibility is based on ICMJE Recommendations 2018.

  • Funding This work was supported by Grant No. Gakushinjyo_No.295 from Grants-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan.

  • Map disclaimer The inclusion of any map (including the depiction of any boundaries therein), or of any geographic or locational reference, does not imply the expression of any opinion whatsoever on the part of BMJ concerning the legal status of any country, territory, jurisdiction or area or of its authorities. Any such expression remains solely that of the relevant source and is not endorsed by BMJ. Maps are provided without any warranty of any kind, either express or implied.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.