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Trial record 1 of 1 for:    NCT03065842
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A Pre and Post Test Intervention Design to Prevent Abortion and Contraceptive-use Stigma Among School Youths in Kenya (SAC)

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ClinicalTrials.gov Identifier: NCT03065842
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
University of Nairobi
Moi University
Information provided by (Responsible Party):
Marlene Makenzius, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE February 28, 2017
Last Update Posted Date March 7, 2018
Actual Study Start Date  ICMJE February 5, 2017
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
Stigmatizing attitudes associated with girls who have had an abortion: To assess a reduction from baseline attitudes at 12 months [ Time Frame: Baseline, and post-test at 12 months ]
Measured with the SABA-scale
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2017)
  • Stigmatizing attitudes associated with girls and abortion: To assess a change from baseline attitudes at 12 months [ Time Frame: Baseline, and post-test at 12 months ]
    Measured with the SABA-scale
  • Stigmatizing attitudes associated with girls and contraceptive-use: To assess a change from baseline attitudes at 12 months [ Time Frame: Baseline, and post-test at 12 months ]
    Measured with a questionnaire (likert scale)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
  • Stigmatizing attitudes associated with girls using a contraceptive method: To assess a reduction from baseline attitudes at 12 months [ Time Frame: baseline, and post-test at 12 month ]
    Measured with a questionnaire (likert scale)
  • Stigmatizing attitudes associated with girls who have had an abortion: To assess a reduction from baseline attitudes at 1 month [ Time Frame: baseline, and post-test at 1 month ]
    Measured with the SABA-scale
  • Stigmatizing attitudes associated with girls using a contraceptive method: To assess a reduction from baseline attitudes at 1 month [ Time Frame: baseline, and post-test at 1 month ]
    Measured with a questionnaire (likert scale)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2017)
  • Stigmatizing attitudes associated with girls and abortion: To assess a change from baseline attitudes at 1 month [ Time Frame: baseline, and post-test at 1 month ]
    Measured with the SABA-scale
  • Stigmatizing attitudes associated with girls and contraceptive-use: To assess a change from baseline attitudes at 1 month [ Time Frame: baseline, and post-test at 1 month ]
    Measured with a questionnaire (likert scale)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pre and Post Test Intervention Design to Prevent Abortion and Contraceptive-use Stigma Among School Youths in Kenya
Official Title  ICMJE Cluster Randomized Trial: A Pre and Post Test Intervention Program to Prevent Abortion and Contraceptive-use Stigma Among School Youths in Kenya
Brief Summary

In many low-income countries, unsafe abortion is recognized as a leading cause of maternal morbidity and mortality. Social stigma surrounding abortion and contraceptive use plays a critical role in the social, medical, and legal marginalization of abortion and contraceptive services. Though this stigma is pervasive and threatens women's health, it is not well understood how it can be reduced. The Stigmatizing Attitudes, Beliefs and Actions Scale (SABAS) was designed in 2013, to measure abortion stigma at individual and community level. Objective: I) to conceptualize abortion stigma among; health care providers, secondary school teachers and students, and II) to determine if a school based intervention targeting stigma specifically faced by girls when accessing abortion and contraceptive services, compared to usual standards, will decrease related stigma and increase contraceptive use among students, who are sexually active. Design, Setting, Participants: I) Focus group discussions (FGD) with service providers at YFC (n=12), secondary school teachers (n=16) and secondary school students (n=20), and II) a quasi-experimental pre- and post-intervention study, targeting 800 secondary school students (14-20 y), in Kisumu, Kenya. Two schools will be cluster-randomised into one interventions unit (n=400 students) and one control unit (n=400 students), according to the study site, size and academic standards of school. The region is chosen because of its low rate of contraceptive use and high rate of unsafe abortion. Standard deviation is the measure of dispersion or variability in the data. The sample size of 400 is based on a previous study and will give a power of 80% to detect differences (95% Cl) between the two groups (sample size and power will be re-calculated after baseline and take into account variability (SD) in the data). Intervention: An abortion- and contraceptive-use stigma reduction intervention (1-month program), capturing negative stereotypes about women that are associated with abortion and contraceptive use. Main Outcome (re-calculated after baseline): Abortion-stigma reduction. Secondary outcome: Contraceptive-use stigma reduction. Measured at baseline (pre-test), and post-test at 1- and 12-months, by using the validated SABA-scale. Analyses: Qualitative content analysis and repeated measures, ANOVA.

Funded by: The Swedish Research Council for Health, Working Life and Welfare 2015-01194, and The Swedish Research Council 2016-05670

Detailed Description

Today, abortion is one of the most common practices within gynaecological care. Despite its existence across time and its persistence across geographic location, the impact of abortion on women, families, communities and societies differs a lot across the world. Safe abortions - done by trained providers in hygienic settings and particularly early medical abortions carry fewer health risks. In countries like Sweden, Romania, Nepal and South Africa, liberalisation of abortion laws has had a direct and positive impact on maternal mortality. Yet, approximately half of the 42 million abortions that take place every year are unsafe. Nearly one in five maternal deaths can be attributed to unsafe abortion, and more than 500 women per 100,000 live births die from consequences of unsafe abortions. There is an inherent need to invest in intervention strategies to improve maternal health, especially amongst youth.

Until recently, abortion was only legally permissible in Kenya to save the life of a woman, but a new constitution adopted in 2010 makes abortion available to protect a woman's health. Article 43 in the constitution further widens access to reproductive health rights, as every person has the right to the highest attainable standard of health, which includes the right to health care services, including reproductive health care. However, contraceptive use remains low in Kenya. Consequently unwanted pregnancy and unsafe abortions are common, many of which require medical care for complications. A Kenyan woman has a one in 55 chance of dying from pregnancy related causes over her lifetime, and about 360 women per 100,000 live births die.

Sexuality education is part of general education. Its preventive nature not only contributes to the prevention of negative consequences linked to sexuality, but can also improve quality of life, health and well-being. In this way, sexuality education contributes to health promotion in general. In some countries SRE in school is compulsory, as for example in Sweden. In Kenya, SRE is not compulsory in the teacher education. Many teachers receive additional training, although this training has a focus on teaching about HIV/AIDS. Oginga (2014) recommend that SRE need to be incorporated and compulsory in the teacher-training curriculum in Kenya.

While extensive research has investigated the public health consequences of unwanted pregnancy and unsafe abortion from a human rights perspective, there is little research on stigma related to contraceptive use and abortion among youths. Causes of abortion stigma such as negative gender stereotypes, intent to control female sexuality, compulsory motherhood - are social constructs that can be deconstructed. Women's subordinate status in most societies has negative implications for women's sexual and reproductive health and rights (SRHR).

Although there is lack of research on stigma related to contraceptive use and abortion and how it can be reduced, the occurrence of such stigma are widely acknowledged in many countries. Few conceptual and methodological tools exist to measure its effects. For many years now, the International Planned Parenthood Federation (IPPF), together with partner organizations, has implemented programmes to specifically address and combatting HIV stigma. In the past five years there has been increased global attention on abortion stigma. IPPF has thus expanded its work to address the impact that negative beliefs and attitudes about abortion has on access to, and scale-up of, safe abortion services. Abortion stigma manifests at many levels, from individuals and service providers to communities, institutions, laws and policies, and wider public discourse including the media.

In 2013, Ipas developed a scale to measure abortion stigma at the individual and community levels, the Stigmatizing Attitudes, Beliefs and Actions Scale (SABAS), to inform the development of interventions to mitigate stigma.

PROJECT DESCRIPTION Purpose and Aims

This project has multi-methods approach, a qualitative and quantitative quasi-experimental pre- and post-intervention design. The purpose is to empirically determine what role stigma related to abortion and contraceptive use plays, how it is expressed, and how it can be countered most effectively.

Firstly, the aim is to conceptualize abortion stigma, among health care providers in YFC, and among teachers and students in secondary schools. Secondly, to determine if a school based intervention, compared to usual standards, will decrease abortion- and contraceptive-use stigma and increase contraceptive use among sexually active secondary school students.

METHODOLOGY The social and political sensitivity surrounding induced abortion makes it very difficult to conduct high-quality research to measure its incidence and related stigma, which automatically introduces bias into the result. Surveys of providers are also problematic for a number of reasons, as for example in countries where safe abortion is illegal for obvious reasons (fear of prosecution). Therefore the investigators have chosen to use qualitative- and quantitative approaches (data triangulation) to conceptualize abortion and contraceptive use stigma, and to estimate and validate the incidence.

Design: I) a qualitative approach with Focus Group Discussions (FGDs), and II) a quantitative quasi-experimental pre- and post-intervention study design, comparing student attitudes in intervention schools and matched control schools will be used. Tool: SABA-scale will be used to assess attitudes and behaviour at baseline (pre-test) and post-test at 1 and 12 month. Primary out outcome: Abortion-stigma. Secondary outcome: Contraceptive-use stigma.

Settings: Potential schools in semi-urban settlements in the county of Kisumu, will be identified according to the study site, size and academic standards (public schools). The schools will be ordered alphabetically by name and imported into a statistical computer software by an IT-assistant at Kisumu Medical and Educational Trust (KMET), Kisumu. The software will randomly generate the allocation schedule for assignment of the stigma reduction intervention to one school, and one to be operated as a control school. This area has a dominance of Christian religions, Luo, Luhya and Kisii ethnic groups, and low socio-economic status (SES) reflect the regional profile.

Participants: I) Service providers (n=12) in YFC, secondary school teachers (n=16) and will participate in gender mixed FGDs, and students (females, n=10; males, n=10), and II) secondary school students between 14 and 20 years (n=200 male students; 200 female students), will be included in the intervention unit, and the about the same number in the control unit.

Measurements: The Stigmatizing Attitudes, Beliefs and Actions Scale (SABAS) is a tool designed to measure abortion stigma at the individual and community level. A 57-item instrument was created in 2013, pre-tested, and administered to 531 individuals (n=250 in Ghana and n=281 in Zambia). All analyses were completed using Stata IC/11.2. SABAS captures three important dimensions of abortion stigma: negative stereotypes (8 items), discrimination and exclusion (7 items), and potential contagion (3 items) (1). IPPF adapted the Stigmatising Attitude, Beliefs and Actions Scale (SABAS) developed by Ipas to measure abortion stigma amongst community members in the project areas in Benin, Burkina Faso, India and Pakistan at the outset and end of the Packard Foundation abortion stigma project 2014-2016. The response categories in SABAS have a Likert format from "strongly disagree" to "strongly agree" with each response being assigned a value ranging from 1-5. The tool can be used in several ways: for example as baseline and/or endline data collection in stigma-reduction interventions or as a "pre and post-test" to measure short-term change at the individual and/or community level. The SABA tool will be further modified to adapt the tool to the context of this setting. In addition new questions will be drafted targeting gender stereotypes related to girls and contraceptive-use and misconceptions (including condom use) at last sexual intercourse (yes/no). These questions will be drafted in collaboration with providers, teachers and students, study I (FGD). This adapted tool will be used at baseline (pre-test) and post-test at 1 and 12 months, to measure short- and long-term change at both group- and individual level.

Analysis and sample size calculation: Study I) data will be qualitatively analysed according to guide for exploring contraceptive- and abortion-related stigma. Study II). The sample size will be re-calculated with a method that takes into account the intracluster correlation coefficient, the number of events, the expected effect, and the power of the study. In addition, the plan is to add new questions regarding contraceptive stigma (secondary outcomes), and adjust for lost to follow up (20%).To identify a relevant reduction in abortion stigma (one-sided t-test), using a 95% CI (α=0.05), the sample size is preliminary calculated to be 200 females and 200 males in each school, intervention/control (90% power).

The outcome of the intervention will be analysed quantitatively according to Shellenberg et al (2013). A higher score on the SABAS represents more stigmatizing attitudes and beliefs. There is no predetermined cut-off or threshold for what represents stigma. The results will guide us if to use the scores as continuous variables or to create cut-offs that are appropriate to the context/setting. For continuous variables, the intervention effect are to be analyzed using repeated measures ANOVA (PASW 20.0), significant p-value >0.05. Within-subjects factor: time. Between-subjects factor: intervention vs. control. Dependent variable: SABAS attitudes, beliefs and actions items.

ETHICAL CONSIDERATIONS Ethical clearance is recieved from JOOTRH/CDC in Kisumu, research and ethics authority who will review the proposal for approval before the project starts. All participants will be asked to give a written consent. For participants who are below 18 years, we will obtain parental consent as well as approval from the Ministry of education. Consent forms will be translated into Kiswahili language and back translated into English to ensure accurate translation. The participants will be informed that they can withdraw from participation at any time without any consequences. The research team will ensure that all research data, regardless of format, is stored securely and backed up or copied regularly. All data will be handled according to national laws and guidelines. Prof Edwin Were, a research team member is also a member in a regional ethical committee, and he will overview the ethical aspects in this study, in accordance to national laws and guidelines.

PROJECT TEAM AND COLLABORATORS Professor Kristina Gemzell-Danielsson, Karolinska University Hospital, head of the research group at the WHO-collaborating centre at the department of Obstetrics and Gynaecology, Karolinska Institutet has extensive experiences from conducting international randomised control trials within Human Reproduction. Professor Elisabeth Faxelid, Karolinska Institutet and Associated professor Marie Klingberg-Allvin, Högskolan Dalarna has long experiences of international intervention- and facility-based research. The applicant, Marlene Makenzius, has previous experiences from research related to induced abortion among Swedish women and men (Uppsala University), Public Health Policy analyses at a national level (The National Agency of Public Health, Sweden), practical work as midwife at YFC and have currently monitored a post-abortion care project in Kisumu (RCT-study).

The following Kenyan researchers will be involved in the project: Monica Oguttu, PhD RNM, Head of KMET, Sam Owoko, Program manager at KMET, currently involved in a male-involvement project and a STI/HIV-intervention in primary schools, Dr. Paul Mitei Obs/Gyn practitioner and traiinig expert with vast experience and also involved in PAC study, currently KCH Obs/Gyn. Caroline Nyandat, Midwife/nurse, Coordinator at KMET, currently involved quality development in a YFC, Edwin Were, is professor of Reproductive Health at Moi University in Eldoret, with long experience in clinical service provision and managing clinical trials and also serves in a local ethics committee. Theresa Mary Awuor, nurse midwife, BscN, a PhD student, experience in leadership currently a member of the Technical working Group-Global Health Leadership with a consortium of universities in the United States of America and African Universities called Afya Bora, and Beatrice Otieno, data clerk at KMET.

PRINCIPLE INVESTIGATORS Marlene Makenzius from Sweden and Monica Oguttu from Kenya.

SIGNIFICANCE IN KENYA The complications from unsafe abortion continue to pose a serious threat to Kenyan women's health. Nearly 120,000 women received care in health facilities for complications resulting from unsafe abortions in 2012, corresponding to an induced abortion ratio of 30 abortions per 100 births in 2012. Severe complications of unsafe abortions were most common among women aged 10-19. More than 70% of women seeking post-abortion care were not using a method of contraception prior to becoming pregnant. The investigators believe that the potential benefit of this study is high on a community level as well as the individual level. The participants may also benefit as the intervention targets contraceptive use and may thus reduce unwanted pregnancy. Unwanted pregnancy undermines young peoples' (especially women's) schooling, health, social status and future opportunities for work. Young people will therefore benefit from reduced abortion-stigma and increased contraceptive use. In addition, in Kisumu this study will

  • Encourage SRH as part of the regular curriculum in secondary schools.
  • Encourage male involvement in health-seeking practices and women's reproductive health.
  • Increase access to contraceptive-use among students .
  • Identify and empower representatives from the communities; school- and church leaders, and open meetings for publics (Baraza), to sensitize and influence communities on problems of unsafe abortion and low contraceptive use.
  • Establishment of environments and capacity among international, national and regional research actors and leading NGO's to mitigate the gap between knowledge and practice in the prevention of unsafe abortions.
  • Enable women within the project to undergo research training that will facilitate development of local and regional academic competence.
  • Create awareness of gender equality perspective in research.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A quasi-experimental design, which is the Comparison Group Pre-test/Post-test Design, as in the current design. This design is the same as the classic controlled experimental design except that the subjects cannot be randomly assigned to either the experimental or the control group. The design came out because of difficulty of applying the classical natural science method to the social or the researcher cannot control which group will get the treatment, for example interventions targeting school students.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Social Stigma
  • Pregnancy
  • Contraception
Intervention  ICMJE
  • Behavioral: Abortion- and contraceptive-use stigma reduction program

    An abortion- and contraceptive-use stigma reduction intervention (3-weeks), capturing i. Negative stereotypes associated with girls who have had an abortion. ii. Discrimination/exclusion of girls who have had an abortion. iii. Fear of coming in contact with a girls who have had an abortion. iv. Negative stereotypes about girls using a contraceptive method. v. Misconceptions about contraceptive use.

    The pedagogy will be based on that gender stereotypes, intent to control female sexuality, compulsory motherhood, are social constructs that can be deconstructed. Pedagogical methods will include role modelling, practice of desired behaviours, activities for building self-efficacy, and didactic instructions.

    Other Name: SAC - Stigma Abortion Contraception
  • Behavioral: Usual Standards
    Usual standards according to the school curriculum in Kenya.
Study Arms  ICMJE
  • Experimental: Abortion- and contraceptive-use stigma reduction program
    Four sessions (à 120 min), every week in 1 month.
    Intervention: Behavioral: Abortion- and contraceptive-use stigma reduction program
  • Active Comparator: Usual standards
    Usual standards
    Intervention: Behavioral: Usual Standards
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2018)
1207
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2017)
800
Actual Study Completion Date  ICMJE March 5, 2018
Actual Primary Completion Date February 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Secondary school students between 14 and 20 years

Exclusion Criteria:

  • Age below 14 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03065842
Other Study ID Numbers  ICMJE 4-3163/2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Marlene Makenzius, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE
  • University of Nairobi
  • Moi University
Investigators  ICMJE
Principal Investigator: Marlene Makenzius, PhD Karolinska Institutet
Principal Investigator: Monica Oguttu, PhD Kisumu Medical Education Trust, Kenya
PRS Account Karolinska Institutet
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP