NCT03065842

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 assigned; one interventions unit (n=400 students) and one control unit (n=400 students). The schools are similar according to the study site, size and academic standards. The region is chosen because of its low rate of contraceptive use, and high rate of teen pregnancy and of unsafe abortions. 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. 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: 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1.1 years

First QC Date

February 17, 2017

Last Update Submit

March 13, 2021

Conditions

Keywords

StigmaPregnancyAbortionContraceptionAdolescence

Outcome Measures

Primary Outcomes (1)

  • Stigmatizing attitudes associated with girls who have had an abortion: To assess a reduction from baseline attitudes at 12 months

    Measured with the SABA-scale

    Baseline, and post-test at 12 months

Secondary Outcomes (3)

  • Stigmatizing attitudes associated with girls using a contraceptive method: To assess a reduction from baseline attitudes at 12 months

    baseline, and post-test at 12 month

  • Stigmatizing attitudes associated with girls who have had an abortion: To assess a reduction from baseline attitudes at 1 month

    baseline, and post-test at 1 month

  • Stigmatizing attitudes associated with girls using a contraceptive method: To assess a reduction from baseline attitudes at 1 month

    baseline, and post-test at 1 month

Study Arms (2)

Abortion- and contraceptive-use stigma reduction program

EXPERIMENTAL

Four sessions (à 120 min), every week in 1 month.

Behavioral: Abortion- and contraceptive-use stigma reduction program

Usual standards

ACTIVE COMPARATOR

Usual standards

Behavioral: Usual Standards

Interventions

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.

Also known as: SAC - Stigma Abortion Contraception
Abortion- and contraceptive-use stigma reduction program
Usual StandardsBEHAVIORAL

Usual standards according to the school curriculum in Kenya.

Usual standards

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Secondary school students between 14 and 20 years

You may not qualify if:

  • Age below 14 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Secondary schools in Kisumu

Kisumu, Kisumu County, Kenya

Location

Related Publications (30)

  • Shellenberg KM, Hessini L, Levandowski BA. Developing a scale to measure stigmatizing attitudes and beliefs about women who have abortions: results from Ghana and Zambia. Women Health. 2014;54(7):599-616. doi: 10.1080/03630242.2014.919982.

    PMID: 25074064BACKGROUND
  • Makenzius M, Tyden T, Darj E, Larsson M. Repeat induced abortion - a matter of individual behaviour or societal factors? A cross-sectional study among Swedish women. Eur J Contracept Reprod Health Care. 2011 Oct;16(5):369-77. doi: 10.3109/13625187.2011.595520. Epub 2011 Jul 21.

    PMID: 21777046BACKGROUND
  • Makenzius M, Tyden T, Darj E, Larsson M. Women and men's satisfaction with care related to induced abortion. Eur J Contracept Reprod Health Care. 2012 Aug;17(4):260-9. doi: 10.3109/13625187.2012.688149. Epub 2012 Jul 3.

    PMID: 22758772BACKGROUND
  • Makenzius M, Tyden T, Darj E, Larsson M. [Sweden has the highest abortion rate among the Nordic countries. Unwanted pregnancies should be seen in a holistic perspective--individuals, health care, community]. Lakartidningen. 2013 Sep 18-24;110(38):1658-61. No abstract available. Swedish.

    PMID: 24199440BACKGROUND
  • Sedgh G, Singh S, Shah IH, Ahman E, Henshaw SK, Bankole A. Induced abortion: incidence and trends worldwide from 1995 to 2008. Lancet. 2012 Feb 18;379(9816):625-32. doi: 10.1016/S0140-6736(11)61786-8. Epub 2012 Jan 19.

    PMID: 22264435BACKGROUND
  • Grimes DA, Benson J, Singh S, Romero M, Ganatra B, Okonofua FE, Shah IH. Unsafe abortion: the preventable pandemic. Lancet. 2006 Nov 25;368(9550):1908-19. doi: 10.1016/S0140-6736(06)69481-6.

    PMID: 17126724BACKGROUND
  • Hord C, David HP, Donnay F, Wolf M. Reproductive health in Romania: reversing the Ceausescu legacy. Stud Fam Plann. 1991 Jul-Aug;22(4):231-40.

    PMID: 1949105BACKGROUND
  • Jewkes R, Rees H. Dramatic decline in abortion mortality due to the Choice on Termination of Pregnancy Act. S Afr Med J. 2005 Apr;95(4):250. No abstract available.

    PMID: 15889846BACKGROUND
  • Swedish National Institute of Public Health [SNIPH]. Sexualitet och reproduktiv hälsa. Kunskapsunderlag för Folkhälsopolitisk rapport 2010 [Sexuality and reproductive health. Public health report 2010] Östersund2011 [cited 2016 12 Februari]. Available from: https://www.folkhalsomyndigheten.se/pagefiles/12538/R2011-02-Sexualitet-och-reproduktiv-halsa.pdf

    BACKGROUND
  • Henderson JT, Puri M, Blum M, Harper CC, Rana A, Gurung G, Pradhan N, Regmi K, Malla K, Sharma S, Grossman D, Bajracharya L, Satyal I, Acharya S, Lamichhane P, Darney PD. Effects of abortion legalization in Nepal, 2001-2010. PLoS One. 2013 May 31;8(5):e64775. doi: 10.1371/journal.pone.0064775. Print 2013.

    PMID: 23741391BACKGROUND
  • National Council for Law Reporting. Constitution of Kenya 2010. National Council for Law Reporting with the Authority of the Attorney-General.

    BACKGROUND
  • Makenzius M, Larsson M. Early onset of sexual intercourse is an indicator for hazardous lifestyle and problematic life situation. Scand J Caring Sci. 2013 Mar;27(1):20-6. doi: 10.1111/j.1471-6712.2012.00989.x. Epub 2012 Mar 28.

    PMID: 22462801BACKGROUND
  • Makenzius M, Gadin KG, Tyden T, Romild U, Larsson M. Male students' behaviour, knowledge, attitudes, and needs in sexual and reproductive health matters. Eur J Contracept Reprod Health Care. 2009 Aug;14(4):268-76. doi: 10.1080/13625180903015871.

    PMID: 19526422BACKGROUND
  • World Health Organization W. Europe and BZgA Standards for Sexuality Education in Europe. A framework for policy makers, educational and health authorities and specialists. Cologne: Federal Centre for Health Education, BZgA 2010.

    BACKGROUND
  • Oginga EA. The Factors Influencing The Teaching Of HIV/AIDS Education In Public Primary Schools In Kisumu East. Int J of Education and Research. 2014;2(1).

    BACKGROUND
  • Makenzius M, Tyden T, Darj E, Larsson M. Risk factors among men who have repeated experience of being the partner of a woman who requests an induced abortion. Scand J Public Health. 2012 Mar;40(2):211-6. doi: 10.1177/1403494811435496. Epub 2012 Feb 3.

    PMID: 22307996BACKGROUND
  • Shellenberg KM, Moore AM, Bankole A, Juarez F, Omideyi AK, Palomino N, Sathar Z, Singh S, Tsui AO. Social stigma and disclosure about induced abortion: results from an exploratory study. Glob Public Health. 2011;6 Suppl 1:S111-25. doi: 10.1080/17441692.2011.594072. Epub 2011 Jul 11.

    PMID: 21745033BACKGROUND
  • Wellings K, Jones KG, Mercer CH, Tanton C, Clifton S, Datta J, Copas AJ, Erens B, Gibson LJ, Macdowall W, Sonnenberg P, Phelps A, Johnson AM. The prevalence of unplanned pregnancy and associated factors in Britain: findings from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3). Lancet. 2013 Nov 30;382(9907):1807-16. doi: 10.1016/S0140-6736(13)62071-1. Epub 2013 Nov 26.

    PMID: 24286786BACKGROUND
  • Makenzius M, Tyden T, Darj E, Larsson M. Autonomy and dependence--experiences of home abortion, contraception and prevention. Scand J Caring Sci. 2013 Sep;27(3):569-79. doi: 10.1111/j.1471-6712.2012.01068.x. Epub 2012 Aug 22.

    PMID: 22913927BACKGROUND
  • Kumar A, Hessini L, Mitchell EM. Conceptualising abortion stigma. Cult Health Sex. 2009 Aug;11(6):625-39. doi: 10.1080/13691050902842741.

    PMID: 19437175BACKGROUND
  • Shellenberg KM, Tsui AO. Correlates of perceived and internalized stigma among abortion patients in the USA: an exploration by race and Hispanic ethnicity. Int J Gynaecol Obstet. 2012 Sep;118 Suppl 2:S152-9. doi: 10.1016/S0020-7292(12)60015-0.

    PMID: 22920620BACKGROUND
  • Onyango MA, Owoko S, Oguttu M. Factors that influence male involvement in sexual and reproductive health in western Kenya: a qualitative study. Afr J Reprod Health. 2010 Dec;14(4 Spec no.):32-42.

    PMID: 21812196BACKGROUND
  • Greene M, Mehta M, Pulerwitz J, Wulf D, Bankole A, Singh S. (2010),.Involving Men in Reproductive Health: Contributions to Development. MillenniumProject. UN. 2010.

    BACKGROUND
  • Billings D, Hessini L, Andersen K. (2016) Focus group guide for exploring abortion-related stigma. Chapel Hill, NC: Ipas: 2009. International Parenthood Federation. Addressing abortion stigma. IPPF, UK,. [cited 2016 25 May]. Available from: http://www.ippf.org/resource/Addressing-abortion-stigma

    BACKGROUND
  • Bandura A. Ontological and epistemological terrains revisited. J Behav Ther Exp Psychiatry. 1996 Dec;27(4):323-45. doi: 10.1016/s0005-7916(96)00049-3.

    PMID: 9120037BACKGROUND
  • Singh S, Remez L, Tartaglione A, eds (2004). Methodologies for Estimating Abortion Incidence and Abortion-Related Morbidity: A Review. New York: Guttmacher Institute and Paris International Union for the Scientific Study of Population, 2010. Research Methods, Instruments, & Computers; 32(2): 347-356.

    BACKGROUND
  • Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.

    PMID: 14769454BACKGROUND
  • Potvin PJ, Schutz RW. Statistical power for the two-factor repeated measures ANOVA. Behav Res Methods Instrum Comput. 2000 May;32(2):347-56. doi: 10.3758/bf03207805.

    PMID: 10875184BACKGROUND
  • Ministry of Health. Incidence and Complications of Unsafe Abortion in Kenya - Key Findings of a National Study. The Republic of Kenya: Ministry of Health, 2013.

    RESULT
  • Hakansson M, Super S, Oguttu M, Makenzius M. Social judgments on abortion and contraceptive use: a mixed methods study among secondary school teachers and student peer-counsellors in western Kenya. BMC Public Health. 2020 Apr 15;20(1):493. doi: 10.1186/s12889-020-08578-9.

MeSH Terms

Conditions

Social Stigma

Interventions

Abortion, Induced

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marlene Makenzius, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR
  • Monica Oguttu, PhD

    Kisumu Medical Education Trust, Kenya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, RNM, MPH, PhD

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 28, 2017

Study Start

February 5, 2017

Primary Completion

February 28, 2018

Study Completion

March 5, 2018

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations