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A Pre and Post Test Intervention Design to Prevent Abortion and Contraceptive-use Stigma Among School Youths in Kenya (SAC)

This study is currently recruiting participants.
Verified February 2017 by Marlene Makenzius, Karolinska Institutet
Sponsor:
ClinicalTrials.gov Identifier:
NCT03065842
First Posted: February 28, 2017
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Nairobi
Moi University
Information provided by (Responsible Party):
Marlene Makenzius, Karolinska Institutet
  Purpose

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


Condition Intervention
Social Stigma Pregnancy Contraception Behavioral: Abortion- and contraceptive-use stigma reduction program Behavioral: Usual Standards

Study Type: Interventional
Study Design: 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
Official Title: Cluster Randomized Trial: A Pre and Post Test Intervention Program to Prevent Abortion and Contraceptive-use Stigma Among School Youths in Kenya

Resource links provided by NLM:


Further study details as provided by Marlene Makenzius, Karolinska Institutet:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 800
Actual Study Start Date: February 17, 2017
Estimated Study Completion Date: February 28, 2018
Estimated Primary Completion Date: February 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abortion- and contraceptive-use stigma reduction program
Four sessions (à 120 min), every week in 1 month.
Behavioral: Abortion- and contraceptive-use stigma reduction program

An abortion- and contraceptive-use stigma reduction intervention (1-month program), 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
Active Comparator: Usual standards
Usual standards
Behavioral: Usual Standards
Usual standards according to the school curriculum in Kenya.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Secondary school students between 14 and 20 years

Exclusion Criteria:

  • Age below 14 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065842


Contacts
Contact: Marlene Makenzius, PhD +46761131076 marlene.makenzius@folkhalsomyndigheten.se
Contact: Kristina Gemzell-Danielsson, Prof. kristina.gemzell@ki.se

Locations
Kenya
Secondary schools in Kisumu Recruiting
Kisumu, Kisumu County, Kenya
Contact: Monica Oguttu, PhD    +254721845948    moguttu@kmet.co.ke   
Contact: Marlene Makenzius, PhD    +254734247498    marlene.makenzius@folkhalsomyndigheten.se   
Sponsors and Collaborators
Karolinska Institutet
University of Nairobi
Moi University
Investigators
Principal Investigator: Marlene Makenzius, PhD Karolinska Institutet
Principal Investigator: Monica Oguttu, PhD Kisumu Medical Education Trust, Kenya
  More Information

Publications:
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.
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
National Council for Law Reporting. Constitution of Kenya 2010. National Council for Law Reporting with the Authority of the Attorney-General.
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.
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).
Greene M, Mehta M, Pulerwitz J, Wulf D, Bankole A, Singh S. (2010),.Involving Men in Reproductive Health: Contributions to Development. MillenniumProject. UN. 2010.
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
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.

Responsible Party: Marlene Makenzius, Principal Investigator, RNM, MPH, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03065842     History of Changes
Other Study ID Numbers: 4-3163/2015
First Submitted: February 17, 2017
First Posted: February 28, 2017
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marlene Makenzius, Karolinska Institutet:
Stigma
Pregnancy
Abortion
Contraception
Adolescence

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs