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
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 or disease||Intervention/treatment||Phase|
|Social Stigma Pregnancy Contraception||Behavioral: Abortion- and contraceptive-use stigma reduction program Behavioral: Usual Standards||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1207 participants|
|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)|
|Official Title:||Cluster Randomized Trial: A Pre and Post Test Intervention Program to Prevent Abortion and Contraceptive-use Stigma Among School Youths in Kenya|
|Actual Study Start Date :||February 5, 2017|
|Actual Primary Completion Date :||February 28, 2018|
|Actual Study Completion Date :||March 5, 2018|
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 (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
Active Comparator: Usual standards
Behavioral: Usual Standards
Usual standards according to the school curriculum in Kenya.
- 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
- 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)
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
|Secondary schools in Kisumu|
|Kisumu, Kisumu County, Kenya|
|Principal Investigator:||Marlene Makenzius, PhD||Karolinska Institutet|
|Principal Investigator:||Monica Oguttu, PhD||Kisumu Medical Education Trust, Kenya|