Adapting, Expanding and Evaluating ARCHES in Kenya

Intimate Partner Violence Clinical Trial

Official title:

Adapting, Expanding, and Evaluating ARCHES (Addressing Reproductive Coercion in Health Settings) in Kenya

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059196
• Other study ID #: 201922S
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: October 2023
• Source: University of California, San Diego
• Contact: Erin Pearson, PhD
• Phone: 12546246937
• Email: eepearson[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Document evidence, via cluster randomized controlled trial, of the effectiveness of the ARCHES intervention, a brief, clinic-based counselling intervention demonstrated to reduce intimate partner violence and reproductive coercion and promote women's reproductive health, as scaled in government health facilities in Kenya, to (1) decrease unintended pregnancy, (2) increase family planning uptake and use/continuation, (3) decrease experiences of reproductive coercion and intimate partner violence of women and girls aged 15 to 49 years seeking family planning services, and, to (4) improve quality of care, (5) increase gender equitable attitudes, and, (6) increase self-efficacy to provide comprehensive family planning counseling among providers trained in ARCHES.

Description:

Background: In Kenya, 17% of women have unmet need for family planning (FP) and the modern contraceptive prevalence rate (mCPR) has plateaued around 45%, contributing to poor reproductive health outcomes. This includes the nearly 50% of women in Kenya who report their last pregnancy as unintended, with those experiencing gender-based violence (GBV), particularly in the forms of intimate partner violence (IPV) and reproductive coercion (RC; behaviors that reduce women's ability to use contraception or otherwise prevent pregnancy), at significantly greater risk. Similar to other LMIC settings, both RC and IPV are highly prevalent in Kenya, particularly among women seeking FP and other reproductive health services (>1/3 of female FP clients). Since 2013, the World Health Organization (WHO) has strongly recommended that IPV and RC be addressed within reproductive health services and, in 2018, the Lancet Commission on Sexual and Reproductive Health and Rights found that RC and IPV were a significant contributor to unmet need for FP and unintended pregnancy, with greatest impacts among women and girls in LMICs. Within Kenya, the Ministry of Health (MOH) has made reduction of unintended pregnancy and gender-based violence (GBV), especially among adolescents, a primary objective. Despite this need and guidance, no clinic-based intervention models outside of the U.S. (apart from one, ARCHES) have demonstrated efficacy to improve FP uptake/use and reduce IPV or RC thereby reducing unintended pregnancy.

Intervention Description: ARCHES (Addressing Reproductive Coercion in Health Settings) is a brief, clinic-based intervention delivered by family planning providers aiming to: 1) Increase women's and girls' ability to use family planning in the face of reproductive coercion, facilitating women's voluntary family planning uptake and continued use without interference, 2) Provide a safe and supportive environment for IPV disclosure and subsequent referral to support services, and 3) Educate and support providers to improve quality of care related to family planning counseling, including addressing reproductive coercion and intimate partner violence.

Objective: The objective of this study is to generate evidence and learnings on scaling integrated family planning services (including family planning, reproductive coercion, and intimate partner violence) in public sector health facilities in Uasin Gishu County, Kenya via adaptation and implementation of ARCHES, in partnership with the Kenya MOH.

Methodology: A cluster randomized controlled trial paired with concurrent implementation science assessments will test effectiveness of the ARCHES model that has been adapted for scale by the Kenya MOH. Female family planning clients aged 15-49 years at selected sites will complete baseline surveys (immediately prior to receiving care), immediately post-visit exit surveys, and 6-month follow-up surveys. Family planning providers trained in ARCHES will complete pre-training, post-training, and 3-month follow-up surveys to assess changes in gender-equitable attitudes and self-efficacy to address issues of violence among their clients. Costs associated with the scale-up strategy will be tracked and utilized in combination with results of the effectiveness trial to assess total cost and cost-effectiveness of ARCHES.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3540
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

All eligibility criteria based on self-report.

Inclusion Criteria:

• Seeking family planning services at a selected study facility

• Aged 15-49 years old

• Female

• Able to provide informed consent

• Able to speak and understand English, Kiswahili, or Kalenjin

• Able to provide a safe phone number at which they can be recontacted for follow-up

• Not planning to move out of the area in the coming 6 months

Exclusion Criteria:

• Sterilized at baseline

• Pregnant at baseline

Related Conditions & MeSH terms

• Intimate Partner Violence

Intervention

Behavioral:
• ARCHES (Addressing Reproductive Coercion in Health Settings)
ARCHES (Addressing Reproductive Coercion in Health Settings) includes training existing contraceptive providers to (1) provide contraceptive clients with education on reproductive coercion and methods/ways to use contraceptive methods covertly if desired, (2) provide screening for reproductive coercion and intimate partner violence, (3) provide a referral to specialized services for those disclosing intimate partner violence, (4) and offer a palm-sized mini-booklet with educational information on reproductive coercion and intimate partner violence. A mobile application was developed to guide contraceptive providers through the counselling protocol.
• BCS+ (Balanced Counseling Strategy Plus)
BCS+ (Balanced Counseling Strategy Plus) is a contraceptive counseling protocol that contraceptive providers use to help clients identify suitable contraceptive methods based on their preferences and previous contraceptive experiences. The BCS+ also includes systematic screening for other health services such as HIV/STI, cervical cancer, and breast cancer. The BCS+ was adopted by the Kenya MOH as the standard contraceptive counseling protocol in the country.

Locations

Country	Name	City	State
Kenya	Burnt Forest Sub-county Hospital	Burnt Forest
Kenya	Kipkabus Health Centre	Burnt Forest
Kenya	Chepkigen Health Centre	Cheptiret
Kenya	Huruma District Hospital	Eldoret
Kenya	Kapsoya Health Centre	Eldoret
Kenya	Kapteldon Health Centre	Eldoret
Kenya	Kapyemit Dispensary	Eldoret
Kenya	Kipkenyo	Eldoret
Kenya	Pioneer Health Centre	Eldoret
Kenya	Railways	Eldoret
Kenya	Uasin Gishu District Hospital	Eldoret
Kenya	Kesses Health Centre	Kesses
Kenya	Chembulet Health Centre	Kimumu
Kenya	Chepkanga Health Centre	Kimumu
Kenya	Merewet Dispensary	Kimumu
Kenya	Moi's Bridge Health Centre	Moi's Bridge
Kenya	Moiben Health Centre	Moiben
Kenya	Chepkero Dispensary	Naiberi
Kenya	Soy Health Centre	Soy
Kenya	Sosiani Health Centre	Turbo
Kenya	Turbo Sub-County Hospital	Turbo
Kenya	Kabobo Health Centre	Ziwa
Kenya	Kipsigak Health Centre	Ziwa
Kenya	Ziwa Sub-County Hospital	Ziwa

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Kenya Ministry of Health, Population Council Kenya

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident unintended pregnancy	Difference in self-reported unintended pregnancy in the past 6 months at the 6-month follow-up in intervention compared to control group (single time point analysis)	6-month follow-up
Secondary	Modern contraceptive use in the past 6 months	Change in prevalence of self-reported modern contraceptive use in the past 6 months between baseline and 6-month follow-up in intervention compared to control group (difference-in differences)	Baseline (at facility prior to receiving care) and 6-month follow-up
Secondary	Physical intimate partner violence in the past 6 months	Change in prevalence of self-reported physical intimate partner violence experience in the past 6 months between combined baseline/post-visit and 6-month follow-up in intervention compared to control group (difference-in differences)	Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Secondary	Sexual intimate partner violence in the past 6 months	Change in prevalence of self-reported sexual intimate partner violence experience in the past 6 months between combined baseline/post-visit and 6-month follow-up in intervention compared to control group (difference-in differences)	Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Secondary	Emotional intimate partner violence in the past 6 months	Change in prevalence of self-reported emotional intimate partner violence experience in the past 6 months between combined baseline/post-visit and 6-month follow-up in intervention compared to control group (difference-in differences)	Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Secondary	Reproductive coercion from a male partner in the past 6 months	Change in prevalence of self-reported reproductive coercion experience in the past 6 months between combined baseline/post-visit and 6-month follow-up in intervention compared to control group (difference-in differences)	Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Secondary	Incident pregnancy	Difference in self-reported pregnancy in the past 6 months at the 6-month follow-up in intervention compared to control group (single time point analysis)	6-month follow-up
Secondary	Uptake of a modern contraceptive method	Difference in prevalence of self-reported modern contraceptive uptake post-visit in intervention compared to control group (single time point analysis)	Post-visit (at facility immediately after receiving care)
Secondary	Covert use of contraception in the past 6 months	Change in prevalence of self-reported covert contraceptive use in the past 6 months between baseline and 6-month follow-up in intervention compared to control group (difference-in differences)	Baseline (at facility prior to receiving care) and 6-month follow-up
Secondary	Contraceptive self-efficacy in the face of reproductive coercion	Change in mean self-efficacy score (range: 3-9, higher=higher self-efficacy) between baseline, post-visit, and 6-month follow-up in intervention compared to control group (difference-in differences)	Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Secondary	Awareness of intimate partner violence services	Change in prevalence of awareness of intimate partner violence services between baseline, post-visit, and 6-month follow-up in intervention compared to control group (difference-in differences)	Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Secondary	Self-efficacy to use intimate partner violence services	Change in mean self-efficacy score (range: 1-3, higher=higher self-efficacy) between baseline, post-visit, and 6-month follow-up in intervention compared to control group (difference-in differences)	Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Secondary	Use of intimate partner violence services	Difference in prevalence of use of intimate partner violence services in the past 6 months at the 6-month follow-up in intervention compared to control group (single time point analysis)	6-month follow-up
Secondary	Attitudes accepting of reproductive coercion	Change in mean attitude score (range: 6-12, higher=attitudes less accepting of reproductive coercion/improved attitudes) between baseline, post-visit, and 6-month follow-up in intervention compared to control group (difference-in differences)	Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Secondary	Quality of family planning care	Difference in mean (range: 11-55, higher=higher quality) interpersonal quality of family planning scale post-visit in intervention compared to control group (single time point analysis)	Post-visit (at facility immediately after receiving care)
Secondary	Discontinuation of modern contraception	Difference in prevalence of modern contraceptive discontinuation in the past 6 months at the 6-month follow-up in intervention compared to control group (single time point analysis)	6-month follow-up