Adapting, Expanding and Evaluating ARCHES in Kenya
- Conditions
- Reproductive CoercionIntimate Partner Violence
- Interventions
- Behavioral: BCS+ (Balanced Counseling Strategy Plus)Behavioral: ARCHES (Addressing Reproductive Coercion in Health Settings)
- Registration Number
- NCT06059196
- Lead Sponsor
- University of California, San Diego
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3928
- 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
- Sterilized at baseline
- Pregnant at baseline
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control - Standard contraceptive counseling BCS+ (Balanced Counseling Strategy Plus) Standard contraceptive counseling, includes provider training on standard BCS+ counseling protocol and use of a companion mobile application to guide counseling Intervention - Integrated contraceptive counseling ARCHES (Addressing Reproductive Coercion in Health Settings) Integrated contraceptive counseling, includes provider training on ARCHES integrated in BCS+ counseling protocol and use of a companion mobile application to guide counseling Intervention - Integrated contraceptive counseling BCS+ (Balanced Counseling Strategy Plus) Integrated contraceptive counseling, includes provider training on ARCHES integrated in BCS+ counseling protocol and use of a companion mobile application to guide counseling
- Primary Outcome Measures
Name Time Method Incident unintended pregnancy 6-month follow-up 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)
- Secondary Outcome Measures
Name Time Method Use of intimate partner violence services 6-month follow-up 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)
Modern contraceptive use in the past 6 months Baseline (at facility prior to receiving care) and 6-month follow-up 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)
Emotional intimate partner violence in the past 6 months 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 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)
Contraceptive self-efficacy in the face of reproductive coercion Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up 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)
Sexual intimate partner violence in the past 6 months 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 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)
Covert use of contraception in the past 6 months Baseline (at facility prior to receiving care) and 6-month follow-up 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)
Awareness of intimate partner violence services Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up 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)
Quality of family planning care Post-visit (at facility immediately after receiving 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)
Reproductive coercion from a male partner in the past 6 months 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 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)
Incident pregnancy 6-month follow-up 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)
Self-efficacy to use intimate partner violence services Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up 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)
Attitudes accepting of reproductive coercion Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up 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)
Discontinuation of modern contraception 6-month follow-up 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)
Physical intimate partner violence in the past 6 months 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 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)
Uptake of a modern contraceptive method Post-visit (at facility immediately after receiving care) Difference in prevalence of self-reported modern contraceptive uptake post-visit in intervention compared to control group (single time point analysis)
Trial Locations
- Locations (24)
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, Kenya