Clinical trial NCT06059196: Adapting, Expanding and Evaluating ARCHES in Kenya
Official title: Adapting, Expanding, and Evaluating ARCHES (Addressing Reproductive Coercion in Health Settings) in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reproductive Coercion
Intimate Partner Violence
Keywords: Reproductive coercion
Intimate partner violence
Contraceptive Usage
Pregnancy Related
Quality of Care
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Population Council Kenya
name: Kenya Ministry of Health
First posted: 2023-09-28
Enrollment: 3928
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized controlled trial; stratified randomization based on facility type and urban/rural location.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incident unintended pregnancy
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Modern contraceptive use in the past 6 months
timeFrame: Baseline (at facility prior to receiving care) and 6-month follow-up
measure: Physical intimate partner violence in the past 6 months
timeFrame: 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
measure: Sexual intimate partner violence in the past 6 months
timeFrame: 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
measure: Emotional intimate partner violence in the past 6 months
timeFrame: 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
measure: Reproductive coercion from a male partner in the past 6 months
timeFrame: 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
measure: Incident pregnancy
timeFrame: 6-month follow-up
measure: Uptake of a modern contraceptive method
timeFrame: Post-visit (at facility immediately after receiving care)
measure: Covert use of contraception in the past 6 months
timeFrame: Baseline (at facility prior to receiving care) and 6-month follow-up
measure: Contraceptive self-efficacy in the face of reproductive coercion
timeFrame: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
measure: Awareness of intimate partner violence services
timeFrame: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
measure: Self-efficacy to use intimate partner violence services
timeFrame: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
measure: Use of intimate partner violence services
timeFrame: 6-month follow-up
measure: Attitudes accepting of reproductive coercion
timeFrame: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
measure: Quality of family planning care
timeFrame: Post-visit (at facility immediately after receiving care)
measure: Discontinuation of modern contraception
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Burnt Forest
country: Kenya
facility: Burnt Forest Sub-county Hospital
city: Burnt Forest
country: Kenya
facility: Kipkabus Health Centre
city: Cheptiret
country: Kenya
facility: Chepkigen Health Centre
city: Eldoret
country: Kenya
facility: Huruma District Hospital
city: Eldoret
country: Kenya
facility: Kapsoya Health Centre
city: Eldoret
country: Kenya
facility: Kapteldon Health Centre
city: Eldoret
country: Kenya
facility: Kapyemit Dispensary
city: Eldoret
country: Kenya
facility: Kipkenyo
city: Eldoret
country: Kenya
facility: Pioneer Health Centre
city: Eldoret
country: Kenya
facility: Railways
city: Eldoret
country: Kenya
facility: Uasin Gishu District Hospital
city: Kesses
country: Kenya
facility: Kesses Health Centre
city: Kimumu
country: Kenya
facility: Chembulet Health Centre
city: Kimumu
country: Kenya
facility: Chepkanga Health Centre
city: Kimumu
country: Kenya
facility: Merewet Dispensary
city: Moi's Bridge
country: Kenya
facility: Moi's Bridge Health Centre
city: Moiben
country: Kenya
facility: Moiben Health Centre
city: Naiberi
country: Kenya
facility: Chepkero Dispensary
city: Soy
country: Kenya
facility: Soy Health Centre
city: Turbo
country: Kenya
facility: Sosiani Health Centre
city: Turbo
country: Kenya
facility: Turbo Sub-County Hospital
city: Ziwa
country: Kenya
facility: Kabobo Health Centre
city: Ziwa
country: Kenya
facility: Kipsigak Health Centre
city: Ziwa
country: Kenya
facility: Ziwa Sub-County Hospital
Study officials:
affiliation: University of California, San Diego
name: Jay G Silverman, PhD
role: PRINCIPAL_INVESTIGATOR
References: