Adapting, Expanding and Evaluating ARCHES in Kenya
Adapting, Expanding, and Evaluating ARCHES (Addressing Reproductive Coercion in Health Settings) in Kenya
1 other identifier
interventional
3,928
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
September 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2024
CompletedNovember 1, 2024
October 1, 2024
8 months
September 6, 2023
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
Modern contraceptive use in the past 6 months
Baseline (at facility prior to receiving care) and 6-month follow-up
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
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
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
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
- +10 more secondary outcomes
Study Arms (2)
Control - Standard contraceptive counseling
ACTIVE COMPARATORStandard contraceptive counseling, includes provider training on standard BCS+ counseling protocol and use of a companion mobile application to guide counseling
Intervention - Integrated contraceptive counseling
EXPERIMENTALIntegrated contraceptive counseling, includes provider training on ARCHES integrated in BCS+ counseling protocol and use of a companion mobile application to guide counseling
Interventions
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) 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Sterilized at baseline
- Pregnant at baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- Population Council Kenyacollaborator
- Kenya Ministry of Healthcollaborator
Study Sites (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
Moiben Health Centre
Moiben, Kenya
Moi's Bridge Health Centre
Moi‘s Bridge, 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
Related Publications (1)
Pearson E, Uysal J, Menzel J, Undie CC, Odwe G, Liambila W, Silverman JG. Evaluating a scalable ARCHES (Addressing Reproductive Coercion in Health Settings) model in government health facilities in Uasin Gishu county, Kenya: study protocol for a cluster-randomized controlled trial. Reprod Health. 2023 Oct 17;20(1):155. doi: 10.1186/s12978-023-01697-7.
PMID: 37848916DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jay G Silverman, PhD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
September 6, 2023
First Posted
September 28, 2023
Study Start
September 29, 2023
Primary Completion
May 17, 2024
Study Completion
May 17, 2024
Last Updated
November 1, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Upon publication of findings
- Access Criteria
- Open access
Will share de-identified participant data analysis sets to the Dyrad public data repository upon publication of findings