Addressing Reproductive Coercion in HEalth Settings - Kenya

NCT03534401 | Completed

• 1 other identifier: 170084
• Study Type: interventional
• Target: 659
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this research is to conduct a small matched cluster control trial of an intervention designed to address reproductive coercion and unintended pregnancy (ARCHES - Addressing Reproductive Coercion within Healthcare Settings) adapted to the Kenyan cultural and family planning healthcare context (ARCHES Kenya) so as to provide initial data regarding acceptability, feasibility and efficacy in this high-need LMIC context.

Conditions

Unintended Pregnancy; Family Planning; Intimate Partner Violence (IPV)

Keywords

Reproductive Coercion; Gender-based violence; Contraception; Clinic-based screening for IPV; Clinic-based counseling

Outcome Measures

Primary Outcomes (4)

• Number of Participants Reporting Reproductive Coercion

  Binary (yes/no) measure based on 9-item indicator list (entitled the Reproductive Coercion Scale) assessing incidence of male partner behaviors that interfere with or prevent use of contraception or coerce pregnancy in prior 3 months. A "yes" response to any of the 9-items indicates reproductive coercion is present.

  Change from baseline number reporting reproductive coercion at 3 and 6 month follow-up (combined)

• Number of Participants Reporting Intimate Partner Violence

  Binary (yes/no) measure based on adapted version of the injury subscale of the Conflict Tactics Scale 2 (CTS-2). A "yes" response to any of the subscale items indicates physical intimate partner violence is present.

  Change from baseline number reporting physical intimate partner violence at 3 and 6 month follow-up (combined)

• Number of Participants Reporting Sexual Intimate Partner Violence

  Binary (yes/no) measure based on single item modified from the Sexual Experiences Short-Form Survey. A "yes" response to this item indicates sexual intimate partner violence is present.

  Change from baseline number reporting sexual intimate partner violence at 3 and 6 month follow-up (combined)

• Number of Participants Reporting Uptake of a Modern Contraceptive Method

  Binary (yes/no) measure based on response if participant received a method from their provider and reported a modern method (IUD, implant, injection, pill, condom). A "yes" response to receiving a method and receiving one of the modern methods listed indicates update a modern contraceptive method.

  Assessed at exit interview on month 0 (immediately after baseline and provider appointment)

Secondary Outcomes (14)

• Number of Participants Reporting Incident Pregnancy

  Assessed at 3 months and 6 month follow-up (combined)

• Number of Participants Reporting Incident Unintended Pregnancy

  Assessed at 3 months and 6 month follow-up (combined)

• Mean Contraception Self-efficacy Including in the Face of Reproductive Coercion Scale Score (1)

  Change from baseline mean contraceptive self-efficacy score at 3 month follow-up

• Mean Contraception Self-efficacy Including in the Face of Reproductive Coercion Scale Score (2)

  Change from baseline mean contraceptive self-efficacy score at 6 month follow-up

• Mean Attitudes Justifying Reproductive Coercion Scale Score (1)

  Change from baseline mean attitudes justifying reproductive coercion score at 3 month follow-up

Study Arms (2)

Standard Contraceptive Counseling

NO INTERVENTION

Providers at control clinics receive no additional training; clients receive standard contraceptive counseling services.

ARCHES Kenya Intervention in Contraceptive Counseling

EXPERIMENTAL

Providers at intervention clinics receive training on ARCHES strategies integrated into contraceptive counseling; clients receive the ARCHES Kenya intervention integrated within standard contraceptive counseling services.

Behavioral: ARCHES Kenya

Interventions

ARCHES Kenya BEHAVIORAL

ARCHES: Contraceptive counselors in intervention clinics will receiving training to ) provide counseling and education regarding risk of partner detection of contraceptive methods, and women's and girls' strategies to use contraceptive methods to minimize partner detection risk integrated into standard contraceptive counseling, b) make brief inquiries to allow clients the opportunity to disclose experiences of RC and IPV (i.e., screening), c) provide method-specific counseling based on this information and the method chosen by the client, d) provide supported linkage of IPV survivors to local IPV support services (i.e. warm referral), and e) offer palm-sized educational materials on RC and IPV, as well as IPV services to all clients.

ARCHES Kenya Intervention in Contraceptive Counseling

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: self-report biologically female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Visiting FHOK study clinic "for family planning or interested in receiving family planning"
• Aged 15-49 years
• Not currently pregnant (self-report)
• Not sterilized (self-report)
• Have a male partner with whom they have had sex in the past 3 months
• Biologically Female
• Not planning to move out of the area in the next 6 months
• Have a mobile phone that can be safely used for recontacting
• Able to safely participate in a private interview

You may not qualify if:

• Declined to participate
• Participated in pilot (measured by taking a women's health survey at the clinic in the past 3 months)
• Unable or unwilling to complete exit survey, or reported not receiving any contraceptive counseling at exit

Sponsors & Collaborators

• University of California, San Diego: lead
• Bill and Melinda Gates Foundation: collaborator
• International Planned Parenthood Federation: collaborator
• Population Council: collaborator

Study Sites (1)

Center on Gender Equity and Health, University of California, San Diego

San Diego, California, 92093, United States

Location

Related Publications (2)

• Uysal J, Schwarz E, Liambila W, Wendoh S, Fonseka RW, Monroy RV, Boyce SC, Pearson E, Silverman JG. Strategies to address reproductive coercion and intimate partner violence in Nairobi family planning services: qualitative client and provider perspectives. Sex Reprod Health Matters. 2025 Dec;33(1):2570528. doi: 10.1080/26410397.2025.2570528. Epub 2025 Dec 15.

  PMID: 41070626 DERIVED

• Uysal J, Carter N, Johns N, Boyce S, Liambila W, Undie CC, Muketo E, Adhiambo J, Gray K, Wendoh S, Silverman JG. Protocol for a matched-pair cluster control trial of ARCHES (Addressing Reproductive Coercion in Health Settings) among women and girls seeking contraceptive services from community-based clinics in Nairobi, Kenya. Reprod Health. 2020 May 27;17(1):77. doi: 10.1186/s12978-020-00916-9.

  PMID: 32460786 DERIVED

Study Officials

• Jay G Silverman, PhD

  UCSD Center on Gender Equity and Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Global Public Health

Model Details: The ARCHES Kenya study will take place in six IPPF-affiliated Family Health Options Kenya (FHOK) clinics in Nairobi, Kenya or surrounding smaller cities for all clients receiving voluntary FP counseling. The intervention study will involve a matched cluster control trial. Three clinics will serve as the intervention sites and three other clinics matched on client volume and demographics, clinic structure and staffing will serve as matched comparison sites and will not receive the intervention.

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 23, 2018
• Study Start: June 1, 2018
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2020
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The study protocol was published in 2020 prior to completion of data collection (https://doi.org/10.1186/s12978-020-00916-9). Informed consent forms and analytic code will be made available at the time of publication.

Locations

US (1)