Adapting, Expanding and Evaluating ARCHES in Kenya

NCT ID: NCT06059196

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3928 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-29
• Study Completion Date: 2024-05-17

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.

Conditions

Reproductive Coercion; Intimate Partner Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control - Standard contraceptive counseling

Standard contraceptive counseling, includes provider training on standard BCS+ counseling protocol and use of a companion mobile application to guide counseling

Group Type: ACTIVE_COMPARATOR

BCS+ (Balanced Counseling Strategy Plus)

Intervention Type: BEHAVIORAL

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.

Intervention - Integrated contraceptive counseling

Integrated contraceptive counseling, includes provider training on ARCHES integrated in BCS+ counseling protocol and use of a companion mobile application to guide counseling

Group Type: EXPERIMENTAL

ARCHES (Addressing Reproductive Coercion in Health Settings)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Population Council Kenya

UNKNOWN

Sponsor Role: collaborator

Kenya Ministry of Health

OTHER_GOV

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Jay G. Silverman, PhD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jay G Silverman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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

Countries

Kenya

References

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.

Reference Type: DERIVED

PMID: 37848916 (View on PubMed)

Other Identifiers

201922S

Identifier Type: -

Identifier Source: org_study_id