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Reproductive CoercionNCT06059196

Adapting, Expanding and Evaluating ARCHES in Kenya

A study testing ARCHES (Addressing Reproductive Coercion in Health Settings) and BCS+ (Balanced Counseling Strategy Plus) in people with Reproductive Coercion and Intimate Partner Violence, run by University of California, San Diego at 24 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 49 years, women only
What is being tested?
ARCHES (Addressing Reproductive Coercion in Health Settings) and BCS+ (Balanced Counseling Strategy Plus)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,928 participants
Where
24 sitesKenya
Study dates
29 Sep 2023to 17 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 49 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • Sterilized at baseline
  • Pregnant at baseline

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Kenya24 sites
  • Burnt Forest Sub-county Hospital

    Burnt Forest

  • Kipkabus Health Centre

    Burnt Forest

  • Chepkigen Health Centre

    Cheptiret

  • Huruma District Hospital

    Eldoret

  • Kapsoya Health Centre

    Eldoret

  • Kapteldon Health Centre

    Eldoret

  • Kapyemit Dispensary

    Eldoret

  • Kipkenyo

    Eldoret

  • Pioneer Health Centre

    Eldoret

  • Railways

    Eldoret

  • Uasin Gishu District Hospital

    Eldoret

  • Kesses Health Centre

    Kesses

  • Chembulet Health Centre

    Kimumu

  • Chepkanga Health Centre

    Kimumu

  • Merewet Dispensary

    Kimumu

  • Moi's Bridge Health Centre

    Moi‘s Bridge

  • Moiben Health Centre

    Moiben

  • Chepkero Dispensary

    Naiberi

  • Soy Health Centre

    Soy

  • Sosiani Health Centre

    Turbo

  • Turbo Sub-County Hospital

    Turbo

  • Kabobo Health Centre

    Ziwa

  • Kipsigak Health Centre

    Ziwa

  • Ziwa Sub-County Hospital

    Ziwa

Other trials in Kenya

About this study

Official title: Adapting, Expanding, and Evaluating ARCHES (Addressing Reproductive Coercion in Health Settings) in Kenya

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.

Read the 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.

Being tested
ARCHES (Addressing Reproductive Coercion in Health Settings), BCS+ (Balanced Counseling Strategy Plus)
Keywords
Reproductive coercion, Intimate partner violence, Contraceptive Usage, Pregnancy Related, Quality of Care
Medical subject headings
Contraception Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARCHES (Addressing Reproductive Coercion in Health Settings)Behavioural

    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)Behavioural

    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.

Study groups in NCT06059196
Study groupRoleWhat they receive
Control - Standard contraceptive counselingActive comparatorStandard contraceptive counseling, includes provider training on standard BCS+ counseling protocol and use of a companion mobile application to guide counseling
Receives: Behavioral: BCS+ (Balanced Counseling Strategy Plus)
Intervention - Integrated contraceptive counselingExperimentalIntegrated contraceptive counseling, includes provider training on ARCHES integrated in BCS+ counseling protocol and use of a companion mobile application to guide counseling
Receives: Behavioral: ARCHES (Addressing Reproductive Coercion in Health Settings); Behavioral: BCS+ (Balanced Counseling Strategy Plus)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 6-month follow-up

Secondary outcomes (15)
  1. Modern contraceptive use in the past 6 months

    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)

    Measured: Baseline (at facility prior to receiving care) and 6-month follow-up

  2. Physical intimate partner violence in the past 6 months

    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)

    Measured: 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

  3. Sexual intimate partner violence in the past 6 months

    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)

    Measured: 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

  4. Emotional intimate partner violence in the past 6 months

    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)

    Measured: 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

  5. Reproductive coercion from a male partner in the past 6 months

    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)

    Measured: 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

  6. Incident pregnancy

    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)

    Measured: 6-month follow-up

  7. Uptake of a modern contraceptive method

    Difference in prevalence of self-reported modern contraceptive uptake post-visit in intervention compared to control group (single time point analysis)

    Measured: Post-visit (at facility immediately after receiving care)

  8. Covert use of contraception in the past 6 months

    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)

    Measured: Baseline (at facility prior to receiving care) and 6-month follow-up

  9. Contraceptive self-efficacy in the face of reproductive coercion

    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)

    Measured: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up

  10. Awareness of intimate partner violence services

    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)

    Measured: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up

  11. Self-efficacy to use intimate partner violence services

    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)

    Measured: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up

  12. Use of intimate partner violence services

    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)

    Measured: 6-month follow-up

  13. Attitudes accepting of reproductive coercion

    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)

    Measured: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up

  14. Quality of family planning 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)

    Measured: Post-visit (at facility immediately after receiving care)

  15. Discontinuation of modern contraception

    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)

    Measured: 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2023
  2. Study start29 Sep 2023
  3. Primary completion17 May 2024
  4. Study completion17 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster-randomized controlled trial; stratified randomization based on facility type and urban/rural location.
Masking
None (open label)
Enrolment
3,928 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06059196
Sponsor's protocol ID
201922S
Status last verified
Oct 2024
First submitted
6 Sep 2023
Last updated
1 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Will share de-identified participant data analysis sets to the Dyrad public data repository upon publication of findings

Publications

  • 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.

    PubMed 37848916

Questions about this trial

What is this clinical trial studying?

A study testing ARCHES (Addressing Reproductive Coercion in Health Settings) and BCS+ (Balanced Counseling Strategy Plus) in people with Reproductive Coercion and Intimate Partner Violence, run by University of California, San Diego at 24 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incident unintended pregnancy (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06059196, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.

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