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Unintended PregnancyARCHESNCT03534401

Addressing Reproductive Coercion in HEalth Settings - Kenya

A study testing ARCHES Kenya in people with Unintended Pregnancy and Family Planning, run by University of California, San Diego at 1 site in United States.

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

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… Read more about this study

Who is it for?
Ages 15 to 49 years, women onlyHealthy volunteers can take part
What is being tested?
ARCHES Kenya
Could I receive a placebo?
No, everyone receives an active treatment
How many people
659 participants
Where
1 siteUnited States
Study dates
1 Jun 2018to 1 Dec 2020
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
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    San Diego, California, 92093

Other trials in United States

About this study

Official title: ARCHES Kenya: Addressing Reproductive Coercion in HEalth Settings

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.

Read the detailed description

The project consortium will implement the ARCHES Kenya model across 6 Family Health Options Kenya clinics in Nairobi, Kenya. A matched-pair cluster control design including 600 female family planning (FP) clients ages 15-49 years (inclusive of 360 clients age 15-24 years) will be utilized to evaluate this intervention. Baseline data will be collected prior to routine FP service delivery, with a short exit survey conducted immediately following the clients' FP appointment (ARCHES or standard FP counseling will be provided during this visit). Follow-up data will be collected at 3 and 6-months post-intervention. Qualitative data will be collected from intervention providers (n=12) regarding implementation via weekly technical assistance sessions during the first three months, and then monthly, regarding acceptability and feasibility of integrating ARCHES into routine FP counseling, including barriers and facilitators to implementation, and any issues with maintaining fidelity to the ARCHES model. Structured interviews with select providers (n=12) will also be conducted at 3-months post-training to delve further into these issues. Structured interviews with intervention participants reporting experience of RC in the past 3 months on the baseline survey (20 participants ages 15-24, 15 ages 25-49; total n=35) will be conducted at 3-months follow-up to assess their experience of the intervention; perceived utility of the messages, care and materials; barriers to utilizing messaging and materials; and suggestions for improvement. Analyses specific to participants ages 15-24 will provide findings to guide consideration of ARCHES as an effective strategy to improve reproductive health and reduce GBV among adolescents in the region. The project consortium will engage Government of Kenya officials, IPPF executive directors and IPPF member associations across the federation to pave the way for the future roll out of this approach in other low and middle-income country (LMIC) contexts.

Being tested
ARCHES Kenya
Keywords
Reproductive Coercion, Gender-based violence, Contraception, Clinic-based screening for IPV, Clinic-based counseling

What participants receive

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

  • ARCHES KenyaBehavioural

    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.

Study groups in NCT03534401
Study groupRoleWhat they receive
Standard Contraceptive CounselingNo interventionProviders at control clinics receive no additional training; clients receive standard contraceptive counseling services.
ARCHES Kenya Intervention in Contraceptive CounselingExperimentalProviders at intervention clinics receive training on ARCHES strategies integrated into contraceptive counseling; clients receive the ARCHES Kenya intervention integrated within standard contraceptive counseling services.
Receives: Behavioral: ARCHES Kenya

What is being measured

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

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Secondary outcomes (14)

  1. Number of Participants Reporting Incident Pregnancy

    Binary (yes/no) measure based on one self-report item asking how many times client has been pregnant in past 3 months. A response of greater than zero indicates incident pregnancy.

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

  2. Number of Participants Reporting Incident Unintended Pregnancy

    Binary (yes/no) measure based on an additional item for those self-reporting incident pregnancy "at the time you became pregnant, did you want to become pregnant then, did you want to wait to become pregnant at a later date, or did you not want any more children?" A response of "wanted to wait until later date" OR "did not want anymore children" for incident pregnancy in prior 3 months indicates incident unintended pregnancy.

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

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

    Investigator developed contraceptive self-efficacy scale, 4-items, Likert response (strongly agree, somewhat agree, disagree), sum score minimum 0 to maximum 8. Higher score indicates better outcome (i.e., greater contraceptive self-efficacy).

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

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

    Investigator developed contraceptive self-efficacy scale, 4-items, Likert response (strongly agree, somewhat agree, disagree), sum score minimum 0 to maximum 8. Higher score indicates better outcome (i.e., greater contraceptive self-efficacy).

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

  5. Mean Attitudes Justifying Reproductive Coercion Scale Score (1)

    Investigator developed scale measuring attitudes justifying reproductive coercion. Sum score based on 8-item scale (minimum 0, maximum 8) asking participants if it is acceptable for husbands or male partners to enact different forms of RC in a variety of situations, based on participant response to agree/disagree and summed number of agrees over the items. Higher scores indicate worse outcome (i.e., greater justification of reproductive coercion).

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

  6. Mean Attitudes Justifying Reproductive Coercion Scale Score (2)

    Investigator developed scale measuring attitudes justifying reproductive coercion. Sum score based on 8-item scale (minimum 0, maximum 8) asking participants if it is acceptable for husbands or male partners to enact different forms of RC in a variety of situations, based on participant response to agree/disagree and summed number of agrees over the items. Higher scores indicate worse outcome (i.e., greater justification of reproductive coercion).

    Measured: Change from baseline mean attitudes justifying reproductive coercion score at 6 month follow-up

  7. Mean Attitudes Justifying Intimate Partner Violence Scale Score (1)

    Adapted scale measuring attitudes justifying intimate partner violence. Sum score (minimum 0, maximum 7) based on adapted DHS justification of wife beating scale (7-items), based on participant response to agree/disagree and summed number of agrees over the items. Higher scores indicate worse outcome (i.e., greater justification of intimate partner violence).

    Measured: Change from baseline mean attitudes justifying intimate partner violence score at 3 month follow-up

  8. Mean Attitudes Justifying Intimate Partner Violence Scale Score (2)

    Adapted scale measuring attitudes justifying intimate partner violence. Sum score (minimum 0, maximum 7) based on adapted DHS justification of wife beating scale (7-items), based on participant response to agree/disagree and summed number of agrees over the items. Higher scores indicate worse outcome (i.e., greater justification of intimate partner violence).

    Measured: Change from baseline mean attitudes justifying intimate partner violence score at 6 month follow-up

  9. Number of Participants Reporting Awareness of Intimate Partner Violence Services (1)

    Binary (yes/no) measure based on four-items assessing reported awareness of listed local services for women and girls experiencing IPV. A "yes" response to any of the four items indicates awareness of IPV services.

    Measured: Change from baseline number reporting awareness of intimate partner violence services at 3 month follow-up

  10. Number of Participants Reporting Awareness of Intimate Partner Violence Services (2)

    Binary (yes/no) measure based on four-items assessing reported awareness of listed local services for women and girls experiencing IPV. A "yes" response to any of the four items indicates awareness of IPV services.

    Measured: Change from baseline number reporting awareness of intimate partner violence services at 6 month follow-up

  11. Number of Participants Reporting Covert Use of Contraceptives (1)

    Binary (yes/no) measure based on one item if a client has "used family planning without telling a male partner" in the past 3 months. A "yes" response indicates covert use of contraceptives in the past 3 months. Assessed for all clients and those reporting RC/IPV separately.

    Measured: Change from baseline number reporting covert use of contraceptives at 3 month follow-up

  12. Number of Participants Reporting Covert Use of Contraceptives (2)

    Binary (yes/no) measure based on one item if a client has "used family planning without telling a male partner" in the past 3 months. A "yes" response indicates covert use of contraceptives in the past 3 months. Assessed for all clients and those reporting RC/IPV separately.

    Measured: Change from baseline number reporting covert use of contraceptives at 6 month follow-up

  13. Utilization of Intimate Partner Violence Services

    Binary (yes/no) measure based on items assessing whether a participant called or visited a listed local service for women or girls experiencing IPV in the past 3 months. A "yes" response indicates utilization of IPV services in the past 3 months. Assessed for all clients and those reporting RC/IPV separately.

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

  14. Leaving a Relationship Because it Felt Unsafe, Unhealthy or Abusive

    Binary (yes/no) measure based on question "in the last three months, have you left a relationship because it felt unhealthy, unsafe, or abusive?" A "yes" response indicates leaving a relationship because it felt unsafe, unhealthy, or abusive. Assessed for all clients and those reporting RC/IPV separately.

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

Timeline

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

  1. First posted23 May 2018
  2. Study start1 Jun 2018
  3. Primary completion1 Aug 2019
  4. Study completion1 Dec 2020

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
659 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03534401
Sponsor's protocol ID
170084
Acronym
ARCHES
Status last verified
Feb 2023
First submitted
7 May 2018
Last updated
13 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified data included in analyses will be shared in a public data repository at the time of publication.

Publications

  • 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.

    PubMed 41070626

  • 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.

    PubMed 32460786

Questions about this trial

What is this clinical trial studying?

A study testing ARCHES Kenya in people with Unintended Pregnancy and Family Planning, run by University of California, San Diego at 1 site in United States.

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 9 inclusion and 3 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 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Number of Participants Reporting Reproductive Coercion (time frame: Change from baseline number reporting reproductive coercion at 3 and 6 month follow-up (combined)). The study lists 4 primary outcomes in all. 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 NCT03534401, which also lists 2 linked publications.

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 13 Feb 2023.

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