Addressing Reproductive Coercion in HEalth Settings - Kenya (ARCHES)

February 8, 2023 updated by: Jay G. Silverman, PhD, University of California, San Diego

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
659

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093
        • Center on Gender Equity and Health, University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 49 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Standard Contraceptive Counseling
Providers at control clinics receive no additional training; clients receive standard contraceptive counseling services.
EXPERIMENTAL: ARCHES Kenya Intervention in Contraceptive Counseling
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Reproductive Coercion
Time Frame: Change from baseline number reporting reproductive coercion at 3 and 6 month follow-up (combined)
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
Time Frame: Change from baseline number reporting physical intimate partner violence at 3 and 6 month follow-up (combined)
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
Time Frame: Change from baseline number reporting sexual intimate partner violence at 3 and 6 month follow-up (combined)
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
Time Frame: Assessed at exit interview on month 0 (immediately after baseline and provider appointment)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Reporting Incident Pregnancy
Time Frame: Assessed at 3 months and 6 month follow-up (combined)
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.
Assessed at 3 months and 6 month follow-up (combined)
Number of Participants Reporting Incident Unintended Pregnancy
Time Frame: Assessed at 3 months and 6 month follow-up (combined)
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.
Assessed at 3 months and 6 month follow-up (combined)
Mean Contraception Self-efficacy Including in the Face of Reproductive Coercion Scale Score (1)
Time Frame: Change from baseline mean contraceptive self-efficacy score at 3 month follow-up
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).
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)
Time Frame: Change from baseline mean contraceptive self-efficacy score at 6 month follow-up
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).
Change from baseline mean contraceptive self-efficacy score at 6 month follow-up
Mean Attitudes Justifying Reproductive Coercion Scale Score (1)
Time Frame: Change from baseline mean attitudes justifying reproductive coercion score at 3 month follow-up
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).
Change from baseline mean attitudes justifying reproductive coercion score at 3 month follow-up
Mean Attitudes Justifying Reproductive Coercion Scale Score (2)
Time Frame: Change from baseline mean attitudes justifying reproductive coercion score at 6 month follow-up
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).
Change from baseline mean attitudes justifying reproductive coercion score at 6 month follow-up
Mean Attitudes Justifying Intimate Partner Violence Scale Score (1)
Time Frame: Change from baseline mean attitudes justifying intimate partner violence score at 3 month follow-up
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).
Change from baseline mean attitudes justifying intimate partner violence score at 3 month follow-up
Mean Attitudes Justifying Intimate Partner Violence Scale Score (2)
Time Frame: Change from baseline mean attitudes justifying intimate partner violence score at 6 month follow-up
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).
Change from baseline mean attitudes justifying intimate partner violence score at 6 month follow-up
Number of Participants Reporting Awareness of Intimate Partner Violence Services (1)
Time Frame: Change from baseline number reporting awareness of intimate partner violence services at 3 month follow-up
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.
Change from baseline number reporting awareness of intimate partner violence services at 3 month follow-up
Number of Participants Reporting Awareness of Intimate Partner Violence Services (2)
Time Frame: Change from baseline number reporting awareness of intimate partner violence services at 6 month follow-up
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.
Change from baseline number reporting awareness of intimate partner violence services at 6 month follow-up
Number of Participants Reporting Covert Use of Contraceptives (1)
Time Frame: Change from baseline number reporting covert use of contraceptives at 3 month follow-up
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.
Change from baseline number reporting covert use of contraceptives at 3 month follow-up
Number of Participants Reporting Covert Use of Contraceptives (2)
Time Frame: Change from baseline number reporting covert use of contraceptives at 6 month follow-up
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.
Change from baseline number reporting covert use of contraceptives at 6 month follow-up
Utilization of Intimate Partner Violence Services
Time Frame: Assessed at 3 months and 6 month follow-up (combined)
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.
Assessed at 3 months and 6 month follow-up (combined)
Leaving a Relationship Because it Felt Unsafe, Unhealthy or Abusive
Time Frame: Assessed at 3 months and 6 month follow-up (combined)
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.
Assessed at 3 months and 6 month follow-up (combined)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bill and Melinda Gates Foundation
Population Council
International Planned Parenthood Federation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jay G Silverman, PhD, UCSD Center on Gender Equity and Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 170084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data included in analyses will be shared in a public data repository at the time of publication.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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