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Completed

NCT Number: NCT03534401

Addressing Reproductive Coercion in HEalth Settings - Kenya

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.

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Key information

Conditions

Unintended Pregnancy Family Planning Intimate Partner Violence (IPV)

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

San Diego, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • International Planned Parenthood Federation
  • Population Council

Registry information

Official study title

ARCHES Kenya: Addressing Reproductive Coercion in HEalth Settings

Acronym: ARCHES

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 23, 2018
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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