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Clinical Trials/NCT03534401
NCT03534401
Completed
Not Applicable

ARCHES Kenya: Addressing Reproductive Coercion in HEalth Settings

University of California, San Diego1 site in 1 country659 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unintended Pregnancy
Sponsor
University of California, San Diego
Enrollment
659
Locations
1
Primary Endpoint
Number of Participants Reporting Reproductive Coercion
Status
Completed
Last Updated
3 years ago

Overview

Brief 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 (ARCHES Kenya) so as to provide initial data regarding acceptability, feasibility and efficacy in this high-need LMIC context.

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
December 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jay G. Silverman, PhD

Professor of Medicine and Global Public Health

University of California, San Diego

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

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

  • Mean Contraception Self-efficacy Including in the Face of Reproductive Coercion Scale Score (1)(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)(Change from baseline mean contraceptive self-efficacy score at 6 month follow-up)
  • Mean Attitudes Justifying Intimate Partner Violence Scale Score (1)(Change from baseline mean attitudes justifying intimate partner violence score at 3 month follow-up)
  • Number of Participants Reporting Awareness of Intimate Partner Violence Services (1)(Change from baseline number reporting awareness of intimate partner violence services at 3 month follow-up)
  • Number of Participants Reporting Incident Pregnancy(Assessed at 3 months and 6 month follow-up (combined))
  • Number of Participants Reporting Incident Unintended Pregnancy(Assessed at 3 months and 6 month follow-up (combined))
  • Mean Attitudes Justifying Reproductive Coercion Scale Score (1)(Change from baseline mean attitudes justifying reproductive coercion score at 3 month follow-up)
  • Mean Attitudes Justifying Reproductive Coercion Scale Score (2)(Change from baseline mean attitudes justifying reproductive coercion score at 6 month follow-up)
  • Mean Attitudes Justifying Intimate Partner Violence Scale Score (2)(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 (2)(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)(Change from baseline number reporting covert use of contraceptives at 3 month follow-up)
  • Number of Participants Reporting Covert Use of Contraceptives (2)(Change from baseline number reporting covert use of contraceptives at 6 month follow-up)
  • Utilization of Intimate Partner Violence Services(Assessed at 3 months and 6 month follow-up (combined))
  • Leaving a Relationship Because it Felt Unsafe, Unhealthy or Abusive(Assessed at 3 months and 6 month follow-up (combined))

Study Sites (1)

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