Addressing Reproductive Coercion in HEalth Settings - Kenya

Study Overview
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Brief Summary
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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
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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.

Official Title
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ARCHES Kenya: Addressing Reproductive Coercion in HEalth Settings

Conditions
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Unintended Pregnancy, Family Planning, Intimate Partner Violence (IPV)

Intervention / Treatment
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* Behavioral: ARCHES Kenya


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Contraceptive Counseling<br>Providers at control clinics receive no additional training; clients receive standard contraceptive counseling services. | |
| Experimental: ARCHES Kenya Intervention in Contraceptive Counseling<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline number reporting reproductive coercion at 3 and 6 month follow-up (combined) | 
| 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. | 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 | 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 | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessed at 3 months and 6 month follow-up (combined) | 
| 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. | Assessed at 3 months and 6 month follow-up (combined) | 
| 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). | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reproductive Coercion, Gender-based violence, Contraception, Clinic-based screening for IPV, Clinic-based counseling