Clinical trial NCT03534401: Addressing Reproductive Coercion in HEalth Settings - Kenya
Official title: ARCHES Kenya: Addressing Reproductive Coercion in HEalth Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unintended Pregnancy
Family Planning
Intimate Partner Violence (IPV)
Keywords: Reproductive Coercion
Gender-based violence
Contraception
Clinic-based screening for IPV
Clinic-based counseling
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: International Planned Parenthood Federation
name: Population Council
First posted: 2018-05-23
Enrollment: 659
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of Participants Reporting Reproductive Coercion
timeFrame: Change from baseline number reporting reproductive coercion at 3 and 6 month follow-up (combined)
measure: Number of Participants Reporting Intimate Partner Violence
timeFrame: Change from baseline number reporting physical intimate partner violence at 3 and 6 month follow-up (combined)
measure: Number of Participants Reporting Sexual Intimate Partner Violence
timeFrame: Change from baseline number reporting sexual intimate partner violence at 3 and 6 month follow-up (combined)
measure: Number of Participants Reporting Uptake of a Modern Contraceptive Method
timeFrame: Assessed at exit interview on month 0 (immediately after baseline and provider appointment)
Secondary outcomes:
measure: Number of Participants Reporting Incident Pregnancy
timeFrame: Assessed at 3 months and 6 month follow-up (combined)
measure: Number of Participants Reporting Incident Unintended Pregnancy
timeFrame: Assessed at 3 months and 6 month follow-up (combined)
measure: Mean Contraception Self-efficacy Including in the Face of Reproductive Coercion Scale Score (1)
timeFrame: Change from baseline mean contraceptive self-efficacy score at 3 month follow-up
measure: Mean Contraception Self-efficacy Including in the Face of Reproductive Coercion Scale Score (2)
timeFrame: Change from baseline mean contraceptive self-efficacy score at 6 month follow-up
measure: Mean Attitudes Justifying Reproductive Coercion Scale Score (1)
timeFrame: Change from baseline mean attitudes justifying reproductive coercion score at 3 month follow-up
measure: Mean Attitudes Justifying Reproductive Coercion Scale Score (2)
timeFrame: Change from baseline mean attitudes justifying reproductive coercion score at 6 month follow-up
measure: Mean Attitudes Justifying Intimate Partner Violence Scale Score (1)
timeFrame: Change from baseline mean attitudes justifying intimate partner violence score at 3 month follow-up
measure: Mean Attitudes Justifying Intimate Partner Violence Scale Score (2)
timeFrame: Change from baseline mean attitudes justifying intimate partner violence score at 6 month follow-up
measure: Number of Participants Reporting Awareness of Intimate Partner Violence Services (1)
timeFrame: Change from baseline number reporting awareness of intimate partner violence services at 3 month follow-up
measure: Number of Participants Reporting Awareness of Intimate Partner Violence Services (2)
timeFrame: Change from baseline number reporting awareness of intimate partner violence services at 6 month follow-up
measure: Number of Participants Reporting Covert Use of Contraceptives (1)
timeFrame: Change from baseline number reporting covert use of contraceptives at 3 month follow-up
measure: Number of Participants Reporting Covert Use of Contraceptives (2)
timeFrame: Change from baseline number reporting covert use of contraceptives at 6 month follow-up
measure: Utilization of Intimate Partner Violence Services
timeFrame: Assessed at 3 months and 6 month follow-up (combined)
measure: Leaving a Relationship Because it Felt Unsafe, Unhealthy or Abusive
timeFrame: Assessed at 3 months and 6 month follow-up (combined)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Center on Gender Equity and Health, University of California, San Diego
state: California
Study officials:
affiliation: UCSD Center on Gender Equity and Health
name: Jay G Silverman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.