ARCHES: Addressing Reproductive Coercion in HEalth Settings - Kenya

Sponsor
University of California, San Diego (Other)
Overall Status
Completed
CT.gov ID
NCT03534401
Collaborator
Bill and Melinda Gates Foundation (Other), International Planned Parenthood Federation (Other), Population Council (Other)
659
1
2
30
21.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ARCHES Kenya
N/A

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 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 Design

Study Type:
Interventional
Actual Enrollment :
659 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Health Services Research
Official Title:
ARCHES Kenya: Addressing Reproductive Coercion in HEalth Settings
Actual Study Start Date :
Jun 1, 2018
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Family Planning Counseling

Clients receive standard FP counseling services.

Experimental: ARCHES Kenya Intervention in FP Counseling

Clients receive the ARCHES Kenya intervention in addition to standard FP counseling services.

Behavioral: ARCHES Kenya
ARCHES: FP counselors in intervention clinics will ) provide counseling and education regarding risk of partner detection of FP methods, and women's and girls' strategies to use FP methods to minimize partner detection risk integrated into standard FP 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) distribute palm-sized educational materials on RC and IPV, as well as IPV services.

Outcome Measures

Primary Outcome Measures

  1. Reproductive coercion [Change from prior 3 months (Baseline) and 3-month follow-up]

    8 items assessing incidence of male partner behaviors that interfere with or prevent use of contraception or coerce pregnancy

Secondary Outcome Measures

  1. Intimate partner violence (IPV) [prior 3 months and 6 months]

    Modified WHO IPV assessment of incidence of violence directed at participants from male partners

  2. Contraception discontinuation [6 months and 12 months]

    Series of items to access discontinuation of use of any method of contraception that the participant reported using during the past 6 or 12 months

  3. Contraception self-efficacy [present assessed at baseline, 3 and 6-month follow-ups]

    Modified HIV risk reduction self-efficacy scale. This contraceptive use self-efficacy scale measures participant reports of the belief that she can enact certain contraceptive behaviors. This is a 4-item scale. Each item has a 3-point measure from 0-2 with a high score of 2 being very confident, 1 being somewhat confident, and 0 being not at all confident, for a total score range of 0-8.

  4. Contraception delivery [Immediate post-intervention]

    Report of receiving a modern contraception method during the clinic visit immediately preceding the survey

  5. Biased and coercive FP provider practices [Immediate post-intervention]

    Items to assess whether specified coercive or discriminatory behaviors were experienced from a FP provider during the clinic visit immediately preceding the survey

  6. Knowledge of IPV services [present, assessed at baseline, 3 and 6 month follow-ups]

    Items assessing reported knowledge of listed local services for women and girls experiencing IPV

  7. Utilization of IPV services among those reporting IPV [prior 3 months and 6 months]

    Items assessing whether a participant called or visited a listed local service for women or girls experiencing IPV - only assessed for participants reporting history of IPV

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • FHOK client seeking voluntary FP services

  • Aged 15-49 years

  • Biologically Female

  • Willing to complete baseline, exit, 3-month, and 6-month follow-up surveys

  • Able to provide informed consent

  • Able to communicate in either English or Swahili

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center on Gender Equity and Health, University of California, San Diego San Diego California United States 92093

Sponsors and Collaborators

  • University of California, San Diego
  • Bill and Melinda Gates Foundation
  • International Planned Parenthood Federation
  • Population Council

Investigators

  • Principal Investigator: Jay G Silverman, PhD, UCSD Center on Gender Equity and Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jay G. Silverman, PhD, Professor of Medicine and Global Public Health, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT03534401
Other Study ID Numbers:
  • 170084
First Posted:
May 23, 2018
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jay G. Silverman, PhD, Professor of Medicine and Global Public Health, University of California, San Diego

Study Results

No Results Posted as of Jun 13, 2022