Reproductive CoercionNCT06059196
Adapting, Expanding and Evaluating ARCHES in Kenya
A study testing ARCHES (Addressing Reproductive Coercion in Health Settings) and BCS+ (Balanced Counseling Strategy Plus) in people with Reproductive Coercion and Intimate Partner Violence, run by University of California, San Diego at 24 sites in Kenya.
Trial summary
Document evidence, via cluster randomized controlled trial, of the effectiveness of the ARCHES intervention, a brief, clinic-based counselling intervention demonstrated to reduce intimate partner violence and reproductive coercion and promote women's reproductive health, as scaled in government health facilities in… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Reproductive Coercion, Intimate Partner Violence
- What is being tested?
- ARCHES (Addressing Reproductive Coercion in Health Settings) and BCS+ (Balanced Counseling Strategy Plus)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,928 participants
- Where
- 24 sitesKenya
- Study dates
- 29 Sep 2023to 17 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Seeking family planning services at a selected study facility
- Aged 15-49 years old
- Female
- Able to provide informed consent
- Able to speak and understand English, Kiswahili, or Kalenjin
- Able to provide a safe phone number at which they can be recontacted for follow-up
- Not planning to move out of the area in the coming 6 months
Who cannot join
- Sterilized at baseline
- Pregnant at baseline
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Kenya24 sites
Burnt Forest Sub-county Hospital
Burnt Forest
Kipkabus Health Centre
Burnt Forest
Chepkigen Health Centre
Cheptiret
Huruma District Hospital
Eldoret
Kapsoya Health Centre
Eldoret
Kapteldon Health Centre
Eldoret
Kapyemit Dispensary
Eldoret
Kipkenyo
Eldoret
Pioneer Health Centre
Eldoret
Railways
Eldoret
Uasin Gishu District Hospital
Eldoret
Kesses Health Centre
Kesses
Chembulet Health Centre
Kimumu
Chepkanga Health Centre
Kimumu
Merewet Dispensary
Kimumu
Moi's Bridge Health Centre
Moi‘s Bridge
Moiben Health Centre
Moiben
Chepkero Dispensary
Naiberi
Soy Health Centre
Soy
Sosiani Health Centre
Turbo
Turbo Sub-County Hospital
Turbo
Kabobo Health Centre
Ziwa
Kipsigak Health Centre
Ziwa
Ziwa Sub-County Hospital
Ziwa
About this study
Official title: Adapting, Expanding, and Evaluating ARCHES (Addressing Reproductive Coercion in Health Settings) in Kenya
Document evidence, via cluster randomized controlled trial, of the effectiveness of the ARCHES intervention, a brief, clinic-based counselling intervention demonstrated to reduce intimate partner violence and reproductive coercion and promote women's reproductive health, as scaled in government health facilities in Kenya, to (1) decrease unintended pregnancy, (2) increase family planning uptake and use/continuation, (3) decrease experiences of reproductive coercion and intimate partner violence of women and girls aged 15 to 49 years seeking family planning services, and, to (4) improve quality of care, (5) increase gender equitable attitudes, and, (6) increase self-efficacy to provide comprehensive family planning counseling among providers trained in ARCHES.
Read the detailed description
Background: In Kenya, 17% of women have unmet need for family planning (FP) and the modern contraceptive prevalence rate (mCPR) has plateaued around 45%, contributing to poor reproductive health outcomes. This includes the nearly 50% of women in Kenya who report their last pregnancy as unintended, with those experiencing gender-based violence (GBV), particularly in the forms of intimate partner violence (IPV) and reproductive coercion (RC; behaviors that reduce women's ability to use contraception or otherwise prevent pregnancy), at significantly greater risk. Similar to other LMIC settings, both RC and IPV are highly prevalent in Kenya, particularly among women seeking FP and other reproductive health services (>1/3 of female FP clients). Since 2013, the World Health Organization (WHO) has strongly recommended that IPV and RC be addressed within reproductive health services and, in 2018, the Lancet Commission on Sexual and Reproductive Health and Rights found that RC and IPV were a significant contributor to unmet need for FP and unintended pregnancy, with greatest impacts among women and girls in LMICs. Within Kenya, the Ministry of Health (MOH) has made reduction of unintended pregnancy and gender-based violence (GBV), especially among adolescents, a primary objective. Despite this need and guidance, no clinic-based intervention models outside of the U.S. (apart from one, ARCHES) have demonstrated efficacy to improve FP uptake/use and reduce IPV or RC thereby reducing unintended pregnancy.
Intervention Description: ARCHES (Addressing Reproductive Coercion in Health Settings) is a brief, clinic-based intervention delivered by family planning providers aiming to: 1) Increase women's and girls' ability to use family planning in the face of reproductive coercion, facilitating women's voluntary family planning uptake and continued use without interference, 2) Provide a safe and supportive environment for IPV disclosure and subsequent referral to support services, and 3) Educate and support providers to improve quality of care related to family planning counseling, including addressing reproductive coercion and intimate partner violence.
Objective: The objective of this study is to generate evidence and learnings on scaling integrated family planning services (including family planning, reproductive coercion, and intimate partner violence) in public sector health facilities in Uasin Gishu County, Kenya via adaptation and implementation of ARCHES, in partnership with the Kenya MOH.
Methodology: A cluster randomized controlled trial paired with concurrent implementation science assessments will test effectiveness of the ARCHES model that has been adapted for scale by the Kenya MOH. Female family planning clients aged 15-49 years at selected sites will complete baseline surveys (immediately prior to receiving care), immediately post-visit exit surveys, and 6-month follow-up surveys. Family planning providers trained in ARCHES will complete pre-training, post-training, and 3-month follow-up surveys to assess changes in gender-equitable attitudes and self-efficacy to address issues of violence among their clients. Costs associated with the scale-up strategy will be tracked and utilized in combination with results of the effectiveness trial to assess total cost and cost-effectiveness of ARCHES.
- Conditions
- Reproductive Coercion, Intimate Partner Violence
- Being tested
- ARCHES (Addressing Reproductive Coercion in Health Settings), BCS+ (Balanced Counseling Strategy Plus)
- Keywords
- Reproductive coercion, Intimate partner violence, Contraceptive Usage, Pregnancy Related, Quality of Care
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARCHES (Addressing Reproductive Coercion in Health Settings)Behavioural
ARCHES (Addressing Reproductive Coercion in Health Settings) includes training existing contraceptive providers to (1) provide contraceptive clients with education on reproductive coercion and methods/ways to use contraceptive methods covertly if desired, (2) provide screening for reproductive coercion and intimate partner violence, (3) provide a referral to specialized services for those disclosing intimate partner violence, (4) and offer a palm-sized mini-booklet with educational information on reproductive coercion and intimate partner violence. A mobile application was developed to guide contraceptive providers through the counselling protocol.
BCS+ (Balanced Counseling Strategy Plus)Behavioural
BCS+ (Balanced Counseling Strategy Plus) is a contraceptive counseling protocol that contraceptive providers use to help clients identify suitable contraceptive methods based on their preferences and previous contraceptive experiences. The BCS+ also includes systematic screening for other health services such as HIV/STI, cervical cancer, and breast cancer. The BCS+ was adopted by the Kenya MOH as the standard contraceptive counseling protocol in the country.
| Study group | Role | What they receive |
|---|---|---|
| Control - Standard contraceptive counseling | Active comparator | Standard contraceptive counseling, includes provider training on standard BCS+ counseling protocol and use of a companion mobile application to guide counseling Receives: Behavioral: BCS+ (Balanced Counseling Strategy Plus) |
| Intervention - Integrated contraceptive counseling | Experimental | Integrated contraceptive counseling, includes provider training on ARCHES integrated in BCS+ counseling protocol and use of a companion mobile application to guide counseling Receives: Behavioral: ARCHES (Addressing Reproductive Coercion in Health Settings); Behavioral: BCS+ (Balanced Counseling Strategy Plus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident unintended pregnancy
Difference in self-reported unintended pregnancy in the past 6 months at the 6-month follow-up in intervention compared to control group (single time point analysis)
Measured: 6-month follow-up
Secondary outcomes (15)
Modern contraceptive use in the past 6 months
Change in prevalence of self-reported modern contraceptive use in the past 6 months between baseline and 6-month follow-up in intervention compared to control group (difference-in differences)
Measured: Baseline (at facility prior to receiving care) and 6-month follow-up
Physical intimate partner violence in the past 6 months
Change in prevalence of self-reported physical intimate partner violence experience in the past 6 months between combined baseline/post-visit and 6-month follow-up in intervention compared to control group (difference-in differences)
Measured: Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Sexual intimate partner violence in the past 6 months
Change in prevalence of self-reported sexual intimate partner violence experience in the past 6 months between combined baseline/post-visit and 6-month follow-up in intervention compared to control group (difference-in differences)
Measured: Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Emotional intimate partner violence in the past 6 months
Change in prevalence of self-reported emotional intimate partner violence experience in the past 6 months between combined baseline/post-visit and 6-month follow-up in intervention compared to control group (difference-in differences)
Measured: Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Reproductive coercion from a male partner in the past 6 months
Change in prevalence of self-reported reproductive coercion experience in the past 6 months between combined baseline/post-visit and 6-month follow-up in intervention compared to control group (difference-in differences)
Measured: Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Incident pregnancy
Difference in self-reported pregnancy in the past 6 months at the 6-month follow-up in intervention compared to control group (single time point analysis)
Measured: 6-month follow-up
Uptake of a modern contraceptive method
Difference in prevalence of self-reported modern contraceptive uptake post-visit in intervention compared to control group (single time point analysis)
Measured: Post-visit (at facility immediately after receiving care)
Covert use of contraception in the past 6 months
Change in prevalence of self-reported covert contraceptive use in the past 6 months between baseline and 6-month follow-up in intervention compared to control group (difference-in differences)
Measured: Baseline (at facility prior to receiving care) and 6-month follow-up
Contraceptive self-efficacy in the face of reproductive coercion
Change in mean self-efficacy score (range: 3-9, higher=higher self-efficacy) between baseline, post-visit, and 6-month follow-up in intervention compared to control group (difference-in differences)
Measured: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Awareness of intimate partner violence services
Change in prevalence of awareness of intimate partner violence services between baseline, post-visit, and 6-month follow-up in intervention compared to control group (difference-in differences)
Measured: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Self-efficacy to use intimate partner violence services
Change in mean self-efficacy score (range: 1-3, higher=higher self-efficacy) between baseline, post-visit, and 6-month follow-up in intervention compared to control group (difference-in differences)
Measured: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Use of intimate partner violence services
Difference in prevalence of use of intimate partner violence services in the past 6 months at the 6-month follow-up in intervention compared to control group (single time point analysis)
Measured: 6-month follow-up
Attitudes accepting of reproductive coercion
Change in mean attitude score (range: 6-12, higher=attitudes less accepting of reproductive coercion/improved attitudes) between baseline, post-visit, and 6-month follow-up in intervention compared to control group (difference-in differences)
Measured: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Quality of family planning care
Difference in mean (range: 11-55, higher=higher quality) interpersonal quality of family planning scale post-visit in intervention compared to control group (single time point analysis)
Measured: Post-visit (at facility immediately after receiving care)
Discontinuation of modern contraception
Difference in prevalence of modern contraceptive discontinuation in the past 6 months at the 6-month follow-up in intervention compared to control group (single time point analysis)
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start29 Sep 2023
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reproductive CoercionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized controlled trial; stratified randomization based on facility type and urban/rural location.
- Masking
- None (open label)
- Enrolment
- 3,928 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Population Council Kenya, Kenya Ministry of Health
- Responsible party
- Principal investigator, Jay G. Silverman, PhD, University of California, San Diego
- Investigators
- Jay G Silverman, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059196
- Sponsor's protocol ID
- 201922S
- Status last verified
- Oct 2024
- First submitted
- 6 Sep 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share de-identified participant data analysis sets to the Dyrad public data repository upon publication of findings
Publications
Pearson E, Uysal J, Menzel J, Undie CC, Odwe G, Liambila W, Silverman JG. Evaluating a scalable ARCHES (Addressing Reproductive Coercion in Health Settings) model in government health facilities in Uasin Gishu county, Kenya: study protocol for a cluster-randomized controlled trial. Reprod Health. 2023 Oct 17;20(1):155. doi: 10.1186/s12978-023-01697-7.
PubMed 37848916
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting, Expanding, and Evaluating ARCHES (Addressing Reproductive Coercion in Health Settings) in Kenya
- ClinicalTrials.gov ID
- NCT06059196
- Acronym / sponsor ID
- 201922S
- Conditions
- Reproductive Coercion, Intimate Partner Violence
- Keywords
- Reproductive coercion, Intimate partner violence, Contraceptive Usage, Pregnancy Related, Quality of Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,928 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Population Council Kenya, Kenya Ministry of Health
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Document evidence, via cluster randomized controlled trial, of the effectiveness of the ARCHES intervention, a brief, clinic-based counselling intervention demonstrated to reduce intimate partner violence and reproductive coercion and promote women's reproductive health, as scaled in government health facilities in Kenya, to (1) decrease unintended pregnancy, (2) increase family planning uptake and use/continuation, (3) decrease experiences of reproductive coercion and intimate partner violence of women and girls aged 15 to 49 years seeking family planning services, and, to (4) improve quality of care, (5) increase gender equitable attitudes, and, (6) increase self-efficacy to provide comprehensive family planning counseling among providers trained in ARCHES.
Detailed description
Background: In Kenya, 17% of women have unmet need for family planning (FP) and the modern contraceptive prevalence rate (mCPR) has plateaued around 45%, contributing to poor reproductive health outcomes. This includes the nearly 50% of women in Kenya who report their last pregnancy as unintended, with those experiencing gender-based violence (GBV), particularly in the forms of intimate partner violence (IPV) and reproductive coercion (RC; behaviors that reduce women's ability to use contraception or otherwise prevent pregnancy), at significantly greater risk. Similar to other LMIC settings, both RC and IPV are highly prevalent in Kenya, particularly among women seeking FP and other reproductive health services (>1/3 of female FP clients). Since 2013, the World Health Organization (WHO) has strongly recommended that IPV and RC be addressed within reproductive health services and, in 2018, the Lancet Commission on Sexual and Reproductive Health and Rights found that RC and IPV were a significant contributor to unmet need for FP and unintended pregnancy, with greatest impacts among women and girls in LMICs. Within Kenya, the Ministry of Health (MOH) has made reduction of unintended pregnancy and gender-based violence (GBV), especially among adolescents, a primary objective. Despite this need and guidance, no clinic-based intervention models outside of the U.S. (apart from one, ARCHES) have demonstrated efficacy to improve FP uptake/use and reduce IPV or RC thereby reducing unintended pregnancy.
Intervention Description: ARCHES (Addressing Reproductive Coercion in Health Settings) is a brief, clinic-based intervention delivered by family planning providers aiming to: 1) Increase women's and girls' ability to use family planning in the face of reproductive coercion, facilitating women's voluntary family planning uptake and continued use without interference, 2) Provide a safe and supportive environment for IPV disclosure and subsequent referral to support services, and 3) Educate and support providers to improve quality of care related to family planning counseling, including addressing reproductive coercion and intimate partner violence.
Objective: The objective of this study is to generate evidence and learnings on scaling integrated family planning services (including family planning, reproductive coercion, and intimate partner violence) in public sector health facilities in Uasin Gishu County, Kenya via adaptation and implementation of ARCHES, in partnership with the Kenya MOH.
Methodology: A cluster randomized controlled trial paired with concurrent implementation science assessments will test effectiveness of the ARCHES model that has been adapted for scale by the Kenya MOH. Female family planning clients aged 15-49 years at selected sites will complete baseline surveys (immediately prior to receiving care), immediately post-visit exit surveys, and 6-month follow-up surveys. Family planning providers trained in ARCHES will complete pre-training, post-training, and 3-month follow-up surveys to assess changes in gender-equitable attitudes and self-efficacy to address issues of violence among their clients. Costs associated with the scale-up strategy will be tracked and utilized in combination with results of the effectiveness trial to assess total cost and cost-effectiveness of ARCHES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled trial; stratified randomization based on facility type and urban/rural location.
| Arm | Type | Receives |
|---|---|---|
| Control - Standard contraceptive counseling | Active comparator | Behavioral: BCS+ (Balanced Counseling Strategy Plus)Standard contraceptive counseling, includes provider training on standard BCS+ counseling protocol and use of a companion mobile application to guide counseling |
| Intervention - Integrated contraceptive counseling | Experimental | Behavioral: ARCHES (Addressing Reproductive Coercion in Health Settings), Behavioral: BCS+ (Balanced Counseling Strategy Plus)Integrated contraceptive counseling, includes provider training on ARCHES integrated in BCS+ counseling protocol and use of a companion mobile application to guide counseling |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Seeking family planning services at a selected study facility
- Aged 15-49 years old
- Female
- Able to provide informed consent
- Able to speak and understand English, Kiswahili, or Kalenjin
Key exclusion criteria (2 listed)
- Sterilized at baseline
- Pregnant at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARCHES (Addressing Reproductive Coercion in Health Settings)ARCHES (Addressing Reproductive Coercion in Health Settings) includes training existing contraceptive providers to (1) provide contraceptive clients with education on reproductive coercion and methods/ways to use contraceptive methods covertly if desired, (2) provide screening for reproductive coercion and intimate partner violence, (3) provide a referral to specialized services for those disclosing intimate partner violence, (4) and offer a palm-sized mini-booklet with educational information on reproductive coercion and intimate partner violence. A mobile application was developed to guide contraceptive providers through the counselling protocol. | Behavioural | Intervention - Integrated contraceptive counseling |
| BCS+ (Balanced Counseling Strategy Plus)BCS+ (Balanced Counseling Strategy Plus) is a contraceptive counseling protocol that contraceptive providers use to help clients identify suitable contraceptive methods based on their preferences and previous contraceptive experiences. The BCS+ also includes systematic screening for other health services such as HIV/STI, cervical cancer, and breast cancer. The BCS+ was adopted by the Kenya MOH as the standard contraceptive counseling protocol in the country. | Behavioural | Control - Standard contraceptive counseling, Intervention - Integrated contraceptive counseling |
Primary outcome
Incident unintended pregnancy
Time frame: 6-month follow-up
Difference in self-reported unintended pregnancy in the past 6 months at the 6-month follow-up in intervention compared to control group (single time point analysis)
15 secondary outcomes
Modern contraceptive use in the past 6 months
Time frame: Baseline (at facility prior to receiving care) and 6-month follow-up
Physical intimate partner violence in the past 6 months
Time frame: Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Sexual intimate partner violence in the past 6 months
Time frame: Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Emotional intimate partner violence in the past 6 months
Time frame: Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Reproductive coercion from a male partner in the past 6 months
Time frame: Baseline (combined report at facility prior to receiving care and report at facility immediately after receiving care (post-visit); combined due to increased reporting post-visit) and 6-month follow-up
Incident pregnancy
Time frame: 6-month follow-up
Uptake of a modern contraceptive method
Time frame: Post-visit (at facility immediately after receiving care)
Covert use of contraception in the past 6 months
Time frame: Baseline (at facility prior to receiving care) and 6-month follow-up
Contraceptive self-efficacy in the face of reproductive coercion
Time frame: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Awareness of intimate partner violence services
Time frame: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Self-efficacy to use intimate partner violence services
Time frame: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Use of intimate partner violence services
Time frame: 6-month follow-up
Attitudes accepting of reproductive coercion
Time frame: Baseline (at facility prior to receiving care), Post-visit (at facility immediately after receiving care), and 6-month follow-up
Quality of family planning care
Time frame: Post-visit (at facility immediately after receiving care)
Discontinuation of modern contraception
Time frame: 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Derived from this study: PubMed 37848916Pearson E, Uysal J, Menzel J, Undie CC, Odwe G, Liambila W, Silverman JG. Evaluating a scalable ARCHES (Addressing Reproductive Coercion in Health Settings) model in government health facilities in Uasin Gishu county, Kenya: study protocol for a cluster-randomized controlled trial. Reprod Health. 2023 Oct 17;20(1):155. doi: 10.1186/s12978-023-01697-7.
- Individual participant dataSharing planned: Yes. Will share de-identified participant data analysis sets to the Dyrad public data repository upon publication of findings
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay G Silverman, PhD principal investigator
University of California, San Diego
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARCHES (Addressing Reproductive Coercion in Health Settings) and BCS+ (Balanced Counseling Strategy Plus) in people with Reproductive Coercion and Intimate Partner Violence, run by University of California, San Diego at 24 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident unintended pregnancy (time frame: 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06059196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.