Gender-based ViolenceNCT05331508
Testing Gender-based Violence Response in Family Planning and Antenatal Care Services in Nigeria
A study testing gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (ARCHES) in people with Gender-based Violence and Reproductive Coercion, run by Jhpiego at 40 sites in Nigeria.
Trial summary
To pilot and evaluate the integration of first-line response to gender- based violence (GBV), particularly intimate partner violence (IPV), sexual violence and reproductive coercion, within family planning (FP) and antenatal care (ANC) services at public health facilities in Ebonyi and Sokoto states in Nigeria. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gender-based Violence, Reproductive Coercion, Intimate Partner Violence
- What is being tested?
- gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (ARCHES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,756 participants
- Where
- 40 sitesNigeria
- Study dates
- 6 Apr 2022to 30 Jun 2023
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Woman of reproductive age (18 to 49 years) seeking FP or ANC services at study sites
- Women who believe they are able to conceive (i.e. who have not undergone a tubal ligation, hysterectomy, or oophorectomy, or are menopausal) (for FP clients)
- Have a male partner they currently have sex with
- Have a mobile phone that can be safely used for re-contacting for follow-up surveys
- Do not have any accompanying male partners or family members aged 5 or above present
Who cannot join
- Any individuals that do not meet all of the above inclusion criteria or do not agree to participate in the study will be excluded from data collection.
- In addition, individuals with impaired cognitive abilities (I.e. unable to make decisions/respond to questions on their own without assistance by someone else)will also be excluded from the data collection.
- Finally, women who share a mobile phone with their partner/husband or another family member will also be excluded.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Nigeria40 sites
AZUIYIOKWU Health Center
Abakaliki, Ebonyi State
GMELINA Health Center
Abakaliki, Ebonyi State
NEW TIMBER SHADE Health Center
Abakaliki, Ebonyi State
AMAECHARA Primary Health Center
Afikpo North, Ebonyi State
Izeke Health Center
Afikpo North, Ebonyi State
NKAGBOGO NDEMIYI MDG Primary Health Center
Afikpo North, Ebonyi State
Owutu Primary Health Center
Afikpo South, Ebonyi State
Uwana Primary Health Center
Afikpo South, Ebonyi State
GH Bodinga
Bodina, Sokoto State
Durbawa Primary Health Center
Dange Sguni, Sokoto State
Kwannawa Primary Health Center
Dange Sguni, Sokoto State
Ruga Dubu
Dange Sguni, Sokoto State
MDG Randa
Ebonyi, Ebonyi State
AZUNRAMURA Health Center
Ezza, Ebonyi State
MCH Onueke
Ezza South, Ebonyi State
GH Gada
Gada, Sokoto State
Mamman Suka Primary Health Center
Gwadabawa, Sokoto State
Cottage Hospital
Ikwo, Ebonyi State
Echara Health Center
Ikwo, Ebonyi State
Item Health Center
Ikwo, Ebonyi State
Noyo Health Center
Ikwo, Ebonyi State
Araba Health Center
Ilela, Sokoto State
Darna Sabon Gari Health Center
Ilela, Sokoto State
Garu
Ilela, Sokoto State
Gidan Chiwake Health Center
Ilela, Sokoto State
Gidan Hamma Health Center
Ilela, Sokoto State
Kalmalo
Ilela, Sokoto State
Rungumawar Gatti Health Center
Ilela, Sokoto State
Tozai Health Center
Ilela, Sokoto State
NDIOKOROUKWU Health Center
Ivo, Ebonyi State
AKAEZEUKWU Health Center
Ivo, Sokoto State
Durbawa Primary Health Center
Kware, Sokoto State
Anike Health Center
Onicha, Ebonyi State
Okaria Health Center
Onicha, Ebonyi State
Oshiri Health Center
Onicha, Ebonyi State
Gan Gam Primary Health Center
Shagari, Sokoto State
Horo Primary Health Center
Shagari, Sokoto State
Kajiji Primary Health Center
Shagari, Sokoto State
Sanyinnawal Primary Health Center
Shagari, Sokoto State
Kaura Kimba Health Post
Wamako, Sokoto State
About this study
Official title: Testing the Integration of Gender-based Violence First-line Response in Family Planning and Antenatal Care Services in Nigeria
To pilot and evaluate the integration of first-line response to gender- based violence (GBV), particularly intimate partner violence (IPV), sexual violence and reproductive coercion, within family planning (FP) and antenatal care (ANC) services at public health facilities in Ebonyi and Sokoto states in Nigeria.
GBV first-line response in the health setting includes screening , empowerment counseling, safety planning, and support to connect to additional services needed.
Read the detailed description
This study seeks to:
- Assess effectiveness of an integrated service delivery model (integration of GBV first-line response and empowerment counseling in standard of care FP or ANC services) in reducing on-going experience of intimate partner violence (IPV) and increasing utilization of modern contraceptive methods among clients.
1a. Assess effectiveness of the intervention in reducing IPV, increasing utilization of modern contraceptive methods, and improving safety and self-efficacy among clients seeking interval FP services.
1b. Assess effectiveness of the intervention in reducing IPV and improving safety and self-efficacy to seek GBV care among clients seeking ANC services.
- Explore factors influencing feasibility, acceptability and ability to implement GBV first-line response as part of FP and ANC services.
- Being tested
- gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (ARCHES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (ARCHES)Behavioural
Also called GBV screening, LIVES and ARCHES
Providers will (1) introduce routine client screening for GBV, including intimate partner violence, sexual violence, and reproductive coercion using a standardized screening form, in FP and ANC services,(2) for individuals disclosing GBV, provide first-line response-empathetic counseling, including listening, inquiring about experiences sensitively, and validating experiences, helping clients develop safety plans, and providing support; (3) regardless of disclosure of GBV, provide counseling and information, education and communication (IEC) materials on IPV, including reproductive coercion, and FP options, to both FP and ANC clients.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Prior to commencement of the study, providers responsible for FP and ANC service provision will participate in a 3-day competency-based skills-building training activity on Caring for women subjected to violence: A WHO curriculum for training health-care providers and the ARCHES intervention. Following the training, providers will (1) introduce routine client screening for GBV, including intimate partner violence, sexual violence, and reproductive coercion using a standardized screening form, in FP and ANC services,(2) for individuals disclosing GBV, provide first-line response-empathetic counseling, including listening, inquiring about experiences sensitively, and validating experiences, helping clients develop safety plans, and providing support; (3) regardless of disclosure of GBV, provide counseling and information, education and communication (IEC) materials on IPV, including reproductive coercion, and FP options, to both FP and ANC clients. Receives: Behavioral: gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (ARCHES) |
| Control group | No intervention | FP clients and ANC clients will receive standard care. For FP services, this includes standard contraceptive care provided by personnel who have completed training on contraceptive service delivery by the Nigerian Federal Ministry of Health and partners. For ANC services, the standard is a minimum of 8 visits with health personnel trained on ANC care during pregnancy. This includes identification of women and girls at increased risk of developing complications during labor and childbirth; prevention, detection, and management of pregnancy-related and concurrent conditions; health education and promotion; promotion of the use of skilled attendance at birth and healthy behaviors such as breastfeeding, early postnatal care, and planning for optimal pregnancy spacing, routine examinations, detection of complications, prevention of malaria in pregnancy and other infections; provision of holistic care to ensure normal progression of the baby and good health of the mother. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of clients disclosing exposure to intimate partner or sexual violence in past 3 months
Disclosure will be defined by a positive response to either of the following questions:
- Has your current partner ever slapped you, punched you, hit or kicked you, or done anything else to hurt you physically?
- Has your current male partner ever forced you to have sex or do something sexual when you didn't want to?
Measured: baseline to 3-months and 6-months post-intervention
Percentage of clients that report receiving a family planning method from healthcare provider
Measured: day of intervention
Secondary outcomes (4)
Change in percentage of clients demonstrating family planning self efficacy, as measured by Contraceptive Self-Efficacy among women in sub-Saharan Africa (CSESSA) sub-scale
Family planning self-efficacy is a women's belief about her own ability to complete the actions necessary for successful family planning.
Measured: baseline to 3-months and 6-months post-intervention
Change in demonstrated self-efficacy to access IPV services
Self-efficacy to access IPV services is an IPV survivor's confidence to develop and execute a plan when her partner becomes violent/ if her partner were to become violent. Self-efficacy will be defined by an affirmative response to the following questions:
- I am confident that I could develop a plan for seeking help 'when my partner becomes violent/ if my partner were to become violent'
- I am confident that I would be able to execute my plan 'in times when my partner becomes violent / if my partner were to become violent'.
Measured: baseline to 3-months and 6-months post-intervention
Change in self-reported use of safety measures to protect respondent or her child/children from violence
Whether an IPV survivor has ever done any of the following to protect herself or her child/children for fear that her partner would become violent:
- Identified a safe place to go in case she needs to leave her home ?
- Identified a friend or relative to whom she could seek help?
- Set aside some things she may need, such as clothes, documents in case she needs to leave in a hurry?
- Set aside funds in case she needs to leave your home/partner?
- Made a plan for what she would do with her child/children in case she needs to leave home?
Measured: baseline to 3-months and 6-months post-intervention
Change in percentage of clients reporting experiences of reproductive coercion in 3 months prior to data collection
Reproductive coercion is behavior that interferes with the autonomous decision-making of a woman, with regards to reproductive health, including whether client felt pressured or forced by current partner to become pregnant or made it difficult to use family planning. Reproductive coercion will be defined by a positive response to either of the following questions:
- Have you ever felt pressured or forced by your current partner to become pregnant when you did not want to be?
- Has your current partner ever made it difficult for you to get family planning or to use family planning?
Measured: baseline to 3-months and 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start6 Apr 2022
- Primary completion30 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Gender-based ViolenceStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Myra Betron, Principal investigator, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331508
- Sponsor's protocol ID
- MCGL-IRB17494
- Status last verified
- Aug 2023
- First submitted
- 28 Feb 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32460786Pallitto C, Garcia-Moreno C, Stoeckl H, Hatcher A, MacPhail C, Mokoatle K, Woollett N. Testing a counselling intervention in antenatal care for women experiencing partner violence: a study protocol for a randomized controlled trial in Johannesburg, South Africa. BMC Health Serv Res. 2016 Nov 5;16(1):630. doi: 10.1186/s12913-016-1872-x.
PubMed 27814706Bacchu L, Mezey G, Bewley S. Women's perceptions and experiences of routine enquiry for domestic violence in a maternity service. BJOG. 2002 Jan;109(1):9-16. doi: 10.1111/j.1471-0528.2002.00514.x.
PubMed 11843378Boyle A, Jones PB. The acceptability of routine inquiry about domestic violence towards women: a survey in three healthcare settings. Br J Gen Pract. 2006 Apr;56(525):258-61.
PubMed 16611513McDonnell E, Holohan M, Reilly MO, Warde L, Collins C, Geary M. Acceptability of routine enquiry regarding domestic violence in the antenatal clinic. Ir Med J. 2006 Apr;99(4):123-4.
PubMed 16972587Waalen J, Goodwin MM, Spitz AM, Petersen R, Saltzman LE. Screening for intimate partner violence by health care providers. Barriers and interventions. Am J Prev Med. 2000 Nov;19(4):230-7. doi: 10.1016/s0749-3797(00)00229-4.
PubMed 11064226Hamberger L.K.; Guse C.; Boerger J.; Minsky D.; Pape D.; Folsom C. Evaluation of a Health Care Provider Training Program to Identify and Help Partner Violence Victims. Journal of Family Violence, Volume 19, Number 1, February 2004, pp. 1-11
McNulty A, Andrews P, Bonner M. Can screening for domestic violence be introduced successfully in a sexual health clinic? Sex Health. 2006 Sep;3(3):179-82. doi: 10.1071/sh05056.
PubMed 17044223McNutt LA, Carlson BE, Rose IM, Robinson DA. Partner violence intervention in the busy primary care environment. Am J Prev Med. 2002 Feb;22(2):84-91. doi: 10.1016/s0749-3797(01)00407-x.
PubMed 11818176Taft A, Colombini M. Healthcare system responses to intimate partner violence in low and middle-income countries: evidence is growing and the challenges become clearer. BMC Med. 2017 Jul 12;15(1):127. doi: 10.1186/s12916-017-0886-5.
PubMed 28697810McFarlane JM, Groff JY, O'Brien JA, Watson K. Secondary prevention of intimate partner violence: a randomized controlled trial. Nurs Res. 2006 Jan-Feb;55(1):52-61. doi: 10.1097/00006199-200601000-00007.
PubMed 16439929Tiwari A, Leung WC, Leung TW, Humphreys J, Parker B, Ho PC. A randomised controlled trial of empowerment training for Chinese abused pregnant women in Hong Kong. BJOG. 2005 Sep;112(9):1249-56. doi: 10.1111/j.1471-0528.2005.00709.x.
PubMed 16101604Miller E, Decker MR, McCauley HL, Tancredi DJ, Levenson RR, Waldman J, Schoenwald P, Silverman JG. A family planning clinic partner violence intervention to reduce risk associated with reproductive coercion. Contraception. 2011 Mar;83(3):274-80. doi: 10.1016/j.contraception.2010.07.013.
PubMed 21310291Kiely M, El-Mohandes AAE, El-Khorazaty MN, Gantz MG. An integrated intervention to reduce intimate partner violence in pregnancy: a randomized controlled trial. Obstet Gynecol. 2010 Feb;115(2 Pt 1):273-283. doi: 10.1097/AOG.0b013e3181cbd482.
PubMed 20093899Betron M, Bryce E, Obafemi S, Yusuf S, Abdullahi H, Ifemenam E, Dikeocha N, Maiakwai A, Kabir B, Oduenyi C. Effectiveness of a clinic-based counselling intervention on risk of experiencing intimate partner violence and reproductive coercion: a matched-pair cluster-controlled trial in Ebonyi and Sokoto, Nigeria. BMJ Glob Health. 2025 Oct 28;10(10):e016898. doi: 10.1136/bmjgh-2024-016898.
PubMed 41151831
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Integration of Gender-based Violence First-line Response in Family Planning and Antenatal Care Services in Nigeria
- ClinicalTrials.gov ID
- NCT05331508
- Acronym / sponsor ID
- MCGL-IRB17494
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,756 participants (actual)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 15 Apr 2022 (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.
To pilot and evaluate the integration of first-line response to gender- based violence (GBV), particularly intimate partner violence (IPV), sexual violence and reproductive coercion, within family planning (FP) and antenatal care (ANC) services at public health facilities in Ebonyi and Sokoto states in Nigeria.
GBV first-line response in the health setting includes screening , empowerment counseling, safety planning, and support to connect to additional services needed.
Detailed description
This study seeks to:
- Assess effectiveness of an integrated service delivery model (integration of GBV first-line response and empowerment counseling in standard of care FP or ANC services) in reducing on-going experience of intimate partner violence (IPV) and increasing utilization of modern contraceptive methods among clients.
1a. Assess effectiveness of the intervention in reducing IPV, increasing utilization of modern contraceptive methods, and improving safety and self-efficacy among clients seeking interval FP services.
1b. Assess effectiveness of the intervention in reducing IPV and improving safety and self-efficacy to seek GBV care among clients seeking ANC services.
- Explore factors influencing feasibility, acceptability and ability to implement GBV first-line response as part of FP and ANC services.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (ARCHES)Prior to commencement of the study, providers responsible for FP and ANC service provision will participate in a 3-day competency-based skills-building training activity on Caring for women subjected to violence: A WHO curriculum for training health-care providers and the ARCHES intervention. Following the training, providers will (1) introduce routine client screening for GBV, including intimate partner violence, sexual violence, and reproductive coercion using a standardized screening form, in FP and ANC services,(2) for individuals disclosing GBV, provide first-line response-empathetic counseling, including listening, inquiring about experiences sensitively, and validating experiences, helping clients develop safety plans, and providing support; (3) regardless of disclosure of GBV, provide counseling and information, education and communication (IEC) materials on IPV, including reproductive coercion, and FP options, to both FP and ANC clients. |
| Control group | No intervention | –FP clients and ANC clients will receive standard care. For FP services, this includes standard contraceptive care provided by personnel who have completed training on contraceptive service delivery by the Nigerian Federal Ministry of Health and partners. For ANC services, the standard is a minimum of 8 visits with health personnel trained on ANC care during pregnancy. This includes identification of women and girls at increased risk of developing complications during labor and childbirth; prevention, detection, and management of pregnancy-related and concurrent conditions; health education and promotion; promotion of the use of skilled attendance at birth and healthy behaviors such as breastfeeding, early postnatal care, and planning for optimal pregnancy spacing, routine examinations, detection of complications, prevention of malaria in pregnancy and other infections; provision of holistic care to ensure normal progression of the baby and good health of the mother. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Woman of reproductive age (18 to 49 years) seeking FP or ANC services at study sites
- Women who believe they are able to conceive (i.e. who have not undergone a tubal ligation, hysterectomy, or oophorectomy, or are menopausal) (for FP clients)
- Have a male partner they currently have sex with
- Have a mobile phone that can be safely used for re-contacting for follow-up surveys
- Do not have any accompanying male partners or family members aged 5 or above present
Key exclusion criteria (3 listed)
- Any individuals that do not meet all of the above inclusion criteria or do not agree to participate in the study will be excluded from data collection.
- In addition, individuals with impaired cognitive abilities (I.e. unable to make decisions/respond to questions on their own without assistance by someone else)will also be excluded from the data collection.
- Finally, women who share a mobile phone with their partner/husband or another family member will also be excluded.
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 |
|---|---|---|
| gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (ARCHES)Also: GBV screening, LIVES and ARCHESProviders will (1) introduce routine client screening for GBV, including intimate partner violence, sexual violence, and reproductive coercion using a standardized screening form, in FP and ANC services,(2) for individuals disclosing GBV, provide first-line response-empathetic counseling, including listening, inquiring about experiences sensitively, and validating experiences, helping clients develop safety plans, and providing support; (3) regardless of disclosure of GBV, provide counseling and information, education and communication (IEC) materials on IPV, including reproductive coercion, and FP options, to both FP and ANC clients. | Behavioural | Treatment group |
Primary outcome
Change in percentage of clients disclosing exposure to intimate partner or sexual violence in past 3 months
Time frame: baseline to 3-months and 6-months post-intervention
Disclosure will be defined by a positive response to either of the following questions: * Has your current partner ever slapped you, punched you, hit or kicked you, or done anything else to hurt you physically? * Has your current male partner ever forced you to have sex or do something sexual when you didn't want to?
Percentage of clients that report receiving a family planning method from healthcare provider
Time frame: day of intervention
4 secondary outcomes
Change in percentage of clients demonstrating family planning self efficacy, as measured by Contraceptive Self-Efficacy among women in sub-Saharan Africa (CSESSA) sub-scale
Time frame: baseline to 3-months and 6-months post-intervention
Change in demonstrated self-efficacy to access IPV services
Time frame: baseline to 3-months and 6-months post-intervention
Change in self-reported use of safety measures to protect respondent or her child/children from violence
Time frame: baseline to 3-months and 6-months post-intervention
Change in percentage of clients reporting experiences of reproductive coercion in 3 months prior to data collection
Time frame: baseline to 3-months and 6-months post-intervention
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 7 Aug 2023.
- Background: PubMed 32460786Uysal 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.
- Background: PubMed 27814706Pallitto C, Garcia-Moreno C, Stoeckl H, Hatcher A, MacPhail C, Mokoatle K, Woollett N. Testing a counselling intervention in antenatal care for women experiencing partner violence: a study protocol for a randomized controlled trial in Johannesburg, South Africa. BMC Health Serv Res. 2016 Nov 5;16(1):630. doi: 10.1186/s12913-016-1872-x.
- Background: PubMed 11843378Bacchu L, Mezey G, Bewley S. Women's perceptions and experiences of routine enquiry for domestic violence in a maternity service. BJOG. 2002 Jan;109(1):9-16. doi: 10.1111/j.1471-0528.2002.00514.x.
- Background: PubMed 16611513Boyle A, Jones PB. The acceptability of routine inquiry about domestic violence towards women: a survey in three healthcare settings. Br J Gen Pract. 2006 Apr;56(525):258-61.
- Background: PubMed 16972587McDonnell E, Holohan M, Reilly MO, Warde L, Collins C, Geary M. Acceptability of routine enquiry regarding domestic violence in the antenatal clinic. Ir Med J. 2006 Apr;99(4):123-4.
- Background: PubMed 11064226Waalen J, Goodwin MM, Spitz AM, Petersen R, Saltzman LE. Screening for intimate partner violence by health care providers. Barriers and interventions. Am J Prev Med. 2000 Nov;19(4):230-7. doi: 10.1016/s0749-3797(00)00229-4.
- BackgroundHamberger L.K.; Guse C.; Boerger J.; Minsky D.; Pape D.; Folsom C. Evaluation of a Health Care Provider Training Program to Identify and Help Partner Violence Victims. Journal of Family Violence, Volume 19, Number 1, February 2004, pp. 1-11
- Background: PubMed 17044223McNulty A, Andrews P, Bonner M. Can screening for domestic violence be introduced successfully in a sexual health clinic? Sex Health. 2006 Sep;3(3):179-82. doi: 10.1071/sh05056.
- Background: PubMed 11818176McNutt LA, Carlson BE, Rose IM, Robinson DA. Partner violence intervention in the busy primary care environment. Am J Prev Med. 2002 Feb;22(2):84-91. doi: 10.1016/s0749-3797(01)00407-x.
- Background: PubMed 28697810Taft A, Colombini M. Healthcare system responses to intimate partner violence in low and middle-income countries: evidence is growing and the challenges become clearer. BMC Med. 2017 Jul 12;15(1):127. doi: 10.1186/s12916-017-0886-5.
- Results publication: PubMed 16439929McFarlane JM, Groff JY, O'Brien JA, Watson K. Secondary prevention of intimate partner violence: a randomized controlled trial. Nurs Res. 2006 Jan-Feb;55(1):52-61. doi: 10.1097/00006199-200601000-00007.
- Results publication: PubMed 16101604Tiwari A, Leung WC, Leung TW, Humphreys J, Parker B, Ho PC. A randomised controlled trial of empowerment training for Chinese abused pregnant women in Hong Kong. BJOG. 2005 Sep;112(9):1249-56. doi: 10.1111/j.1471-0528.2005.00709.x.
- World Health Organization. (2019). Caring for women subjected to violence: a WHO curriculum for training health-care providers. World Health Organization.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Myra Betron principal investigator
Jhpiego
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (ARCHES) in people with Gender-based Violence and Reproductive Coercion, run by Jhpiego at 40 sites in Nigeria.
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 5 inclusion and 3 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 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Nigeria. 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?
Change in percentage of clients disclosing exposure to intimate partner or sexual violence in past 3 months (time frame: baseline to 3-months and 6-months post-intervention). The study lists 2 primary outcomes in all. 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 NCT05331508, which also lists 15 linked publications.
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 7 Aug 2023.