Testing Gender-based Violence Response in Family Planning and Antenatal Care Services in Nigeria
NCT ID: NCT05331508
Last Updated: 2023-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
1756 participants
INTERVENTIONAL
2022-04-06
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
GBV first-line response in the health setting includes screening , empowerment counseling, safety planning, and support to connect to additional services needed.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Controlled Trial to Address Unintended Pregnancy Rates in Low Resource Settings
NCT05328648
Birth Companion Intervention in Ethiopia, Kenya and Nigeria
NCT05565196
Addressing Reproductive Coercion in HEalth Settings - Kenya
NCT03534401
Strengthening Women's Agency During Pregnancy
NCT05515094
A Study Comparing Implant Provision by Community Health Extension Workers With Nurses and Midwives in Nigeria
NCT03088722
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1\. 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.
2\. Explore factors influencing feasibility, acceptability and ability to implement GBV first-line response as part of FP and ANC services.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment group
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.
gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (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.
Control group
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
49 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jhpiego
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Myra Betron
Role: PRINCIPAL_INVESTIGATOR
Jhpiego
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AZUIYIOKWU Health Center
Abakaliki, Ebonyi State, Nigeria
GMELINA Health Center
Abakaliki, Ebonyi State, Nigeria
NEW TIMBER SHADE Health Center
Abakaliki, Ebonyi State, Nigeria
AMAECHARA Primary Health Center
Afikpo North, Ebonyi State, Nigeria
Izeke Health Center
Afikpo North, Ebonyi State, Nigeria
NKAGBOGO NDEMIYI MDG Primary Health Center
Afikpo North, Ebonyi State, Nigeria
Owutu Primary Health Center
Afikpo South, Ebonyi State, Nigeria
Uwana Primary Health Center
Afikpo South, Ebonyi State, Nigeria
MDG Randa
Ebonyi, Ebonyi State, Nigeria
MCH Onueke
Ezza South, Ebonyi State, Nigeria
AZUNRAMURA Health Center
Ezza, Ebonyi State, Nigeria
Cottage Hospital
Ikwo, Ebonyi State, Nigeria
Echara Health Center
Ikwo, Ebonyi State, Nigeria
Item Health Center
Ikwo, Ebonyi State, Nigeria
Noyo Health Center
Ikwo, Ebonyi State, Nigeria
NDIOKOROUKWU Health Center
Ivo, Ebonyi State, Nigeria
Anike Health Center
Onicha, Ebonyi State, Nigeria
Okaria Health Center
Onicha, Ebonyi State, Nigeria
Oshiri Health Center
Onicha, Ebonyi State, Nigeria
GH Bodinga
Bodina, Sokoto State, Nigeria
Durbawa Primary Health Center
Dange Sguni, Sokoto State, Nigeria
Kwannawa Primary Health Center
Dange Sguni, Sokoto State, Nigeria
Ruga Dubu
Dange Sguni, Sokoto State, Nigeria
GH Gada
Gada, Sokoto State, Nigeria
Mamman Suka Primary Health Center
Gwadabawa, Sokoto State, Nigeria
Araba Health Center
Ilela, Sokoto State, Nigeria
Darna Sabon Gari Health Center
Ilela, Sokoto State, Nigeria
Garu
Ilela, Sokoto State, Nigeria
Gidan Chiwake Health Center
Ilela, Sokoto State, Nigeria
Gidan Hamma Health Center
Ilela, Sokoto State, Nigeria
Kalmalo
Ilela, Sokoto State, Nigeria
Rungumawar Gatti Health Center
Ilela, Sokoto State, Nigeria
Tozai Health Center
Ilela, Sokoto State, Nigeria
AKAEZEUKWU Health Center
Ivo, Sokoto State, Nigeria
Durbawa Primary Health Center
Kware, Sokoto State, Nigeria
Gan Gam Primary Health Center
Shagari, Sokoto State, Nigeria
Horo Primary Health Center
Shagari, Sokoto State, Nigeria
Kajiji Primary Health Center
Shagari, Sokoto State, Nigeria
Sanyinnawal Primary Health Center
Shagari, Sokoto State, Nigeria
Kaura Kimba Health Post
Wamako, Sokoto State, Nigeria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Pallitto 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.
Bacchu 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.
Boyle 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.
McDonnell 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.
Waalen 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.
Hamberger 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.
McNutt 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.
Taft 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.
McFarlane 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.
Tiwari 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.
Miller 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.
Kiely 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.
Betron 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.
Related Links
Access external resources that provide additional context or updates about the study.
World Health Organization. (2019). Caring for women subjected to violence: a WHO curriculum for training health-care providers. World Health Organization.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MCGL-IRB17494
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.