Testing Gender-based Violence Response in Family Planning and Antenatal Care Services in Nigeria

Intimate Partner Violence Clinical Trial

Official title:

Testing the Integration of Gender-based Violence First-line Response in Family Planning and Antenatal Care Services in Nigeria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05331508
• Other study ID #: MCGL-IRB17494
• Status: Completed
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Jhpiego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. GBV first-line response in the health setting includes screening , empowerment counseling, safety planning, and support to connect to additional services needed.

Description:

This study seeks to: 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1756
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Gender-based Violence
• Intimate Partner Violence

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Nigeria	AZUIYIOKWU Health Center	Abakaliki	Ebonyi
Nigeria	GMELINA Health Center	Abakaliki	Ebonyi
Nigeria	NEW TIMBER SHADE Health Center	Abakaliki	Ebonyi
Nigeria	AMAECHARA Primary Health Center	Afikpo North	Ebonyi
Nigeria	Izeke Health Center	Afikpo North	Ebonyi
Nigeria	NKAGBOGO NDEMIYI MDG Primary Health Center	Afikpo North	Ebonyi
Nigeria	Owutu Primary Health Center	Afikpo South	Ebonyi
Nigeria	Uwana Primary Health Center	Afikpo South	Ebonyi
Nigeria	GH Bodinga	Bodina	Sokoto
Nigeria	Durbawa Primary Health Center	Dange Sguni	Sokoto
Nigeria	Kwannawa Primary Health Center	Dange Sguni	Sokoto
Nigeria	Ruga Dubu	Dange Sguni	Sokoto
Nigeria	MDG Randa	Ebonyi
Nigeria	AZUNRAMURA Health Center	Ezza	Ebonyi
Nigeria	MCH Onueke	Ezza South	Ebonyi
Nigeria	GH Gada	Gada	Sokoto
Nigeria	Mamman Suka Primary Health Center	Gwadabawa	Sokoto
Nigeria	Cottage Hospital	Ikwo	Ebonyi
Nigeria	Echara Health Center	Ikwo	Ebonyi
Nigeria	Item Health Center	Ikwo	Ebonyi
Nigeria	Noyo Health Center	Ikwo	Ebonyi
Nigeria	Araba Health Center	Ilela	Sokoto
Nigeria	Darna Sabon Gari Health Center	Ilela	Sokoto
Nigeria	Garu	Ilela	Sokoto
Nigeria	Gidan Chiwake Health Center	Ilela	Sokoto
Nigeria	Gidan Hamma Health Center	Ilela	Sokoto
Nigeria	Kalmalo	Ilela	Sokoto
Nigeria	Rungumawar Gatti Health Center	Ilela	Sokoto
Nigeria	Tozai Health Center	Ilela	Sokoto
Nigeria	AKAEZEUKWU Health Center	Ivo	Sokoto
Nigeria	NDIOKOROUKWU Health Center	Ivo	Ebonyi
Nigeria	Durbawa Primary Health Center	Kware	Sokoto
Nigeria	Anike Health Center	Onicha	Ebonyi
Nigeria	Okaria Health Center	Onicha	Ebonyi
Nigeria	Oshiri Health Center	Onicha	Ebonyi
Nigeria	Gan Gam Primary Health Center	Shagari	Sokoto
Nigeria	Horo Primary Health Center	Shagari	Sokoto
Nigeria	Kajiji Primary Health Center	Shagari	Sokoto
Nigeria	Sanyinnawal Primary Health Center	Shagari	Sokoto
Nigeria	Kaura Kimba Health Post	Wamakko	Sokoto

Sponsors (1)

Lead Sponsor	Collaborator
Jhpiego

Country where clinical trial is conducted

Nigeria, 

References & Publications (14)

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. — View Citation

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. — View Citation

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

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. Erratum In: O — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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: 10.1 — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clients perception of quality of services provided	Perception of service quality will be defined by a positive or negative response to the following question: • Has any provider from this clinic made you feel uncomfortable or treated you badly (e.g. insulted or disrespected you) for wanting to use or for using a family planning method?	day of intervention
Other	Knowledge of intimate partner violence (IPV) and sexual violence (SV) related services	Knowledge will be defined as a positive response to whether client thinks a woman experiencing physical or sexual violence from her male partner could get help at specified services (health services, law enforcement, legal aid services, psychosocial support services, shelter/temporary accomodation, economic reintegration services).	baseline to 3-months and 6-months post-intervention
Other	Change in self-reported communication with partner about family planning	Couple communication about family planning will be defined by a positive response to the following question: • In the last 3 months, did you discuss whether to use a family planning method with your husbands/partner?	baseline to 3-months and 6-months post-intervention
Other	Change in self-reported communication with partner about birth plan	Couple communication about birth plan will be defined by a positive response to the following question: • In the past 3 months, did you discuss your birth plan with your partner?	baseline to 3-months and 6-months post-intervention
Primary	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?	baseline to 3-months and 6-months post-intervention
Primary	Percentage of clients that report receiving a family planning method from healthcare provider		day of intervention
Secondary	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.	baseline to 3-months and 6-months post-intervention
Secondary	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'.	baseline to 3-months and 6-months post-intervention
Secondary	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?	baseline to 3-months and 6-months post-intervention
Secondary	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?	baseline to 3-months and 6-months post-intervention

External Links

•   World Health Organization. (2019). Caring for women subjected to violence: a WHO curriculum for training health-care providers. World Health Organization.