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

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.

Study Overview

• Status: Completed
• Conditions: Intimate Partner Violence; Gender-based Violence; Reproductive Coercion
• Intervention / Treatment: Behavioral: gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (ARCHES)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1756
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Ebonyi, Nigeria
    • MDG Randa
  • Ebonyi
    • Abakaliki, Ebonyi, Nigeria
      • AZUIYIOKWU Health Center
    • Abakaliki, Ebonyi, Nigeria
      • GMELINA Health Center
    • Abakaliki, Ebonyi, Nigeria
      • NEW TIMBER SHADE Health Center
    • Afikpo North, Ebonyi, Nigeria
      • AMAECHARA Primary Health Center
    • Afikpo North, Ebonyi, Nigeria
      • Izeke Health Center
    • Afikpo North, Ebonyi, Nigeria
      • NKAGBOGO NDEMIYI MDG Primary Health Center
    • Afikpo South, Ebonyi, Nigeria
      • Owutu Primary Health Center
    • Afikpo South, Ebonyi, Nigeria
      • Uwana Primary Health Center
    • Ezza, Ebonyi, Nigeria
      • AZUNRAMURA Health Center
    • Ezza South, Ebonyi, Nigeria
      • MCH Onueke
    • Ikwo, Ebonyi, Nigeria
      • Cottage Hospital
    • Ikwo, Ebonyi, Nigeria
      • Echara Health Center
    • Ikwo, Ebonyi, Nigeria
      • Item Health Center
    • Ikwo, Ebonyi, Nigeria
      • Noyo Health Center
    • Ivo, Ebonyi, Nigeria
      • NDIOKOROUKWU Health Center
    • Onicha, Ebonyi, Nigeria
      • Anike Health Center
    • Onicha, Ebonyi, Nigeria
      • Okaria Health Center
    • Onicha, Ebonyi, Nigeria
      • Oshiri Health Center
  • Sokoto
    • Bodina, Sokoto, Nigeria
      • GH Bodinga
    • Dange Sguni, Sokoto, Nigeria
      • Durbawa Primary Health Center
    • Dange Sguni, Sokoto, Nigeria
      • Kwannawa Primary Health Center
    • Dange Sguni, Sokoto, Nigeria
      • Ruga Dubu
    • Gada, Sokoto, Nigeria
      • GH Gada
    • Gwadabawa, Sokoto, Nigeria
      • Mamman Suka Primary Health Center
    • Ilela, Sokoto, 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
    • Ivo, Sokoto, Nigeria
      • AKAEZEUKWU Health Center
    • Kware, Sokoto, Nigeria
      • Durbawa Primary Health Center
    • Shagari, Sokoto, 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
    • Wamakko, Sokoto, Nigeria
      • Kaura Kimba Health Post

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: GBV screening, LIVES and ARCHES
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of clients that report receiving a family planning method from healthcare provider		day of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Jhpiego
• Investigators: Principal Investigator: Myra Betron, Jhpiego

Publications and helpful links

General 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.
• 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.
• 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
• 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.
• 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. Erratum In: Obstet Gynecol. 2011 May;117(5):1232. Blake, Susan M [added].
• 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.
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MCGL-IRB17494

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No