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

NCT05331508 | Completed

• 1 other identifier: MCGL-IRB17494
• Study Type: interventional
• Target: 1,756
• Locations: 1 country
• Sites: 40

Brief 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.

Conditions

Gender-based Violence; Reproductive Coercion; Intimate Partner Violence

Outcome Measures

Primary Outcomes (2)

• 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 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

  baseline to 3-months and 6-months post-intervention

• Change in demonstrated self-efficacy to access IPV services

  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

  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

  baseline to 3-months and 6-months post-intervention

Other Outcomes (4)

• Clients perception of quality of services provided

  day of intervention

• Knowledge of intimate partner violence (IPV) and sexual violence (SV) related services

  baseline to 3-months and 6-months post-intervention

• Change in self-reported communication with partner about family planning

  baseline to 3-months and 6-months post-intervention

Study Arms (2)

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.

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.

Interventions

gender-based violence screening, first-line support (LIVES) and reproductive coercion empowerment counseling (ARCHES) BEHAVIORAL

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.

Also known as: GBV screening, LIVES and ARCHES

Treatment group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jhpiego: lead

Study Sites (40)

AZUIYIOKWU Health Center

Abakaliki, Ebonyi State, Nigeria

Location

GMELINA Health Center

Abakaliki, Ebonyi State, Nigeria

Location

NEW TIMBER SHADE Health Center

Abakaliki, Ebonyi State, Nigeria

Location

AMAECHARA Primary Health Center

Afikpo North, Ebonyi State, Nigeria

Location

Izeke Health Center

Afikpo North, Ebonyi State, Nigeria

Location

NKAGBOGO NDEMIYI MDG Primary Health Center

Afikpo North, Ebonyi State, Nigeria

Location

Owutu Primary Health Center

Afikpo South, Ebonyi State, Nigeria

Location

Uwana Primary Health Center

Afikpo South, Ebonyi State, Nigeria

Location

MDG Randa

Ebonyi, Ebonyi State, Nigeria

Location

MCH Onueke

Ezza South, Ebonyi State, Nigeria

Location

AZUNRAMURA Health Center

Ezza, Ebonyi State, Nigeria

Location

Cottage Hospital

Ikwo, Ebonyi State, Nigeria

Location

Echara Health Center

Ikwo, Ebonyi State, Nigeria

Location

Item Health Center

Ikwo, Ebonyi State, Nigeria

Location

Noyo Health Center

Ikwo, Ebonyi State, Nigeria

Location

NDIOKOROUKWU Health Center

Ivo, Ebonyi State, Nigeria

Location

Anike Health Center

Onicha, Ebonyi State, Nigeria

Location

Okaria Health Center

Onicha, Ebonyi State, Nigeria

Location

Oshiri Health Center

Onicha, Ebonyi State, Nigeria

Location

GH Bodinga

Bodina, Sokoto State, Nigeria

Location

Durbawa Primary Health Center

Dange Sguni, Sokoto State, Nigeria

Location

Kwannawa Primary Health Center

Dange Sguni, Sokoto State, Nigeria

Location

Ruga Dubu

Dange Sguni, Sokoto State, Nigeria

Location

GH Gada

Gada, Sokoto State, Nigeria

Location

Mamman Suka Primary Health Center

Gwadabawa, Sokoto State, Nigeria

Location

Araba Health Center

Ilela, Sokoto State, Nigeria

Location

Darna Sabon Gari Health Center

Ilela, Sokoto State, Nigeria

Location

Garu

Ilela, Sokoto State, Nigeria

Location

Gidan Chiwake Health Center

Ilela, Sokoto State, Nigeria

Location

Gidan Hamma Health Center

Ilela, Sokoto State, Nigeria

Location

Kalmalo

Ilela, Sokoto State, Nigeria

Location

Rungumawar Gatti Health Center

Ilela, Sokoto State, Nigeria

Location

Tozai Health Center

Ilela, Sokoto State, Nigeria

Location

AKAEZEUKWU Health Center

Ivo, Sokoto State, Nigeria

Location

Durbawa Primary Health Center

Kware, Sokoto State, Nigeria

Location

Gan Gam Primary Health Center

Shagari, Sokoto State, Nigeria

Location

Horo Primary Health Center

Shagari, Sokoto State, Nigeria

Location

Kajiji Primary Health Center

Shagari, Sokoto State, Nigeria

Location

Sanyinnawal Primary Health Center

Shagari, Sokoto State, Nigeria

Location

Kaura Kimba Health Post

Wamako, Sokoto State, Nigeria

Location

Related Publications (15)

• 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.

  PMID: 32460786 BACKGROUND

• 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.

  PMID: 27814706 BACKGROUND

• 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.

  PMID: 11843378 BACKGROUND

• 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.

  PMID: 16611513 BACKGROUND

• 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.

  PMID: 16972587 BACKGROUND

• 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.

  PMID: 11064226 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 17044223 BACKGROUND

• 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.

  PMID: 11818176 BACKGROUND

• 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.

  PMID: 28697810 BACKGROUND

• 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.

  PMID: 16439929 RESULT

• 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.

  PMID: 16101604 RESULT

• 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.

  PMID: 21310291 RESULT

• 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.

  PMID: 20093899 RESULT

• 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.

  PMID: 41151831 DERIVED

Related Links

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

Study Officials

• Myra Betron

  Jhpiego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: April 15, 2022
• Study Start: April 6, 2022
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NG (40)