Clinical trial NCT05331508: Testing Gender-based Violence Response in Family Planning and Antenatal Care Services in Nigeria
Official title: Testing the Integration of Gender-based Violence First-line Response in Family Planning and Antenatal Care Services in Nigeria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gender-based Violence
Reproductive Coercion
Intimate Partner Violence
Lead sponsor: Jhpiego
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 1756
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in percentage of clients disclosing exposure to intimate partner or sexual violence in past 3 months
timeFrame: baseline to 3-months and 6-months post-intervention
measure: Percentage of clients that report receiving a family planning method from healthcare provider
timeFrame: day of intervention
Secondary outcomes:
measure: 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
timeFrame: baseline to 3-months and 6-months post-intervention
measure: Change in demonstrated self-efficacy to access IPV services
timeFrame: baseline to 3-months and 6-months post-intervention
measure: Change in self-reported use of safety measures to protect respondent or her child/children from violence
timeFrame: baseline to 3-months and 6-months post-intervention
measure: Change in percentage of clients reporting experiences of reproductive coercion in 3 months prior to data collection
timeFrame: baseline to 3-months and 6-months post-intervention
Other outcomes:
measure: Clients perception of quality of services provided
timeFrame: day of intervention
measure: Knowledge of intimate partner violence (IPV) and sexual violence (SV) related services
timeFrame: baseline to 3-months and 6-months post-intervention
measure: Change in self-reported communication with partner about family planning
timeFrame: baseline to 3-months and 6-months post-intervention
measure: Change in self-reported communication with partner about birth plan
timeFrame: baseline to 3-months and 6-months post-intervention
Locations:
city: Abakaliki
country: Nigeria
facility: AZUIYIOKWU Health Center
state: Ebonyi
city: Abakaliki
country: Nigeria
facility: GMELINA Health Center
state: Ebonyi
city: Abakaliki
country: Nigeria
facility: NEW TIMBER SHADE Health Center
state: Ebonyi
city: Afikpo North
country: Nigeria
facility: AMAECHARA Primary Health Center
state: Ebonyi
city: Afikpo North
country: Nigeria
facility: Izeke Health Center
state: Ebonyi
city: Afikpo North
country: Nigeria
facility: NKAGBOGO NDEMIYI MDG Primary Health Center
state: Ebonyi
city: Afikpo South
country: Nigeria
facility: Owutu Primary Health Center
state: Ebonyi
city: Afikpo South
country: Nigeria
facility: Uwana Primary Health Center
state: Ebonyi
city: Ezza South
country: Nigeria
facility: MCH Onueke
state: Ebonyi
city: Ezza
country: Nigeria
facility: AZUNRAMURA Health Center
state: Ebonyi
city: Ikwo
country: Nigeria
facility: Cottage Hospital
state: Ebonyi
city: Ikwo
country: Nigeria
facility: Echara Health Center
state: Ebonyi
city: Ikwo
country: Nigeria
facility: Item Health Center
state: Ebonyi
city: Ikwo
country: Nigeria
facility: Noyo Health Center
state: Ebonyi
city: Ivo
country: Nigeria
facility: NDIOKOROUKWU Health Center
state: Ebonyi
city: Onicha
country: Nigeria
facility: Anike Health Center
state: Ebonyi
city: Onicha
country: Nigeria
facility: Okaria Health Center
state: Ebonyi
city: Onicha
country: Nigeria
facility: Oshiri Health Center
state: Ebonyi
city: Bodina
country: Nigeria
facility: GH Bodinga
state: Sokoto
city: Dange Sguni
country: Nigeria
facility: Durbawa Primary Health Center
state: Sokoto
city: Dange Sguni
country: Nigeria
facility: Kwannawa Primary Health Center
state: Sokoto
city: Dange Sguni
country: Nigeria
facility: Ruga Dubu
state: Sokoto
city: Gada
country: Nigeria
facility: GH Gada
state: Sokoto
city: Gwadabawa
country: Nigeria
facility: Mamman Suka Primary Health Center
state: Sokoto
city: Ilela
country: Nigeria
facility: Araba Health Center
state: Sokoto
city: Ilela
country: Nigeria
facility: Darna Sabon Gari Health Center
state: Sokoto
city: Ilela
country: Nigeria
facility: Garu
state: Sokoto
city: Ilela
country: Nigeria
facility: Gidan Chiwake Health Center
state: Sokoto
city: Ilela
country: Nigeria
facility: Gidan Hamma Health Center
state: Sokoto
city: Ilela
country: Nigeria
facility: Kalmalo
state: Sokoto
city: Ilela
country: Nigeria
facility: Rungumawar Gatti Health Center
state: Sokoto
city: Ilela
country: Nigeria
facility: Tozai Health Center
state: Sokoto
city: Ivo
country: Nigeria
facility: AKAEZEUKWU Health Center
state: Sokoto
city: Kware
country: Nigeria
facility: Durbawa Primary Health Center
state: Sokoto
city: Shagari
country: Nigeria
facility: Gan Gam Primary Health Center
state: Sokoto
city: Shagari
country: Nigeria
facility: Horo Primary Health Center
state: Sokoto
city: Shagari
country: Nigeria
facility: Kajiji Primary Health Center
state: Sokoto
city: Shagari
country: Nigeria
facility: Sanyinnawal Primary Health Center
state: Sokoto
city: Wamakko
country: Nigeria
facility: Kaura Kimba Health Post
state: Sokoto
city: Ebonyi
country: Nigeria
facility: MDG Randa
Study officials:
affiliation: Jhpiego
name: Myra Betron
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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: 10.1016/j.contraception.2010.07.013.
citation: 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.