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Completed

NCT Number: NCT05331508

Testing Gender-based Violence 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.

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Key information

Conditions

Gender-Based Violence Intimate Partner Violence Reproductive Coercion

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AZUIYIOKWU Health Center, Abakaliki, Ebonyi State, Nigeria

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About this study

This study seeks to:

  • 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.

  • Explore factors influencing feasibility, acceptability and ability to implement GBV first-line response as part of FP and ANC services.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: GBV screening, LIVES and ARCHES

Primary outcomes

  1. Change in percentage of clients disclosing exposure to intimate partner or sexual violence in past 3 months

    Time frame: baseline to 3-months and 6-months post-intervention

    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?

  2. Percentage of clients that report receiving a family planning method from healthcare provider

    Time frame: day of intervention

Secondary outcomes

  1. 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

    Time frame: baseline to 3-months and 6-months post-intervention

    Family planning self-efficacy is a women's belief about her own ability to complete the actions necessary for successful family planning.

  2. Change in demonstrated self-efficacy to access IPV services

    Time frame: baseline to 3-months and 6-months post-intervention

    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'.

  3. Change in self-reported use of safety measures to protect respondent or her child/children from violence

    Time frame: baseline to 3-months and 6-months post-intervention

    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?

  4. Change in percentage of clients reporting experiences of reproductive coercion in 3 months prior to data collection

    Time frame: baseline to 3-months and 6-months post-intervention

    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?

Other outcomes

  1. Clients perception of quality of services provided

    Time frame: day of intervention

    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?

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

    Time frame: baseline to 3-months and 6-months post-intervention

    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).

  3. Change in self-reported communication with partner about family planning

    Time frame: baseline to 3-months and 6-months post-intervention

    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?

  4. Change in self-reported communication with partner about birth plan

    Time frame: baseline to 3-months and 6-months post-intervention

    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?

Sponsors and collaborators

Lead sponsor

Jhpiego

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 15, 2022
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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