NCT05331248

Brief Summary

Leaders in Action (LIA) is a norms-centered intervention that aims to reduce the acceptance and prevent the incidence of Intimate Partner Violence (IPV) in Peru by shifting social norms. This project takes advantage of the randomization of LIA across 250 villages. LIA has two delivery models: a household-based module (HT), consisting of household training sessions by Community Health Volunteers, and a group-based module (GT) with education sessions in small gender-segregated groups organized by trained facilitators. The investigators will cross-randomize each approach to assess efficiency in reducing domestic violence and changing social norms about tolerance toward violence and gender roles. The study disentangles the impact of the two modules separately, as well as the interaction of the modules, while explicitly addressing methodological concerns of previous studies: reporting bias from self-reported domestic violence, limited statistical power and lack of long-term effects measures. Potential and actual victims of IPV may profit from the intimate atmosphere of household visits, and that on the side of women, the transmission of information about IPV and services for victims may be facilitated in more private settings. At the same time, group-level workshops about harmful gender stereotypes and gender norms for women should, through social interactions and norm change, reinforce the effects of household-level treatments for women. The experiment will shed light on the potential mechanisms at play and the theoretical framework underlying IPV through extensive data collection and the calculation of heterogeneous effects. The goal of this project is to deliver new rigorous evidence to the scientific and policy community by experimentally evaluating the impact of a state-run IPV intervention and its main components. It provides insights into the effectiveness of distinct program components, assesses cost-effectiveness as well as potential to scale, and evaluates the mechanisms leading to the reduction of IPV.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,754

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

May 2, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

February 16, 2022

Last Update Submit

August 26, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • Women's Reporting of Intimate Partner Violence

    For women only. The researchers will replicate a standard Demographic Household Survey domestic violence module, administered through a self-paced ballot-style questionnaire. The indicator will take the value of 1 if a woman reports at least 1 event of intimate-partner violence, and 0 if a woman reports not having experienced any events of intimate-partner violence. The indicator values are 0 and 1; with 1 meaning a woman suffered from intimate-partner violence and 0 meaning a woman did not suffer intimate-partner violence in the reporting period.

    06 months after the intervention

  • Women's Index of Physical Health

    For women only. The researchers will use World Health Organization questionnaires on physical health. The index values are 0 to 1; higher scores mean better outcomes.

    06 months after the intervention

  • Women's Index of Mental Health

    For women. The researchers will use questions from the Kessler Psychological Distress Scale 6 (K6) for mental distress. The index values are 0 to 1; higher scores mean better outcomes.

    06 months after the intervention

  • Men's Index of Mental Health

    For men. The researchers will use questions from the Kessler Psychological Distress Scale 6 (K6) for mental distress. The index values are 0 to 1; higher scores mean better outcomes.

    06 months after the intervention

  • Men's Index of Tolerance towards Violence against Women

    For men. The researchers will use 9 statements about the justification of violence (asking whether the participants agree or disagree with these statements). The index values are 0 to 1; higher scores mean worse outcomes.

    06 months after the intervention

  • Women's Index of Tolerance towards Violence against Women

    For women. The researchers will use 9 statements about the justification of violence (asking whether the participants agree or disagree with these statements). The index values are 0 to 1; higher scores mean worse outcomes.

    06 months after the intervention

Secondary Outcomes (5)

  • Women's Index of Agency

    06 months after the intervention

  • Men's Index of Social Norms

    06 months after the intervention

  • Women's Index of Social Norms

    06 months after the intervention

  • Women's reporting of Violence from non-Partner

    06 months after the intervention

  • Men's reporting of Intimate Partner Violence

    06 months after the intervention

Study Arms (4)

LIA Household Training

EXPERIMENTAL

This treatment arm is an 8-session training with a tailored schedule at the household level that targets couples at risk of domestic violence. The sessions are delivered by Community Health Volunteers: 1 Facilitator and 1 Community Agent. The training aims to raise awareness of IPV and social norms around domestic violence and is delivered at the household level in a private environment. Additionally, the intervention includes sessions on soft skills and conflict resolution. The session topics are: i) gender roles, beliefs and stereotypes; ii) violence, cultural patterns and human rights; iii) healthy relationships within the family; iv) good treatment between family members and self-care; v) Assertive communication; vi) resolution and conflict management; vii) resources for domestic violence cases; and viii) leadership and women's agency.

Behavioral: Leaders in Action: Household Treatment

LIA Group Training

EXPERIMENTAL

This treatment arm is an 4-session training delivered in gender-segregated groups at the village level that targets couples at risk of domestic violence in separate spaces. The sessions are delivered by Community Health Volunteers: 1 Facilitator and 1 Community Agent. The training aims to raise awareness of IPV and social norms around domestic violence and is delivered at the household in a private environment. The sessions topics are: i) gender roles, beliefs and stereotypes; ii) violence, cultural patterns and human rights; iii) healthy relationships within the family; iv) good treatment between family members and self-care; v) assertive communication; vi) resolution and conflict management; vii) resources for domestic violence cases; and viii) leadership and women's agency.

Behavioral: Leaders in Action: Group Treatment

LIA Household and Group Training

EXPERIMENTAL

This treatment arm combines LIA Household and Group training. Villages in this arm will first receive the 8-sessions household-level intervention, then the 4-sessions of village-level gender-segregated group intervention will follow. The session topics for both interventions are: i) gender roles, beliefs and stereotypes; ii) violence, cultural patterns and human rights; iii) healthy relationships within the family; iv) good treatment between family members and self-care; v) assertive communication; vi) resolution and conflict management; vii) resources for domestic violence cases; and viii) leadership and women's agency.

Behavioral: Leaders in Action: Household TreatmentBehavioral: Leaders in Action: Group Treatment

Control group

NO INTERVENTION

Villages in the control group will not receive any intervention.

Interventions

The Household Treatment (HT) followed a door-to-door delivery approach: CHVs, in coordination with the local Women Emergency Center (CEM), offered 8 treatment sessions to households in the targeted sample. The sessions took place over a period of 1 to 2 months at the residences of the female participants. This intervention was subject to a second-stage randomization to include edutainment videos in its implementation for the HT only treatment arm. In 31 randomly selected HT villages, all targeted households watched the edutainment component as part of the HT program, and in the other 31 HT villages, only 50% of the targeted households were randomly assigned to watch the edutainment component.

Also known as: HT
LIA Household TrainingLIA Household and Group Training

The group-based approach (Group Treatment, or GT) entailed 4 workshops involving various activities and group discussions. The group sessions directed at men had a slightly different curriculum than those directed at women, and always had at least one male CHV in the room facilitating the session. GT sessions took place over one month in each community in village community centers, schools, churches, or other communal spaces where village residents would often gather, and lasted for approximately two hours. The edutainment component was screened in every GT workshop.

Also known as: GT
LIA Group TrainingLIA Household and Group Training

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Eligibility to receive the initial census: Women between the ages of 18-59 in 2022, who lived with a male partner, and who were permanent residents in villages from our sample (defined as living in the village for at least 4 months of the year). Eligibility to be part of the targeted sample: * Women identified to be at risk of suffering from IPV in the census, who as a result, also received a baseline survey. * In 50 percent of the treatment villages chosen at random, an additional 30% of women randomly selected from the census. * Male partners of women in the targeted sample. * Across a sub-sample of 94 treatment villages chosen at random, 1 village leader. Specifically, we identified two village leaders, one male and one female, and randomly selected which of the genders was selected for targeting. This resulted in 50 women leaders and 44 men leaders, and their partners. Eligibility for the endline survey sample: * We plan to interview all men, women, and village leaders in our targeted sample. * We will also interview 4 additional women per village who were eligible to receive the initial census but were not part of the targeted sample, as well as their male partners, to measure spillover effects.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Innovations for Poverty Action

Lima, Peru

Location

Related Publications (3)

  • Ellsberg M, Arango DJ, Morton M, Gennari F, Kiplesund S, Contreras M, Watts C. Prevention of violence against women and girls: what does the evidence say? Lancet. 2015 Apr 18;385(9977):1555-66. doi: 10.1016/S0140-6736(14)61703-7. Epub 2014 Nov 21.

    PMID: 25467575BACKGROUND
  • Chakraborty P, Osrin D, Daruwalla N. "We Learn How to Become Good Men": Working with Male Allies to Prevent Violence against Women and Girls in Urban Informal Settlements in Mumbai, India. Men Masc. 2020 Aug;23(3-4):749-771. doi: 10.1177/1097184X18806544. Epub 2018 Oct 18.

    PMID: 32903823BACKGROUND
  • Abramsky T, Devries K, Kiss L, Nakuti J, Kyegombe N, Starmann E, Cundill B, Francisco L, Kaye D, Musuya T, Michau L, Watts C. Findings from the SASA! Study: a cluster randomized controlled trial to assess the impact of a community mobilization intervention to prevent violence against women and reduce HIV risk in Kampala, Uganda. BMC Med. 2014 Jul 31;12:122. doi: 10.1186/s12916-014-0122-5.

    PMID: 25248996BACKGROUND

Study Officials

  • Erica Field, PhD

    Duke University

    PRINCIPAL INVESTIGATOR
  • Livia Schubiger, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR
  • Ursula Aldana, PhD

    Instituto de Estudios Peruanos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2022

First Posted

April 15, 2022

Study Start

May 2, 2022

Primary Completion

April 20, 2025

Study Completion

April 30, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations