Domestic ViolenceLIANCT05331248
Training Local Leaders to Prevent and Reduce Domestic Violence Evidence From Peru
A study testing Leaders in Action: Household Treatment and Leaders in Action: Group Treatment in people with Domestic Violence, run by Duke University at 1 site in Peru.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Leaders in Action: Household Treatment and Leaders in Action: Group Treatment
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,754 participants
- Where
- 1 sitePeru
- Study dates
- 2 May 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Training Leaders to Prevent and Reduce Domestic Violence in Their Communities: Experimental Evidence From Peru
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.
Read the detailed description
Leaders in Action (LIA) is a norms-centered intervention run by the Peruvian Ministry for Women and Vulnerable Populations (MIMP) that aims to reduce the acceptance and incidence of Intimate Partner Violence (IPV) in Peru by shifting social norms. LIA has two main implementation phases: first, the recruitment of Community Health Volunteers (CHVs) and second, the delivery of content against IPV. The delivery of the intervention is assisted by MIMP professionals working in local "Women Emergency Centers" (Centro de Emergencia Mujer, or CEM), a nationwide network of hubs run by the MIMP that offer wide-ranging support services to IPV victims. The CEMs also implement other IPV prevention interventions at the local level.
CEM's Promotors (MIMP's professionals working at local CEM) recruit leaders of local social organizations and train them to be Facilitators of LIA. Facilitators are the principal CHVs located in each district center who conduct LIA activities. Another type of CHVs are leaders at the village-level who are trained by Facilitators to become Community Agents (CAs). Both CAs and Facilitators work together to conduct the second phase of LIA: the delivery of the intervention through its two delivery models, the Household Treatment (HT) and the Group Treatment (GT).
Originally, the study was designed to only evaluate the HT. Thus, a first randomization was conducted on our study sample with an even split of 125 control villages and 125 treatment villages. The research team and Innovations for Poverty Action (IPA) Peru deployed a census to identify the population of women in sample villages who met the eligibility criteria for the study, and conducted an in-depth baseline survey on women who reported IPV in the census. The implementation of the HT began in 2020, and was interrupted by the Covid-19 pandemic. The MIMP paused the program in March 2020 until national lockdowns were rescinded in February 2022. Given the intense migration and other demographic changes that took place during the 23-month interruption, as well as the potential for new IPV exposure over that period, new census and baseline surveys were conducted in 2022, which were used to define the final targeted sample for the intervention.
Our study tests two different delivery modes of the program, the HT and the GT, as well as their combination, in a cross-randomized design. The 250 villages in our study sample were randomized into 4 treatment arms following a factorial randomization model. This resulted in 62 villages receiving only the HT (HT only), 62 villages receiving only the GT (GT only), 63 villages receiving both the HT and GT (HT+GT), and 63 villages in the control group. The randomization procedure was stratified by CEM, the level of IPV risk, and the 2018 treatment status (villages that had begun implementation of the HT were restricted to remain in the HT only or HT+GT treatment arms).
The MIMP's original HT design followed a door-to-door delivery approach: CHVs, in coordination with the local CEM, offered 8 treatment sessions to households at risk of IPV. These HT sessions took place over a period of 1 to 2 months and were conducted in participants' residences. While all adult household members were invited to participate, the recipients of the HT were, in practice, primarily women. As a result, this delivery mode may have been ineffective at influencing norms and beliefs of male participants. The household-centered approach is also expensive and difficult to scale up. Thus, together with the MIMP, the research team developed modifications to the HT which resulted in the innovations described below.
First, in collaboration with the MIMP, the research team and IPA Peru developed a telenovela-style series as a key component of the LIA program (edutainment component). The series consists of four videos that reinforce themes of relationship conflict, masculinity, and social norms around gender. The edutainment component was randomized for the HT only treatment arm, so that in 31 villages, all households targeted for HT watched the edutainment component as part of the program, and in other 31 villages, only 50% of the households targeted for HT watched the edutainment component. In this second group, the households selected to watch the edutainment videos were randomly selected, which will allow the research team to experimentally identify the effect of the edutainment videos. In the other treatment arms (GT only and HT+GT), the edutainment component is implemented for all participants.
Second, in order to strengthen the effect of LIA and to reach potential perpetrators, which are predominantly men, as well as victims of IPV, we developed a different delivery format with the MIMP: the GT. The GT follows a gender-segregated yet community-wide delivery approach in a group discussion format. Existing evidence suggests that interventions which target both perpetrators and victims can have a substantial impact on attitudes towards and the incidence of IPV, and that simultaneously addressing IPV from different angles can be particularly effective (Chakraborty, P., Osrin, D. and Daruwalla, N., 2020; Abramsky, T. et al., 2014). These approaches commonly stress the importance of collaborative learning in support-group-style sessions to confront ideas of masculinity and gender norms. Moreover, norms change is more likely to happen when individuals are aware of relevant peers who are also changing their beliefs (Bursztyn, L., González, A. L., Yanagizawa-Drott, D. (2018)). As a result, the investigators proposed separating groups by gender to provide tailored settings during intervention.
- This group-based approach entailed 4 GT workshops that integrated various activities and group discussions focused on the same content as the HT. The group workshops 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 workshop. In order to meet this criteria during implementation, the MIMP required a larger number of male CHVs than those who were initially recruited through social organizations; men are usually recruited in disproportionately low numbers for this style of volunteer work, and the initial number of male CHVs was not sufficient for implementation of the GT. As a result, male CHVs were recruited as program Facilitators from local universities, communal associations, and other frequently-transited areas. GT sessions took place over the course of one month in village community centers, schools, churches, or other communal spaces where village residents would often gather, and lasted for approximately two hours. Larger villages held multiple GT sessions per workshop to cover all potential participants, and some villages were re-visited some months after the expected implementation time to ensure a high uptake.
- Participant targeting during the GT was the same as in other treatment arms: MIMP CHVs approached the houses of women in the targeted sample, and extended an invitation for them and their male partners to participate in the intervention. However, given that the GT is designed to involve the village community at large, invitations for the GT were extended to all adults in the village. Households in the targeted sample were approached door-to-door multiple times in the week before the GT session, while the rest of the village households were only approached once per workshop. Aside from door-to-door recruiting, the whole village received a notice an hour before each GT session through a loudspeaker usually used for other village-wide activities.
- The topics covered during both the HT and GT were equivalent to ensure comparability. These topics were: i) gender roles, beliefs and stereotypes; ii) violence, cultural patterns and human rights; iii) healthy relationships within the family; iv) respect 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.
Third, 50% of the villages assigned for either the HT only, GT only, or HT+GT treatment arms (94 villages total) were randomly selected to target one village leader (e.g. village president) to receive treatment given the village's treatment assignment. This will evaluate if community leaders are impactful in shifting norms at the village level.
Fourth, we randomized 50 percent of the treated villages to target a random selection of 30% of women who were interviewed in the census but did not report ever experiencing any form of IPV by their current partner. This will allow the research team to measure community-level impacts of the intervention through treatment density.
After the conclusion of both the HT and the GT, a set of qualitative interviews were conducted with the goal of informing the research team on the channels through which the treatments could be reducing IPV, as well as capturing information relevant to the design of the endline survey.
The research team plans to conduct an endline survey 6-months after the MIMP's implementation of the HT and GT to evaluate the impact of the LIA program and its different innovations on outcome measures such as: IPV, physical health, mental health, tolerance towards IPV, female agency, and social norms.
- Conditions
- Domestic Violence
- Being tested
- Leaders in Action: Household Treatment, Leaders in Action: Group Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leaders in Action: Household TreatmentBehavioural
Also called HT
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.
Leaders in Action: Group TreatmentBehavioural
Also called GT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Leaders in Action: Household Treatment; Behavioral: Leaders in Action: Group Treatment |
| Control group | No intervention | Villages in the control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 06 months after the intervention
Secondary outcomes (5)
Women's Index of Agency
For women only. The researchers will use 3 items of a self-efficacy scale. The scale values are 0 to 1; higher scores mean better outcomes.
Measured: 06 months after the intervention
Men's Index of Social Norms
For men. The researchers will use 6 statements about gender roles and norms 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 better outcomes.
Measured: 06 months after the intervention
Women's Index of Social Norms
For women. The researchers will use 6 statements about gender roles and norms (asking whether the participants agree or disagree with these statements). The index values are 0 to 1; higher scores mean better outcomes.
Measured: 06 months after the intervention
Women's reporting of Violence from non-Partner
For women only. The researchers will replicate standard Demographic Household Survey questions for non-partner violence, administered through a self-paced questionnaire. The indicator will take the value of 1 if a woman reports at least 1 event of non-partner violence, and 0 if a woman reports not having experienced any events of non-partner violence. The indicator values are 0 and 1; with 1 meaning a woman suffered from non-partner violence and 0 meaning a woman did not suffer non-partner violence in the period.
Measured: 06 months after the intervention
Men's reporting of Intimate Partner Violence
For men only. The researchers will replicate some sections from the Demographic Household Survey domestic violence module, administered through a self-paced ballot-style questionnaire. Researchers will limit the questions asked about violence experienced to psychological IPV only when surveying men. The indicator will take the value of 1 if the man reports at least 1 event of psychological intimate-partner violence, and 0 if a man reports not having experienced any events of psychological intimate-partner violence. The indicator values are 0 and 1; with 1 meaning a man suffered from psychological intimate-partner violence and 0 meaning a man did not suffer psychological intimate- partner violence in the reporting period.
Measured: 06 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start2 May 2022
- Primary completion20 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Domestic ViolenceStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 8,754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Abdul Latif Jameel Poverty Action Lab, Innovations for Poverty Action, Medical Research Council, South Africa, Inter-American Development Bank, Wellspring Philanthropic Fund
- Responsible party
- Sponsor
- Investigators
- Erica Field, PhD, Principal investigator, Duke UniversityLivia Schubiger, PhD, Principal investigator, University of OxfordUrsula Aldana, PhD, Principal investigator, Instituto de Estudios Peruanos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331248
- Sponsor's protocol ID
- 2022-0228
- Other IDs
- 1R01HD101581-01A1, 14498
- Acronym
- LIA
- Status last verified
- Aug 2025
- First submitted
- 16 Feb 2022
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25467575Chakraborty 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.
PubMed 32903823Abramsky 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.
PubMed 25248996
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Leaders to Prevent and Reduce Domestic Violence in Their Communities: Experimental Evidence From Peru
- ClinicalTrials.gov ID
- NCT05331248
- Acronym / sponsor ID
- LIA / 2022-0228
- Conditions
- Domestic Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,754 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Abdul Latif Jameel Poverty Action Lab, Innovations for Poverty Action, Medical Research Council, South Africa, Inter-American Development Bank, Wellspring Philanthropic Fund
- Study start
- 2 May 2022 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Leaders in Action (LIA) is a norms-centered intervention run by the Peruvian Ministry for Women and Vulnerable Populations (MIMP) that aims to reduce the acceptance and incidence of Intimate Partner Violence (IPV) in Peru by shifting social norms. LIA has two main implementation phases: first, the recruitment of Community Health Volunteers (CHVs) and second, the delivery of content against IPV. The delivery of the intervention is assisted by MIMP professionals working in local "Women Emergency Centers" (Centro de Emergencia Mujer, or CEM), a nationwide network of hubs run by the MIMP that offer wide-ranging support services to IPV victims. The CEMs also implement other IPV prevention interventions at the local level.
CEM's Promotors (MIMP's professionals working at local CEM) recruit leaders of local social organizations and train them to be Facilitators of LIA. Facilitators are the principal CHVs located in each district center who conduct LIA activities. Another type of CHVs are leaders at the village-level who are trained by Facilitators to become Community Agents (CAs). Both CAs and Facilitators work together to conduct the second phase of LIA: the delivery of the intervention through its two delivery models, the Household Treatment (HT) and the Group Treatment (GT).
Originally, the study was designed to only evaluate the HT. Thus, a first randomization was conducted on our study sample with an even split of 125 control villages and 125 treatment villages. The research team and Innovations for Poverty Action (IPA) Peru deployed a census to identify the population of women in sample villages who met the eligibility criteria for the study, and conducted an in-depth baseline survey on women who reported IPV in the census. The implementation of the HT began in 2020, and was interrupted by the Covid-19 pandemic. The MIMP paused the program in March 2020 until national lockdowns were rescinded in February 2022. Given the intense migration and other demographic changes that took place during the 23-month interruption, as well as the potential for new IPV exposure over that period, new census and baseline surveys were conducted in 2022, which were used to define the final targeted sample for the intervention.
Our study tests two different delivery modes of the program, the HT and the GT, as well as their combination, in a cross-randomized design. The 250 villages in our study sample were randomized into 4 treatment arms following a factorial randomization model. This resulted in 62 villages receiving only the HT (HT only), 62 villages receiving only the GT (GT only), 63 villages receiving both the HT and GT (HT+GT), and 63 villages in the control group. The randomization procedure was stratified by CEM, the level of IPV risk, and the 2018 treatment status (villages that had begun implementation of the HT were restricted to remain in the HT only or HT+GT treatment arms).
The MIMP's original HT design followed a door-to-door delivery approach: CHVs, in coordination with the local CEM, offered 8 treatment sessions to households at risk of IPV. These HT sessions took place over a period of 1 to 2 months and were conducted in participants' residences. While all adult household members were invited to participate, the recipients of the HT were, in practice, primarily women. As a result, this delivery mode may have been ineffective at influencing norms and beliefs of male participants. The household-centered approach is also expensive and difficult to scale up. Thus, together with the MIMP, the research team developed modifications to the HT which resulted in the innovations described below.
First, in collaboration with the MIMP, the research team and IPA Peru developed a telenovela-style series as a key component of the LIA program (edutainment component). The series consists of four videos that reinforce themes of relationship conflict, masculinity, and social norms around gender. The edutainment component was randomized for the HT only treatment arm, so that in 31 villages, all households targeted for HT watched the edutainment component as part of the program, and in other 31 villages, only 50% of the households targeted for HT watched the edutainment component. In this second group, the households selected to watch the edutainment videos were randomly selected, which will allow the research team to experimentally identify the effect of the edutainment videos. In the other treatment arms (GT only and HT+GT), the edutainment component is implemented for all participants.
Second, in order to strengthen the effect of LIA and to reach potential perpetrators, which are predominantly men, as well as victims of IPV, we developed a different delivery format with the MIMP: the GT. The GT follows a gender-segregated yet community-wide delivery approach in a group discussion format. Existing evidence suggests that interventions which target both perpetrators and victims can have a substantial impact on attitudes towards and the incidence of IPV, and that simultaneously addressing IPV from different angles can be particularly effective (Chakraborty, P., Osrin, D. and Daruwalla, N., 2020; Abramsky, T. et al., 2014). These approaches commonly stress the importance of collaborative learning in support-group-style sessions to confront ideas of masculinity and gender norms. Moreover, norms change is more likely to happen when individuals are aware of relevant peers who are also changing their beliefs (Bursztyn, L., González, A. L., Yanagizawa-Drott, D. (2018)). As a result, the investigators proposed separating groups by gender to provide tailored settings during intervention.
- This group-based approach entailed 4 GT workshops that integrated various activities and group discussions focused on the same content as the HT. The group workshops 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 workshop. In order to meet this criteria during implementation, the MIMP required a larger number of male CHVs than those who were initially recruited through social organizations; men are usually recruited in disproportionately low numbers for this style of volunteer work, and the initial number of male CHVs was not sufficient for implementation of the GT. As a result, male CHVs were recruited as program Facilitators from local universities, communal associations, and other frequently-transited areas. GT sessions took place over the course of one month in village community centers, schools, churches, or other communal spaces where village residents would often gather, and lasted for approximately two hours. Larger villages held multiple GT sessions per workshop to cover all potential participants, and some villages were re-visited some months after the expected implementation time to ensure a high uptake.
- Participant targeting during the GT was the same as in other treatment arms: MIMP CHVs approached the houses of women in the targeted sample, and extended an invitation for them and their male partners to participate in the intervention. However, given that the GT is designed to involve the village community at large, invitations for the GT were extended to all adults in the village. Households in the targeted sample were approached door-to-door multiple times in the week before the GT session, while the rest of the village households were only approached once per workshop. Aside from door-to-door recruiting, the whole village received a notice an hour before each GT session through a loudspeaker usually used for other village-wide activities.
- The topics covered during both the HT and GT were equivalent to ensure comparability. These topics were: i) gender roles, beliefs and stereotypes; ii) violence, cultural patterns and human rights; iii) healthy relationships within the family; iv) respect 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.
Third, 50% of the villages assigned for either the HT only, GT only, or HT+GT treatment arms (94 villages total) were randomly selected to target one village leader (e.g. village president) to receive treatment given the village's treatment assignment. This will evaluate if community leaders are impactful in shifting norms at the village level.
Fourth, we randomized 50 percent of the treated villages to target a random selection of 30% of women who were interviewed in the census but did not report ever experiencing any form of IPV by their current partner. This will allow the research team to measure community-level impacts of the intervention through treatment density.
After the conclusion of both the HT and the GT, a set of qualitative interviews were conducted with the goal of informing the research team on the channels through which the treatments could be reducing IPV, as well as capturing information relevant to the design of the endline survey.
The research team plans to conduct an endline survey 6-months after the MIMP's implementation of the HT and GT to evaluate the impact of the LIA program and its different innovations on outcome measures such as: IPV, physical health, mental health, tolerance towards IPV, female agency, and social norms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LIA Household Training | Experimental | Behavioral: Leaders in Action: Household TreatmentThis 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. |
| LIA Group Training | Experimental | Behavioral: Leaders in Action: Group TreatmentThis 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. |
| LIA Household and Group Training | Experimental | Behavioral: Leaders in Action: Household Treatment, Behavioral: Leaders in Action: Group TreatmentThis 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. |
| Control group | No intervention | –Villages in the control group will not receive any intervention. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leaders in Action: Household TreatmentAlso: HTThe 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. | Behavioural | LIA Household Training, LIA Household and Group Training |
| Leaders in Action: Group TreatmentAlso: GTThe 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. | Behavioural | LIA Group Training, LIA Household and Group Training |
Primary outcome
Women's Reporting of Intimate Partner Violence
Time frame: 06 months after the intervention
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.
Women's Index of Physical Health
Time frame: 06 months after the intervention
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.
Women's Index of Mental Health
Time frame: 06 months after the intervention
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.
Men's Index of Mental Health
Time frame: 06 months after the intervention
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.
Men's Index of Tolerance towards Violence against Women
Time frame: 06 months after the intervention
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.
Women's Index of Tolerance towards Violence against Women
Time frame: 06 months after the intervention
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.
5 secondary outcomes
Women's Index of Agency
Time frame: 06 months after the intervention
Men's Index of Social Norms
Time frame: 06 months after the intervention
Women's Index of Social Norms
Time frame: 06 months after the intervention
Women's reporting of Violence from non-Partner
Time frame: 06 months after the intervention
Men's reporting of Intimate Partner Violence
Time frame: 06 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 25467575Ellsberg 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.
- Background: PubMed 32903823Chakraborty 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.
- Background: PubMed 25248996Abramsky 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Field, PhD principal investigator
Duke University
Livia Schubiger, PhD principal investigator
University of Oxford
Ursula Aldana, PhD principal investigator
Instituto de Estudios Peruanos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leaders in Action: Household Treatment and Leaders in Action: Group Treatment in people with Domestic Violence, run by Duke University at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Women's Reporting of Intimate Partner Violence (time frame: 06 months after the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05331248, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.