Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05331248
Other study ID # 2022-0228
Secondary ID 1R01HD101581-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2, 2022
Est. completion date June 30, 2025

Study information

Verified date February 2024
Source Duke University
Contact Julianne Chambers
Phone 919-660-1800
Email julianne.chambers@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Leaders in Action (LIA) is a norms-centered intervention that aims to reduce the acceptance and prevent the incidence of Gender-based Violence (GBV) 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 GBV may profit from the intimate atmosphere of household visits, and that on the side of women, the transmission of information about GBV 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 GBV 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 GBV 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 GBV.


Description:

Leaders in Action (LIA) is a norms-centered intervention that aims to reduce the acceptance and prevent the incidence of gender-based violence (GBV) in Peru by shifting social norms. LIA has two main phases: first, the recruitment of community health volunteers (CHVs) and second, delivering content against GBV to the population at risk in rural villages. There are two types of CHV. First, government's women centers' (CEM) Promotors (professionals from the Peruvian Ministry of Women (MIMP) working at local CEMs) recruit leaders of local social organizations and trained them to be Facilitators of LIA. These Facilitators are to be located in each district center and will conduct LIA activities across all treated villages in the district. The second type are leaders at the village level who will be trained by Facilitators to become Community Agents. Both Community Agents and Facilitators are to be known as CHVs and will work together to conduct the second phase of LIA: training sessions of the two delivery models, a household model (HT) and a group-based and gender-segregated model (GT). Under the HT, LIA follows a door-to-door delivery approach: CHVs, in coordination with the local CEM, offer 8 training sessions to households at risk of domestic violence (Household Treatment - HT). However, the recipients of the HT are in practice primarily women. This is because the treatment is delivered door-to-door by mainly female CHVs, who are recruited disproportionately for this style of volunteer work in any setting. Female CHVs may be ineffective at influencing norms and beliefs of male participants given strong local masculinity norms. The household-centered approach is also expensive and difficult to scale. In order to strengthen the effect of LIA and to reach potential perpetrators as well as victims of GBV, the MIMP will implement a gender-segregated yet community-wide delivery approach in a group discussion format. This group-based approach (GT) will entail 4 workshops using media dramatizations of social problems/education entertainment ("edutainment"), on the same content as delivered in the HT. Existing evidence suggests that interventions that target perpetrators as well as victims can have a substantial impact on attitudes towards and the incidence of domestic violence, and that simultaneously addressing GBV from different angles can be particularly effective. These approaches commonly stress the importance of collaborative learning in support-group style sessions to confront ideas of masculinity and gender norms. Norms change is dependent on belief change at the individual-level, which is more likely to happen when individuals are aware of relevant peers also changing beliefs. The investigators propose separating groups by gender to provide tailored settings. The series of workshops will engage potential GBV victims and perpetrators in group discussions about their social reality using participatory methods. The topics for the series of workshops will be equivalent to those covered in household visits to ensure comparability: 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 agency. Sessions will take place over four months in a village community center, school, or church, and will last for approximately two hours and consist of groups of 15-20 participants per session. Larger villages will hold multiple sessions per month to cover all potential participants. To maximize attendance, the workshops will have the same hierarchy as traditional village meetings - events the population of this setting attends regularly - and will be coordinated with the village leader.


Recruitment information / eligibility

Status Recruiting
Enrollment 9396
Est. completion date June 30, 2025
Est. primary completion date January 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Women with a male current partner. - Women who reported having ever experienced any form of physiological, physical, or sexual violence from the current partner. - Male partners of women who reported having ever experienced any form of physiological, physical, or sexual violence from their current partner. Exclusion Criteria: - Women and men with formal complaints of domestic violence are excluded to participate as Facilitators and Community Agents

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Leaders in Action: Household Training
Leaders in Action (LIA) is a norms-centered intervention that aims to reduce the acceptance and prevent the incidence of gender-based violence (GBV) in Peru by shifting social norms around GBV. LIA has two main phases: first, the recruitment of CHVs and second, delivering content against GBV to population at risk in rural villages. There are two types of CHV, first CEM's Promotors (MIMP's professionals working at local Women Centers - CEM) recruit leaders of local social organizations and trained them to be Facilitators of LIA. These Facilitators are to be located in each district center and will conduct LIA activities across all treated villages in the district. The second type are leaders at the village level who will be trained by Facilitators to become Community Agents. Both Community Agents and Facilitators are to be known as CHVs and will work together to conduct the second phase of LIA: training sessions at households level to women at risk of IPV.
Leaders in Action: Group Training
Leaders in Action (LIA) is a norms-centered intervention that aims to reduce the acceptance and prevent the incidence of gender-based violence (GBV) in Peru by shifting social norms around GBV. LIA has two main phases: first, the recruitment of CHVs and second, delivering content against GBV to population at risk in rural villages. First CEM's Promotors (MIMP's professionals working at local Women Centers - CEM) recruit leaders of local social organizations and trained them to be Facilitators of LIA. These Facilitators are to be located in each district center and will conduct LIA activities across all treated villages in the district. Then, Facilitators train additional volunteers at the village level who will become Community Agents. Both Community Agents and Facilitators are to be known as CHVs and will work together to conduct the second phase of LIA: gender-segregated and village-level group sessions using edutainment and workshop-style sessions to men and women at risk of IPV.
Leaders in Action: Village Leaders Targeting
Leaders in Action (LIA) would target one village leader (e.g. president, mayor, etc.) to receive either LIA's household or group treatment. The treatment will be based on the original village treatment assignment.

Locations

Country Name City State
Peru Innovations for Poverty Action Lima

Sponsors (7)

Lead Sponsor Collaborator
Duke University Abdul Latif Jameel Poverty Action Lab, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Innovations for Poverty Action, Inter-American Development Bank, Medical Research Council, South Africa, Wellspring Philanthropic Fund

Country where clinical trial is conducted

Peru, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Intimate Partner Violence For women only. The researchers will replicate a standard Demographic Household Survey domestic violence module, administered through self-paced 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 intimate-partner violence. The indicator values are 0 and 1; with 1 meaning a woman suffered from intimate-partner violence and 0 meaning a women did not suffered intimate-partner violence in the period. 06 months after the intervention
Primary 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
Primary Women's Index of Mental health For women. The researchers will use World Health Organization SQR20 questionnaires for mental distress. The index values are 0 to 1; higher scores mean better outcomes. 06 months after the intervention
Primary Men's Index of Mental health For men. The researchers will use World Health Organization SQR20 questionnaires for mental distress. The index values are 0 to 1; higher scores mean better outcomes. 06 months after the intervention
Primary Men's Index of Tolerance towards Violence against Women For men. The researchers will use 8 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
Primary Women's Index of Tolerance towards Violence against Women For women. The researchers will use 8 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 Index Women Agency For women only. The researchers will use 8 items of a self-efficacy scale. The scale values are 0 to 1; higher scores mean better outcomes. 06 months after the intervention
Secondary Men's Index of Social Norms For men. The researchers will use 8 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. 06 months after the intervention
Secondary Women's Index of Social Norms For women. The researchers will use 8 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. 06 months after the intervention
Secondary Violence from non-Partner For women only. The researchers will replicate a standard Demographic Household Survey questions for non-partner violence, administered through 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 women did not suffered non-partner violence in the period. 06 months after the intervention
See also
  Status Clinical Trial Phase
Completed NCT03037749 - Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence N/A
Completed NCT02606344 - Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV N/A
Completed NCT03482687 - It's Your Game: An Innovative Approach to Preventing Teen Dating Violence N/A
Active, not recruiting NCT00847548 - Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting N/A
Completed NCT01207258 - Brief Intervention for Problem Drinking and Partner Violence Phase 2
Completed NCT01621334 - The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use Phase 1
Completed NCT00983593 - A Randomized Clinical Study of a Mind-Body Approach to Domestic Violence Offender Treatment N/A
Completed NCT01803932 - Evaluation of a Male-focused Intervention to Prevent Intimate Partner Violence in a Conflict-affected Setting N/A
Completed NCT00289939 - Reducing HIV & Domestic Violence Risk in Women Offenders Phase 3
Completed NCT05598697 - Economic Evaluation of the MEWE Intervention N/A
Not yet recruiting NCT03672942 - Communication Skills vs. Mindfulness for IPV N/A
Completed NCT03883932 - Fatherhood Focused Family Violence Education Program N/A
Completed NCT05129501 - The Impact of an Adapted Version of the Strengthening Families Program on IPV Among Caregivers and ACEs Among Children N/A
Enrolling by invitation NCT05139069 - Using Implementation Science to Increase Pre-Exposure Prophylaxis Uptake Among African American Women N/A
Recruiting NCT03198429 - Cluster RCT of Embedded Parenting Intervention to Prevent Recurrence and Reduce Impairment in Young Children Exposed to Domestic Violence N/A
Completed NCT04125251 - Men Engagement in Women Empowerment for Improving Maternal Mental Health Through Cash Transfer and Life Skills Building N/A
Active, not recruiting NCT03236948 - RCT of the Effectiveness of the WfWI Intervention in Afghanistan Phase 3
Completed NCT02258841 - Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence N/A
Completed NCT01958554 - Impact of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence Phase 2
Completed NCT01688427 - Perinatal Nurse Home Visiting Enhanced With mHealth Technology N/A