Study setting

This pilot RCT will take place in three Colombian cities—Cali, Pasto, and Popayan—where Venezuelan migrants have sought shelter from economic hardship and political instability [22]. Colombia has made sizable progress towards welcoming Venezuelan migrants and fostering self-resiliency, most notably by instituting a mass regularization program to grant legal status and work authorization to this population. However, with a new government and legislation that has reduced support services for forcibly displaced Venezuelans, progress on economic inclusion and integration has drastically decreased and many migrants lack access to food, shelter, healthcare, education, and formal employment [23]. The Colombian government has also stopped coordinating humanitarian actors and NGOs, reducing non-governmental support for refugees and migrants [24]. This evolving situation necessitates further response and investment for the refugee populations within Colombia.

These three cities also serve as hubs for internally displaced Colombians. Colombia has one of the largest internally displaced people (IDP) populations in the world at 6.8 million [23]. In 2013, one-in-eight Colombian citizens were displaced [25]. With the demobilization of the Revolutionary Armed Forces of Colombia (FARC) and the COVID-19 pandemic, dissidents of the peace process and other non-State armed groups have fought for territorial and social control, leading to increases in forced displacement, confinements of communities, extortion, forced recruitment, and targeted violence [23,25]. Vulnerable populations primarily consist of campesinos, indigenous peoples, and Afro-Colombians, whose lands have most often been confiscated forcing these groups to migrate from rural to urban areas. As such, IDP populations are mainly made up of women, children, and ethnic minorities [25].

Intervention description

Hebrew Immigrant Aid Society (HIAS) is a non-profit organization that provides humanitarian aid and assistance to refugees, asylum seekers and other forcibly displaced populations around the world. HIAS will promote the incubation of businesses through its nine-month long Entrepreneurship School with Gender Lens (ESGL) intervention, which targets forcibly displaced women who have experienced GBV or are at risk of GBV to help them develop business ideas, access needed support for the prevention of and response to GBV and improve participants’ households’ self-reliance. The business training stage includes seven four-hour group training sessions facilitated by Economic Inclusion Officers (See Table 1) and one individual counseling session facilitated by mental health and psychosocial support (MHPSS) staff. These sessions transversally integrate topics of MHPSS and GBV prevention, mitigation and response, empowerment, and protection. At the end of the training, an additional preparatory session is held in preparation for the presentation of the business plan to the evaluation committee.

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Table 1. ESGL program modules.

https://doi.org/10.1371/journal.pone.0318224.t001

The training methodology applies a pedagogical approach that facilitates the construction of concepts based on participants’ prior knowledge, and the construction of new knowledge and skills contextualized to the experience and life of the participating women.

Upon training completion, participants are eligible to pitch their business idea to a panel of experts and receive up to USD$800 of seed capital. Participants also receive business advisory support for at least six months, focusing on access to markets and building support networks. HIAS Economic Inclusion Officers work on establishing goals with participants and track, adjust and revise goals during the follow-up sessions. These sessions also provide the opportunity to assess protection risks and offer additional referrals, as needed.,It is hypothesized that building these skills while also strengthening participants’ ability to engage in dignified livelihoods will lead to improvements in mental health, psychosocial wellbeing, and self-reliance.

Study population, recruitment, and retention

Eligibility criteria for this study include: having ever experienced or being at risk of GBV; being an adult of 18 years or older; have lived in Colombia for at least six months; are Venezuelan or Colombian; have already shared an entrepreneur profile with HIAS; and score within a predetermined range on the SRI. Eligibility criteria will be assessed across three stages: pre-targeting, pre-screening, and screening.

In the pre-targeting phase, HIAS will identify potential participants through organizational databases, referrals from other organizations, and calls to the community. The objective of the pre-targeting stage is to identify women who may be at risk of or who have experienced GBV. To identify women meeting this criteria, HIAS program staff will employ an instrument that flags relevant risk factors, including female headed households, access to resources and autonomy, and pregnancy and breastfeeding. Additionally, it identifies whether women are GBV survivors, have ever experienced incidents of GBV, or have ever accessed GBV response services. Given that many women find it difficult to recognize GBV, a definition of GBV will be provided to ensure clarity when questions are asked.

Women who are identified as experiencing GBV will be referred to HIAS GBV Case Management services if they consent. Forms for risk characterization and assessment will also be applied within the framework of those services. Using that information, case workers will build action and safety plans according to HIAS global standards and international GBV case management guidelines.

In the pre-screening phase, HIAS will pre-screen approximately 90–100 pre-targeted women per city using the pre-screening tool. Eligibility criteria assessed during this stage include: being an adult of 18 years or older; have lived in Colombia for at least six months; are Venezuelan or Colombian; and have already shared an entrepreneur profile with HIAS.

Official enrollment, consenting, and formal assessment of eligibility will be carried out by the research team. Data collectors will obtain written consent from previously pre-targeted and pre-screened women prior to administering the SRI. Before obtaining written consent, data collectors will explain the purpose of the study, discuss any benefits or risks to participation and safeguarding procedures, and answer any questions the potential participant may have. Data collectors will explain that participation in the study is voluntary and that participants may decide to leave the study at any time, without penalty or consequence.

After administering the SRI, data collectors will immediately administer the remaining survey questionnaire modules for participants whose SRI scores fall within the eligible range of 2 to 4.25 (the final eligibility criterion). This range of self-reliance (measured on a scale from 1 to 5; please see more on the SRI, below) was selected as an appropriate range for target participants for two reasons: (i) Those who score below a ‘2’ are in such dire circumstances that they are unlikely to be able to capitalize on an entrepreneurial program, and (ii) those who score above a 4.25 have achieved a level of self-reliance that may not leave substantial room for growth. Women whose scores fall outside of the 2–4 range will be thanked for their time and not assigned to an evaluation arm.

Participants will be recruited from three cities: Cali, Pasto, and Popayan. Recruitment is scheduled to start in July 2024. The study will aim to enroll at least 80 women in each city. where participants in each city will be randomly assigned to the intervention or control arm using a random number generator. The number of participants randomized to the treatment and control arm within each city will be determined by the number of women HIAS has the capacity to support in the intervention. For example, if HIAS can (and is required to) support 50 women in the intervention in one city, 50 women will be randomly assigned to the treatment arm and 30 to the control arm.

At the time of enrollment, participants will receive a unique study ID. The unique study ID will be used to track participants over time for future points of data collection.

Study timeline, data collection and outcomes of interest

Generating learning on SRI thresholds

Data will also be collected from approximately 80 participants in a fourth city, Ipiales, though these participants will not be included in the RCT. Data from this group will instead be used to explore current implementation practices and eligibility thresholds. The current practice to only include respondents in the study who score between a 2 and 4 on the SRI was based on discussions between the research and implementation teams around who has the capacity to most benefit from ESGL. The teams agreed that households scoring below a certain value on the SRI are likely to be more in need of acute aid, and unlikely to be able to take advantage of livelihoods support. The teams also agreed that households scoring above a certain value are more likely to be sustainably self-reliant and thus not a priority target for the program. Discussions around the appropriate floor and ceiling thresholds were speculative in nature, with the teams ultimately agreeing to define eligibility as scoring between 2 and 4 on the SRI. In order to further inform discussions on appropriate thresholds, participants in Ipiales will be assigned to a study arm based on their SRI score, where those with the lowest scores will be assigned to the treatment arm and those with the highest scores will be in the control group. This data will help us understand whether those with a low SRI score of 2 at baseline can realize significant gains, while also examining whether those who are already nearing self-reliance continue to progress without the aid of programming.