Intimate partner violence (IPV), defined by the World Health Organization as “behavior by an intimate partner or ex-partner that causes physical, sexual or psychological harm, including physical aggression, sexual coercion, psychological abuse and controlling behaviors,” is experienced by approximately one-third (30%) of women worldwide during their lifetime [1]. The National Family Health Survey data suggest that women in India experience IPV with high frequency as well [2], but Indian women of lower socioeconomic status (SES) suffer substantially greater rates, with prevalence estimates ranging from 21% to 99% [3-8]. In addition to being a violation of basic human rights, IPV is associated with numerous negative mental and physical health outcomes and adoption of maladaptive health behaviors [1]. The high IPV prevalence among low-SES populations in India [2,9] and its associated negative health outcomes underscore the need for effective tailored prevention strategies.

To date, the majority of IPV prevention efforts by the government sector, nongovernmental organizations, and research-based organizations in India has focused on secondary and tertiary IPV prevention [10,11]. However, saturation of legal, mental health, and other IPV support services; high cost and resource limitations hindering expansion of these services; and the high IPV prevalence speak to the need to develop evidence-based affordable, effective, sustainable, and scalable primary prevention strategies to better address the epidemic. Primary prevention in other countries typically begins in schools and colleges and focuses on dating relationships [12]; however, in India, sociocultural barriers, such as social taboos associated with discussing intimacy and sexual relations in schools and colleges [13], and elevated school dropout rates among girls of low SES [14] impede such efforts. The period between engagement and marriage is also not opportune as it is often short and consumed by religious rituals and social and family gatherings for the couple. Fortunately, interventions for primary prevention can be timed later (ie, after marriage) as premarital courtship is still limited (at a nascent stage in the country), 90% of marriages are arranged by parents, and the age of first sexual relationship is often delayed to postmarriage [2,9].

The international literature suggests that most evidence-based IPV prevention interventions engage women alone [10,15,16], men alone [17-21], men and women in parallel gender-concordant groups [22-24], men and women together in large groups [25], or communities (ie, through large-scale community mobilization campaigns) [26,27]. Interdependence theory posits that both intrapersonal and interpersonal dyadic processes serve as determinants of couple’s behavior change [28], suggesting IPV prevention may be most effective, working with the couple as a unit. Our search only found 2 IPV prevention efforts that worked with dyads [29,30], both of which demonstrated reductions in IPV but were developed and conducted in resource-rich settings. In India, 3 major evidence-based interventions have been developed or adapted and tested but again worked solely with women [10], men [19], or mother-in-law and daughter-in-law pairs [31]. We herein describe the development of a dyadic intervention for the primary prevention of IPV among newly married couples residing in slum communities. Specifically, we provide the evidence and theoretical basis for the intervention content and delivery.

The intervention, Ghya Bharari Ekatra (take a flight together), was developed using a community-based, mixed-methods design, rooted in couple-interdependence theory and guided by the intervention mapping (IM) framework outlined by Bartholomew et al [32]. IM is a systematic approach to intervention planning, implementation, and evaluation that is driven by evidence, theory, and community participation [32]. It involves 6 critical steps: (1) a needs assessment, (2) preparation of matrices of change objectives, (3) selection of theory-based methods and practical applications, (4) production of intervention components and materials, (5) intervention adoption and implementation, and (6) evaluation planning.

The methods used to develop the intervention include (1) cross-sectional surveys with newly married men and women residing in slums to identify correlates of IPV to inform intervention change objectives, (2) 21 key informant interviews (with individuals who bring expertise in IPV, gender equality, marital health, sexual and reproductive health, or work with slum communities) to inform the content and delivery of the intervention, (3) feedback from gender-based violence (GBV) experts and the Indian Council of Medical Research-National AIDS Research Institute (ICMR-NARI, Pune, India) community advisory board (CAB) on the intervention protocol, and (4) 3 focus group discussions with married men, married women, and parents-in-law (each of 7-10 participants) to assess acceptance of some of the more controversial topics included in the intervention.

The intervention was developed in Pune, India, the second largest city in the western state of Maharashtra. It has a population of 3.1 million, a female:male sex ratio of 0.948, and significant religious diversity (79% [2,449,000/3,100,000] Hindu; 11% [341,000/3,100,000] Muslim; 4% [124,000/3,100,000] Buddhist; 2% [62,000/3,100,000] Jain; and 2% [62,000/3,100,000] Christian). Approximately, a quarter (22% or 690,545 individuals) of Pune resides in slums [33].

The study was approved by the Ethics Committee of ICMR-NARI and the institutional review board of Emory University (Atlanta, USA) and registered at ClinicalTrials.gov (NCT03332134) and the Clinical Trials Registry-India (CTRI/2018/01/011596).

First, we conducted a systematic review of the literature to assess the breadth and depth of IPV in India and to identify high-risk groups (ie, women of low SES) [34]. Confirmation of IPV as a major priority area for the target community came from prior work within the Pune community [9,35], regular reporting on IPV by local media [36,37], and recognition of need for the development and evaluation of an evidence-based IPV intervention by ICMR-NARI CAB.

Afterward, an analysis of IPV causation in Pune slums was undertaken to inform the development of the PRECEDE logic model (Figure 1). This included identification of correlates of IPV perpetration and experience through respective cross-sectional surveys with 100 newly married male and 100 newly married female residents of Pune slums and extraction of themes regarding IPV causation from key informant interviews.

We then assessed the community capacity by exploring services provided by local community-based organizations (CBOs); engaging in informal discussions with community leaders and individuals working in the intervention communities (ie, from anganwadis [Integrated Child Development Scheme, ICDS, child care centers] and mitramandals [male youth social clubs]); reviewing Indian laws, policies, and government schemes that address IPV; and surveying the physical environment (ie, space to conduct the intervention) and local resources (ie, police stations for safety concerns).

To develop matrices of change objectives (Multimedia Appendix 1, we used the IPV correlates noted in IM step 1 to draw causal pathways for influencing change in IPV perpetration for men and IPV experience for women, defined the desired behavioral outcomes of the intervention, and then subdivided the behavioral outcomes into performance objectives. Afterward, the stated performance objectives were linked with key, changeable determinants informed by behavior change theories [32] to ultimately define and prioritize the change objectives for the intervention.

Together with the research field team (that brought working knowledge of the needs and interests of individuals residing in Pune slums through years of field experience), we brainstormed ideas for the intervention that would accomplish each of the change objectives. We narrowed the list of applications based on the extent to which we felt they could appeal to and meet the needs of the intervention population and whether the application was justified by a theory-based behavior change method. The selected intervention applications were individually again examined by ASK, SS, and RS to ensure they addressed the respective change objectives.

The phase II key informant interview data were used to inform the production of the application content and materials. Specifically, we extracted case stories and common marital conflict scenarios, and key informant suggestions about information content, delivery methods (including language considerations), order of module delivery, and duration. We then reviewed and revised the content and delivery for the 6-intervention modules exercise-by-exercise until team consensus was achieved about the material being relevant, stimulating, clear, and appropriate in addressing the change objectives.

Thereafter, the intervention materials and delivery strategy were presented to the ICMR-NARI CAB and regional GBV experts and revised based on their feedback. The content of specific exercises for which there remained uncertainty about participant acceptance or comprehension (ie, exercises related to sexual communication and knowledge, career planning, and government schemes) was presented to the community for feedback through 3 focus group discussions with married men (n=7), married women (n=7), and mothers-in-law and fathers-in-law (n=8). Finally, the research team worked intimately with the module publishers and film producers (for the short films used in module 3 to ensure quality and appropriateness of the final product.

We brainstormed potential adopters of the intervention, consulting recommendations from the qualitative data about existing government and nongovernment programs with whom to partner to enhance future scalability and sustainability of the intervention. The brainstorming included free listing of community gatekeepers who could raise awareness about the intervention and recruit participants, individuals and agencies who could deliver the intervention, and potential intervention venues. Subsequently, we met the individuals and agencies to gauge their interest, capacity, and processes they required to formally establish the partnership. Selected interventionists underwent a 1-week interactive training. Necessary paperwork for partnering agencies was completed.

To develop the plan for evaluation of intervention effect, we consulted the matrices of change objectives and the scientific literature to find appropriate, validated tools to measure the desired change. In developing the measures of acceptance, feasibility, and safety, we ensured the evaluation included the perspectives of multilevel stakeholders (ie, participants, interventionists, police stations, CBOs, and community members) as is emphasized by Bartholmew et al [32]. Process indicators related to fidelity, dose delivered, dose received, reach, recruitment, and context were developed in consultation with the Consolidated Standards of Reporting Trials guidance for pilot trials [38] and the process evaluation guide by Saunders et al [39].

The resulting Ghya Bharari Ekatra intervention (Figure 2) was a 6-session intervention that was intended to be delivered by a trained pair of male and female community educators to groups of 3 to 5 newly married couples in the slum community in which the participants resided. Community educators were lay people who either belonged to the community in which the intervention was conducted or were members of other communities interested in grassroots-level community work. The intervention employed competitive games, intensive discussions, self-reflections, and skill-building exercises and covered the following topics in 2-hour sessions over 6 weeks: enhancing relationship quality time, self-esteem and resilience, communication and conflict management, goal setting and implementation, sexual communication and sexual health and reproductive health knowledge, and redefining and challenging norms surrounding IPV occurrence. All sessions were delivered to groups of couples with the exception of the sexual communication and sexual and reproductive health module, which was to be delivered in gender-concordant groups of 3 to 5. In this section, we demonstrate how the results of each IM step contributed to the development of the intervention.

The systematic review [34], formative work [9,35], and NARI CAB meetings identified the need for a targeted primary IPV prevention intervention for low-income, slum communities in India. The cross-sectional surveys and key informant interviews isolated key behavioral factors contributing to IPV in this community and led to the development of the PRECEDE logic model (Figure 1). The assessment of community capacity highlighted that individual slum communities had many resources (ie, venues) to foster implementation of the intervention: community halls, anganwadis, mitramandals, mahilabachatghat groups (women’s savings groups), CBOs, and schools.

Figure 1 was used to define and prioritize, based on changeability and importance, the desired behavioral outcomes for each of the 6 intervention modules. Each of the behavioral outcomes became the focus of a session in the 6-session intervention: (1) increased quality time spent in the relationship, (2) increased self-esteem and resilience, (3) enhanced communication and conflict management skills, (4) improved goal setting and goal implementation skills, (5) improved sexual communication and sexual health and reproductive health knowledge, and (6) expansion of definitions of behaviors constituting IPV and challenge subjective norms surrounding IPV occurrence. For each of the 6 sessions, individual matrices of change objectives were developed (Multimedia Appendix 1).

Couple’s interdependence theory is the unifying theory in which the intervention is grounded [28]. The Interdependence model [28], which we used to guide intervention development, has 3 major components: (1) transformation of motivation or shift in orientation from self- to relationship-centered (ie, the husband internalizing the impact of IPV and poor relationship quality on his spouse and the relationship), (2) communal coping in which the dyad has a shared assessment of the threat of IPV and poor relationship quality to their health and quality of life and share a vision of the action plan to reduce IPV and improve relationship quality, and (3) behavior change through which the couple together adopts and sustains behaviors to reduce IPV and enhance relationship quality. In addition to couple’s interdependence theory, several theoretical behavior change methods along with the change objectives guided the development of the practical applications for each module (Multimedia Appendix 2).

The qualitative data guided the intervention duration, module order, content, and delivery.

The decision to engage male and female community educators as the primary interventionists, to bring in community resource people to lead specific intervention exercises, to work with anganwadi workers in recruiting participants, and to utilize community-based venues was driven by key informant data.

The detailed evaluation plan, developed using the Multimedia Appendix 1 matrices of change, is presented in Table 1. It includes both outcome and process indicators and assesses preliminary efficacy, safety, feasibility, and acceptance. Evaluation methods include a preintervention and 3-month postintervention survey administered to participants, postsession open-ended discussions with participants to assess acceptance, postsession open-ended discussions with community educators to assess acceptance and challenges with delivery, research team logging of recruitment and retention numbers and associated facilitators and barriers, and semistructured evaluation of fidelity, dose delivered, and dose received by the research team during each session.

Primary prevention of IPV in low-SES communities in India is critical, as IPV is not only a human rights violation but also a critical public health problem, with high frequency and significant associated psychosocial and physical morbidity. Ghya Bharari Ekatra is evidence-based, developed using theory (ie, couple-interdependence theory as a unifying framework as well as individual behavior change theories to inform intervention methods), grounded in intervention-mapping, and developed and iteratively refined using a community-based participatory research approach, suggesting it has great potential to be an acceptable and effective solution to preventing IPV among newly married couples. The greatest strengths of Ghya Bharari Ekatra include that it is peer-led, community-based, interactive, and introduces novel concepts that are of importance to the participants. Furthermore, integration of the intervention into existing community resources and government program infrastructure will foster future sustainability and scalability throughout slum communities in India if it is deemed effective.

Enrollment into the pilot study to assess the safety, acceptance, feasibility, and preliminary efficacy in 40 couples (20 intervention and 20 control) commenced in January 2018 and was completed in May 2018. Preliminary feedback from participants, community educators, and the research field team suggests the intervention was highly accepted and safe. Three-month follow-up visits have been completed, and pilot results will be available in the spring of 2019. If pilot results are promising, the efficacy of Ghya Bharari Ekatra will be tested on a large scale throughout India.