Developing a Theoretical Framework for a Complex Maternal–Child Health Intervention: Health Beginning Initiative

Abstract

A theoretical framework serves as a roadmap for the implementation and application of a complex, health promotion intervention; is used to test hypotheses; and guides analysis and evaluation of the intervention. The purpose of this article is to demonstrate how a theoretical framework was developed and used to guide the implementation of Healthy Beginning Initiative (HBI) to promote uptake of HIV services in a low-income country. We used the guide for developing a theoretical framework published in Health Promotion Practice. Developing the theoretical framework included seven steps: (1) identifying the essential elements of the intervention; (2) identifying the variables and the context; (3) listing the postulated mechanisms, mediating variables, and postulated outcomes; (4) identifying existing theoretical models supporting the theoretical framework underdevelopment; (5) scripting the theoretical framework into either a figure or sets of statements; (6) conducting content and face validation of the theoretical framework; and (7) revising the theoretical framework. The theoretical framework was developed and used to evaluate HBI’s impact on HIV testing, linkage to care and retention in care for pregnant women, their male partners, and newborns. The theoretical framework will also be adapted for other screenings and other settings while remaining true to the essential elements of HBI.

Keywords

HIV/AIDS maternal and infant health health promotion

Introduction

In resource-limited countries, disease screening and identification often constitute a rate-limiting step to engagement in prevention and treatment. Most disease prevention programs are complex interventions that (1) target a number of multifaceted health behaviors at multiple levels, (2) include a variety of possible outcomes, and (3) involve an array of populations, communities, groups, or organizations that are affected by and affect the intervention (Angeles, Dolovich, Kaczorowski, & Thabane, 2014). A theoretical framework can serve as a roadmap for implementation of a complex intervention in a specific context because it allows for the connection to previous research, testing of assumptions, development of research questions, and testing of hypotheses through analysis and evaluation of the intervention (Sinclair, 2007; Tabak, Stamatakis, Jacobs, & Brownson, 2014). Additionally, a theoretical framework allows the implementation team to visualize and understand how different components of an intervention will interact with each other and affect the outcomes and how the intervention can be applied within the community (Grol, Bosch, Hulscher, Eccles, & Wensing, 2007).

The Healthy Beginning Initiative (HBI) is an example of a complex intervention that addressed multiple health problems at a community level. The initial impetus for developing HBI was the high rate of pediatric HIV in Nigeria and the abiding low uptake of available services for prevention of mother-to-child transmission (PMTCT) of HIV among pregnant women and their male partners (Joint United Nations Programme on HIV/AIDS, 2014a, 2014b, 2016). However, we found that the theoretical framework that underpinned the development and implementation of HBI could be used to address additional health problems, including prenatal screening for other diseases (hepatitis B, malaria, syphilis, anemia, and sickle cell), as well as screening for mental health and hypertension (Ezeanolue et al., 2015; Iheanacho et al., 2014; Pharr et al., 2016). HBI protocol has been described in detail elsewhere (Ezeanolue et al., 2013). It is a culturally adapted, family-centered approach developed to promote individual testing for HIV and to increase linkage to, and retention in, care among pregnant women and their male partners. A total of 40 churches in Enugu State of Nigeria participated in the HBI two-arm cluster randomized trial (Ezeanolue et al., 2013). Each church had a health team (HT) consisting of the priest, one women’s leader and one men’s leader, and two volunteer health advisors (Church Health Advisors), one of whom is trained to perform venipuncture (Ezeanolue et al., 2013). The HTs received training on HIV screening, delivering HIV screening results, postscreening counseling, and confidentiality. Working with priests and trained church health advisors, HBI employed prayer sessions held each Sunday to recruit pregnant women and their partners. Baby showers held one Sunday each month for the participating pregnant women were used to deliver the intervention (education in PMTCT), and free, on-site and integrated testing (HIV, sickle cell genotype, and hepatitis B) rather than HIV-only testing (aimed at reducing access barriers and cost and at addressing stigma). Culturally appropriate baby receptions integrated into traditional family and community celebrations of childbirth were used to encourage postdelivery follow-up and care. HBI in intervention churches was led by lay church health advisors. Pregnant women and their male partners in 20 control churches received the usual care (i.e., referral to a health facility; Ezeanolue et al., 2015; Ezeanolue et al., 2016).

The purpose of this article is to demonstrate how a theoretical framework was developed and used to guide implementation of a successful culturally appropriate, congregation-based initiative to promote uptake of PMTCT services in a low-income country. It is hoped that this approach could serve as a case-study example for other low-income countries that are facing similar challenges in increasing uptake of PMTCT services and related interventions. We used Angeles and colleagues’ (2014) guide for developing a theoretical framework. Developing a theoretical framework typically involves the following:

Identifying the essential elements of the intervention (Angeles et al., 2014; Craig et al., 2008; Greenhalgh, Robert, Macfarlane, Bate, & Kyriakidou, 2004)

Identifying the variables and the context (Angeles et al., 2014; Craig et al., 2008)

Listing the postulated mechanisms, mediating variables, and postulated outcomes (Angeles et al., 2014)

Identifying existing theoretical models supporting the theoretical framework underdevelopment (Angeles et al., 2014; Creswell, 2013)

Scripting the theoretical framework into either a figure or sets of statements (i.e., a logic model) (Angeles et al., 2014)

Conducting content and face validation of the theoretical framework (Angeles et al., 2014; Craig et al., 2008)

Revising the theoretical framework based on Step 6 (Angeles et al., 2014)

Development of a theoretical framework is often done prospectively. However, in their guide, Angeles et al. (2014) developed the theoretical framework for the Cardiovascular Health Awareness Program (CHAP) retrospectively. Additionally, Lorthios-Guilledroit, Richard, and Filiatrault (2018) used Angeles et al.’s guide to develop a framework for community-based peer-led health promotion programs retrospectively based on their systematic review of these programs. HBI theoretical framework for HIV testing and for other health screenings (sickle cell, mental health, contraception, hepatitis B, hypertension) was developed using a similar retrospective approach. The setting for model development and intervention deployment was in Enugu, southeast Nigeria. In the following sections, we describe how we developed the theoretical framework for HBI using the guide developed by Angeles and colleagues.

Identifying the Essential Elements of the Intervention

Before developing the theoretical framework for HBI, we identified and described the essential elements of the initiative (Craig et al., 2008; Greenhalgh et al., 2004). The essential elements were characteristics that defined and made HBI unique and clearly identifiable. We considered these to be minimal requirements or the “core elements for the intervention” (Angeles et al., 2014).

To identify the essential elements of a complex intervention such as HBI, it was important to consider the influence of culture on health and health behaviors (Airhihenbuwa & Liburd, 2006; Airhihenbuwa & Webster, 2004; Shaw, Huebner, Armin, Orzech, & Vivian, 2009). One model used to understand this relationship is the PEN-3 cultural model developed by Airhihenbuwa (Airhihenbuwa, 1989; Airhihenbuwa & Webster, 2004). The PEN-3 cultural model can be used as an organizational framework for defining health problems and identifying solutions to those problems by placing culture at the core of development and implementation of health interventions (Airhihenbuwa & Webster, 2004; Iwelunmor, Newsome, & Airhihenbuwa, 2014). The PEN-3 model consists of three primary domains with each domain having three factors: Cultural Identity (person, extended family, and neighborhood), Relationships and Expectations (perceptions, enablers, nurturers), and Cultural Empowerment (positive, existential, negative) (Iwelunmor et al., 2014).

The Cultural Identity domain of the PEN-3 model can be used to develop the point of entry into an intervention. The point of entry can occur at the level of the person (i.e., pregnant women, male partners), at the level of the family or the level of the neighborhood (i.e., community, village, congregation) (Iwelunmor et al., 2014). Using the PEN-3 model to develop the HBI intervention to increase HIV screening among pregnant women and their male partners, we identified the significant role faith plays in the personal, cultural, social, and community life of Nigerians (Pew Research Center, 2010; World Values Survey, 2015). A study by Titus, Adebisola, and Adeniji (2015) found that only 58% of people living in rural villages in Nigeria had access to health care services. However, every village has a church, and church attendance in Nigeria is nearly 90% (Pew Research Center, 2010). Additionally, Nigeria has an extensive network of faith-based organizations (Pew Research Center, 2010; World Values Survey, 2015). Religious leaders are well informed about HIV/AIDS and use their position for HIV prevention and interventions (Ucheaga & Hartwig, 2010).

Additionally, because HBI is a complex intervention, a planning team was assembled to assist in the identification and development of its essential elements by identifying barriers and solutions to HIV screening among pregnant women in Nigeria. The planning team represented the second domain of PEN-3 model, Relationships and Expectations, as it consisted of enablers from local organizations involved in HIV education, advocacy groups, faith-based organizations, HIV support groups, representatives of women groups, hospitals, delivery centers, and representatives from government agencies. Over a 12-month period, meetings were held to identify barriers to HIV screening and potential solutions. Barriers to screening and optimal PMTCT were identified at individual and health systems levels (Kinuthia et al., 2011; Youngleson et al., 2010). Most women in Nigeria do not access prenatal care, and only 35% of pregnant women deliver in a health facility, creating missed opportunities for HIV screening (Federal Ministry of Health, Nigeria, 2010; National Population Commission [Nigeria] & ICF International, 2014). Additional barriers to HIV screening among pregnant women include low perception of personal risk, lack of knowledge, poor access to screening sites, cost, concern about confidentiality, HIV-related stigma, and lack of male partner involvement (Hardon et al., 2012; Monjok, Smesny, & Essien, 2009; Nunn et al., 2011; Turan et al., 2011). The planning team determined that an essential element of the intervention had to address the third domain of the PEN-3 model, that is, the Cultural Empowerment. This includes factors that are critical to health behavior change, and may be positive, existential, or negative. Positive factors include values and relationships that promote the health behavior of interest, existential factors include cultural health beliefs and practices that are unique or indigenous to a group, and negative aspects include health beliefs and actions that are harmful.

From these meetings, the essential elements of HBI were categorized as process components, organizational components, and contextual components (Table 1). The process component of HBI includes IIF (I = Identify [Prayer Sessions]; I = Intervene [Baby Shower Initiative]; F = Follow up [Baby Reception]).

Table 1

Essential Elements of Healthy Beginning Initiative.

Process Components	Organizational Components	Contextual Components
● Identify: identify pregnant women and their male partners at prayer sessions led by priest at each church ● Intervene: - education about the importance of prenatal screenings and free, on-site integrated HIV testing during a baby shower - linkage to care—link HIV-infected women and men to care antiretroviral (ARV) therapy at nearest health care facility - ARV therapy for HIV-infected pregnant women ARV prophylaxis for exposed infants - Early infant diagnosis for HIV status - ARV therapy for HIV-infected newborns ● Follow up: follow up with women postpartum at baby reception for retention in care	● Implemented by the health team at each church (priest, one women’s leader and one men’s leader, two volunteer health advisors) ● Activities coordinated by Sunrise Foundation’s research team ● Partner with Prevention, Education, Training Treatment and Research—Global Solutions, a local nongovernmental organization to provide: care, treatment, and supportive supervision to HIV-infected patients and their families	● Community wide in scope (90% of Nigerians attend church at least once per week) ● Congregation based ● Priority population—pregnant women ● Secondary population—male partners of pregnant women ● Rural or urban communities ● Funded through Sunrise Foundation and the National Institutes of Health

Developing the Theoretical Framework

Step 1: Identifying the Variables and the Context

The first step in developing our theoretical framework included identifying variables and context (Angeles et al., 2014). We needed to identify our independent variables (HBI and process components of HBI), dependent variables (outcome variables), and moderating variables (Fairchild & MacKinnon, 2014). Additionally, because HBI may be implemented in different settings, the context for development of the framework needed to be clearly described. The contexts for HBI included within-systems organization and external neighboring organization context (Denis, Hébert, Langley, Lozeau, & Trottier, 2002; Gearing et al., 2011; Greenhalgh et al., 2004). Some of the contextual aspects of HBI were considered to be moderating and control variables. Table 2 identifies the variables and the context for HBI.

Table 2

Variables of Healthy Beginning Initiative.

Independent Variables	Moderating Variables	Dependent Variables	Context
Independent Variables	Moderating Variables	Dependent Variables	Variable	Type
The Intervention including ● Prayer session - Identify and recruit participants ● Baby Shower Initiative - Education - Integrated HIV testing - Linkage to care at health care facility ● Baby reception - Retention in care (ARV therapy) for HIV-infected participants	Demographics: ● Age ● Educational level ● Employment ● Income ● Area of residence Intrapersonal factors: ● Knowledge of HIV ● Age at first pregnancy ● History of previous HIV testing ● Number of previous births ● Perceived HIV stigma ● Perceived HIV susceptibility	● Recruitment of pregnant women ● Recruitment of male partner ● HIV testing among pregnant women ● HIV testing among male partners ● Linkage to care among HIV-infected pregnant women ● Linkage to care among HIV-infected male partners ● ARV therapy for HIV-infected pregnant women ● ARV prophylaxis for exposed newborns ● EID ● Linkage to care for HIV-infected newborns ● Retention in HBI ● Retention in care	Number and location of churches	Control
			Size of churches	Control
			Geographic location (urban or rural)	Moderating
			Locations of nearest health care facility	Moderating

NOTE: ARV = antiretroviral; EID = early infant diagnosis; HBI = Healthy Beginning Initiative.

Step 2: Listing the Postulated Mechanisms, Moderating Variables, and Postulated Outcome Variables

The second step in developing our theoretical framework was to establish the postulated mechanisms for how the independent variable would lead to the dependent variables, and identifying the different moderating variables (Table 2). The main mechanisms of HBI were pregnant women and their male partners will be educated about HBI and the importance of HIV testing during pregnancy; barriers to HIV testing will be reduced by providing free, integrated HIV testing on-site immediately following education (in this case at churches); HT and Prevention, Education, Training Treatment and Research—Global Solutions (PeTR-GS) representatives will provide counseling and link HIV-infected participants to care at nearest health care facility; and HT will provide support to participants postpartum. These mechanisms of HBI were selected because previous interventions have found that knowledge of the importance of HIV testing, male partner involvement, reduced stigma, and reduced access and cost barriers increases HIV testing and linkage to care (Albarracín, Durantini, & Earl, 2006; Albarracín et al., 2005; Farquhar et al., 2004; Young et al., 2010).

In this step, we also identified moderating variables, or variables that might be associated with both the independent and the dependent variables (Lachowycz & Jones, 2013). Previous research has found that willingness to participate in antenatal care programs similar to HBI or HIV testing are influenced by demographic characteristics of the pregnant women, including their age, location (rural vs. urban), income, and employment (Mesfin & Farrow, 2017; Obermeyer et al., 2013; Peltzer & Matseke, 2013; Sawleshwarkar, Harrison, Britt, & Mindel, 2011; Simkhada, Teijlingen, Porter, & Simkhada, 2008; Tsegay et al., 2013). Additionally, women are more likely to seek antenatal care or HIV testing based on intrapersonal characteristic such as perceived susceptibility or perceived stigma (Sambisa, Curtis, & Mishra, 2010; Turan, Miller, Bukusi, Sande, & Cohen, 2008; Turan et al., 2011; Turan et al., 2012). Women who have low perceptions of susceptibility are less likely to seek antenatal care or HIV testing. Women who have a high perception of stigma associated with accessing health care are less likely to seek it.

Step 3: Identifying Existing Theoretical Models Supporting the Theoretical Framework Underdevelopment

The third step in developing a theoretical framework for a complex intervention is to identify existing theoretical models that support the theoretical framework under development (Angeles et al., 2014). For complex interventions, it is possible that more than one theoretical model can be applied. HBI attempted to eliminate previously identified barriers to HIV testing (behavior) among pregnant women that exist at the individual (e.g., lack of knowledge), at structural environment (e.g., access to testing), and social environment (e.g., stigma) levels (Hardon et al., 2012; Monjok et al., 2009; Nunn et al., 2011; Turan et al., 2011). Because of this, we determined that the social cognitive theory (SCT) best supported our developing theoretical framework (Bandura, 2004). We selected SCT over other behavior theories such as the Health Belief Model because it focuses on constructs that exist within the person and within the person’s structural/social environment.

The SCT constructs are particularly relevant to PMTCT of HIV. They recognize that health behavior is influenced by factors at the individual level (e.g., knowledge of HIV risk and prevention, self-efficacy regarding HIV prevention, testing and treatment) as well as facilitators or barriers within a person’s social (stigma, lack of male partner involvement) and structural environments (lack of health care facilities, cost, transportation, confidentiality of results) (Bandura, 1994, 1998, 2004).

Research suggests that the SCT is an effective model for developing interventions to reduce HIV because the intervention focuses on not only the person but also the person within the context of their environment. According to SCT, human behavior for PMTCT of HIV is guided by six constructs, including (1) knowledge about HIV, risk factors for HIV, behaviors necessary for PMTCT, and the importance of prenatal testing for HIV and ARV therapy; (2) belief that behaviors to prevent HIV and receive HIV testing and treatment can be performed successfully (self-efficacy); (3) beliefs about and evaluations of the likely outcomes of the behavior for PMTCT (outcome expectation); (4) goals that the person has for their life, including their health and the health of their child; (5) beliefs about normative expectations of others (i.e., friends and family) and the motivation to comply with those expectations (social facilitator or barrier); and (6) beliefs about the presence and influence of factors that may facilitate or impede performance of the behavior (structural facilitators or barriers) (Bandura, 1994, 1998, 2004).

SCT emphasizes that health behaviors are not solely a personal matter and that some of the barriers or facilitators to healthy behaviors exist in the social and structural environment rather than in the individual (Bandura, 2004). Building on this concept, HBI emphasizes the importance of reducing barriers to HIV testing, linkage to care and retention in care by reducing social and structural barriers and increasing social and structural facilitators.

Step 4: Scripting the Theoretical Framework Into Either a Figure or Sets of Statements

The fourth step in the process of developing a theoretical framework is to illustrate the framework as a figure or set of statements based on Table 3 (Step 2) and the supporting theoretical model (Step 3). Figure 1 illustrates the steps in HBI and who is responsible for each of the steps.

Table 3

Postulated Mechanisms and Possible Associated Mediating/Moderating and Dependent Variables of HBI.

Postulated Mechanism	Mediating Outcomes	Postulated Outcomes
● Educate pregnant women and male partners about HBI through the prayer session ● Educate pregnant women and their male partners about the importance of HIV testing during pregnancy through BSI ● Increase accessibility of HIV testing through BSI—free, integrated testing at churches ● HT provides counseling for HIV-infected participants and contacts PeTR-GS representative ● HT provides support and follow-up for participants at baby shower	● Increased awareness of the benefits of participating in HBI because it is presented by trusted member of the community (priest) ● Improved awareness of the importance of HIV testing in the continuum of PMTCT of HIV ● Decrease in barriers to HIV testing which include access, cost and stigma ● PeTR-GS links HIV-infected participant to nearest health care facility (pre and postnatal care for pregnant women and newborns)	● Increased recruitment of pregnant women & male partners ● Increased desire to be tested for HIV ● Increased HIV testing rates among pregnant women and their male partners ● Increased identification of HIV-infected participants ● Increased linkage to care for HIV-infected pregnant women and their male partners ● ARV therapy for HIV-infected pregnant women ARV prophylaxis for exposed newborns ● EID ● Linkage to care for HIV-infected newborns ● Increased retention in HBI Increased retention in care

NOTE: ARV = antiretroviral; BSI = Baby Shower Initiative; EID = early infant diagnosis; HBI = Healthy Beginning Initiative; HT = health team; PeTR-GS = Prevention, Education, Training Treatment and Research—Global Solutions; PMTCT = prevention of mother-to-child transmission.

Figure 1.

Theoretical Framework for Healthy Beginning Initiative

Steps 5 and 6: Content and Face Validation of the Theoretical Framework and Revising the Theoretical Framework–Based Feedback

After the HBI model was scripted, it was sent to key stakeholders, including members of the planning team, research team, HTs, and participants to provide content and face validation of the theoretical framework (Angeles et al., 2014). Feedback from key stakeholders was considered and included in the final version of the theoretical framework provided in Figure 1. Because the development of this framework was done retrospectively, we did not revise the framework during the implementation of the intervention. Similar to the theoretical framework developed retrospectively by Lorthios-Guilledroit et al. (2018) for peer-led health promotion programs, our framework will serve as a guide as we implement HBI in other settings.

Discussion

We developed a theoretical framework for HBI that provides details regarding how the different components of HBI interact with each other and may ultimately influence the success or failure of HBI intervention. Our framework also allows us to evaluate HBI because we had identified independent variables, mediators, and moderators as well as dependent variables of interest. The evaluation found that HBI was an effective intervention to increase HIV testing and linkage to care among pregnant women, their male partners, and exposed infants (Ezeanolue et al., 2015; Ezeanolue et al., 2016; Pharr et al., 2016). Our framework will enable us to adapt HBI to other settings because we have identified and defined its essential or core elements.

A theoretical framework should guide research and the use of interventions (Sinclair, 2007). Researchers and implementers should revisit the framework, evaluate the data at each stage of the intervention, and further develop, test, or confirm relationships among variables to more effectively implement and sustain complex interventions in health (Cleary, Gross, Zaslavsky, & Taplin, 2012). The guide provided by Angeles and colleagues (2014) was very useful for developing our framework as well as the framework developed by Lorthios-Guilledroit et al. (2018). We have shown that a theoretical framework can be developed retrospectively; however, it would ideally be developed prospectively. As researchers begin to develop a complex health intervention, they should consider using the Angeles et al. guide to develop their theoretical framework so that they can identify their core elements; independent, dependent, and moderating variables; and the context within which their intervention will occur.

The next step is to adapt HBI for other health interventions (e.g., promotion of uptake of contraception, breast cancer screening) in Enugu, Nigeria, as well as in other settings (e.g., Mosques in Northern Nigeria or Hindu Temples in India). This may entail some modifications to the current theoretical framework. However, the essential elements should remain. For example, the interventions will be delivered by volunteer health advisors, and the intervention will occur in a place where people normally congregate on a regular basis. Other aspects of the intervention should be integrated into widely accepted traditional practices as in celebration of pregnancy (baby showers) or the birth of a child (baby receptions). Our theoretical framework was not designed to be rigid and inflexible. Rather, it is a working document that will be revisited and revised as the intervention is adapted for other settings.

Conclusion

The guide developed by Angeles et al. (2014) provides a step-by-step process for developing a theoretical framework for a complex health intervention. We were able to use this guide to help develop the theoretical framework for HBI. The theoretical framework was used to evaluate the HBI intervention that increased HIV testing, linkage, and retention in care for pregnant women, their male partners, and newborns. The theoretical framework will be adapted for other screenings and other settings while remaining true to the essential elements of HBI.

Footnotes

Authors’ Note:

We are grateful to HealthySunrise Foundation, Sunrise Foundation, Bishop John Okoye (Catholic Bishop of Awgu diocese), Archbishop Emmanuel Chukwuma (Anglican Bishop of Enugu), Bishop Callistus Onaga (Catholic Bishop of Enugu) and Archbishop Amos Madu (Anglican Bishop of Oji-River). Their support was instrumental to the successful implementation of Healthy Beginning Initiative. Healthy Beginning Initiative implementation would not have been possible without the support and tireless effort of the priests in the participating churches. The church-based Volunteer Health Advisors took ownership of the program and made the process of recruitment and implementation smooth for our study team and participants. This study would have been impossible to conduct without the support of PeTR-GS (our President’s Emergency Plan for AIDS Relief [PEPFAR]–supported partner), staff and volunteers. The research was cofunded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Mental Health, PEPFAR under award number R01HD075050 to Echezona E. Ezeanolue, MD. Trial was registered with ClinicalTrials.gov, identifier number NCT 01795261. Full study operating procedure manual is available on the website. Echezona E. Ezeanolue is now also at the University of Nigeria.

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