Community Health Workers

We will use a range of research designs to answer our key questions, as shown in Table 2. In the Inception phase we conducted a situational analysis of the mental health system in the selected district in each country. Using these data, we engaged in formative research to refine the substance and delivery of the proposed mental health care plan. This formative work has included three aspects. (1) We conducted a series of “theory of change” consultative workshops [22] . Theory of change is a structured participatory approach to the design and evaluation of interventions that provides “a systematic and cumulative study of the links between activities, outcomes, and contexts of the initiative” ([22] , p. 16). In the theory of change workshops, local stakeholders were asked to work with the research team to map out the steps in the causal pathway that lead to the intended outcome of the mental health care plan. This provided an opportunity for the research team and local stakeholders to interrogate the assumptions in each step of the proposed system change, as well as identify key indicators needed to monitor that change. (2) We conducted individual semi-structured interviews and focus group discussions to gather information from local stakeholders on the acceptability and feasibility of the proposed intervention packages. A wide range of stakeholders were interviewed, including national policy makers, district health managers, mental health specialists, primary care practitioners, community health workers, people living with the priority mental disorders, and local NGOs. Interview schedules addressed a range of topics, including experience and understanding of mental health problems, and participants' views on the draft mental health plans, training needs of primary care practitioners, task shifting, barriers to care, and health system requirements for integrating mental health into primary health care. (3) We developed a costing tool to estimate the resources required to implement the mental health care plan in each district, informed by local data and consultations.
Once the final mental health care plan has been approved by all stakeholders, training materials will be developed, the proposed interventions will be piloted, and the intervention will then be implemented and evaluated in each district. The primary quantitative methodologies for this evaluation are influenced by recent innovations for evaluating complex interventions implemented at the level of health systems or populations. These include community-based surveys to assess changes in coverage and stigma, facility-based surveys to assess changes in case detection, case studies of district level mental health systems, and studies of cohorts of individuals treated by the mental health care plans, to assess changes in mental health, social, and economic outcomes [23] (link)–[26] (link). All data will be disaggregated by gender, residence (rural/urban), and economic status to monitor equity of access to services and outcomes.

We are currently piloting the use of ToC to design, implement and evaluate complex interventions for mental health in a number of research projects in low- and middle-income countries. These include both RCTs and observational designs to which ToC is also suited. Throughout the paper we use the example of the South Asian Hub for Advocacy, Research and Education on mental health (SHARE) trial ^b to illustrate the process of developing a ToC within the MRC framework. SHARE is adapting an evidence-based counselling intervention for maternal depression delivered by Community Health Workers in Pakistan
[24 (link)] to be delivered by peer support workers as this is more sustainable in a low resource context. The effectiveness of the peer-delivery system is being evaluated through a cluster RCT in Pakistan and an individual RCT in India. The SHARE example also demonstrates that ToC can be used both to develop new interventions and also to adapt existing interventions to new contexts or models of service delivery. To provide further examples, Case Study 1 describes the use of ToC in the Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE) trial, and Case Study 2 describes the use of ToC in a non-randomized evaluation in the PRogramme for Improving Mental health care (PRIME), integrating mental health into primary care in five low- and middle-income countries.

For in-depth interviews, the research team selected a purposive sample of learners (N=12) across health professions from different regions globally. Because the course series was designed for community-based health workers, sampling focused on identifying health professionals with experience using and sharing course content as part of community-based pandemic responses.
The study considered the following learners for recruitment: (1) learners who indicated that they had shared course content with others in their network in a voluntary follow-up course satisfaction survey (administered by the consortium in December 2020; N=112); (2) learners in a community-based health worker role or in a supervisory role in a position to share information with community-based health workers (ie, doctors, nurses, health worker trainers/supervisors, and technical assistance providers) and at an organization with more than one enrollee in the course series; and (3) learners holding an educator role at a higher education institution with more than one enrollee in the course series. Learners who indicated that they did not consent to be contacted further in the follow-up course satisfaction survey were excluded from recruitment.
A total of 119 learners met the purposive sampling criteria and were recruited to participate via email in the study. Learners were sent an introductory recruitment email, and those who did not respond to the initial email were sent several follow-up email requests. Fourteen learners responded with willingness to participate in an in-depth interview (11.8% response rate). The research team was able to schedule in-depth interviews with a sample of 12 of these learners and made efforts to ensure representation across geographic regions and from LMICs. No additional recruitment was deemed necessary as the research team determined saturation was achieved.
As illustrated in Table 1, the 12 interview participants represented a diversity of geographic regions, with 42% (5/12) from Sub-Saharan Africa, followed by 25% (3/12) from North America and 25% (3/12) from South/Southeast Asia. Half (6/12, 50%) of the interviewed learners identified as female. The majority of interviewed learners (7/12, 58%) indicated affiliation with nongovernmental organizations (NGOs). The remaining interviewed learners held roles in governments (2/12, 17%), academic institutions (2/12, 17%), or intergovernmental organizations (1/12, 8%). Interviewed learners were doctors (3/12, 25%), health worker trainers or supervisors (3/12, 25%), community-based health workers (2/12, 17%), technical assistance providers (2/12, 17%), or educators (2/12, 17%). All were involved in community-based COVID-19 response activities, with nearly all (10/12, 83%) involved in risk communication and community engagement.
The 12 in-depth interviews were conducted one-on-one in English via videoconference by 2 investigators (NAS and NJ) using a semistructured interview guide. The interviewers asked learners about their experiences with the curriculum and their roles in using, adapting, and disseminating the curriculum. The interviews were audio recorded and transcribed. Interviews lasted between 20 and 57 minutes, with a mean duration of 38 minutes.

The follow-up plan is determined by the analysis results (Fig. 1). If antibodies to HPV16-L1 and/or HR-HPV DNA are detected in baseline samples, the participant will be contacted within 7–14 days by phone or, if unreachable, personally notified by a community health worker, in order to plan the physical examination at the patient’s earliest convenience (either at the next CTC appointment or at an extra visit). Independently from these results and any further treatment (LEEP or thermal ablation), participants who have antibodies to HPV16-L1 and/or HR-HPV detected at baseline will be asked to repeat cervico-vaginal swab collection for Anyplex™ II HPV28 Detection and QG-MPH after 6 months. If baseline samples are negative for HR-HPV and for antibodies to HPV16-L1, re-screening will be recommended after 12 months according to the NACP guidelines.

This study used a prospective, longitudinal design to examine predictors of parent engagement in one component of the Imperial County, California, Childhood Obesity Research Demonstration study (CA-CORD). The objective of CA-CORD (conducted January 2012-June 2015), was to prevent and control childhood obesity by improving four weight-related behaviors: fruit and vegetable consumption, water consumption, physical activity, quality sleep. CA-CORD used a quasi-experimental pre/post-test design with three intervention arms and one control group, and implemented intervention strategies in five sectors: (1) healthcare, (2) early care and education centers, (3) schools, (4) community recreation organizations, and (5) restaurants. It was designed and implemented via a partnership between San Diego State University Research Foundation’s Institute for Behavioral and Community Health, Clínicas de Salud Del Pueblo, Inc., and the Imperial County Public Health Department. The full design and protocol of CA-CORD is described elsewhere [29 (link)]; it was registered as a clinical trial 22/07/2014 (Trial registration: NCT02197390).
The present study examined predictors of parent engagement in the Family Wellness Program, which was part of the CA-CORD healthcare sector intervention. The Family Wellness Program was included as part of an obesity care model implemented at Clínicas de Salud Del Pueblo, Inc., a large, federally-qualified health center. The program included a series of six healthy lifestyle workshops typically held weekly in small group settings (5–10 families per workshop). The workshops were led by trained community health workers (CHWs) and the content was rooted in health behavior change research and family systems theory [21 (link), 30 , 31 (link)]. Specifically, the evidence-based workshop curriculum was planned to promote health within the home by encouraging both parents and children to adopt healthy lifestyle behaviors by teaching them to navigate common challenges, such as social and structural barriers at home and in the community. For instance, parents received education on effective communication and parenting practices surrounding weight-related behaviors, including increasing parental capacity to set limits on certain behaviors, such as amount of screen time or sugary beverage consumption. Most workshop content was delivered to parents and children separately, though several joint activities were conducted. Families enrolled in the Family Wellness Program were also invited to attend a series of eight physical activity classes during the same six-week period as the lifestyle workshops. The physical activity classes taught families activities they could perform together at home. Parents received motivational interviewing phone calls at the start of the program and at quarterly intervals for the following year, to encourage attendance at workshops and classes, and the continued use of the new skills. Finally, parents received monthly educational newsletters. While the Family Wellness Program included many components, the outcome for the present study was attendance at the lifestyle workshops, as participation in the other components was either optional (i.e., physical activity classes) or passive (i.e., newsletters). All recruitment, informed consent, and measurement materials were approved by the SDSU Institutional Review Board and available in English and Spanish.