Optimizing knowledge and behavioral intention of women and their partners in the perinatal period in South Africa: a randomized control trial study protocol in the Tshwane district, Gauteng province, South Africa

Background: Maternal knowledge that motivates improvements in critical perinatal health behaviors has the potential to significantly reduce maternal and neonatal mortality. However, evidence-based health information often fails to reach mothers and their partners. mHealth video micro-messages, which disseminate evidence-based perinatal health messages, have the potential to address this gap. Methods: The study will make use of a mixed method design, using both qualitative and quantitative methods. The study consists of two phases. During Phase 1, qualitative in-depth interviews will be used as part of a human-centered design approach to co-create 10 videos on priority perinatal behaviors. During Phase 2, quantitative methods (a randomized control trial) will be used to test the effectiveness of the videos in improving maternal knowledge and intended behavioral change. Discussion: We hypothesize that by engaging mothers and their partners through emotive, resonant narratives and visuals, we can facilitate the delivery of evidence-based health messages at the foundation of perinatal health, thereby motivating life-saving improvements in health behaviors during the perinatal period. Trial registration: This trial has been prospectively registered on the Pan African Clinical Trials Registry (PACTR), with the registration number PACTR202203673222680. Registration date: 14 March 2022. Trial registration WHO data set: Registry – Pan African Clinical Trials Registry (PACTR). Date: 14 March 2022. Secondary identification number – grant number: GCCSOAFMNH1. Source of support: Science for Africa Foundation. Primary sponsor – Clinton Health Access Initiative South Africa. Secondary sponsor – Stanford University School of Medicine and Heidelberg University. Contact for public & scientific queries: amandlamamasa@clintonhealthaccess.org; +27 123,426,911; 1166 Francis Baard St, Hatfield, Pretoria, 0028. Public title – Amandla Mama. Scientific title – Optimizing knowledge and behavioral intention of women and their partners in the perinatal period in South Africa. Countries of recruitment – South Africa. Health conditions – antenatal care. Intervention – Amandla Mama mHealth videos, short 2D animated health promotional videos that promote healthy behavior in expectant mothers. Inclusion and exclusion criteria – Expectant mothers and their partners must be 18 years and older. Study type – randomized control trial. Date of first enrollment – 14 March 2021. Sample size – plan to enrol 450 participants, participants enrolled 29 participants. Recruitment Status – suspended. Primary outcome – improving knowledge. Secondary outcome – intended behavioral change. Ethics review – Approved on 24 January 2022 by Pharma-Ethics, contact Mrs. Marzelle Haskins, marzelle@pharma-ethics.co.za. Completion date – N/A. Summary results – N/A. IPD sharing statement – yes, through the publication of results in a journal article. This study uses a mixed method design, incorporating both qualitative and quantitative methods. The study consists of two phases: An overview of the study methodology is shown in Fig. 1. Overview of the Amandla Mama Study Methodology In Phase 1 the Amandla Mama videos will be iteratively developed through, (i) scripting, (ii) storyboard development, and (iii) refining the developed storyboards by incorporating formative qualitative feedback from expectant mothers, their partners, and health workers gathered through in-depth interviews. During Phase 2 of the study, the Amandla Mama videos, developed in Phase 1, will be tested using a randomized control trial. Participants will be expectant mothers and their partners living in South Africa accessing routine perinatal healthcare services. The intervention group will watch the Amandla Mama Videos, and the control group will receive treatment as usual for antenatal care only. Treatment as usual antenatal care consists of standard maternity care, as outlined in the South African National Department of Health’s “Guidelines for Maternity Care in South Africa” [10]. Maternity care is offered free of charge in the South African public health sector and is integrated into primary healthcare [10]. A survey will be used to gauge whether the intervention results in knowledge change. The surveys, developed by the research team, have been designed to measure change in maternal knowledge, intended behavior, and, user satisfaction. These will be administered to patients 3 months after receiving the intervention. Surveys will also be conducted with partners of the recruited expectant mothers in the study, given the documented benefits to mothers having partners participate in accessing maternal health care services. The partner surveys will have the same content as those designed for the expectant mothers but will be adapted to be relevant to the partner. Knowledge will be the primary outcome and intended behavior change will be the secondary outcome of this randomized control trial. The study sites are two high volume community health centers (CHC) in the Tshwane district of Gauteng province in South Africa, FF Ribeiro Clinic and Kgabo CHC. FF Ribeiro Clinic is situated in the central business district of Tshwane, catering to an urban community and Kgabo CHC, is situated in a large settlement, Ga-Rankuwa, catering to a semi-rural community. The study population includes expectant mothers, 18 years or older attending antenatal care services, pregnant women’s partners, and health workers. Expectant mothers without partners will not be excluded from participating in our study. The inclusion criteria for expectant mothers and their partners include: The inclusion criteria for health workers include: There are no specific exclusion criteria beyond the inclusion criteria. To collect valuable qualitative data during Phase 1 of the study, purposive sampling (non-probability sampling) will be utilized. During the quantitative Phase 2, random sampling will be utilized to create an unbiased representation of the study population. The random allocation will be generated by MD. ZK, EL and the research assistants will be responsible for enrolling and assigning participants. During Phase 1, purposive sampling will be used to select women and their partners attending antenatal care visits at the study sites for in-depth interviews. Health workers will be purposively selected based on their designated positions. Selected health workers could include community health workers, maternal-child health decision makers or experts, CHC managers, maternity and neonatal unit managers and sub-district or district managers of maternal, neonatal and child health programs. Only participants who provide informed consent to participate in the first phase of the study will be interviewed. The interview guide used during Phase 1 is presented in Additional file 1: Annexure 1. In-depth interviews will be conducted with 10-15 pregnant women, who present for an antenatal care visit at the study sites. Additionally, in-depth interviews will be conducted with 10-15 health workers at the study sites. A semi-structured questionnaire will be used to guide the qualitative interviews of Phase 1. The researchers will recruit expectant mothers and their partners after they present at the study sites for an antenatal care visit and will explain the purpose of the study. Expectant mothers who show an interest in participating in the qualitative study will be screened to assess if they meet the inclusion criteria. Informed consent will then be obtained from eligible expectant mothers and their partners. Researchers and research assistants will conduct the interviews in a private area at the respective study sites. All participants will receive ZAR 100 to compensate them for their time and expenses incurred by participating in our study. During Phase 2 of the study, the randomized control trial, researchers and research assistants will randomly recruit women attending an antenatal care visit and their partners, inviting them to participate in the randomized control trial. Every participant will be required to provide informed consent before they can be included in the sample. Participants will be randomized into either the intervention group or the control group until the sample size of 420 has been reached. To implement the randomization, a table with the generated randomization sequence will be used, and as a participant agrees to participate in the study, they will be sequentially allocated to a row in the table that will determining the group that the participant will form part of. The sample size for the randomized control trial, was determined using the primary outcome of the study, change in knowledge. We will allocate participants equally to the treatment and control groups, through a balanced computer-generated random sequence. We use a 0.05 level of significance (P < 0.05) and a power of 0.9 with a two tailed test for significance. Our hypothesis is that at the 3-month follow-up, participants in the control group will score 43% on the intention to change behavior score (12 points out of 28 points in the survey). We propose that after the 3-month follow-up the intervention group will score 61% (17 out of 28 points). This is an 18% absolute increase and a 1.41 times relative increase. A sample size of n = 140 was calculated for the intervention group and the control group. We then used an increase of 50% to account for potential participant drop-outs, bringing the sample size for the intervention group to n = 210 and the sample size for the control group to n = 210, spread equally and randomly across the two sites (Kgabo CHC[urban site] and Ga-Rankuwa[rural site]). Thus, a total of n = 420 participants for the entire randomized control trial will be required. These sample size calculations were carried out on G-Power 3.1.9.6. Sample size calculations were based on the difference between two independent proportions using a z-test (Power: 0.9, Alpha 0.05, Allocation N1/N2: 1, p1 = 0.43, p2 = 0.61). The sample size per group was rounded up to the nearest 10 patients (N1 = 140, N2 = 140). Expectant mothers assigned to the intervention group will watch the 10 Amandla Mama videos and their partners will receive the same 10 Amandla Mama videos via the social media platform, WhatsApp or short messaging service (SMS). The expectant mothers will be asked to provide the researchers with their contact details and the contact details of their partners. Partners who agree to participate in the study and who provide informed consent will receive the Amandla Mama videos by SMS or WhatsApp. The control group will receive existing treatment as usual-antenatal care only. After 3 months, knowledge, behavioral intent, and user satisfaction surveys will be administered telephonically to all participants. The follow-up is conducted after 3 months to test long-term retention providing a better predictor for ongoing change. The research assistants under supervision of the researchers, will administer the telephonic survey. Data collected from participants who discontinue with or deviate from the study will not be used. Surveys for the expectant mothers consist of a total of 61 questions: 10 background questions, 15 behavioral intention questions, 30 knowledge questions and 8 user satisfaction questions (refer to Additional file 1: Annexure 2). Surveys for partners consist of a total of 63 questions: 8 background questions, 18 behavioral intention questions, 30 knowledge questions and 8 user satisfaction questions (refer to Additional file 1: Annexure 3). The user-satisfaction questions, which consider how satisfied the participants are with the Amandla Mama videos, will only be administered to participants in the intervention group. All Phase 2 study participants will receive ZAR 100 to compensate them their time and expenses incurred by participating in our study. As a mixed-methods approach will be used for the study, two different data analysis approaches will be used. In Phase 1, a qualitative descriptive approach will be used, and in Phase 2, a statistical analysis will be conducted. The qualitative data collected during the Phase 1 interviews will be transcribed, coded in two cycles analyzed using a qualitative descriptive approach. The qualitative descriptive approach has been successfully used to interpret and describe a broad variety of perspectives on health interventions. This naturalistic approach recognizes the subjective nature of participants’ preferences and is often incorporated into mixed-methods studies. This approach also supports the co-creation of health messages that relate to the participants’ local cultures and experiences to optimize engagement and support quality improvements, rather than advancing theoretical or conceptual understanding in this phase [11]. For Phase 2 of the study, descriptive statistics will be collected and reported to compare the two groups. Confounders that will be measured include demographic characteristics of age, education, race group, religion, nationality, employment and earnings. Another confounder that should be balanced is the exposure of participants to Mom-Connect, an online platform that provides mothers with information about maternal and neonatal care. Confounders will be reported by video intervention and treatment as usual (TAU) across rural and urban sites and overall, for the entire cohort (see mock Table 1). Since this is a large enough randomized control trial the confounders should be balanced. We will compare differences between the control and intervention groups in knowledge and intended behavior change at a 3-month follow-up. Mock table of confounders The outcome variables will also be described overall and by rural and urban sties (see mock Table 2). The reported effect size will be an unadjusted relative risk using Poisson regression. Rates for Poisson regression will be total correct answers divided by total questions. This keeps with the intention to treat paradigm, so questions not attempted or answered as “don’t know” are included as incorrect answers). Mock table of outcome variables Results will be reported by comparing video intervention arm and treatment as usual across rural and urban sites and by outcome sub-groupings (see mock Table 3). Statistical significance will be set at 5% and results will be presented with 95% Confidence Intervals. A Fisher’s exact P-value will be reported for all associations. Mock table of results reporting Relative Risk calculated using Poisson Regression (rate of correctly answered questions over total questions) Ethical approval for the study has been granted by the Human Research Ethics Committee at the Pharma-Ethics and by Clinton Health Access Initiative Research Ethics Committee. Additionally, ethics clearance has been obtained from the Tshwane Regional Research Ethics Committee. Written informed consent will be obtained from prospective research participants prior to them partaking in Phase 1 (Additional file 1: Annexure 4) and Phase 2 (Additional file 1: Annexure 5) of the study. Participation is voluntary and participants can withdraw their consent at any time without any threat or punitive measures. Under South Africa data protection law “Protection of Personal Information Act 2013” the study sites (FF Ribeiro Clinic and Kgabo CHC) and the researchers (investigators, coordinators and study sponsors) will be jointly responsible as ‘controllers’ to ensure that the participants’ information is safeguarded. Data collected during both phases of the study will be de-identified; participants will be assigned unique identifiers (e.g., Participant 1, Participant 2). Data collected during the study will be stored on an encrypted and secure server which will be password protected and only the researchers and study sponsors will have access to it. The data collected will be deleted 2 years after the study has been completed. Dara.