CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa

Abstract

Background: South Africa is home to the world's largest antiretroviral therapy program but sustaining engagement along the HIV care continuum has proven challenging in the country and throughout the wider region. Population mobility is common in South Africa, but there are important research gaps in describing this mobility and its impact on engagement in HIV care. Postpartum women and their infants in South Africa are known to be at high risk of dropping out of HIV care after delivery and are frequently mobile. Methods: In 2017, we developed a beta version of a smartphone application (app)-CareConekta-that detects a user's smartphone location to allow for prospective characterization of mobility. Now we will adapt and test CareConekta to conduct essential formative work on mobility and evaluate an intervention-the CareConekta app plus text notifications and phone calls and/or WhatsApp messages-to facilitate engagement in HIV care during times of mobility. During the 3-year project period, our first objective is to evaluate the feasibility, acceptability, and initial efficacy of using CareConekta as an intervention to improve engagement in HIV care. Our second objective is to characterize mobility among South African women during the peripartum period and its impact on engagement in HIV care. We will enroll 200 eligible pregnant women living with HIV and receiving care at the Gugulethu Midwife Obstetric Unit in Cape Town, South Africa. Discussion: This work will provide critical information about mobility during the peripartum period and the impact on engagement in HIV care. Simultaneously, we will pilot test an intervention to improve engagement with rigorously assessed outcomes. If successful, CareConekta offers tremendous potential as a research and service tool that can be adapted and evaluated in multiple geographic regions, study contexts, and patient populations. Trial registration: ClinicalTrials.gov: NCT03836625. Registered on 8 February 2019.

The practice of pilot/feasibility studies in informing the conduct of HIV related clinical trials in sub-Saharan Africa: A scoping review

“…A total of 32 clinical trial protocols met the selection criteria. Of these, 44% (14/32) [ [16] , [17] , [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] ]were informed by a pilot/feasibility study while the majority [56% (18/32)] [ [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] ] were not informed by a pilot/feasibility study ( Fig. 2 ).…”

Scaling up public mental health care in Sub-Saharan Africa: insights from infectious disease

“…New technologies like social media can grow diverse networks to raise awareness of the importance of mental health, and new partnerships with traditional media can reach those with limited technology access. Mobile health communication interventions are currently in development that would improve migrants' engagement with HIV care during times of mobility (Clouse et al ., 2020 ). Global mental health communication frameworks should thoughtfully integrate intercultural competencies, such as neurodiversity, ethnicity, gender, language proficiency, trust, and context to reach the populations most vulnerable to mental illnesses and to positively influence behavior and policy (Faregh et al ., 2019 ).…”

Improved virologic outcomes in postpartum women living with HIV referred to differentiated models of care

“…A range of intervention strategies has been suggested to help improve WLH's adherence to ART during the postpartum period. These include psychological counselling interventions, mobile phone communications [11] and integration of postpartum health services for WLH and their children [12]. Data to support these interventions are heterogenous in terms of both the strength of the evidence and quality of evaluation, and there is a need for rigorous evaluations of different interventions that may improve engagement in care among postpartum WLH [13].…”