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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.

SUBMITTER: Clouse K

PROVIDER: S-EPMC7068940 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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

Clouse Kate K Phillips Tamsin K TK Camlin Carol C Noholoza Sandisiwe S Mogoba Phepo P Naidoo Julian J Langford Richard R Weiss Martin M Seebregts Christopher J CJ Myer Landon L

Trials 20200312 1

<h4>Background</h4>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 an ...[more]

PMID: 32164771

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Project description:IntroductionKwaZulu-Natal (KZN), South Africa (SA) has the highest prevalence of pregnant women living with HIV in the world. Pregnancy and the postpartum period offer opportunities to engage women in HIV care, to prevent perinatal transmission and to optimise maternal and infant well-being. However, research suggests that remaining engaged in HIV care during this time can be challenging.Methods and analysisWe are conducting a 5-year prospective cohort study among pregnant women living with HIV in KZN to estimate the rates and factors associated with attrition from HIV care during this critical period. To determine who is most likely to fall out of care, we are examining a range of relevant variables informed by a socioecological model of HIV care, including individual, relational, community and healthcare system variables. We are enrolling 18-45-year-old women, at 28 weeks or more of pregnancy, who are living with HIV and currently taking antiretroviral therapies. Participants complete quantitative assessments at baseline (pregnancy) and at 6, 12, 18 and 24 months postpartum. A subset of women and their partners are invited to complete qualitative interviews to further explore their experiences in HIV care. The main study outcomes are suppressed HIV RNA and retention in care at each study assessment. Our understanding of the factors that drive postpartum attrition from HIV care will ultimately inform the development of interventions to facilitate continued engagement in postpartum HIV care.Ethics and disseminationThis protocol has been approved by the Human Research Ethics Committee (Medical) at The University of the Witwatersrand (Johannesburg, SA) and the Partners Human Research Committee at Partners HealthCare (Boston, Massachusetts, USA). Site support and approval were obtained from the District Hospital and the KZN Provincial Department of Health. Results will be disseminated through peer-reviewed manuscripts, reports and both local and international presentations (Ethics Registration #170 212).

Project description:PurposePregnant and postpartum women living with HIV in South Africa are at high risk of dropping out of care, particularly after delivery. Population mobility may contribute to disruptions in HIV care, and postpartum women are known to be especially mobile. To improve engagement in HIV care during the peripartum period, we developed CareConekta, a smartphone application (app) that uses GPS coordinates to characterise mobility and allow for real-time intervention. We conducted a randomised controlled pilot study to assess feasibility, acceptability and initial efficacy of the app intervention to improve engagement in HIV care. This cohort profile describes participant enrolment and follow-up, describes the data collected and provides participant characteristics.ParticipantsWe enrolled 200 pregnant women living with HIV attending routine antenatal care at the Gugulethu Midwife Obstetric Unit in Cape Town, South Africa. Eligible women must have owned smartphones that met the app's technical requirements. Seven participants were withdrawn near enrolment, leaving 193 in the cohort.Findings to dateData were collected from detailed participant questionnaires at enrolment and follow-up (6 months after delivery), as well as GPS data from the app, and medical records. Follow-up is complete; initial analyses have explored smartphone ownership, preferences and patterns of use among women screened for eligibility and those enrolled in the study.Future plansAdditional planned analyses will characterise mobility in the population using the phone GPS data and participant self-reported data. We will assess the impact of mobility on engagement in care for the mother and infant. We also will describe the acceptability and feasibility of the study, including operational lessons learnt. By linking this cohort to the National Health Laboratory Service National HIV Cohort in South Africa, we will continue to assess engagement in care and mobility outcomes for years to come. Collaborations are welcome.Trial registration numberNCT03836625.

Project description:BACKGROUND:HIV transmission can be decreased substantially by reducing the burden of undiagnosed HIV infection and expanding early and consistent use of antiretroviral therapy (ART). Treatment as prevention (TasP) has been proposed as key to ending the HIV epidemic. To activate TasP in high prevalence countries, like South Africa, communities must be motivated to know their status, engage in care, and remain in care. Community mobilization (CM) has the potential to significantly increase uptake testing, linkage to and retention in care by addressing the primary social barriers to engagement with HIV care-including poor understanding of HIV care; fear and stigma associated with infection, clinic attendance and disclosure; lack of social support; and gender norms that deter men from accessing care. METHODS/DESIGN:Using a cluster randomized trial design, we are implementing a 3-year-theory-based CM intervention and comparing gains in HIV testing, linkage, and retention in care among individuals residing in 8 intervention communities to that of individuals residing in 7 control communities. Eligible communities include 15 villages within a health and demographic surveillance site (HDSS) in rural Mpumalanga, South Africa, that were not exposed to previous CM efforts. CM activities conducted in the 8 intervention villages map onto six mobilization domains that comprise the key components for community mobilization around HIV prevention. To evaluate the intervention, we will link a clinic-based electronic clinical tracking system in all area clinics to the HDSS longitudinal census data, thus creating an open, population-based cohort with over 30,000 18-49-year-old residents. We will estimate the marginal effect of the intervention on individual outcomes using generalized estimating equations. In addition, we will evaluate CM processes by conducting baseline and endline surveys among a random sample of 1200 community residents at each time point to monitor intervention exposure and community level change using validated measures of CM. DISCUSSION:Given the known importance of community social factors with regard to uptake of testing and HIV care, and the lack of rigorously evaluated community-level interventions effective in improving testing uptake, linkage and retention, the proposed study will yield much needed data to understand the potential of CM to improve the prevention and care cascade. Further, our work in developing a CM framework and domain measures will permit validation of a CM conceptual framework and process, which should prove valuable for community programming in Africa. TRIAL REGISTRATION:NCT02197793 Registered July 21, 2014.

Project description:BackgroundCommunity mobilisation, engaging communities in a process to collectively enact change, could improve HIV testing and care engagement. In South Africa, current rates fall below those needed for epidemic control. We assessed whether community mobilisation increased HIV testing, linkage to care, and retention in care over time in intervention relative to control communities.MethodsWe conducted a cluster-randomised controlled trial in villages in the Agincourt sub-district of the rural Mpumalanga Province in South Africa. 15 villages were randomly assigned to either a community mobilisation intervention engaging residents to address social barriers to HIV testing and treatment (intervention arm) or to a control arm using balanced randomisation. Villages were eligible if they had been fully enumerated in 2014, had not been included in previous mobilisation activities, and included over 500 permanent adult residents aged 18-49 years. Primary outcomes included quarterly rates of HIV testing, linkage to care, and retention in care documented from health facility records among residents of the intervention and control communities over the 3-year study period. Intention-to-treat analyses employed generalised estimating equations stratified by sex. This trial is registered with ClinicalTrials.gov, NCT02197793.FindingsBetween Aug 1, 2015, and July 31, 2018, residents in eight intervention communities (n=20 544 residents) and seven control communities (n=17 848) contributed data; 92 residents contributed to both arms. Among men, HIV testing increased quarterly by 12·1% (relative change [RC] 1·121, 95% CI 1·099 to 1·143, p<0·0001) in the intervention communities and 9·5% (1·095, 1·075 to 1·114, p=0·011) in the control communities; although increases in testing were greater in the intervention villages, differences did not reach significance (exponentiated interaction coefficient 1·024, 95% CI 0·997 to 1·052, p=0·078). Among women, HIV testing increased quarterly by 10·6% (RC 1·106, 95% CI 1·097 to 1·114, p<0·0001) in the intervention communities and 9·3% (1·093, 1·084 to 1·102, p=0·053) in the control communities; increases were greater in intervention communities (exponentiated interaction coefficient 1·012, 95% CI 1·001 to 1·023, p=0·043). Quarterly linkage increased significantly among women in the intervention communities (RC 1·013, 95% CI 1·002 to 1·023, p=0·018) only. Quarterly linkage fell among men in both arms, but decreased significantly among men in the control communities (0·977, 0·954 to 1·002, p=0·043). Quarterly retention fell among women in both arms; however, reductions were tempered among women in the intervention communities (exponentiated interaction coefficient 1·003, 95% CI <1·000 to 1·006, p=0·062). Retention fell significantly among men in both arms with difference in rates of decline.InterpretationCommunity mobilisation was associated with modest improvements in select trial outcomes. The sum of these incremental, quarterly improvements achieved by addressing social barriers to HIV care engagement can impact epidemic control. However, achieving optimal impacts will probably require integrated efforts addressing both social barriers through community mobilisation and provision of improved service delivery.FundingUS National Institutes of Health, National Institute of Mental Health, and United States President's Emergency Plan for AIDS Relief through Right to Care and Project SOAR.

Project description:IntroductionAdvances in HIV treatment have proven to be effective in increasing virological suppression, thereby decreasing morbidity, and increasing survival. Medication adherence is an important factor in reducing viral load among people living with HIV (PLWH) and in the elimination of transmission of HIV to uninfected partners. Achieving optimal medication adherence involves individuals taking their medications every day or as prescribed by their provider. However, not all PLWH in the USA are engaged in care, and only a minority have achieved suppressed viral load (viral load that is lower than the detectable limit of the assay). Sexual and gender minorities (SGM; those who do not identify as heterosexual or those who do not identify as the sex they were assigned at birth) represent a high-risk population for poor clinical outcomes and increased risk of HIV transmission, as they face barriers that can prevent optimal engagement in HIV care. Research in dyadic support, specifically within primary romantic partnerships, offers a promising avenue to improving engagement in care and treatment outcomes among SGM couples. Dyadic interventions, especially focused on primary romantic partnerships, have the potential to have a sustained impact after the structured intervention ends.Methods and analysisThis paper describes the protocol for a randomised control trial of a theory-grounded, piloted intervention (DuoPACT) that cultivates and leverages the inherent sources of support within primary romantic relationships to improve engagement in HIV care and thus clinical outcomes among persons who are living with HIV and who identify as SGM (or their partners). Eligible participants must report being in a primary romantic relationship for at least 3 months, speak English, at least one partner must identify as a sexual or gender minority and at least one partner must be HIV+ with suboptimal engagement in HIV care, defined as less than excellent medication adherence, having not seen a provider in at least the past 8 months, having a detectable or unknown viral load or not currently on antiretroviral therapy. Eligible consenting couples are allocated equally to the two study arms: a structured six-session couples counselling intervention (DuoPACT) or a three-session individually-delivered HIV adherence counselling intervention (LifeSteps). The primary aim is to evaluate the efficacy of DuoPACT on virological suppression among HIV+ members of SGM couples with suboptimal engagement in care. The DuoPACT study began its target enrolment of 150 couples (300 individuals) in August 2017, and will continue to enrol until June 2021.Ethics and disseminationAll procedures are approved by the Institutional Review Board at the University of California, San Francisco. Written informed consent is obtained from all participants at enrolment, and study progress is reviewed twice yearly by an external Safety Monitoring Committee. Dissemination activities will include formal publications and report back sessions with the community.Trial registration numberNCT02925949; Pre-results.

Project description:In countries with a high burden of HIV, such as South Africa, where the epidemic remains the world's largest, improving early uptake of and consistent adherence to antiretroviral therapy could bring substantial HIV prevention gains. However, patients are not linked to or retained in care at rates needed to curtail the epidemic. Two strategies that have demonstrated a potential to stem losses along the HIV care cascade in the sub-Saharan African context are use of text messaging or short message service (SMS) and peer-navigation services.We designed a cluster randomized trial to assess the efficacy of an SMS intervention and a peer-navigation intervention to improve retention in care and treatment, timely linkage to care and treatment, medication adherence, and prevention behaviors in South Africa. Eighteen primary and community healthcare clinics in Rustenburg and Moses Kotane Sub-districts in the North West Province were randomized to one of three conditions: SMS intervention (n = 7), peer navigation intervention (n = 7), or standard of care (n = 4). Approximately 42 participants are being recruited at each clinic, which will result in a target of 750 participants. Eligible participants include patients accessing HIV testing or care in a study clinic, recently diagnosed with HIV, aged 18 years or older, and with access to a cellular telephone where they are willing to receive automated SMS with HIV-related messaging. Data collection includes extraction of visit information from clinical files and participant surveys at baseline, 6 months, and 12 months. Intent-to-treat (ITT) analysis will explore differences between randomization arms and the primary outcome of patient retention in care at 12 months following enrollment. We will also explore secondary outcomes including participants' a) timely linkage to care (within 3 months of HIV diagnosis), b) adherence to treatment based on self-report and clinic's medication dispensation dates, and c) condom-use behaviors.The findings will allow us to compare the efficacy of two complementary interventions, one that requires fewer resources to implement (SMS) and one (peer navigation) that offers more flexibility in terms of the patient barriers to care that it can address.NCT02417233, registered 12 December 2014.

Project description:People living with HIV (PLWH) with a substance use disorder (SUD) tend to receive inadequate medical care in part because of a siloed healthcare system in which HIV and substance use services are delivered separately. Ideal treatment requires an interdisciplinary, team-based coordinated care approach, but many structural and systemic barriers impede the integration of HIV and SUD services. The current protocol describes the development and preliminary evaluation of a care coordination intervention (CCI), consisting of a tablet-based mobile platform for HIV and SUD treatment providers, an interagency communication protocol, and a training protocol. We hypothesize that HIV and SUD treatment providers will find the CCI to be acceptable, and that after receipt of the CCI, providers will: exhibit higher retention in dual care among patients, report increased frequency and quality of communication, and report increased rates of relational coordination.A three phase approach is used to refine and evaluate the CCI. Phase 1 consists of in-depth qualitative interviews with 8 key stakeholders as well as clinical audits of participating HIV and SUD treatment agencies. Phase 2 contains functionality testing of the mobile platform with frontline HIV and SUD treatment providers, followed by refinement of the CCI. Phase 3 consists of a pre-, post-test trial with 30 SUD and 30 HIV treatment providers. Data will be collected at the provider, organization, and patient levels. Providers will complete assessments at baseline, immediately post-training, and at 1-, 3-, and 6-months post-training. Organizational data will be collected at baseline, 1-, 3-, and 6-months post training, while patient data will be collected at baseline and 6-months post training.This study will develop and evaluate a CCI consisting of a tablet-based mobile platform for treatment providers, an interagency communication protocol, and a training protocol as a means of improving the integration of care for PLWH who have a SUD. Results have the potential to advance the field by bridging gaps in a fragmented healthcare system, and improving treatment efficiency, work flow, and communication among interdisciplinary providers from different treatment settings.NCT02906215.

Project description:BackgroundMobile health interventions are common in public health settings in Africa, and our preliminary work showed that smartphones are increasing in South Africa. We developed a novel smartphone app-CareConekta-that used GPS location data to characterize personal mobility to improve engagement in HIV care among pregnant and postpartum women living with HIV in South Africa. The app also used the user's location to map nearby clinics.ObjectiveWe aimed to describe the feasibility, acceptability, and initial efficacy of using the app in a real-world setting.MethodsWe conducted a prospective randomized controlled trial at a public sector clinic near Cape Town, South Africa. We enrolled 200 pregnant (third trimester) women living with HIV who owned a smartphone that met the required specifications. All participants installed the app, designed to collect 2 GPS heartbeats per day to geolocate the participant within a random 1-km fuzzy radius (for privacy). We randomized (1:1) participants to a control arm to receive the app with no additional support or an intervention arm to receive supportive phone calls, WhatsApp (Meta Platforms, Inc) messages, or both from the study team when traveling >50 km from the study area for >7 days. In addition to mobility data collected daily through the phone, participants completed questionnaires at enrollment and follow-up (approximately 6 months post partum).ResultsA total of 7 participants were withdrawn at enrollment or shortly after because of app installation failure (6/200, 3%) or changing to an unsuitable phone (1/200, 0.50%). During the study period, no participant's smartphone recorded at least 1 heartbeat per day, which was our primary feasibility measure. Of the 171 participants who completed follow-up, only half (91/171, 53.2%) reported using the same phone as that used at enrollment, with the CareConekta app still installed on the phone and GPS usually enabled. The top reasons reported for the lack of heartbeat data were not having mobile data, uninstalling the app, and no longer having a smartphone. Acceptability measures were positive, but participants at follow-up demonstrated a lack of understanding of the app's purpose and function. The clinic finder was a popular feature. Owing to the lack of consistent GPS heartbeats throughout the study, we were unable to assess the efficacy of the intervention.ConclusionsSeveral key challenges impeded our study feasibility. Although the app was designed to reverse bill participants for any data use, the lack of mobile data was a substantial barrier to our study success. Participants reported purchasing WhatsApp data, which could not support the app. Problems with the web-based dashboard meant that we could not consistently monitor mobility. Our study provides important lessons about implementing an ambitious GPS-based study under real-world conditions in a limited-resource setting.Trial registrationClinicalTrials.gov NCT03836625; https://clinicaltrials.gov/ct2/show/NCT03836625.International registered report identifier (irrid)RR2-10.1186/s13063-020-4190-x.

Dataset Information

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

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

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