Gugulethu Community Health Centre
Cape Town, South Africa
NCT Number: NCT03836625
Population mobility is common in South Africa, but important research gaps exist describing this mobility and its impact on engagement in HIV care, particularly among pregnant and postpartum women. Through this study, the investigators propose to test a smartphone application - CareConekta - to conduct essential formative work on mobility and evaluate this app as an intervention to facilitate engagement in HIV care during times of mobility. This work is critical to adapting CareConekta for widespread use, providing critical information about mobility during the peripartum period and the impact on engagement in HIV care, and piloting this intervention to improve engagement.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Cape Town, South Africa
South Africa is home to the world's largest antiretroviral therapy (ART) program, but sustaining high retention along the HIV care continuum has proven challenging in the country and throughout the wider region. Population mobility is common in South Africa, but important research gaps exist 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. The investigators recently developed a beta version of a smartphone application (app) - CareConekta - that detects a user's smartphone location to allow for prospective characterization of mobility. Through this three-year study, the investigators propose to test CareConekta to conduct essential formative work on mobility and evaluate an intervention - the CareConekta app plus text notifications and optional staff phone calls and/or WhatsApp messages - to facilitate engagement in HIV care during times of mobility. After first adapting CareConekta to use appropriate smartphone technology for the local population, the investigators will characterize mobility among South African women during the peripartum period and its impact on engagement in HIV care. The investigators also will evaluate the acceptability, feasibility, and initial efficacy of using CareConekta as an intervention to improve engagement in HIV care. The investigators will work with a South African technology company with a strong connection to the South African Department of Health to adapt the app prior to enrolling study participants. The study will observe mobility within an observational cohort and will then assess the impact of the intervention among participants who travel during the study period. This work is critical to adapting an existing app for widespread use, providing critical information about mobility during the peripartum period and the impact on engagement in HIV care, and piloting an intervention to improve engagement. This study will lay the necessary groundwork for a larger efficacy trial of the intervention within different geographic settings.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.
Time frame: Baseline to End of Study (up to 2 years)
The investigators will report the number of participants who travel during the study period (defined as 3 or more nights away from home), over the denominator of all participants who completed follow-up.
Time frame: Baseline to End of Study (up to 2 years)
Among those who travel, the investigators will report the median and interquartile range number of trips during the study period.
Time frame: Baseline to End of Study (up to 2 years)
The number of participants who report using the same phone from enrollment at follow-up
Time frame: Baseline to End of Study (up to 2 years)
The investigators will determine timing of travel as it relates to delivery date, which will be obtained from participant questionnaire.
Time frame: Baseline to End of Study (up to 2 years)
Was the move permanent (yes/no)
Time frame: Baseline to End of Study (up to 2 years)
The number of participants who disabled GPS during the study period
Time frame: Baseline to End of Study (up to 2 years)
The number of participants who reported sharing their phone with another person during the study period
Time frame: Baseline to End of Study (up to 2 years)
The number of participants who reported opening the CareConekta app at least once after enrollment visit
Time frame: Baseline to End of Study (up to 2 years)
The number of participants who reported using the CareConekta app to locate a new health facility.
Time frame: 6 months after delivery
The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and maternal retention in care and viral suppression 6 months after delivery.
Time frame: 10 weeks after delivery, study end
The investigators will assess the initial efficacy of CareConekta as an intervention to improve engagement in HIV care. Efficacy will be assessed as the association (estimating adjusted hazard ratios) between study arm and vertical HIV transmission and completion of 10-week infant HIV PCR test.
Time frame: 6 months after delivery
In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and engagement in HIV care for the mother (defined as retention in care and viral suppression six months after delivery).
Time frame: 10 weeks after delivery, study end
In the standard arm, the investigators will assess the association (estimating hazard ratios) between mobility during the study period and completion of routine early infant diagnosis.
Vanderbilt University
Other
CareConekta: A Pilot Study of a Smartphone App to Improve Engagement in Postpartum HIV Care in South Africa
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03671109
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Lambaréné, Gabon
View Trial DetailsNCT04405700
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Eldoret, Kenya
View Trial DetailsNCT05609513
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Kampala, Uganda
View Trial DetailsNCT06739915
Acquired Immunodeficiency Syndrome, Actinomycetales Infections
Soweto, Gauteng, South Africa
View Trial Details