NCT03836625

CareConekta: A Smartphone App to Improve Engagement in HIV Care

Completed NA Results posted Last updated 1 February 2023

What this trial tests

NA trial testing CareConekta in HIV/AIDS in 200 participants. Completed in 30 November 2021.

Timeline

9 December 2019

Primary endpoint
30 November 2021

30 November 2021

Quick facts

Lead sponsor	Vanderbilt University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	200
Start date	9 December 2019
Primary completion	30 November 2021
Estimated completion	30 November 2021
Sites	1 location across South Africa

Drugs / interventions tested

• CareConekta

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Pregnancy Related — all drugs for Pregnancy Related →

Sponsor

Vanderbilt University

Who can join

18 and older, female only, with HIV/AIDS or Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mobility Prevalence Primary · 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.

Traveled yes

Group	Value	95% CI
Control	30
Intervention	24

Traveled no

Group	Value	95% CI
Control	54
Intervention	65

Median Number of Trips Per Person Primary · 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.

Group	Value	95% CI
Control	1	1 – 1
Intervention	1	1 – 1

CareConekta Feasibility: Same Phone at Follow-up Primary · Baseline to End of Study (up to 2 years)

The number of participants who report using the same phone from enrollment at follow-up

No

Group	Value	95% CI
Control	31
Intervention	33

Yes

Group	Value	95% CI
Control	52
Intervention	55

Missing

Group	Value	95% CI
Control	1
Intervention	1

Timing of Travel Secondary · 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.

Traveled before delivery

Group	Value	95% CI
Control	4
Intervention	9

Traveled after delivery

Group	Value	95% CI
Control	29
Intervention	18

Permanent Move Secondary · Baseline to End of Study (up to 2 years)

Was the move permanent (yes/no)

Yes

Group	Value	95% CI
Control	5
Intervention	1

No

Group	Value	95% CI
Control	28
Intervention	26

CareConekta Feasibility: GPS Disabled During the Study Period Secondary · Baseline to End of Study (up to 2 years)

The number of participants who disabled GPS during the study period

No

Group	Value	95% CI
Control	74
Intervention	82

Yes

Group	Value	95% CI
Control	8
Intervention	5

I don't know

Group	Value	95% CI
Control	1
Intervention	1

Missing

Group	Value	95% CI
Control	1
Intervention	1

CareConekta Feasibility -- Participant Reported Sharing Phone Secondary · 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

No

Group	Value	95% CI
Control	77
Intervention	71

Yes

Group	Value	95% CI
Control	7
Intervention	18

CareConekta Feasibility -- Participant Ever Opened App Secondary · 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

No

Group	Value	95% CI
Control	4
Intervention	12

Yes

Group	Value	95% CI
Control	80
Intervention	77

CareConekta Feasibility -- Participant Used the App to Locate New Health Facilities Secondary · 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.

No

Group	Value	95% CI
Control	69
Intervention	68

Yes

Group	Value	95% CI
Control	11
Intervention	9

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa.
   Clouse K, Phillips TK, Camlin C, Noholoza S, et al · · 2020 · cited 18× · PMID 32164771 · DOI 10.1186/s13063-020-4190-x
2. The Implementation of a GPS-Based Location-Tracking Smartphone App in South Africa to Improve Engagement in HIV Care: Randomized Controlled Trial.
   Clouse K, Noholoza S, Madwayi S, Mrubata M, et al · · 2023 · cited 13× · PMID 37204838 · DOI 10.2196/44945
3. Smartphone Ownership and Usage Among Pregnant Women Living With HIV in South Africa: Secondary Analysis of CareConekta Trial Data.
   Noholoza S, Phillips TK, Madwayi S, Mrubata M, et al · · 2023 · cited 3× · PMID 37347521 · DOI 10.2196/43855
4. Cohort profile: CareConekta: a pilot study of a smartphone application to improve engagement in postpartum HIV care in South Africa.
   Clouse K, Noholoza S, Ngcobo N, Madwayi S, et al · · 2022 · cited 2× · PMID 36414286 · DOI 10.1136/bmjopen-2022-064946
5. CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa
   Clouse K, Phillips TK, Camlin C, Noholoza S, et al · · 2020 · DOI 10.21203/rs.2.22822/v2