NCT02756949

Brief Summary

This randomized controlled trial evaluates the provision of individual patient laboratory results to newly diagnosed HIV positive smartphone users through a secure application (app) as a method to get them linked to and retained in care, and engage with educational materials purposefully developed to explain their results. Message prompts will also be used to alert patients that their results are ready and provide information on how to link to care, and assistance to re-link to care if they fall out of the health system for any reason. Prompts will be sent to patients to remind health care workers if they are due for repeat laboratory monitoring. The primary endpoint is linkage to care (a HIV-related laboratory test) at 6 months. The control group received standard of care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

October 24, 2019

Completed
Last Updated

October 24, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

April 27, 2016

Results QC Date

April 29, 2019

Last Update Submit

October 1, 2019

Conditions

HIV InfectionsViral LoadPatient ComplianceAntiretroviral TherapyCell Phone

Keywords

HIVViral loadCD4 countmHealthSmartphoneLinkage to careRetention in careAntiretroviral treatmentRandomized controlled trialJohannesburgMobile appTreatment adherence

Outcome Measures

Primary Outcomes (1)

  • Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)

    To test whether linkage to HIV care is improved by providing new HIV clients with access to a smartphone-enabled application (app) when compared to standard of care around 6 months post-diagnosis.

    Recruitment +8 months

Secondary Outcomes (1)

  • Linkage to HIV Care Among Young People (Indicated by a HIV-related Laboratory Blood Test Within 8 Months)

    Recruitment +8 months

Study Arms (2)

Smartphone-enabled app for linkage to care

EXPERIMENTAL

Participants in this arm are randomised to receive the smartphone application which provides direct access to HIV-related laboratory test results.

Other: Smartphone applicationDevice: Smartphone

Standard of care

NO INTERVENTION

Participants in this arm are randomised to receive standard of care services.

Interventions

Smartphone applicationOTHER

Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.

Also known as: App, Customised smartphone app
Smartphone-enabled app for linkage to care
SmartphoneDEVICE
Smartphone-enabled app for linkage to care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed HIV positive clients presenting at selected public health facilities, irrespective of CD4 count
  • Access to an Android smartphone with data
  • Willing to pay the (very small) cost to access their laboratory result
  • Age - 18 years and older
  • Proof of ID/passport/refugee number (for identification/security, and to confirm the single patient identifier)
  • Can read English or Zulu
  • Ability and willingness to sign informed consent

You may not qualify if:

  • Clients presenting for antenatal care services, as these women will be enrolled in the national MomConnect program
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wits Reproductive Health and HIV Institute

Johannesburg, Gauteng, 2001, South Africa

Location

Related Publications (3)

  • Venter WDF, Fischer A, Lalla-Edward ST, Coleman J, Lau Chan V, Shubber Z, Phatsoane M, Gorgens M, Stewart-Isherwood L, Carmona S, Fraser-Hurt N. Improving Linkage to and Retention in Care in Newly Diagnosed HIV-Positive Patients Using Smartphones in South Africa: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Apr 2;7(4):e12652. doi: 10.2196/12652.

    PMID: 30938681RESULT

  • Venter W, Coleman J, Chan VL, Shubber Z, Phatsoane M, Gorgens M, Stewart-Isherwood L, Carmona S, Fraser-Hurt N. Improving Linkage to HIV Care Through Mobile Phone Apps: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jul 17;6(7):e155. doi: 10.2196/mhealth.8376.

    PMID: 30021706RESULT

  • Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

    PMID: 32779730DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsPatient ComplianceTreatment Adherence and Compliance

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPatient Acceptance of Health CareHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Multiprotein ComplexesMacromolecular SubstancesProteinsAmino Acids, Peptides, and Proteins

Limitations and Caveats

ART initiation, participant satisfaction, knowledge scores) could not be evaluated. Analytics on app use could not be conducted. Generalization of findings is limited due to smart phone requirement for trial participation (selection bias).

Results Point of Contact

Title
Ms Marelize Gorgens
Organization
World Bank
mgorgens@worldbank.org
0012024730547

Study Officials

  • Francois Venter, Prof

    Wits Reproductive Health and HIV Institute

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2016

First Posted

April 29, 2016

Study Start

October 1, 2015

Primary Completion

February 1, 2017

Study Completion

June 1, 2017

Last Updated

October 24, 2019

Results First Posted

October 24, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)