NCT04781400

Brief Summary

Sub Saharan Africa is home to only 12% of the population, but accounts for approximately 70% of the global burden of HIV infection and 84% of infections among young people aged 10-24 years. South Africa, which currently has the largest SARS-CoV-2 pandemic in SSA, also has the largest HIV epidemic globally. Access and service delivery barriers to engaging in HIV care have contributed to estimates that only 49% of adolescents (aged 10-19 years) entering care from 2005-2016 have initiated antiretroviral therapy (ART). In response to the SARS-CoV-2 pandemic the South African government has implemented national lock-down orders that we predict will further inhibit treatment engagement among young people. Research is needed to identify best practices for safely retaining young people living with HIV (YPLWH) in care during COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
536

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable hiv-infections

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

February 8, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

1.3 years

First QC Date

February 22, 2021

Last Update Submit

August 16, 2022

Conditions

HIV InfectionsCovid19Health Care UtilizationGender-based Violence

Outcome Measures

Primary Outcomes (3)

  • Acceptability of a remote service delivery and mobile support intervention assessed by the number of participants opting in to receive courier delivery of ART.

    Program evaluation of a remote service delivery including mobile support intervention and courier delivery of ART amongst young people living with HIV.

    6 months

  • Engagement in HIV care assessed by serial measurements of HIV Viral load.

    Measurement of HIV viral load will be done at baseline, month three and month six to determine whether adherence to ART has been met (decrease or increase in HIV Viral load)

    6 months

  • Changes in Gender Based Violence (GBV) incidence as a result of COVID lock-down measures as assessed by self reported surveys.

    Investigate changes in self-reported GBV experience or perpetration, and other individual, social-behavioral, and structural factors that have been impacted by COVID-19 lock down orders.

    6 months

Secondary Outcomes (2)

  • Incidence of COVID-19 infection by assessing participant IgG antibody levels.

    6 months

  • Qualitative themes assessed from in-depth individual interview data

    6 months

Study Arms (2)

Remote service delivery model PLUS mobile phone support

EXPERIMENTAL

Remote service delivery plus mobile intervention via SMS will include weekly check-ins from study staff, calls from a trained counsellor on request, and access to a two-way messaging feature.

Behavioral: Mobile phone supportBehavioral: Remote service delivery model

Remote service delivery model

ACTIVE COMPARATOR

Remote service delivery model.

Behavioral: Remote service delivery model

Interventions

Mobile phone supportBEHAVIORAL

Mobile phone support (SMS)

Remote service delivery model PLUS mobile phone support
Remote service delivery modelBEHAVIORAL

ART treatment delivery via a courier service

Remote service delivery modelRemote service delivery model PLUS mobile phone support

Eligibility Criteria

Age13 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Speak isiXhosa and or English, residing in the Khayelitsha /Mitchell's Plain area
  • years (inclusive)
  • Willing and able to provide informed telephonic or in person consent
  • Initiated ART at one of two health facilities and are currently in HIV care (i.e. received ART and had a viral load measurement in the past six months)
  • Regular access to a mobile phone with SMS or WhatsApp capacity (can include the phone of a parent/caregiver if the participant is \<18 years or does not have their own phone)
  • Speak isiXhosa and or English, residing in the Khayelitsha / Mitchell's Plain area
  • years (inclusive)
  • Willing and able to provide informed telephonic or in person consent
  • Has not previously tested positive for HIV and self-reports being HIV negative (i.e., not known to be living with HIV).
  • Regular access to a mobile phone (can include the phone of a parent/caregiver if the participant is \<18 years or does not have their own phone)

You may not qualify if:

  • Young people living with HIV who meet any of the following criteria will be excluded from this study:
  • Not 13-24 years (inclusive)
  • Unwilling or unable to provide informed telephonic or in person consent
  • Not currently receiving ART care at a Desmond Tutu Health Foundation health facility
  • No regular access to a mobile phone with SMS or WhatsApp capacity
  • Planning to relocate in the next 6 months
  • Young people living without HIV from the same communities who meet any of the following criteria will be excluded this study:
  • Not 13-24 years (inclusive)
  • Unwilling or unable to provide informed telephonic or in person consent
  • Previously tested positive for HIV or is known to be living with HIV
  • No regular access to a mobile phone
  • Planning to relocate in the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gugulethu Community Health Centre

Cape Town, Western Cape, 7806, South Africa

Location

MeSH Terms

Conditions

HIV InfectionsCOVID-19Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsLung DiseasesRespiratory Tract DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Linda-Gail Bekker

    Desmond Tutu HIV Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

March 4, 2021

Study Start

February 8, 2021

Primary Completion

May 13, 2022

Study Completion

May 13, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)