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Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People (BUDDY)

Primary Purpose

HIV Infections, Covid19, Health Care Utilization

Status

Completed

Phase

Not Applicable

Locations

South Africa

Study Type

Interventional

Intervention

Mobile phone support

Remote service delivery model

About this trial

This is an interventional health services research trial for HIV Infections

Eligibility Criteria

13 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Young people living with HIV who meet all of the following criteria will be eligible for inclusion into this study:

Speak isiXhosa and or English, residing in the Khayelitsha /Mitchell's Plain area
13-24 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)

Young people living without HIV from the same communities who meet all of the following criteria will be eligible for inclusion into this study:

Speak isiXhosa and or English, residing in the Khayelitsha / Mitchell's Plain area
13-24 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)

Exclusion Criteria:

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

Sites / Locations

Gugulethu Community Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remote service delivery model PLUS mobile phone support

Remote service delivery model

Arm Description

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.

Remote service delivery model.

Outcomes

Primary Outcome Measures

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.

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)

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.

Secondary Outcome Measures

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

Retrospective COVID-19 antibody testing at baseline and month

Qualitative themes assessed from in-depth individual interview data

Qualitative interviews will be used to inform intervention utility and the development of an intervention to reduce GBV

Full Information

NCT ID

NCT04781400

First Posted

February 22, 2021

Last Updated

August 16, 2022

Sponsor

Desmond Tutu HIV Foundation

Collaborators

ViiV Healthcare, Karolinska Institutet, University of North Carolina, Chapel Hill, University of KwaZulu

1. Study Identification

Unique Protocol Identification Number

NCT04781400

Brief Title

Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People

Acronym

BUDDY

Official Title

Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

February 8, 2021 (Actual)

Primary Completion Date

May 13, 2022 (Actual)

Study Completion Date

May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Desmond Tutu HIV Foundation

Collaborators

ViiV Healthcare, Karolinska Institutet, University of North Carolina, Chapel Hill, University of KwaZulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The primary objectives of this study are to examine the feasibility, acceptability, and preliminary efficacy of a remote service delivery model for young people living with HIV aged 13-24 years that will include a monthly service needs assessment and optional delivery of HIV treatment services. YPLWH will also be randomized to receive (or not receive) mobile check-ins from study staff and access to two-way messaging capabilities to obtain continuous support for adherence to ART and COVID-19 prevention guidelines. Investigators will also assess the impact of the COVID-19 lock-down orders on multi-level factors (individual, socio-behavioral, structural) over time among young people aged 13-24 years living with HIV (same cohort as above) and without HIV. Particular focus will be given to experience and perpetration of gender based violence. In addition, investigators will assess the impact of multi-level factors on compliance with COVID-19 prevention guidelines, health service utilization, and engagement in HIV care (YPLWH only). Findings will be examined overall and stratified by HIV status and gender. Ultimately investigators hope to: (i) determine whether a remote service delivery model will help retain young people in HIV care and (ii) Inform the development of an intervention for young people in the study communities who may be experiencing GBV and associated outcomes in the wake of the pandemic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Covid19, Health Care Utilization, Gender-based Violence

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

536 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Remote service delivery model PLUS mobile phone support

Arm Type

Experimental

Arm Description

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.

Arm Title

Remote service delivery model

Arm Type

Active Comparator

Arm Description

Remote service delivery model.

Intervention Type

Behavioral

Intervention Name(s)

Mobile phone support

Intervention Description

Mobile phone support (SMS)

Intervention Type

Behavioral

Intervention Name(s)

Remote service delivery model

Intervention Description

ART treatment delivery via a courier service

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

6 months

Title

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

Description

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)

Time Frame

6 months

Title

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

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Description

Retrospective COVID-19 antibody testing at baseline and month

Time Frame

6 months

Title

Qualitative themes assessed from in-depth individual interview data

Description

Qualitative interviews will be used to inform intervention utility and the development of an intervention to reduce GBV

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Young people living with HIV who meet all of the following criteria will be eligible for inclusion into this study: Speak isiXhosa and or English, residing in the Khayelitsha /Mitchell's Plain area 13-24 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) Young people living without HIV from the same communities who meet all of the following criteria will be eligible for inclusion into this study: Speak isiXhosa and or English, residing in the Khayelitsha / Mitchell's Plain area 13-24 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) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda-Gail Bekker

Organizational Affiliation

Desmond Tutu HIV Foundation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gugulethu Community Health Centre

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7806

Country

South Africa

12. IPD Sharing Statement

Plan to Share IPD

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Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People

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