Clinical trial NCT04568460: Standing Tall (Yima Nkqo)
Official title: Standing Tall (Yima Nkqo): A Pilot Randomized Controlled Trial of a Community-Based Intervention to Improve Health Outcomes for Young Adults Newly Diagnosed With HIV in South Africa
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: HIV
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Desmond Tutu Health Foundation
name: University of Connecticut
name: Columbia University
name: Massachusetts General Hospital
name: Harvard Medical School (HMS and HSDM)
name: University of Washington
First posted: 2020-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: The investigators propose the Standing Tall study, a prospective randomised study of strategy to optimize community-based ART initiation in South Africa. Investigators will work closely with community members to integrate community-based ART. One hundred participants will be enrolled and followed for a total of up to 6 months. Those in the intervention arm will be provided with the ST intervention which includes a behavioral component and access to ART. The intervention will be linked to a clinic through a "Nurse Initiated Management of ART."

Detailed description: The premise for our study is based on three decades of HIV research that supports the need for multi-component, multisystem interventions to promote testing, and adherence to treatment and care for young people living with HIV. The proposed intervention, Standing Tall, is informed and guided by Social Action Theory - a conceptual framework reflecting a holistic understanding of health behavior and motivational factors that foster and maintain behavior change. Standing Tall, a pilot randomized controlled trial, is designed to address multi-factorial barriers using (1) a socio-behavioral group intervention; (2) social support; (3) provision of immediate ART and refills. The primary outcome is ART initiation at three months, and the secondary outcome is viral load suppression at six months. Other tertiary/exploratory outcomes include behavioral outcomes and process evaluation of the intervention itself, and the use of point-of-care diagnostics.

The administrative supplemental funding provides support for an additional objective of this study: to understand how best to use point-of-care (POC) testing in clinical practice in order to improve HIV care and treatment for South African young people. Understanding patient perspectives and perceived barriers is critical to developing feasible, acceptable, and effective protocols for implementing POC testing. The primary aim for achieving this objective is to assess patient perspectives regarding POC testing through in-depth, semi-structured interviews among study participants enrolled in Standing Tall's second aim.

Eligibility criteria: Inclusion Criteria:

* Complete an assessment of understanding
* Provide informed consent
* Are between ages 18-24
* Present to Tutu Tester vans in Cape Town OR East London DTHF clinics (Duncan Village Day Hospital, Empilweni Gompo Health Centre, Gompo C Clinic) and test HIV+
* Are ART-naïve
* Are English or isiXhosa speakers
* Reside in the Cape Town or East London metro area

Exclusion Criteria:

* Are pregnant (must be referred to antenatal clinic if living with HIV)
* Test positive for tuberculosis (must be referred to clinic for TB treatment prior to ART initiation)
* Are unable to understand the process of informed consent

Primary outcomes:
measure: ART Initiation
timeFrame: Three Months
measure: ART Initiation
timeFrame: Three Months
measure: ART Initiation
timeFrame: Six months
measure: ART Initiation
timeFrame: Six months
Secondary outcomes:
measure: Viral Load Suppression
timeFrame: Six Months
measure: Household Food Security
timeFrame: Six Months
measure: Mental Health
timeFrame: Six Months
measure: Substance Use
timeFrame: Six Months
measure: Wellness
timeFrame: Six Months
measure: Stress
timeFrame: Six Months
measure: Resilience
timeFrame: Six Months
measure: Implementation Factors
timeFrame: Six Months
measure: Perceptions of Acceptability
timeFrame: Six Months
measure: Perceptions of Fidelity
timeFrame: Six Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: East London
country: South Africa
facility: Desmond Tutu Health Foundation
state: Eastern Cape
city: Cape Town
country: South Africa
facility: Desmond Tutu Health Foundation
state: Western Cape
Study officials:
References: