Standing Tall (Yima Nkqo)

HIV Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04568460
• Other study ID #: 2019P002671
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 25, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Intervention Group Sessions
Participants will undergo a multi-session group intervention over the course of six months.

Locations

Country	Name	City	State
South Africa	Desmond Tutu Health Foundation	Cape Town	Western Cape
South Africa	Desmond Tutu Health Foundation	East London	Eastern Cape
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (7)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Columbia University, Desmond Tutu Health Foundation, Harvard Medical School (HMS and HSDM), Massachusetts General Hospital, University of Connecticut, University of Washington

Countries where clinical trial is conducted

United States,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ART Initiation	ART initiation will be assessed via a self-report measure of participants who will report whether they have or have not initiated ART.	Three Months
Primary	ART Initiation	ART initiation will also be assessed via a point-of-care diagnostic detecting Tenofovir concentrations in participants.	Three Months
Primary	ART Initiation	ART initiation will be assessed via a self-report measure of participants who will report whether they have or have not initiated ART.	Six months
Primary	ART Initiation	ART initiation will also be assessed via a point-of-care diagnostic detecting Tenofovir concentrations in participants.	Six months
Secondary	Viral Load Suppression	Viral suppression will be measured from plasma specimen collected at 6 months from enrollment. Persons missing plasma HIV RNA results for any reason (e.g. death) will be counted as not initiated. Additional records obtained through PHDC and NHLS will provide additional data (such as plasma HIV RNA concentration) that will be used for confirmation.	Six Months
Secondary	Household Food Security	We will assess household food security via a self-report questionnaire. Participants will report how many times in the last 30 days they experienced anxiety and uncertainty about household food access and insufficient quality and quantity on a scale from rarely to more than 10 times.	Six Months
Secondary	Mental Health	We will assess generalized anxiety disorder using the GAD-7 questionnaire and major depressive disorder using the Patient Health Questionnaire (PHQ-9). Participants will self-report how many times in the last 2 weeks they experienced symptoms from not at all to nearly every day.	Six Months
Secondary	Substance Use	We will assess participants alcohol and drug use via the SAMISS (Substance Use Subsection - AUDIT) questionnaire. Participants will self-report how many times a month they partake in alcohol or drug use on a scale ranging from never to less than monthly, to daily. Participants may also refuse to answer questions.	Six Months
Secondary	Wellness	We will assess participant's comprehensive health status measure using the Measure of Wellness (Medical Outcomes Study-HIV) survey. Participants will self-report how frequently they experienced symptoms relating to mental health, quality of life, health distress, cognitive function, energy/fatigue, overall health, role function, physical function, pain, and social function on a scale from all of the time to none of the time.	Six Months
Secondary	Stress	We will assess participant's ability to cope with stressful live events using the brief COPE self-report questionnaire. Participants will indicate how frequently they have utilized different coping mechanisms on a scale from not at all to a lot.	Six Months
Secondary	Resilience	We will assess participant's resilience using the Connor-Davidson Resilience Scale (CDRISC-100) self-report questionnaire. Participants will indicate the extent to which they identify with resilience statements from a scale from not at all true to true nearly all the time.	Six Months
Secondary	Implementation Factors	Acceptability, feasibility and appropriateness of our intervention will be quantitatively be measured as participants indicate how confident they feel in varying aspects of the intervention from not at all confident to completely confident.	Six Months
Secondary	Perceptions of Acceptability	Participant's views of the acceptability of our intervention will be measured using qualitative exit interviews.	Six Months
Secondary	Perceptions of Fidelity	The fidelity of our intervention will be measured using a fidelity monitoring tool. A research assistant (RA) will report yes, no, partially, or not applicable in response to statements about facilitators. The RA will also assess how well the facilitator did using a scale from poor to always.	Six Months