Standing Tall (Yima Nkqo)

NCT ID: NCT04568460

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2024-03-31

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group Sessions

Intervention group sessions will be delivered by lay health counselors. The sessions will reflect principles of co-learning, participatory design, and empowerment to promote engagement of young people in critical thinking and problem solving - including modeling, roleplaying, and interactive activities.

Group Type: EXPERIMENTAL

Intervention Group Sessions

Intervention Type: OTHER

Participants will undergo a multi-session group intervention over the course of six months.

Standard of Care

This is the standard of care arm. Participants newly diagnosed with HIV will get a referral to the local primary health care setting of their choice for further management, including ART.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intervention Group Sessions

Participants will undergo a multi-session group intervention over the course of six months.

Intervention Type: OTHER

Other Intervention Names

Yima Nkqo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Desmond Tutu Health Foundation

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Theresa Katz, M.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Desmond Tutu Health Foundation

East London, Eastern Cape, South Africa

Desmond Tutu Health Foundation

Cape Town, Western Cape, South Africa

Countries

United States; South Africa

References

Nardell MF, Sindelo S, Rousseau E, Siko N, Fuzile P, Julies R, Bassett IV, Mellins CA, Bekker LG, Butler LM, Katz IT. Development of "Yima Nkqo," a community-based, peer group intervention to support treatment initiation for young adults with HIV in South Africa. PLoS One. 2023 Jun 15;18(6):e0280895. doi: 10.1371/journal.pone.0280895. eCollection 2023.

Reference Type: DERIVED

PMID: 37319250 (View on PubMed)

Other Identifiers

2019P002671

Identifier Type: -

Identifier Source: org_study_id