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Behavioural Intervention

Group Sessions for HIV/AIDS

Phase 2

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Awards & highlights

Study Summary

This trial will study a new way to provide ART to people in South Africa that includes a behavioral component and access to ART through a "Nurse Initiated Management of ART."

Who is the study for?

The Standing Tall study is for young adults aged 18-24 living with HIV/AIDS who have never started antiretroviral therapy (ART). Participants must live in Cape Town or East London, South Africa, speak English or isiXhosa, and understand the consent process. Pregnant individuals or those with tuberculosis are excluded.Check my eligibility

What is being tested?

This study tests a community-based ART initiation strategy called 'Standing Tall,' which includes behavioral support and nurse-managed ART access. It's a randomized trial where half of the 100 participants will receive this intervention linked to clinics.See study design

What are the potential side effects?

Since the intervention focuses on group sessions and improved access to ART rather than new medications, side effects may be more related to social or psychological aspects rather than typical drug side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

ART Initiation

Secondary outcome measures

Household Food Security

Implementation Factors

Mental Health

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Group SessionsExperimental Treatment1 Intervention

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 II: Standard of CareActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER

2,929 Previous Clinical Trials

13,198,205 Total Patients Enrolled

Brigham and Women's HospitalLead Sponsor

1,611 Previous Clinical Trials

11,470,419 Total Patients Enrolled

University of WashingtonOTHER

1,739 Previous Clinical Trials

1,847,828 Total Patients Enrolled

Media Library

Standing Tall (Yima Nkqo) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04568460 — Phase 2

HIV/AIDS Research Study Groups: Intervention Group Sessions, Standard of Care

HIV/AIDS Clinical Trial 2023: Standing Tall (Yima Nkqo) Highlights & Side Effects. Trial Name: NCT04568460 — Phase 2

Standing Tall (Yima Nkqo) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04568460 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current vacancies for participants in this research?

"The trial, as stated on clinicaltrials.gov, is still looking for volunteers. The first posting was on November 25th 2020 with the most recent update being from February 7th of this year."

Answered by AI

Who would be an eligible candidate for this clinical trial?

"This study is looking for 100 participants that are 18-24 years old and currently have hiv. In order to be eligible, they must also meet the following requirements: Provide informed consent, Complete an assessment of understanding, 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-naive, Are English or isiXhosa speakers, Reside in the Cape Town or East London metro area."

Answered by AI

Are Intervention Group Sessions backed by the FDA?

"While there is data supporting the safety of Intervention Group Sessions, it remains unproven whether or not it is an effective treatment. Consequently, it received a score of 2."

Answered by AI

Does this research project restrict volunteers to those under 55 years old?

"This particular clinical trial only includes patients who are 18 to 24 years old. Out of the 240 total trials, 62 involve minors and 178 involve adults over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Standing Tall (Yima Nkqo)

Ingrid Theresa Katz, M.D. 2020. "Standing Tall (Yima Nkqo)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04568460.