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HIVPhase 2NCT04568460

Standing Tall (Yima Nkqo)

A Phase 2 study testing Intervention Group Sessions in people with HIV, run by Brigham and Women's Hospital at 3 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 24 years
Conditions the study is for
HIV
What is being tested?
Intervention Group Sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesin 2 countries
Study dates
25 Nov 2020to 31 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 24 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

South Africa2 sites

  • Desmond Tutu Health Foundation

    Cape Town, Western Cape

  • Desmond Tutu Health Foundation

    East London, Eastern Cape

Other trials in South Africa

United States1 site

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

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

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."

Read the 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
Being tested
Intervention Group Sessions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention Group SessionsOther

    Also called Yima Nkqo

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

Study groups in NCT04568460
Study groupRoleWhat they receive
Intervention Group SessionsExperimentalIntervention 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.
Receives: Other: Intervention Group Sessions
Standard of CareNo interventionThis 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Three Months

  2. ART Initiation

    ART initiation will also be assessed via a point-of-care diagnostic detecting Tenofovir concentrations in participants.

    Measured: Three Months

  3. 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.

    Measured: Six months

  4. ART Initiation

    ART initiation will also be assessed via a point-of-care diagnostic detecting Tenofovir concentrations in participants.

    Measured: Six months

Secondary outcomes (10)

  1. 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.

    Measured: Six Months

  2. 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.

    Measured: Six Months

  3. 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.

    Measured: Six Months

  4. 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.

    Measured: Six Months

  5. 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.

    Measured: Six Months

  6. 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.

    Measured: Six Months

  7. 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.

    Measured: Six Months

  8. 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.

    Measured: Six Months

  9. Perceptions of Acceptability

    Participant's views of the acceptability of our intervention will be measured using qualitative exit interviews.

    Measured: Six Months

  10. 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.

    Measured: Six Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2020
  2. Study start25 Nov 2020
  3. Primary completion31 Mar 2024 (estimated)
  4. Study completion31 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04568460
Sponsor's protocol ID
2019P002671
Status last verified
Mar 2024
First submitted
12 Aug 2020
Last updated
18 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bondarchuk CP, Lemon T, Medina-Marino A, Rousseau E, Sindelo S, Sibanda N, Butler LM, Bekker LG, Earnshaw VA, Katz IT. A Moderated Mediation Model of HIV-Related Anticipated Stigma and Social Capital on the Relationship Between Diagnosis During the COVID-19 Pandemic and Potentially Problematic Substance Use Among Young South Africans. Int J Behav Med. 2025 Nov 18. doi: 10.1007/s12529-025-10415-5. Online ahead of print.

    PubMed 41249762

  • 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.

    PubMed 37319250

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intervention Group Sessions in people with HIV, run by Brigham and Women's Hospital at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Africa, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ART Initiation (time frame: Three Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04568460, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024; AzTrials last refreshed its copy on 27 Oct 2026.

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