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Integrating U=U Into HIV Counseling in South Africa (INTUIT-SA)

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ClinicalTrials.gov Identifier: NCT04504357
Recruitment Status : Not yet recruiting
First Posted : August 7, 2020
Last Update Posted : August 2, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boston University

Brief Summary:

The near-elimination of HIV transmission with antiretroviral therapy (ART) has provided the world with a clear path to end the HIV epidemic through the mass provision of ART at diagnosis, i.e. test-and-treat. Despite the substantial prevention benefits of ART, the investigators found minimal knowledge of treatment-as-prevention (TasP) in two population-based surveys recently conducted in South Africa. In addition, current public health messaging and clinical HIV counselling in South Africa do not emphasize the prevention benefits of ART.

In this formative research study the investigators will develop an app-based educational video intervention that will provide information on Undetectable = Untransmittable (U=U) that is locally-appropriate and can be integrated into routine HIV counselling. The intervention will be piloted in a clinical trial of patients in South Africa receiving HIV post-test and adherence counselling services, to determine feasibility and acceptability, impact on U=U knowledge and attitudes, impact on stigma and psychological well being, and preliminary evidence for ART uptake and adherence.

The study builds on a longstanding collaboration between Boston University and the Health Economics and Epidemiology Research Office (HE2RO) at the University of Witwatersrand in Johannesburg, South Africa. The study is highly innovative because the investigators take a novel approach - disseminating information on the prevention benefits of ART - to improve the wellbeing of people living with HIV (PLWH) and motivate early uptake of ART in South Africa.

The investigators hypothesize that selling treatment-as-prevention on its merits could substantially improve the wellbeing of PLWH and increase demand for ART, enabling countries to maximize the impact of test-and-treat.


Condition or disease Intervention/treatment Phase
HIV Behavioral: Tablet based U=U app Behavioral: U=U videos played in clinic waiting rooms and integrated into HIV counseling session Other: Text messages Not Applicable

Detailed Description:

Phase 1- A video-based "app" will be developed to provide HIV patients with information on TasP/U=U. The investigators will design a series of short video modules on the prevention benefits of ART leading to viral suppression and package them as a tablet-based app to augment existing HIV counseling. In collaboration with the Prevention Access Campaign, locally-appropriate videos will be developed on (a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing. Content will be developed with HIV counselors, PLWH, and other stakeholders in an Intervention Mapping exercise. After training clinic staff, the videos will be shown in clinic waiting rooms and the tablet-based "app" will be integrated into HIV counseling sessions. Intervention content will also be pushed to participants via SMS, and the app will be shared with those with smart phones. The intervention will be pre-tested in focus groups (n=3) and interviews (n=20) with counselors and patients. (NOTE: THE RESPONDENTS FOR PHASE 1 ARE NOT INCLUDED IN CLINICAL TRIAL REPORTING.)

Phase 2- A clinical trial will be conducted using two recruitment periods at three public sector clinics to establish intervention acceptability, effects on knowledge and attitudes, and preliminary impact on ART uptake, adherence, and viral suppression in a pilot trial and demonstration project (n=135).

During recruitment period 1 (n=90), patients completing HIV post-test or adherence counseling will be referred to study staff and randomized 1:1 to no intervention (Arm A) vs. "controlled exposure" to the tablet-based U=U app (Arm B). In recruitment period 2 (n=45), U=U videos will be shown in clinic waiting rooms and the tablet-based app will be integrated into routine counseling (Arm C) in a "clinical exposure" demonstration project.

All participants will be cross-randomized to monthly text messages reinforcing intervention content. For all study arms, investigators will assess feasibility and acceptability, resonance of different key messages and videos, knowledge and attitudes related to TasP, internalized stigma and mental health, HIV prevention altruism, and behaviours related to disclosure, risk-taking, and care-seeking in surveys at enrolment, post-test, and 6 months. ART uptake, appointment adherence, and 6-month VL will be assessed in clinical records. Qualitative exit interviews will be conducted with participants and staff (n=30).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Integrating U=U Into HIV Counseling in South Africa
Estimated Study Start Date : December 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Arm A- No intervention
Participants randomized to Arm A will receive no research intervention.
Experimental: Arm B- U=U app
Participants randomized to Arm B will receive "controlled exposure" to the tablet-based U=U app.
Behavioral: Tablet based U=U app
Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.

Other: Text messages
Monthly text messages reinforcing intervention content

Active Comparator: Arm C- clinical exposure demonstration
Participants randomized to Arm C will be shown U=U videos in clinic waiting rooms and the tablet-based app will be integrated into routine counseling
Behavioral: U=U videos played in clinic waiting rooms and integrated into HIV counseling session
TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.

Other: Text messages
Monthly text messages reinforcing intervention content




Primary Outcome Measures :
  1. ART uptake and adherence through 6 months [ Time Frame: 6 month ]
    Number of monthly ART medication disbursements occurring over the six months following study enrollment, obtained from linked clinical records

  2. Change in TasP knowledge from baseline to 6 months [ Time Frame: 6 months ]
    Change in perceived reduction in transmission risk due to HIV treatment in 52 condomless sex acts from baseline to 6 months

  3. Percentage with suppressed HIV viral load (<50 copies/mL) at 6 months [ Time Frame: 6 months ]
    As documented in linked clinical records. We will extract the first VL value taken during the period 6-10 months after baseline

  4. Change in TasP attitudes [ Time Frame: baseline, 6 months ]
    Change in Tasp attitudes towards HIV treatment as prevention will be assessed using a scale for several (TBD) Likert-style response questions. The scale will be transformed into a z-score, with higher values representing more positive attitudes towards TasP


Secondary Outcome Measures :
  1. Percentage who started ART within 30 days of baseline [ Time Frame: 1 month ]
    As documented in linked clinical records

  2. Percentage retained in care at 6 months [ Time Frame: 6 months ]
    Percentage no more than 30 days late for scheduled clinic visit closest to 6 months.

  3. Percentage returning to clinic for couples HIV counseling and testing within 6 months [ Time Frame: 6 months ]
    Returning to the clinic for couples testing and counseling within six months, based on linked clinical records

  4. Percentage participating in HIV viral load monitoring at 6 months [ Time Frame: 6 months ]
    Based on linked clinical records, 6-10 months after baseline

  5. Change in HIV prevention altruism [ Time Frame: baseline, 6 months ]
    The Nimmons-Acree-Folkman 7-item Likert-type scale will be used to measure level of altruistic motivations toward prevention of HIV transmission. Higher scores indicate a higher level of HIV prevention altruism.

  6. Change in internalized HIV stigma, baseline to 6 months [ Time Frame: 6 months ]
    Internalized HIV stigma will be measured with the 3-item scale used in PopART Trial. Scores can range between 0 and 3 with higher scores indicating greater levels of stigma.

  7. Change in depression score [ Time Frame: baseline, 6 months ]
    The Hopkins Checklist-25 will be used to measure depression and emotional distress. The scale for each question includes four categories of response ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items, while the depression score is the average of the 15 depression items. Higher scores are associated with more distress and depression.

  8. Change in emotional distress score [ Time Frame: baseline, 6 months ]
    The Hopkins Checklist-25 will be used to measure depression and emotional distress. The scale for each question includes four categories of response ("Not at all," "A little," "Quite a bit," "Extremely," rated 1 to 4, respectively). Two scores are calculated: the total score is the average of all 25 items, while the depression score is the average of the 15 depression items. Higher scores are associated with more distress and depression.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • receiving HIV care at a public sector health facility in South Africa
  • Speaks English, Zulu, or Sotho

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504357


Contacts
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Contact: Jacob Bor, ScD SM (617) 358-2176 jbor@bu.edu
Contact: Dorina Onoya, PhD donoya@heroza.org

Sponsors and Collaborators
Boston University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Jacob Bor, ScD SM BU School of Public Health, Global Health
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT04504357    
Other Study ID Numbers: H-40706
R34MH122323 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
Antiretroviral treatment (ART)
Person living with HIV (PLWH)
Treatment-as-prevention (TasP)
Undetectable=Untransmittable (U=U)
HIV counseling
South Africa