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

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 disseminating 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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Tablet based U=U app; Other: Text messages; Behavioral: U=U videos played in clinic waiting rooms and integrated into HIV counseling session

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 web "app" will be integrated into HIV counseling sessions, to be shown to patients using tablets. Intervention content will also be pushed to participants via SMS, and the web "app" will be shared with those with any device with a web browser application. We will conduct three formative focus groups (n=27) and formative key interviews (n=27) with PLWHIV. The intervention will be pre-tested in two focus groups (n=17). (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.

Participants in Arms B and C will also receive monthly text messages reinforcing intervention content. The order of the messages will be randomized to ascertain whether different messages were better at driving engagement with the App. Respondents will be free to opt out of these text messages. 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 clinic staff (n=30).

In addition to the primary and secondary outcomes specified below, we will assess for effect modification in primary outcomes by key constructs of our theoretical model including baseline awareness of TasP; baseline altruistic motivations; and baseline behavioral skills associated with TasP.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob Bor, ScD SM; Phone Number: (617) 358-2176; Email: jbor@bu.edu
• Study Contact Backup: Name: Dorina Onoya, PhD; Email: donoya@heroza.org

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa
      • Primary Health Clinic A
    • Johannesburg, Gauteng, South Africa
      • Primary Health Clinic B

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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	Other: Text messages; Monthly text messages reinforcing intervention content; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ART uptake and first refill within 60 days (Composite outcome)	Indicator = 1 if the participant started ART and returned to the clinic for their first ART medication refill within 60 days after enrollment. Indicator = 0 if the participant did not start ART, or if patient started ART but did not have a medication refill within 60 days of enrollment.	2 months
Documented HIV viral load <50 copies/mL at 6-10 months	As documented in linked clinical records. The first viral load (VL) value taken during the period 6-10 months after baseline. Outcome will be defined as documented viral suppression among all patients: 1 = VL<50; 0 = VL>=50 OR no VL.	10 months
ART uptake and adherence through 6 months	Number of days during the six months following study enrollment for which ART medication was disbursed; obtained from linked clinical records (range: 0 to 182). Outcome defined such that the length of the last disbursement is censored at 182 days after study enrollment.	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Started ART within 30 days of baseline	As documented in linked clinical records	1 month
Retained in care at 6 months	No more than 30 days late for scheduled clinic visit closest to 6 months post-study enrollment.	6 months
Returned to clinic for couples HIV counseling and testing within 6 months	Returned to the clinic for couples testing and counseling within six months, based on linked clinical records	6 months
Participated in HIV viral load monitoring at 6 months	Based on linked clinical records, 6-10 months after baseline	10 months
Change in HIV prevention altruism	An adapted version of an HIV prevention altruism scale developed by King et al. 2009 (https://pubmed.ncbi.nlm.nih.gov/19101063/) will be used to assess this outcome. The scale measures level of altruistic motivations toward prevention of HIV transmission. The scale has nine 4-category Likert items (three are reverse-coded). The total has a range of 9 to 36, with higher scores indicating a higher level of HIV prevention altruism. This outcome will be assessed at baseline (pre-intervention) and 6 months.	baseline, 6 months
Change in internalized HIV stigma, baseline to 6 months	Internalized HIV stigma will be measured with the Internalized AIDS-Related Stigma Scale (Kalichman et al. 2009). The scale includes six dichotomous items, which are summed so that the total score has a range of 0 to 6, with higher numbers reflecting greater internalized stigma.	baseline, 6 months
Change in depression score	The Kessler Psychological Distress Scale (K6+) is a 6-item self-report measure of psychological distress is a quick tool to assess risk for serious mental illness in the general population during the past 30 days using a 5-point Likert scale: 4 (All of the time), 3 (Most of the time), 2 (Some of the time), 1 (A little of the time), and 0 (None of the time). This generates a scoring scale with a range of 0 to 24. Higher scores are associated with more distress and depression. This outcome will be assessed at baseline (pre-intervention) and 6 months. We will assess differences in changes between treated and controls.	baseline, 6 months
TasP knowledge at baseline (post-intervention)	TasP knowledge will be defined as the "perceived reduction in transmission risk due to HIV treatment". Participants will be asked about the likelihood of HIV transmission (on a 0 to 10 scale) in a hypothetical mixed-status couple after a year of weekly condomless sex, where the HIV+ partner is NOT on ART. Participants will then be asked about a a similar scenario in which the HIV+ partner is on virally-suppressive ART. Perceived reduction in transmission risk due to HIV treatment will be defined as "100% minus 100%* the ratio of perceived risk of transmission with virally-suppressive ART vs. perceived risk of transmission without ART." (For details on the measure, see Bor et al. 2021 STI: http://dx.doi.org/10.1136/sextrans-2021-055031.	baseline (0 months)

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jacob Bor, ScD SM, BU School of Public Health, Global Health

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Actual): February 15, 2024
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: South Africa; HIV counseling; Antiretroviral treatment (ART); Person living with HIV (PLWH); Treatment-as-prevention (TasP); Undetectable=Untransmittable (U=U)
• Other Study ID Numbers: H-40706; R34MH122323 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No