Choice-Based Support for Adults Starting or Restarting Antiretroviral Therapy in Cape Town, South Africa
Zikhethele
Zikhethele - Choose For You Aim 3 Exploring the Feasibility, Acceptability and Preliminary Impact of Choice-based Antiretroviral Therapy (ART) Support Interventions for Adults Starting and Restarting ART in Cape Town, South Africa: A Pilot Randomised Controlled Trial
1 other identifier
interventional
140
1 country
1
Brief Summary
Disengagement from HIV care is very common in the first year after starting or restarting antiretroviral therapy (ART). There is increasing recognition of people cycling in and out of HIV care over time people newly starting and restarting treatment after an interruption are at high risk of subsequent disengagement from care. While guidelines advocate for patient-centered models of care, patient preferences are often not considered fully in the design of interventions. Building on existing support intervention modalities, formative qualitative research and a stated preference survey, the investigators have designed a choice-based ART support intervention. The intervention offers a choice of a) in-person group support, b) low-touch WhatsApp support group, and c) individual digital support through the AI Coach chatbot. This study will explore the feasibility, acceptability and preliminary impact of choice-based ART support for adults starting and restarting ART in Cape Town, South Africa, through a randomized pilot feasibility trial. The objectives of this study are:
- 1.To determine the feasibility, acceptability, appropriateness and fidelity of the Zikhethele intervention components, including offering patients a choice of ART support intervention.
- 2.To describe the distribution of actual choices in the choice arm.
- 3.To describe outcomes in each pilot trial arm and explore the preliminary impact of offering a choice, compared allocation to a support intervention or standard of care, on patient empowerment and treatment outcomes.
- 4.To explore the hypothesised mechanisms of action and contextual moderators through in-depth interviews with participants and providers including consideration of patient empowerment, stigma and social support, and trust in provider, peers and digital tools.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2026
CompletedFirst Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
CompletedFebruary 27, 2026
February 1, 2026
6 months
February 9, 2026
February 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (19)
Intervention fidelity: intervention completion
% completion of intervention components
Through study completion, on average four months
Experiences and perceptions of receiving or implementing the intervention
Themes in in-depth-interviews and open-ended responses: practicality and resources for implementation.
Through study completion, on average four months
Intervention acceptability
Experiences and perceptions of receiving or implementing the intervention. Themes: satisfaction, preferences, benefits and risks, and relevance for context from in-depth interviews and open-ended survey questions.
Assessed at month 4
Recruitment feasibility: Refusals
Number of of eligible participants refusing participation
Through end of recruitment, expected duration one month
Retention in study
% enrolled participants completing the four month interview
Through study completion, an average of four months
Study measurement feasibility: Interview completion
Number of enrolled participants not completing or partially completing study measures
Through study completion, an average of four months
Patient empowerment
Qualitative interviews Health Care Empowerment Inventory: 8-item scale separated into "informed, committed, collaborative, engaged" and "tolerance of uncertainty" subscales. Each item scored from 1-5. Each sub scale has a maximum score of 20 and a minimum of 4. Higher scores indicated higher levels of empowerment.
Enrolment and month 4
Perceived Availability of Social Support
7-item scale used to assess the perceived availability of instrumental and emotional social support. Each item scored from 1-5 (minimum score 7, maximum 35). Higher scores indicate higher levels of social support.
Enrolment and month 4
Social Impact Scale
7-item scale used to assess HIV-related stigma, including social rejection (2 items, minimum score 2, maximum score 10) and internalized stigma (5 items, minimum score 5, maximum score 25). Each item scored from 1-5. Higher scores indicate higher levels of stigma.
Enrolment and month 4
Health Care Relationship Trust Scale
13-item scale assessing participants trust in their HIV provider. Each item scored 0-4. Minimum score 0, maximum score 52. Higher scores indicate higher levels of trust in the health provider.
Enrolment and month 4
Start/restart perceptions
Description of themes from qualitative interviews and open-ended survey questions assessing ease of ART start or restart along with barriers and enablers.
At month 4
Feasibility of Intervention Measure (FIM)
Four item scale with values ranging from 1-completely disagree to 5-completely agree. Higher scores indicate high feasibility.
Assessed at month 4
Choice of support
Number choosing each support option and number participating in the chosen support
Through study completion, on average four months
Safety
Report of any privacy/safety events through the interventions or study measurement data collection.
Through study completion, on average four months
Acceptability of Intervention Measure (AIM)
Four item scale with values ranging from 1-completely disagree to 5-completely agree. Higher scores indicated higher acceptability.
Assessed at month 4
Recruitment feasibility: time to complete recruitment
Documenting time to complete recruitment along with periods when unable to recruit.
Through end of recruitment, expected duration one month
Study measurement feasibility: Interview length
Average time to complete measurement interviews
Through study completion, an average of four months
Study measurement feasibility: user-engagement data
Frequency and type of intervention user-engagement data not accessed for interventions along with reasons for delay or lack of access
Through study completion, an average of four months
Intervention fidelity: User engagement
Frequency and context of engagement with each intervention component.
Through study completion, an average of four months
Secondary Outcomes (5)
Retention in HV care
Month 4 and month 12
Intervention adaptations
Through study completions, an average of four months
HIV viral load suppression
Month 3 and month 12
HIV self-management
Month 4
Self-reported ART adherence
Month 4
Study Arms (3)
Standard of care support
NO INTERVENTIONParticipants allocated to the standard of care arm will receive no additional adherence support. Following ART start or restart, they will be supported per standard of care in the routine services. This includes follow-up after missed visits and additional counselling should any challenges be flagged by providers.
In-person group support
EXPERIMENTALParticipants allocated to the in-person group support arm will receive the usual standard of care support, and will also be enrolled into an in-person support group (described in detail in the intervention description).
Choice of support
EXPERIMENTALParticipants allocated to the choice arm will be offered a structured choice of adherence support and asked to select the modality that best fits their needs and circumstances. The choice process will be facilitated by a trained community health worker, who will also support coordination and enrolment into the selected option. The choice options (described in detail in the intervention descriptions) are: In-person group support, WhatsApp group support, AI coach, No support (standard of care support only)
Interventions
The in-person group is framed around chronic medication adherence (including HIV, diabetes, and hypertension). It will consist of monthly informal and discussion-based sessions (60-90 minutes) designed to create a safe and supportive space where participants can share experiences, problem-solve together, and build motivation to remain in care. The group seeks to provide a semi-structured, peer-supported environment. Groups will consist of maximum 15 people. Participants will not be provided with any transport costs or reimbursement as this would not be feasible to scale. Tea and coffee and light refreshments will be provided. Each participant will be able to attend a minimum of three sessions over a four-month period. Sessions will be supported by a trained facilitator (peer living with a chronic health condition).
The WhatsApp group support will be a virtual adaptation of the in-person group support model, designed to provide an accessible, low-barrier option for participants who prefer remote or flexible engagement. The group is framed as a virtual support community for people living with chronic health conditions such as HIV, diabetes, or hypertension. The group size will be 15-20 people. This virtual space aims to maintain the benefits of peer connection and mutual motivation while minimizing logistical and social barriers to participation. It builds on growing evidence for mHealth peer support in ART adherence and retention interventions in South Africa. Participants will be added to a single WhatsApp group called Zikhethele, moderated by a trained community health worker. The group will remain active for approximately four months, mirroring the duration of the in-person group. Members may join or leave the group at any time.
AI coach (developed by Population Services International (PSI), Wits Health Consortium (WCI), and Audere) is a digital version of the in-person Coach Mpilo model where a peer navigator case management approach in South Africa that employs men living with HIV as "coaches" to support linkage, retention, and re-engagement in care. The digital version is an AI-based chatbot over WhatsApp, which aims to replicate the motivational, supportive functions of a human coach. The AI coach is available anytime, anywhere via WhatsApp, and offers trusted information (through a curated large-language model), and empathetic counselling and behavioural nudges to encourage healthy habits. Users are able to engage with the chatbot on their own phone or other device, via WhatsApp, at any time, from any location, free of charge (other than the use of WhatsApp data). The chatbot is not structured or scripted but rather designed to respond to any question or statement posed by the user.
Participants will receive a brief description of the available support options (in-person club, WhatsApp group, or AI coach) following a standard script. They will be able to discuss and select the modality that best fits their needs and circumstances. Participants in the choice arm will be asked to select one of the available intervention options, or they will be able to choose not to sign up for additional ART support (standard of care). The choice process will be facilitated by a trained community health worker, who will also support coordination and enrolment into the selected option. Offering choice has the potential to promote patient empowerment, strengthen engagement in care, and optimize treatment outcomes. Allowing patients to select a preferred health intervention, this can increase satisfaction, self-efficacy and health care empowerment, which in turn may improve engagement and health outcomes.
Eligibility Criteria
You may qualify if:
- Adults aged 18 years or older
- Living with HIV
- Starting ART for the first time or restarting ART after an interruption of at least three months
- Eligible to start or restart ART based on local guidelines
- Clinically stable (no acute illness or evidence of TB/meningitis)
- English or isiXhosa speaking
- Willing and able to provide informed consent to participate.
You may not qualify if:
- \- Pregnancy at the time of enrolment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gugulethu Community Health Centre
Cape Town, Western Cape, South Africa
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
February 9, 2026
First Posted
February 27, 2026
Study Start
February 1, 2026
Primary Completion
August 1, 2026
Study Completion
August 1, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Access Criteria
- Where appropriate, de-identified data will be: * Deposited in a publicly accessible data repository, or * Made available as supplementary material accompanying peer-reviewed publications. If open public release is not feasible due to POPIA or ethics restrictions, data will be shared via a controlled-access mechanism. Access will be granted upon reasonable request and subject to approval by the study team and, where applicable, the relevant ethics committee. Data will be shared for research purposes only, in accordance with the Protection of Personal Information Act (POPIA). Data users will be required to: * Agree not to attempt to re-identify participants * Use the data only for the approved purpose * Cite the original study appropriately * Comply with applicable data protection and governance requirements
De-identified individual participant data that underlie the primary and secondary outcome analyses of this pilot randomised trial will be shared where feasible. These data may include trial arm assignment, baseline characteristics, outcome measures, and derived variables used in published analyses. Certain individual-level data will not be shared due to ethical constraints and limitations in the ability to adequately de-identify the data, particularly given the small sample size and sensitive contextual information. Data excluded from sharing may include variables that pose a risk of re-identification or deductive disclosure.