An interventional study of In-person group support and WhatsApp group support in HIV Care Loss to Followup, sponsored by University of Cape Town. Not yet recruiting at 1 site in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by University of Cape Town · Not applicable, Interventional, and Supportive care
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:
A total of 140 adults starting or restarting ART will be consecutively recruited and randomised to a) standard of care (n=35), b) in-person support (n=35) and c) a choice (n=70) of in-person support, WhatsApp group support, AI coach, or no additional support (standard of care).
The intervention components will run for the first four months after start or restart, through to the first viral load and eligibility assessment for routine differentiated models of care. Briefly, the in-person group support will consist of monthly informal and discussion-based sessions framed around chronic medication adherence (including HIV, diabetes, and hypertension), designed to create a safe and supportive space where participants can share experiences, problem-solve, and build motivation to remain in care. The WhatsApp group support will be a virtual adaptation of the in-person model, designed to provide an accessible, low-barrier option for participants who prefer remote or flexible engagement. The AI Coach is a pilot AI chatbot (developed by Audere, PSI, HSRC, and Matchboxology, and being piloted in Gauteng and KwaZulu Natal by HE2RO at the Wits Health Consortium) inspired by the in-person Coach Mpilo model-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 AI coach is available anytime via WhatsApp, and offers trusted information (through a curated large-language model), and empathetic counselling and behavioural nudges to encourage healthy habits.
Individuals (aged 18 and older, living with HIV and currently attending the clinic to start ART for the first time or to restart after an interruption of 3 or more months) will be approached during their routine clinic visit by a trained research fieldworker. Eligible individuals will undergo informed consent and be enrolled. Participants will complete an interviewer administered questionnaire at enrolment and at four months. Outcome data will also be abstracted from paper and electronic medical records, as well study and intervention logs, intervention debriefings and chatbot logs. A subset of 20 participants, purposefully selected to include each intervention component, will be invited to complete an in-depth interview at 4 months. Providers (n=6), while not involved directly in this pilot implementation, will also be invited to participate in an in-depth interview to explore the potential of this intervention.
This exploratory pilot study serves as a proof-of-concept for offering people living with HIV different modalities of support for engagement in care in the first four months. The study is not powered for efficacy but will provide valuable insights into feasibility (of both the trial design and intervention components) and acceptability, as well as real-world preferences and trade-offs. The investigators hypothesize that those able to choose a support intervention most appealing or most fitting to their life circumstances may have improved health empowerment which may in turn improve health outcomes.
University of Cape Town is the lead sponsor of 116 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Pregnancy at the time of enrolment
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Participants 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).
Behavioral: In-person group support
Participants 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)
Behavioral: In-person group support · Behavioral: WhatsApp group support · Behavioral: AI coach · Behavioral: Choice of support
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.
Intervention fidelity: intervention completion
% completion of intervention components
Time frame: 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.
Time frame: 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.
Time frame: Assessed at month 4
Recruitment feasibility: Refusals
Number of of eligible participants refusing participation
Time frame: Through end of recruitment, expected duration one month
Retention in study
% enrolled participants completing the four month interview
Time frame: Through study completion, an average of four months
Study measurement feasibility: Interview completion
Number of enrolled participants not completing or partially completing study measures
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Assessed at month 4
Choice of support
Number choosing each support option and number participating in the chosen support
Time frame: Through study completion, on average four months
Safety
Report of any privacy/safety events through the interventions or study measurement data collection.
Time frame: 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.
Time frame: Assessed at month 4
Recruitment feasibility: time to complete recruitment
Documenting time to complete recruitment along with periods when unable to recruit.
Time frame: Through end of recruitment, expected duration one month
Study measurement feasibility: Interview length
Average time to complete measurement interviews
Time frame: 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
Time frame: Through study completion, an average of four months
Intervention fidelity: User engagement
Frequency and context of engagement with each intervention component.
Time frame: Through study completion, an average of four months
Retention in HV care
* in care with no ART interruption 4 months after start/restart collected through interview and medical records. * in care with no ART interruption 6 and 12 months after start/restart collected through medical records.
Time frame: Month 4 and month 12
Intervention adaptations
Documented challenges and resulting adaptations emerging from weekly intervention debriefing discussions
Time frame: Through study completions, an average of four months
HIV viral load suppression
* virally suppressed at 3 months after start/restart based on medical records * virally suppressed at 12-18 months after start/restart based on medical records
Time frame: Month 3 and month 12
HIV self-management
Four item scale measuring reported self regulation in medication taking. Each item scored 1-5 (minimum 4, maximum 20). Higher scores indicate better self-management.
Time frame: Month 4
Self-reported ART adherence
3-item self-reported adherence scale assessing adherence in the past 30 days
Time frame: Month 4
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form
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
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Aug 2026, 6 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.