HIV Care Loss to FollowupZikhetheleNCT07439562
Choice-Based Support for Adults Starting or Restarting Antiretroviral Therapy in Cape Town, South Africa
A study testing In-person group support, WhatsApp group support and AI coach in people with HIV Care Loss to Followup, run by University of Cape Town at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Care Loss to Followup
- What is being tested?
- In-person group support, WhatsApp group support and AI coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Africa
- Study dates
- Feb 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy at the time of enrolment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site
Gugulethu Community Health Centre
Cape Town, Western Cape
Tamsin K Phillips, MPH, PhD, +27216501646, tammy.phillips@uct.ac.za
About this study
Official title: 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
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.
Read more
The objectives of this study are:
- To determine the feasibility, acceptability, appropriateness and fidelity of the Zikhethele intervention components, including offering patients a choice of ART support intervention.
- To describe the distribution of actual choices in the choice arm.
- 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.
- 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.
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.
- Conditions
- HIV Care Loss to Followup
- Being tested
- In-person group support, WhatsApp group support, AI coach, Choice of support
- Keywords
- HIV, antiretroviral therapy, engagement in care, patient choice, adherence support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person group supportBehavioural
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).
WhatsApp group supportBehavioural
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 coachBehavioural
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.
Choice of supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care support | No intervention | 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. |
| In-person group support | Experimental | 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). Receives: Behavioral: In-person group support |
| Choice of support | Experimental | 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) Receives: Behavioral: In-person group support; Behavioral: WhatsApp group support; Behavioral: AI coach; Behavioral: Choice of support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention fidelity: intervention completion
% completion of intervention components
Measured: 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.
Measured: 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.
Measured: Assessed at month 4
Recruitment feasibility: Refusals
Number of of eligible participants refusing participation
Measured: Through end of recruitment, expected duration one month
Retention in study
% enrolled participants completing the four month interview
Measured: Through study completion, an average of four months
Study measurement feasibility: Interview completion
Number of enrolled participants not completing or partially completing study measures
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at month 4
Choice of support
Number choosing each support option and number participating in the chosen support
Measured: Through study completion, on average four months
Safety
Report of any privacy/safety events through the interventions or study measurement data collection.
Measured: 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.
Measured: Assessed at month 4
Recruitment feasibility: time to complete recruitment
Documenting time to complete recruitment along with periods when unable to recruit.
Measured: Through end of recruitment, expected duration one month
Study measurement feasibility: Interview length
Average time to complete measurement interviews
Measured: 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
Measured: Through study completion, an average of four months
Intervention fidelity: User engagement
Frequency and context of engagement with each intervention component.
Measured: Through study completion, an average of four months
Secondary outcomes (5)
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.
Measured: Month 4 and month 12
Intervention adaptations
Documented challenges and resulting adaptations emerging from weekly intervention debriefing discussions
Measured: 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
Measured: 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.
Measured: Month 4
Self-reported ART adherence
3-item self-reported adherence scale assessing adherence in the past 30 days
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Care Loss to FollowupStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-stage, three-arm, non-blinded, individually randomized pilot feasibility trial. Participants will be allocated in a 1:1:2 ratio to standard of care, in-person group support, or a choice group (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)
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tammy Phillips, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439562
- Sponsor's protocol ID
- K43TW011943
- Other IDs
- K43TW011943
- Acronym
- Zikhethele
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07439562
- Acronym / sponsor ID
- Zikhethele / K43TW011943
- Conditions
- HIV Care Loss to Followup
- Keywords
- HIV, antiretroviral therapy, engagement in care, patient choice, adherence support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, National Institute of Mental Health (NIMH)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the feasibility, acceptability, appropriateness and fidelity of the Zikhethele intervention components, including offering patients a choice of ART support intervention.
- To describe the distribution of actual choices in the choice arm.
- 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.
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a two-stage, three-arm, non-blinded, individually randomized pilot feasibility trial. Participants will be allocated in a 1:1:2 ratio to standard of care, in-person group support, or a choice group (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)
| Arm | Type | Receives |
|---|---|---|
| Standard of care support | No intervention | –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. |
| In-person group support | Experimental | Behavioral: In-person group supportParticipants 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 | Experimental | Behavioral: In-person group support, Behavioral: WhatsApp group support, Behavioral: AI coach, Behavioral: Choice of supportParticipants 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- Pregnancy at the time of enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person group supportThe 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). | Behavioural | Choice of support, In-person group support |
| WhatsApp group supportThe 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. | Behavioural | Choice of support |
| AI coachAI 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. | Behavioural | Choice of support |
| Choice of supportParticipants 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. | Behavioural | Choice of support |
Primary outcome
Intervention fidelity: intervention completion
Time frame: Through study completion, on average four months
% completion of intervention components
Experiences and perceptions of receiving or implementing the intervention
Time frame: Through study completion, on average four months
Themes in in-depth-interviews and open-ended responses: practicality and resources for implementation.
Intervention acceptability
Time frame: Assessed at month 4
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.
Recruitment feasibility: Refusals
Time frame: Through end of recruitment, expected duration one month
Number of of eligible participants refusing participation
Retention in study
Time frame: Through study completion, an average of four months
% enrolled participants completing the four month interview
Study measurement feasibility: Interview completion
Time frame: Through study completion, an average of four months
Number of enrolled participants not completing or partially completing study measures
Patient empowerment
Time frame: Enrolment and month 4
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.
Perceived Availability of Social Support
Time frame: Enrolment and month 4
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.
Social Impact Scale
Time frame: Enrolment and month 4
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.
Health Care Relationship Trust Scale
Time frame: Enrolment and month 4
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.
Start/restart perceptions
Time frame: At month 4
Description of themes from qualitative interviews and open-ended survey questions assessing ease of ART start or restart along with barriers and enablers.
Feasibility of Intervention Measure (FIM)
Time frame: Assessed at month 4
Four item scale with values ranging from 1-completely disagree to 5-completely agree. Higher scores indicate high feasibility.
Choice of support
Time frame: Through study completion, on average four months
Number choosing each support option and number participating in the chosen support
Safety
Time frame: Through study completion, on average four months
Report of any privacy/safety events through the interventions or study measurement data collection.
Acceptability of Intervention Measure (AIM)
Time frame: Assessed at month 4
Four item scale with values ranging from 1-completely disagree to 5-completely agree. Higher scores indicated higher acceptability.
Recruitment feasibility: time to complete recruitment
Time frame: Through end of recruitment, expected duration one month
Documenting time to complete recruitment along with periods when unable to recruit.
Study measurement feasibility: Interview length
Time frame: Through study completion, an average of four months
Average time to complete measurement interviews
Study measurement feasibility: user-engagement data
Time frame: Through study completion, an average of four months
Frequency and type of intervention user-engagement data not accessed for interventions along with reasons for delay or lack of access
Intervention fidelity: User engagement
Time frame: Through study completion, an average of four months
Frequency and context of engagement with each intervention component.
5 secondary outcomes
Retention in HV care
Time frame: Month 4 and month 12
Intervention adaptations
Time frame: Through study completions, an average of four months
HIV viral load suppression
Time frame: Month 3 and month 12
HIV self-management
Time frame: Month 4
Self-reported ART adherence
Time frame: Month 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person group support, WhatsApp group support and AI coach in people with HIV Care Loss to Followup, run by University of Cape Town at 1 site in South Africa.
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 1 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: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tamsin K Phillips, MPH, PhD (+27216501646, tammy.phillips@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention fidelity: intervention completion (time frame: Through study completion, on average four months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.