HIV Care Loss to Followup
Conditions
Keywords
HIV, antiretroviral therapy, engagement in care, patient choice, adherence support
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. 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.
Interventions
BEHAVIORALIn-person group 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).
BEHAVIORALWhatsApp group support
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.
BEHAVIORALAI coach
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.
BEHAVIORALChoice of support
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.
Sponsors
University of Cape Town
Fogarty International Center of the National Institute of Health
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
\- Pregnancy at the time of enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study measurement feasibility: Interview completion | Through study completion, an average of four months | Number of enrolled participants not completing or partially completing study measures |
| Intervention fidelity: intervention completion | Through study completion, on average four months | % completion of intervention components |
| Experiences and perceptions of receiving or implementing the intervention | Through study completion, on average four months | Themes in in-depth-interviews and open-ended responses: practicality and resources for implementation. |
| Intervention acceptability | 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 | Through end of recruitment, expected duration one month | Number of of eligible participants refusing participation |
| Retention in study | Through study completion, an average of four months | % enrolled participants completing the four month interview |
| Patient empowerment | 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 | 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 | 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 | 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 | 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) | 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 | Through study completion, on average four months | Number choosing each support option and number participating in the chosen support |
| Safety | 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) | 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 | 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 | Through study completion, an average of four months | Average time to complete measurement interviews |
| Study measurement feasibility: user-engagement data | 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 | Through study completion, an average of four months | Frequency and context of engagement with each intervention component. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retention in HV care | Month 4 and month 12 | * 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. |
| Intervention adaptations | Through study completions, an average of four months | Documented challenges and resulting adaptations emerging from weekly intervention debriefing discussions |
| HIV viral load suppression | Month 3 and month 12 | * 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 |
| HIV self-management | Month 4 | 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. |
| Self-reported ART adherence | Month 4 | 3-item self-reported adherence scale assessing adherence in the past 30 days |
Countries
South Africa
Contacts
CONTACTTamsin K Phillips, MPH, PhD
Outcome results
None listed