Human Immunodeficiency VirusNCT06554223
The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
A study testing SUSTAIN-DSD in people with Human Immunodeficiency Virus, run by Brigham and Women's Hospital at 1 site in South Africa.
Trial summary
The goal of this clinical trial is to learn if the DSD model (SUSTAIN-DSD) is effective in improving participants HIV treatment adherence. The main questions it aims to answer are: Does the SUSTAIN-DSD intervention significantly improve participants' treatment adherence and increase rates of viral suppression? Does… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- SUSTAIN-DSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteSouth Africa
- Study dates
- 14 Nov 2025to 31 Mar 2029
- 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 (≥18 years or age)
- Living with HIV
- On a dolutegravir-based first-line ART regimen
- Evidence of a care gap (>28 days late for appointment) or having a raised viral load (≥50 copies/ml) in the preceding year, either from SUSTAIN study data or from clinic records.
- Able to provide full informed consent.
- Willingness to comply with study procedures, including providing regular update of contact details or locator information.
- A purposively selected subset of 30 enrolled participants will be invited for a semi-structured, in-depth interview at (or within 2 months after) the month 24 visit (for experience and perceptions; aim 2); and 20 different participants will be invited to participate in in-depth interviews to determine acceptability and feasibility (aim 3) within the same time frame.
Who cannot join
- Clinical conditions as assessed by the ART clinicians as requiring clinic-based follow-up e.g. tuberculosis or epilepsy.
- Pregnant at enrollment and requiring care in the antenatal clinic system.
- Sustained retention in care (no gaps of >28days) and viral suppression in the preceding year.
- Plans to leave Cape Town permanently within the next 24 months.
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, 1 recruiting
- Recruiting
University of Cape Town
Cape Town
Catherine Orrell, MBChB, PhD, +27834561969, catherine.orrell@mrc.ac.za
About this study
The goal of this clinical trial is to learn if the DSD model (SUSTAIN-DSD) is effective in improving participants HIV treatment adherence. The main questions it aims to answer are:
- Does the SUSTAIN-DSD intervention significantly improve participants' treatment adherence and increase rates of viral suppression?
- Does the SUSTAIN-DSD intervention help retain people in care?
- Does SUSTAIN-DSD intervention help reduce the length of treatment interruptions?
- for 24 months, Participants will either receive the SUSTAIN-DSD intervention (i.e. be enrolled in an adherence club where the participants will pick up 6-months of ART medication and have the option to use peer support and additional counseling), and or enhanced standard of care (i.e. visit the clinic for treatment and participate in optional counseling sessions).
Read more
Blood will be drawn from the participants at the adherence club visits for viral load tests at baseline and every 12 months.
- Participants will take part in interviews to discuss the participants' experience with the SUSTAIN-DSD intervention.
Read the detailed description
Differentiated Service Delivery (DSD) models have been shown to provide equivalent or better retention in healthcare and viral (VL) suppression for people with HIV than conventional care models. However, to date, DSD models have been offered only to people with HIV (PWH) considered 'stable' (i.e., retained in care and virally suppressed). Thus, those at high risk of poor outcomes are ineligible for DSD models. In response, the investigators will work with the City of Cape Town to provide the data needed to impact policy guidelines. The investigators designed SUSTAIN2: SUStained HIV Treatment Adherence After INterruption, which will test a scalable, evidence-based DSD model (SUSTAIN-DSD) to address individual, social, and structural barriers to long-term engagement and to increase VL suppression among PWH with an ART treatment interruption or unsuppressed VL (PWH-Gaps).
SUSTAIN-DSD is a six-month adherence club model of care that offers flexible services with multi-month dispensing of medication (de-linked from clinic processes) and support from lay counselors and peers, which has been proven to help PWH to sustain retention and viral suppression in the Western Cape. The study will implement a Hybrid Type 1 randomized controlled trial (RCT) to evaluate the effectiveness of SUSTAIN-DSD on viral suppression among PWH-Gaps at 24 months post-enrollment, as compared to an enhanced standard-of-care (an optimized guidelines-based approach). The investigators will recruit 300 participants from the parent study and clinics (SUSTAIN, R01MH125703, MPI: Orrell/Sabin; UCT Ethics Reference 568/2021), through which the investigators have identified persistent engagement gaps in approximately 45% of the participants, despite adherence counseling, to test this model of care. The investigators will then assess the mechanisms of intervention impact using mixed methods, guided by the Capability, Opportunity, and Motivation model of Behavior (COM-B), and determine implementation outcomes using Proctor's model.
Ultimately, the investigators' goal is to ensure that PWH are able to achieve and maintain virologic suppression through provision of an effective and efficient model of care, which can be used in South Africa's efforts to reach the 2030 goals.
The investigators' central hypothesis is that PWH-Gaps receiving SUSTAIN-DSD will have higher rates of viral suppression than those who receive enhanced routine care. The investigators will use a Hybrid Type 1 RCT design to answer the study questions.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- SUSTAIN-DSD, Enhanced (guideline-driven) Standard of Care (E-SoC)
- Keywords
- Differentiated Service Delivery
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUSTAIN-DSDBehavioural
Participants randomized to SUSTAIN-DSD will be enrolled into an Adherence Club and will have 6 months of ART dispensed through a pre-packed dispensing service. Participants may choose to use the decentralized pick-up point solely for medication retrieval or may opt into the peer-support aspect of the Clubs by attending the group session of up to 30 PWH, who will meet once every 6 months in a safe space (e.g., clinic meeting room, church, or local library).
At 6 months, 12 months, and every 12 months thereafter, a visiting nurse will draw a blood specimen for viral load. Optional process uptake will be recorded. Participants with a raised viral load will be called and offered enhanced adherence counselling; then recalled for a repeat viral load in 3 months.
Enhanced (guideline-driven) Standard of Care (E-SoC)Other
As per current SA ART guidelines, all patients who are >28 days late for a scheduled visit are offered enhanced adherence counselling (EAC) at reengagement and restarted on ART. Patients who are >90 days late also have blood drawn for a CD4 count to test for advanced HIV disease. Individual clinic visits occur every 3 months, with 3-month ART dispensing. VL testing is repeated 3 months after restart, then at 12 months and annually there-after, if suppressed.
These visits will be managed by clinic staff (nurse or doctor). EAC is a single counselling session delivered by a lay counsellor.
The study team will ensure all SoC processes are complete as per the guidelines; and reported to the COCT team as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| SUSTAIN-DSD Arm | Experimental | Participants randomized to SUSTAIN-DSD will be enrolled into an Adherence Club and will have 6 months of ART dispensed through a pre-packed dispensing service. Participants may choose to use the decentralized pick-up point solely for medication retrieval or may opt into the peer-support aspect of the Clubs by attending the group session of up to 30 PWH, who will meet once every 6 months in a safe space (e.g., clinic meeting room, church, or local library). At baseline and every 12 months thereafter, a visiting nurse will draw a blood specimen for viral load. Optional process uptake will be recorded. Participants with a raised viral load will be called and offered enhanced adherence counselling; then recalled for a repeat viral load in 3 months. Receives: Behavioral: SUSTAIN-DSD |
| Enhanced (guideline-driven) Standard of Care (E-SoC) | Other | As per current SA ART guidelines, all patients who are >28 days late for a scheduled visit are offered enhanced adherence counselling (EAC) at reengagement and restarted on ART. Patients who are >90 days late also have blood drawn for a CD4 count to test for advanced HIV disease. Individual clinic visits occur every 3 months, with 3-month ART dispensing. VL testing is repeated 3 months after restart, then at 12 months and annually there-after, if suppressed. These visits will be managed by clinic staff (nurse or doctor). EAC is a single counselling session delivered by a lay counsellor. The study team will ensure all SoC processes are complete as per the guidelines; and reported to the COCT team as appropriate. Receives: Other: Enhanced (guideline-driven) Standard of Care (E-SoC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression (Viral load <50 c/ml)
Viral suppression (Viral load c/ml) will be measured at 24 months post-enrollment.
Measured: 24 months post-enrollment
Secondary outcomes (7)
Viral suppression (Viral load <50 c/ml) at 12 months
Viral suppression (Viral load <50 c/ml) will be measured at 12 months post-enrollment.
Measured: 12 months post-enrollment
Viremia
% Plasma VL 50-999 / ≥1000 copies/mL (dichotomous) | Blood Draw and/or NHLS database at 12 and 24 months
Measured: 12-24 months
Retention in care at study clinics
Retention in care at study clinics (and in care at any other clinic) will be measured at 12 and 24 months (measured by proportion attending club or clinic visits at months 12 and 24).
Measured: 12 and 24 months post-enrollment
Treatment interruptions
Treatment interruptions will be measured using pharmacy refill data.
Measured: 0-24 months post-enrollment
ART adherence using urine tenofovir rapid assays
ART adherence will be measured using urine tenofovir rapid assays to detect Tenofovir concentrations in participants.
Measured: 12 and 24 months post-enrollment
ART adherence using pharmacy data
ART adherence will be measured using medication possession ratio calculated from pharmacy refill data.
Measured: 12 and 24 months post-enrollment
Success in HIV self-management of care
This outcome will be assessed with the self-regulatory processes 4-item scale, which includes these items:
I closely monitor whether I take all my ARVs every day (never - always) I make sure that I get new ARVs at the clinic before my ARVs are finished (never - always) If I notice that I have not taken my ARVs or I have taken them too late, I think about what the reason for that was and how I can prevent that from happening again (never - always) I watch carefully that I take all my ARVs every day (never - always)
Potential responses are given on a scale from 'never' (1) to 'always' (5). The minimum score is 4 and the maximum score is 20. Higher scores are associated with more successful HIV self-management of care.
Measured: 12 and 24 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start14 Nov 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ingrid Theresa Katz, M.D., Brigham and Women's Hospital
- Investigators
- Ingrid T Katz, MD, MHS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554223
- Sponsor's protocol ID
- 2024P001983
- Status last verified
- Nov 2025
- First submitted
- 2 Aug 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be de-identified prior to deposit into the repository, but individual-level data will retain a global unique patient identification number to facilitate analyses. The investigators will also make qualitative data available via de-identified transcripts from audio-recorded interviews. The investigators will do so to comply with the NIH requirement that data generated from human subjects be shared broadly. In addition to the subject level data, the investigators will develop and deposit a data dictionary (describing quantitative variables included in datasets), the study protocol, and data collection instruments into the NIMH data archive (NDA) repository to facilitate further analyses and interpretation of data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
- ClinicalTrials.gov ID
- NCT06554223
- Acronym / sponsor ID
- 2024P001983
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Differentiated Service Delivery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 15 Aug 2024 (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.
The goal of this clinical trial is to learn if the DSD model (SUSTAIN-DSD) is effective in improving participants HIV treatment adherence. The main questions it aims to answer are:
- Does the SUSTAIN-DSD intervention significantly improve participants' treatment adherence and increase rates of viral suppression?
- Does the SUSTAIN-DSD intervention help retain people in care?
- Does SUSTAIN-DSD intervention help reduce the length of treatment interruptions?
- for 24 months, Participants will either receive the SUSTAIN-DSD intervention (i.e. be enrolled in an adherence club where the participants will pick up 6-months of ART medication and have the option to use peer support and additional counseling), and or enhanced standard of care (i.e. visit the clinic for treatment and participate in optional counseling sessions).
Blood will be drawn from the participants at the adherence club visits for viral load tests at baseline and every 12 months.
- Participants will take part in interviews to discuss the participants' experience with the SUSTAIN-DSD intervention.
Detailed description
Differentiated Service Delivery (DSD) models have been shown to provide equivalent or better retention in healthcare and viral (VL) suppression for people with HIV than conventional care models. However, to date, DSD models have been offered only to people with HIV (PWH) considered 'stable' (i.e., retained in care and virally suppressed). Thus, those at high risk of poor outcomes are ineligible for DSD models. In response, the investigators will work with the City of Cape Town to provide the data needed to impact policy guidelines. The investigators designed SUSTAIN2: SUStained HIV Treatment Adherence After INterruption, which will test a scalable, evidence-based DSD model (SUSTAIN-DSD) to address individual, social, and structural barriers to long-term engagement and to increase VL suppression among PWH with an ART treatment interruption or unsuppressed VL (PWH-Gaps).
SUSTAIN-DSD is a six-month adherence club model of care that offers flexible services with multi-month dispensing of medication (de-linked from clinic processes) and support from lay counselors and peers, which has been proven to help PWH to sustain retention and viral suppression in the Western Cape. The study will implement a Hybrid Type 1 randomized controlled trial (RCT) to evaluate the effectiveness of SUSTAIN-DSD on viral suppression among PWH-Gaps at 24 months post-enrollment, as compared to an enhanced standard-of-care (an optimized guidelines-based approach). The investigators will recruit 300 participants from the parent study and clinics (SUSTAIN, R01MH125703, MPI: Orrell/Sabin; UCT Ethics Reference 568/2021), through which the investigators have identified persistent engagement gaps in approximately 45% of the participants, despite adherence counseling, to test this model of care. The investigators will then assess the mechanisms of intervention impact using mixed methods, guided by the Capability, Opportunity, and Motivation model of Behavior (COM-B), and determine implementation outcomes using Proctor's model.
Ultimately, the investigators' goal is to ensure that PWH are able to achieve and maintain virologic suppression through provision of an effective and efficient model of care, which can be used in South Africa's efforts to reach the 2030 goals.
The investigators' central hypothesis is that PWH-Gaps receiving SUSTAIN-DSD will have higher rates of viral suppression than those who receive enhanced routine care. The investigators will use a Hybrid Type 1 RCT design to answer the study questions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUSTAIN-DSD Arm | Experimental | Behavioral: SUSTAIN-DSDParticipants randomized to SUSTAIN-DSD will be enrolled into an Adherence Club and will have 6 months of ART dispensed through a pre-packed dispensing service. Participants may choose to use the decentralized pick-up point solely for medication retrieval or may opt into the peer-support aspect of the Clubs by attending the group session of up to 30 PWH, who will meet once every 6 months in a safe space (e.g., clinic meeting room, church, or local library). At baseline and every 12 months thereafter, a visiting nurse will draw a blood specimen for viral load. Optional process uptake will be recorded. Participants with a raised viral load will be called and offered enhanced adherence counselling; then recalled for a repeat viral load in 3 months. |
| Enhanced (guideline-driven) Standard of Care (E-SoC) | Other | Other: Enhanced (guideline-driven) Standard of Care (E-SoC)As per current SA ART guidelines, all patients who are >28 days late for a scheduled visit are offered enhanced adherence counselling (EAC) at reengagement and restarted on ART. Patients who are >90 days late also have blood drawn for a CD4 count to test for advanced HIV disease. Individual clinic visits occur every 3 months, with 3-month ART dispensing. VL testing is repeated 3 months after restart, then at 12 months and annually there-after, if suppressed. These visits will be managed by clinic staff (nurse or doctor). EAC is a single counselling session delivered by a lay counsellor. The study team will ensure all SoC processes are complete as per the guidelines; and reported to the COCT team as appropriate. |
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 (≥18 years or age)
- Living with HIV
- On a dolutegravir-based first-line ART regimen
- Evidence of a care gap (>28 days late for appointment) or having a raised viral load (≥50 copies/ml) in the preceding year, either from SUSTAIN study data or from clinic records.
- Able to provide full informed consent.
Key exclusion criteria (4 listed)
- Clinical conditions as assessed by the ART clinicians as requiring clinic-based follow-up e.g. tuberculosis or epilepsy.
- Pregnant at enrollment and requiring care in the antenatal clinic system.
- Sustained retention in care (no gaps of >28days) and viral suppression in the preceding year.
- Plans to leave Cape Town permanently within the next 24 months.
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 |
|---|---|---|
| SUSTAIN-DSDParticipants randomized to SUSTAIN-DSD will be enrolled into an Adherence Club and will have 6 months of ART dispensed through a pre-packed dispensing service. Participants may choose to use the decentralized pick-up point solely for medication retrieval or may opt into the peer-support aspect of the Clubs by attending the group session of up to 30 PWH, who will meet once every 6 months in a safe space (e.g., clinic meeting room, church, or local library). At 6 months, 12 months, and every 12 months thereafter, a visiting nurse will draw a blood specimen for viral load. Optional process uptake will be recorded. Participants with a raised viral load will be called and offered enhanced adherence counselling; then recalled for a repeat viral load in 3 months. | Behavioural | SUSTAIN-DSD Arm |
| Enhanced (guideline-driven) Standard of Care (E-SoC)As per current SA ART guidelines, all patients who are >28 days late for a scheduled visit are offered enhanced adherence counselling (EAC) at reengagement and restarted on ART. Patients who are >90 days late also have blood drawn for a CD4 count to test for advanced HIV disease. Individual clinic visits occur every 3 months, with 3-month ART dispensing. VL testing is repeated 3 months after restart, then at 12 months and annually there-after, if suppressed. These visits will be managed by clinic staff (nurse or doctor). EAC is a single counselling session delivered by a lay counsellor. The study team will ensure all SoC processes are complete as per the guidelines; and reported to the COCT team as appropriate. | Other | Enhanced (guideline-driven) Standard of Care (E-SoC) |
Primary outcome
Viral suppression (Viral load <50 c/ml)
Time frame: 24 months post-enrollment
Viral suppression (Viral load c/ml) will be measured at 24 months post-enrollment.
7 secondary outcomes
Viral suppression (Viral load <50 c/ml) at 12 months
Time frame: 12 months post-enrollment
Viremia
Time frame: 12-24 months
Retention in care at study clinics
Time frame: 12 and 24 months post-enrollment
Treatment interruptions
Time frame: 0-24 months post-enrollment
ART adherence using urine tenofovir rapid assays
Time frame: 12 and 24 months post-enrollment
ART adherence using pharmacy data
Time frame: 12 and 24 months post-enrollment
Success in HIV self-management of care
Time frame: 12 and 24 months post-enrollment
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 24 Nov 2025.
- Individual participant dataSharing planned: Yes. Data will be de-identified prior to deposit into the repository, but individual-level data will retain a global unique patient identification number to facilitate analyses. The investigators will also make qualitative data available via de-identified transcripts from audio-recorded interviews. The investigators will do so to comply with the NIH requirement that data generated from human subjects be shared broadly. In addition to the subject level data, the investigators will develop and deposit a data dictionary (describing quantitative variables included in datasets), the study protocol, and data collection instruments into the NIMH data archive (NDA) repository to facilitate further analyses and interpretation of data.
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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.
Ingrid T Katz, MD, MHS principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUSTAIN-DSD in people with Human Immunodeficiency Virus, run by Brigham and Women's Hospital 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 4 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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 Ingrid T Katz, MD, MHS (617-525-8194, ikatz2@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral suppression (Viral load <50 c/ml) (time frame: 24 months post-enrollment). 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 24 Nov 2025.