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HIV InfectionsENHANCENCT06248190

ENHANCE-EvideNce Led Co-created HeAlth Systems interventioNs for MLTCs CarE

A study testing ENHANCE intervention (health systems) in people with HIV Infections and Hypertension, run by University of KwaZulu at 32 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes. The specific questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
HIV Infections, Hypertension, Diabetes Mellitus
What is being tested?
ENHANCE intervention (health systems)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,837 participants
Where
32 sitesSouth Africa
Study dates
19 Sep 2023to 1 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 40 years or older
  • Receiving care for at least two of the following conditions, with at least one of the first five listed conditions being uncontrolled or patients indicated as struggling with the management of their condition:
  • HIV (Self-reported current treatment). ii. hypertension (Self-reported current treatment. iii. diabetes (Self-reported current treatment). iv. asthma (Self-reported current treatment). vi. depression (Self-reported current treatment). vii. previous myocardial infarction (self-reported). viii. previous stroke (self-reported history).

Who cannot join

  • Participants planning to relocate from either uMgungundlovu, KwaZulu-Natal, and Cape Metro in Western Cape, or changing their facilities during the period of the study.
  • Participants who are unable to give informed consent due to loss of capacity.
  • Participants self-reporting pregnancy
  • Participants who cannot communicate in English, isiXhosa, isiZulu, or Afrikaans.
  • Participants who are not willing to receive care for chronic conditions in their homes.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

South Africa32 sites

  • Delft CHC

    Cape Town, Western Cape, 7700

  • Dr Abdurahman CHC

    Cape Town, Western Cape, 7700

  • DuNoon CHC

    Cape Town, Western Cape, 7700

  • Durbanville CHC

    Cape Town, Western Cape, 7700

  • Elsies CHC

    Cape Town, Western Cape, 7700

  • Gugulethu CHC

    Cape Town, Western Cape, 7700

  • Gustrouw CDC

    Cape Town, Western Cape, 7700

  • Hanover Park CHC

    Cape Town, Western Cape, 7700

  • Heideveld CHC

    Cape Town, Western Cape, 7700

  • Kleinvlei CHC

    Cape Town, Western Cape, 7700

  • Kraaifontein CHC

    Cape Town, Western Cape, 7700

  • Macassar CDC

    Cape Town, Western Cape, 7700

  • Michael M

    Cape Town, Western Cape, 7700

  • Mitchells Plain CHC

    Cape Town, Western Cape, 7700

  • Retreat CHC

    Cape Town, Western Cape, 7700

  • Vanguard CHC

    Cape Town, Western Cape, 7700

  • Eastwood Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Esigodini Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Gcumisa Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Gomane Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Howick Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Impilwenhle Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Injabulo Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Mafatini Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Mphophomeni Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Ndaleni Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Northdale Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Pata Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Richmond Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Songonzima Clinic

    Pietermaritzburg, KwaZulu-Natal

  • Willowfontein CHC

    Pietermaritzburg, KwaZulu-Natal

  • Caluza Clinic

    Pietermaritzburg

Other trials in South Africa

About this study

Official title: Effectiveness of a Health Systems Strengthening Intervention to Improve Detection, Treatment, and Control of Multiple Long-Term Conditions in Primary Health Care Facilities in the Western Cape and KwaZulu Natal, South Africa

The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes. The specific questions it aims to answer are:

  1. To test and estimate the effect of the intervention in people with MLTCs attending PHCs on:
  2. Detection of, and initiation of treatment for, additional chronic conditions ii. Treatment intensification and changes in medication iii. Control of chronic conditions iv. patient reported health-related quality of life and functioning v. health care utilisation and adherence vi. costs of health care
  3. To use the RE-AIM framework to assess implementation processes and outcomes through measurements of reach, adoption, implementation, and maintenance.
  4. To understand implementation processes and outcomes within the wider context of primary healthcare, provide explanations for the observed effects of the clinical findings and identify recommendations for wider implementation of the ENHANCE intervention.

The participants in the control group will receive usual care at their primary health care facility, which includes the use of the Practical Approach to Care Kit (PACK) or Adult Primary Care (APC) clinical decision support tool. Participants in the intervention group will receive care for their multiple chronic condition by a clinician trained to use the ENHANCE clinical decision support tool (intervention tool), and receive two CHW visits in their home to provide treatment literacy and adherence support.

Read the detailed description

Control facilities Participants in control facilities will continue to receive usual care. Primary health care of long-term conditions is delivered free-at-point-of-care in public sector primary care facilities which includes the management of HIV, NCDs and mental health problems, according to South Africa's Ideal Clinic and Integrated Clinical Services Management model. This care model, which has combined the long-term care of HIV together with NCDs within each facility, has greatly enabled the feasibility of further interventions specifically addressing MLTCs and includes the Adult Primary Care (APC) or PACK clinical guidance. Patients attending these chronic services usually attend the same clinic regularly, 3 to 6-monthly for periodic monitoring of their chronic conditions. Chronic medication is collected monthly either at the facility (through fast-track queues), or through decentralised chronic medication dispensing systems which provide for collection from a range of sites including community venues (e.g. halls), wellness or adherence clubs, trailers, retail pharmacies (in KZN) or e-Lockers.

Intervention clinics

Participants in intervention clinics will continue with usual care as described for control clinics but in addition will receive the ENHANCE health systems intervention comprising tools and implementation strategies that have been co-developed with stakeholders through an iterative process, drawing on:

  1. Evidence on the commonest MLTC combinations ii. Scoping reviews conducted on effectiveness of MLTCS interventions and systems barriers and enablers of person-centred care for MLTCs in LMICs iii. Provincial and district learning collaborative workshops with stakeholders from KZN and Western Cape. iv. Clinical working groups with clinicians and health workers, a Guidance Oversight Board v. Input from our ENHANCE advocacy academy of 16 people living with MLTCs in the Western Cape and KZN

The intervention targets screening and early identification of other chronic conditions; improving follow-up and support for people with a new diagnosis, at risk of treatment failure (e.g. poorly controlled HIV or diabetes), and strengthen bi-directional referral pathways between the facility and community. Tools and implementation strategies will be layered into existing architecture of the chronic care system and support provision of more person-centred and empowering care across the treatment cascade.

Tools to support the implementation of the health systems intervention comprise:

  • An integrated clinical decision support tool for care of MLTCs drawing on PACK/ APC.
  • A range of patient-focussed materials to support condition, treatment, and systems (care-seeking) literacy (e.g., medication list, posters, scripts for health education talks)
  • A personal health diary (paper-based)

Implementation strategies include:

  • 1 facility team session to introduce the ENHANCE study to the whole team
  • 3 clinical sessions for nurses and doctors
  • 2 sessions for community health workers and health promoters
  • Maintenance sessions to keep the ENHANCE intervention going for at least 12 months.
Being tested
ENHANCE intervention (health systems)
Keywords
Multiple Chronic Conditions, Person Centered Care, Health Systems Intervention
Medical subject headings
HIV Infections, Hypertension, Diabetes Mellitus, Asthma, Depression, Myocardial Infarction, Stroke, Multiple Chronic Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ENHANCE intervention (health systems)Other

    The intervention tools include a consolidated clinical decision support tool, health education posters, waiting room talks, medication list for treatment literacy and a patient health diary. Training session are delivered at all intervention sites and include 1 facility team session to introduce the ENHANCE study to the whole team; 3 clinical sessions for nurses and doctors; 2 sessions for community health workers and health promoters; Maintenance sessions to keep the ENHANCE intervention going for at least 12 months

Study groups in NCT06248190
Study groupRoleWhat they receive
InterventionOther1. Treatment literacy in chronic condition waiting rooms/pick-up points (posters, health promotion talks) 2. 1-2 longer consultations with ENHANCE guide trained clinician 3. Treatment literacy event - a contact between a CHW and a person with MLTC in their home (hopefully with carer), at 2 weeks and 4 weeks, using Health Diary 4. Referrals to additional adherence counselling if necessary
Receives: Other: ENHANCE intervention (health systems)
ControlNo interventionUsual care at primary health care clinic, which includes consultation with a clinician using the PACK/APC guide. No additional support is usually provided for care of MLTCs.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite outcome: Diagnosis and treatment initiation for a new condition, intensification or change of treatment for a condition treated at enrolment, or improved control for a condition not optimally controlled at enrolment.

    Number of participants who meet any of the following criteria during follow-up:

    1. . Diagnosis and initiation of treatment during follow-up of one or more additional chronic conditions,
    2. . Intensification or change of treatment during follow-up for at least one of the chronic conditions present and treated at enrolment, or,
    3. . Improved control of at least one condition that was not optimally controlled at baseline, defined as follows: HIV - viral suppression (viral load <50 copies/mL); hypertension - systolic blood pressure<140 mmHg and diastolic blood pressure less than 90mmHg; diabetes - HbA1c <8%, asthma - Asthma Control Test score ≥16, depression - Patient Health Questionnaire 8 (PHQ-8) <10

    Measured: 12 months

Secondary outcomes (15)

  1. Diagnosis and initiation of treatment during follow-up of one or more additional chronic conditions

    The number of participants having a diagnosis and treatment initiation during follow-up of one or more additional chronic conditions

    Measured: 12 months

  2. Intensification or change of treatment during follow-up for at least one of the chronic conditions present and treated at enrolment

    The number of participants with intensification or change of treatment during follow-up for at least one of the chronic conditions present and treated at enrolment

    Measured: 12 months

  3. Improved control of at least one condition that was not optimally controlled at baseline

    The number of participants with improved control of at least one condition that was not optimally controlled at baseline, defined as follows: HIV - viral suppression (viral load <50 copies/mL); hypertension - systolic blood pressure<140 mmHg and diastolic blood pressure less than 90mmHg; diabetes - HbA1c <8%, asthma - Asthma Control Test score ≥16, depression - Patient Health Questionnaire 8 (PHQ-8) <10

    Measured: 12 months

  4. World Health Organisation Disability Assessment Schedule 2.0 score

    Mean functional disability score assessed using the 12-item WHODAS-2.0 (World Health Organisation Disability Assessment Schedule 2.0) tool. The scores range from 0-100, with higher scores indicating more functional limitations/disability

    Measured: 12 months

  5. Health-related quality of life EuroQol 5-Dimension 5-Level score

    Mean health-related quality of life score assessed using the EuroQol 5D-5L (EQ5D-5L). The EQ5D-5L score ranges from -0.493 (indicating the worst health state) to 1 (indicating the best health state

    Measured: 12 months

  6. Health-related quality of life visual analogue scale score

    Mean self-reported health-related quality of life score assessed using a visual analogue scale (VAS). The VAS score ranges from 0-100, with higher scores indicating better health status.

    Measured: 12 months

  7. Patient Assessment of Chronic Illness Care

    Mean Patient Assessment of Chronic Illness Care (PACIC) score. The score ranges from 1 - 5, with lower scores indicating worse satisfaction with chronic care and higher scores indicating more satisfaction

    Measured: 12 months

  8. Patient experience with treatment and self-management

    Mean scores for patient experience with treatment and self-management (PETS), assessed using a shortened version of the PETS tool. The tool has no overall score and uses domain scores with different ranges. Lower scores indicate more difficulty, and higher scores indicate more ease.

    Measured: 12 months

  9. Patient Health Questionnaire-8 (PHQ-8) score

    Mean scores for depressive symptoms assessed using the patient health questionnaire-8 (PHQ-8) tool. The score ranges from 0-24, with higher scores indicating worse depressive symptoms

    Measured: 12 months

  10. Social Support

    Number of patients reporting having social support for their care and medical needs, and mean social support score

    Measured: 12 months

  11. Healthcare utilisation - Number of clinic visits

    Number of clinic visits

    Measured: 12 months

  12. Healthcare utilisation - Number of hospital outpatient visits

    Number of hospital outpatient visits

    Measured: 12 months

  13. Healthcare utilisation - hospital admissions

    Number of hospital admissions

    Measured: 12 months

  14. Healthcare utilisation - hospital admission days

    Number of hospital in-patient days

    Measured: 12 months

  15. Health care costs

    The costs of accessing healthcare

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2024
  2. Study start19 Sep 2023
  3. Primary completion1 Nov 2025
  4. Study completion1 Nov 2025

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will be a type 2 hybrid trial, testing the effect of the intervention in improving clinical outcomes, and also testing and observing the effects of the intervention on implementation processes and outcomes using the RE-AIM (reach, effectiveness, adoption, implementation, maintenance) framework. The trial will be a cluster randomised parallel arm trial with embedded process evaluation.
Masking
None (open label)
Enrolment
1,837 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06248190
Sponsor's protocol ID
686/2022
Other IDs
201816, BREC/00005033/2022
Acronym
ENHANCE
Status last verified
Feb 2026
First submitted
17 Jan 2024
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).

Publications

  • Peer N, Uthman OA, Kengne AP. Rising prevalence, and improved but suboptimal management, of hypertension in South Africa: A comparison of two national surveys. Glob Epidemiol. 2021 Sep 10;3:100063. doi: 10.1016/j.gloepi.2021.100063. eCollection 2021 Nov.

    PubMed 37635713

  • Nguyen H, Manolova G, Daskalopoulou C, Vitoratou S, Prince M, Prina AM. Prevalence of multimorbidity in community settings: A systematic review and meta-analysis of observational studies. J Comorb. 2019 Aug 22;9:2235042X19870934. doi: 10.1177/2235042X19870934. eCollection 2019 Jan-Dec.

    PubMed 31489279

  • Hurst JR, Dickhaus J, Maulik PK, Miranda JJ, Pastakia SD, Soriano JB, Siddharthan T, Vedanthan R; GACD Multi-Morbidity Working Group. Global Alliance for Chronic Disease researchers' statement on multimorbidity. Lancet Glob Health. 2018 Dec;6(12):e1270-e1271. doi: 10.1016/S2214-109X(18)30391-7. No abstract available.

    PubMed 30420026

  • Mayosi BM, Flisher AJ, Lalloo UG, Sitas F, Tollman SM, Bradshaw D. The burden of non-communicable diseases in South Africa. Lancet. 2009 Sep 12;374(9693):934-47. doi: 10.1016/S0140-6736(09)61087-4. Epub 2009 Aug 24.

    PubMed 19709736

  • Oni T, Youngblood E, Boulle A, McGrath N, Wilkinson RJ, Levitt NS. Patterns of HIV, TB, and non-communicable disease multi-morbidity in peri-urban South Africa- a cross sectional study. BMC Infect Dis. 2015 Jan 17;15:20. doi: 10.1186/s12879-015-0750-1.

    PubMed 25595711

  • Gouda HN, Charlson F, Sorsdahl K, Ahmadzada S, Ferrari AJ, Erskine H, Leung J, Santamauro D, Lund C, Aminde LN, Mayosi BM, Kengne AP, Harris M, Achoki T, Wiysonge CS, Stein DJ, Whiteford H. Burden of non-communicable diseases in sub-Saharan Africa, 1990-2017: results from the Global Burden of Disease Study 2017. Lancet Glob Health. 2019 Oct;7(10):e1375-e1387. doi: 10.1016/S2214-109X(19)30374-2.

    PubMed 31537368

  • Kamkuemah M, Gausi B, Oni T. Missed opportunities for NCD multimorbidity prevention in adolescents and youth living with HIV in urban South Africa. BMC Public Health. 2020 Jun 1;20(1):821. doi: 10.1186/s12889-020-08921-0.

    PubMed 32487118

  • Herman AA, Stein DJ, Seedat S, Heeringa SG, Moomal H, Williams DR. The South African Stress and Health (SASH) study: 12-month and lifetime prevalence of common mental disorders. S Afr Med J. 2009 May;99(5 Pt 2):339-44.

    PubMed 19588796

  • COVID-19 Mental Disorders Collaborators. Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic. Lancet. 2021 Nov 6;398(10312):1700-1712. doi: 10.1016/S0140-6736(21)02143-7. Epub 2021 Oct 8.

    PubMed 34634250

  • Roomaney RA, van Wyk B, Turawa EB, Pillay-van Wyk V. Multimorbidity in South Africa: a systematic review of prevalence studies. BMJ Open. 2021 Oct 6;11(10):e048676. doi: 10.1136/bmjopen-2021-048676.

    PubMed 34615675

Questions about this trial

What is this clinical trial studying?

A study testing ENHANCE intervention (health systems) in people with HIV Infections and Hypertension, run by University of KwaZulu at 32 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 24 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 32 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite outcome: Diagnosis and treatment initiation for a new condition, intensification or change of treatment for a condition treated at enrolment, or improved control for a condition not optimally controlled at enrolment. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06248190, which also lists 10 linked publications.

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 Feb 2026.

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