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HIV InfectionsInterCARENCT05414526

Integrating Hypertension and Cardiovascular Diseases Care Into Existing HIV Services Package in Botswana (InterCARE)

A study testing InterCARE package in people with HIV Infections and Hypertension, run by University of Botswana at 3 sites in Botswana.

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 InterCARE research project proposes to leverage a successful national ART program to develop an effective package to improve the uptake of established effective hypertension and CVD risk factors management interventions among PLWHIV in Botswana and other low- and middle-income countries. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
HIV Infections, Hypertension
What is being tested?
InterCARE package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,655 participants
Where
3 sitesBotswana
Study dates
31 Jan 2023to 10 Sep 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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 20-75 years old
  • Documented HIV-infection on ART
  • Confirmed diagnosis of hypertension or elevated blood pressure >140/90mmHg versus >130/80mmHg if they have underlying Diabetes Mellitus or Chronic Kidney Disease
  • Receiving regular care at the selected clinics
  • Adults aged 18 years of age or older
  • Selected to be a treatment partner by participant.

Who cannot join

  • ● Positive for HIV-related dementia

Trial locations and contacts

3 sites in 1 country.

Botswana3 sites

  • 14 Infectious Diseases Care centres (IDCCs) nationwide

    Gaborone, 0000

  • Phitsane-Molopo IDCC Clinic

    Pitsane

  • Tonota IDCC Clinic

    Tonota

Other trials in Botswana

About this study

The InterCARE research project proposes to leverage a successful national ART program to develop an effective package to improve the uptake of established effective hypertension and CVD risk factors management interventions among PLWHIV in Botswana and other low- and middle-income countries.

Being the first project of its kind in Botswana, if successful, the InterCARE package could be readily rolled out to health facilities nationwide to diagnose, treat, track, and support the estimated 25-30% Batswana with hypertension.

Read the detailed description

The InterCARE research project is in 2 phases:

  1. Phase 1 is a pilot study to refine the 3 interventions mentioned above. This formative phase will take place between September 2021 and November 2022. Clinics staff will receive training on the management of CVD (and hypertension in particular) in-person or online. Attendees feedback will be sought to improve the curriculum prior to being rolled-out in the next phase of this research project. In parallel, the InterCARE Study Team will work with the 2 clinics Information Technology teams to adapt the existing electronic health records with CVD-specific flags, medication lists and laboratory panels. Finally, up to 288 participants (PLWHIV) and their treatment partners will be enrolled from those 2 clinics patients lists to pilot the overall InterCARE package. The results and experiences from the pilot stage will be assessed and collated to make improvements to each of the 3 intervention in the package. This final set of improved interventions will be the basis of the second phase of the InterCARE research project. Phase 1 was successfully completed in November 2022.
  2. The InterCARE package will be tested as a cluster randomised trial in 14 clinics around Botswana: 7 clinics will receive the InterCARE package while the remaining 7 clinics will not received any intervention, continuing with the local standard of care, with a target combined recruitment target of 4652 participants overall, to be followed up for 24 months.

Phase 2 is anticipated to take place from January 2023 to July 2025.

Being tested
InterCARE package
Medical subject headings
HIV Infections, Hypertension

What participants receive

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

  • InterCARE packageOther

    The InterCARE package includes:

    1. Healthcare Provider HTN/CVD Curriculum A new HTN curriculum will be developed in collaboration with local stakeholders using KITSO Master trainer program documents (Healthcare provider HIV curriculum), Primary Care Guidelines, HTN/CVD curriculum/protocols trialled in Kweneng District and the CDC Prevention Hypertension Management Curriculum.
    2. Adaptation of HIV care EHR for HTN/CVD care EHR modifications will be done to enhance data collection around HTN/CVD care, with input from MoH.
    3. Patient and treatment partner sessions Clinic staff will provide in-clinic education and counselling on HTN/CVD to all PLWHIV with a diagnosis of hypertension during their routine HIV clinic visit. All patients will be provided a take-home easy-to-read pamphlet on HTN/CVD risk factor management. All PLWHIV will be asked to bring a treatment partner from their social network at the 2nd study visit so that they can practice role-plays with each other.
Study groups in NCT05414526
Study groupRoleWhat they receive
InterCARE packageExperimentalThe type 2 hybrid effectiveness-implementation study will be cluster randomized trial with 1:1 paired randomization (Intervention arm vs Control arm )Using the coin flip randomization method, one clinic will be randomized to the intervention condition, and one to the control condition.
Receives: Other: InterCARE package

What is being measured

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

  1. Effectiveness

    Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication with controlled blood pressure

    Measured: Every 6 months for 2 years

  2. Implementation

    Proportion of clinic encounters in electronic health records where anti-hypertensive medications are prescribed if indicated, as attained from electronic health records

    Measured: Every 6 months for 2 years

Secondary outcomes (11)

  1. Reach

    Proportion of PLWHIV who are aware of their hypertension status

    Measured: Every 6 months for 2 years

  2. Effectiveness

    Decrease in mean systolic blood pressure and mean diastolic blood pressure at 12 and 24 months

    Measured: Every 12 months for 2 years

  3. Adoption

    Proportion of PLWHIV with hypertension with 10-year cardiovascular risk calculated in the electronic health records

    Measured: Every 6 months for 2 years

  4. Reach

    Proportion of PLWHIV with diagnosed hypertension receiving anti-hypertensive medication or with BP control not on medications

    Measured: Every 6 months for 2 years

  5. Maintenance

    Proportion of PLWHIV with HTN enrolled in InterCARE with BP control who maintain blood pressure control in next study visit

    Measured: Every 6 months for 2 years

  6. Adoption

    Proportion of PLWHIV with HTN enrolled in InterCARE receiving HTN and HIV care in the same clinic visit

    Measured: Every 6 months for 2 years

  7. Fidelity

    Proportion of PLWH and HTN on medications with correct regimen per national guidelines

    Measured: Every 6 months for 2 years

  8. Maintenance

    Provider and patient perceptions of ability to maintain a change in blood pressure control:Pre and Post implementation surveys will be used to assess this outcome

    Measured: Every 12 months for 2 years

  9. Maintenance

    Proportion of intervention clinics that implemented the three components of InterCARE

    Measured: At the end of the trial (24 months)

  10. Acceptability

    Acceptability to patients,mopati and providers (survey and interviews) of the implementation strategy

    Measured: At the end of the trial

  11. Effectiveness

    Proportion of PLWHIV with >70% pass on Heart Disease Fact Questionnaire (HDFQ) (health knowledge) .HDFQ score (out of 100):Minimum 0,maximum score 100 :Better Score >70%

    Measured: Every 6 months for 2 years

Timeline

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

  1. First posted10 Jun 2022
  2. Study start31 Jan 2023
  3. Primary completion10 Sep 2025
  4. Study completion10 Sep 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
Not applicable
Intervention model
Single group
Model description
InterCARE is the name of the package of implementation strategies proposed by the investigators that are intended to integrate cardiovascular care services into existing HIV care systems in Botswana. The InterCARE package includes 3 main interventions: 1. a tailored inter-professional training curriculum on management of CVD risk and HIV 2. adaptation of the existing electronic health records (PIMS) 3. adoption of a treatment partner support system.
Masking
None (open label)
Enrolment
4,655 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05414526
Sponsor's protocol ID
InterCARE project
Acronym
InterCARE
Status last verified
May 2026
First submitted
18 May 2022
Last updated
12 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data recorded as part of the study will be anonymised and will be deposited in a secured archiving facility at the University of Botswana Health Records Unit. Researchers may request access to data as part of transparency and data sharing however this is strictly upon request and will be governed through the required legal office, with at the least, a Data Sharing Agreement in place. Further details on this can be found in our Data Management plan.

Publications

  • Mosepele M, Gaolathe T, Kebotsamang K, Moshomo T, Mawi M, Seipone K, Kgotlaetsile K, Molebatsi K, Molefe-Baikai OJ, Kelepile M, Ramotsababa M, Mogaetsho EG, Ponatshego P, Jarvis JN, Gala P, Van Pelt A, Phaladze N, Bogart L, Jaffar S, Wang D, Hirschhorn LR. Integrating hypertension care into the existing HIV services package in Botswana (InterCARE): a pair-matched, cluster-randomised, type 2 hybrid effectiveness-implementation trial. Lancet Glob Health. 2026 Aug 12:104041. doi: 10.1016/j.langlo.2026.104041. Online ahead of print.

    PubMed 42586107

  • Gala P, Mugala A, Hickey MD, Ordonez CE, Gimbel S, Galaviz KI, Lalla-Edward ST, Kiggundu JB, Henry DA, Mogaetsho GE, Aifah A, Katahoire A, Semitala F, Hirschhorn LR. Models for Integrated HIV-Hypertension Care: Comparative Analysis of Six Integration Approaches from Implementation Research Projects Across Africa. Res Sq [Preprint]. 2026 Jun 17:rs.3.rs-9464167. doi: 10.21203/rs.3.rs-9464167/v1.

    PubMed 42370263

  • Youssouf N, Mogaetsho GE, Moshomo T, Gaolathe T, Ponatshego P, Ramotsababa M, Molefe-Baikai OJ, Dintwa E, Kiki T, Van Pelt AE, Steger-May K, Bogart LM, Jaffar S, Gala P, Wang D, Seipone K, Bennett K, Hurwitz KW, Kebotsamang K, Hirschhorn LR, Mosepele M. Designing an implementation science clinical trial to integrate hypertension and cardiovascular diseases care into existing HIV services package in Botswana (InterCARE). Trials. 2024 Jul 29;25(1):510. doi: 10.1186/s13063-024-08333-0.

    PubMed 39075506

  • Moshomo T, Gaolathe T, Ramotsababa M, Molefe-Baikai OJ, Mogaetsho E, Dintwa E, Gala P, Ponatshego P, Bogart LM, Youssouf N, Seipone K, Van Pelt AE, Bennett K, Jaffar S, Ilias M, Tonwe V, Hurwitz KW, Kebotsamang K, Steger-May K, Hirschhorn LR, Mosepele M. Quantitative outcomes of a type 2 single arm hybrid effectiveness implementation pilot study for hypertension-HIV integration in Botswana. Implement Sci Commun. 2024 Jul 22;5(1):80. doi: 10.1186/s43058-024-00620-w.

    PubMed 39039609

  • Gala P, Ponatshego P, Bogart LM, Youssouf N, Ramotsababa M, Van Pelt AE, Moshomo T, Dintwa E, Seipone K, Ilias M, Tonwe V, Gaolathe T, Hirschhorn LR, Mosepele M. A mixed methods approach identifying facilitators and barriers to guide adaptations to InterCARE strategies: an integrated HIV and hypertension care model in Botswana. Implement Sci Commun. 2024 Jun 20;5(1):67. doi: 10.1186/s43058-024-00603-x.

    PubMed 38902846

Questions about this trial

What is this clinical trial studying?

A study testing InterCARE package in people with HIV Infections and Hypertension, run by University of Botswana at 3 sites in Botswana.

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 6 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: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Botswana. 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?

Effectiveness (time frame: Every 6 months for 2 years). The study lists 2 primary outcomes in all. 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 NCT05414526, which also lists 5 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 12 May 2026.

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