CancerNCT06934369
Improving Engagement in HIV and Cancer Care in Zimbabwe
A study testing Strategies to improve HIV care engagement in people with Cancer and HIV, run by Fred Hutchinson Cancer Center at 1 site in Zimbabwe.
Trial summary
In Zimbabwe, people who have cancer and HIV may have a difficult time staying engaged in their HIV care while they are being treated for cancer. This is because HIV and cancer care are usually provided at different health facilities, which can result in barriers to accessing clinical care for both HIV and cancer at… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Strategies to improve HIV care engagement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteZimbabwe
- Study dates
- 18 Nov 2024to 1 Dec 2028
- 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
- Age 18 or older
- Registered patient at Parirenyatwa Hospital Radiotherapy Centre, receiving cancer treatment for a new diagnosis
- HIV-positive
Who cannot join
- Benign diagnosis or cancer recurrence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zimbabwe1 site, 1 recruiting
- Recruiting
Parirenyatwa Hospital
Harare
Margaret Borok, 263 (0) 712 400713, mborok@mweb.co.zw
About this study
Official title: Development and Evaluation of a Multi-Component Intervention to Support HIV Care Engagement Among Patients Receiving Cancer Treatment in Zimbabwe
In Zimbabwe, people who have cancer and HIV may have a difficult time staying engaged in their HIV care while they are being treated for cancer. This is because HIV and cancer care are usually provided at different health facilities, which can result in barriers to accessing clinical care for both HIV and cancer at the same time. It is important to remain engaged in HIV care, and continue taking medication to treat HIV throughout cancer treatment. The goal of this project is to identify barriers that make it difficult to stay engaged in HIV care and continue HIV treatment during cancer treatment and develop strategies to address them. The investigators will accomplish this by first observing a group of 150 people with cancer and HIV who are receiving cancer treatment at Parirenyatwa Hospital, in Harare, Zimbabwe. The investigators will measure barriers to accessing HIV care, and disruptions to HIV care engagement during cancer treatment. Next, the investigators will work with experts and key stakeholders to develop strategies that can be put in place at Parirenyatwa Hospital to better support engagement in HIV care during cancer treatment. The investigators will work with the cancer ward at the hospital to implement these strategies. Finally, the investigators will observe a second group of 150 people with cancer and HIV, who begin their cancer treatment at Parirenyatwa Hospital after the strategies have been put in place. The investigators will measure acceptability of these strategies to both patients and hospital staff. The investigators will also measure barriers to accessing HIV care and disruptions to HIV care engagement in the second group. The investigators will compare barriers to HIV care and HIV care engagement in the second group to the first group, to determine whether the strategies make it easier for people with cancer and HIV to remain engaged in HIV care during cancer treatment.
- Being tested
- Strategies to improve HIV care engagement
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategies to improve HIV care engagementOther
Based on the barriers to HIV care experienced by the pre-intervention cohort, we will design a system intervention to be implemented at the Radiotherapy Centre at Parirenyatwa Hospital. This intervention will include 2-3 components, each intended to improve engagement in HIV care or address specific barriers to HIV care. It may include strategies like improving documentation of HIV-related information in oncology patient records, improving processes for referrals and access to HIV-related prescriptions, and supporting better communication between oncology and HIV clinical care teams.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention cohort | No intervention | This is a pre-post study. The pre-intervention cohort will not experience any intervention. The barriers to HIV care experienced by the pre-intervention cohort will be documented and used to develop strategies to support engagement in HIV care during cancer treatment. After follow-up is complete for the pre-intervention cohort, we will implement the strategies to support engagement in HIV care at the Parirenyatwa Hospital Radiotherapy Centre. |
| Post-intervention cohort | Experimental | The intervention will be developed based on barriers to HIV care experienced by the pre-intervention cohort. It will be a system intervention, implemented at the Radiotherapy Centre at Parirenyatwa Hospital. It may include strategies like improving documentation of HIV-related information in oncology patient records, improving processes for referrals and access to HIV-related prescriptions, and supporting better communication between oncology and HIV clinical care teams. These strategies will be implemented with a period of process improvement between the pre- and post-intervention cohorts. Because the intervention will change the health system, all new patients who begin cancer treatment after the intervention is implemented will experience the health system updates. We will begin enrollment in the post-intervention cohort after process improvement is complete. Receives: Other: Strategies to improve HIV care engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of strategies to improve engagement in HIV care during cancer treatment
Acceptability of the strategies to improve engagement in HIV care during cancer treatment will be assessed using questionnaires administered during 6 months of follow-up after enrollment in the post-intervention cohort. The primary outcome will only be assessed in the post-intervention cohort.
Measured: Acceptability assessed at Months 1, 3, and 6 after enrollment in pilot cohort
Secondary outcomes (3)
Missed ART prescription refills
We will measure missed ART prescription refills by self-reported ability to collect ART during cancer treatment
Measured: From enrollment through 6 months of follow-up or completion of cancer treatment
ART adherence
We will measure ART adherence via self-reported missed ART doses, collected by questionnaire
Measured: From enrollment through 6 months of follow-up or completion of cancer treatment
Missed HIV clinical visits
We will measure missed HIV clinical visits by self-reported ability to attend HIV clinic visits during cancer treatment
Measured: From study enrollment through 6 months of follow-up or completion of cancer treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start18 Nov 2024
- Primary completion1 May 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a pre-post, quasi-experimental study design, consisting of an initial (pre-intervention) observational cohort, a period of intervention development and process improvement, and a second observational (post-intervention) cohort. The primary outcome of acceptability will be assessed only in the second cohort. Secondary outcomes will be compared between the pre-intervention and post-intervention cohorts.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michalina Montaño, Fred Hutchinson Cancer Center
- Investigators
- Michalina Montaño, PhD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934369
- Sponsor's protocol ID
- RG1123169
- Other IDs
- K01MH132505, NCI-2023-02951, 11131
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not an individual intervention - the intervention under study will be to the health system
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Multi-Component Intervention to Support HIV Care Engagement Among Patients Receiving Cancer Treatment in Zimbabwe
- ClinicalTrials.gov ID
- NCT06934369
- Acronym / sponsor ID
- RG1123169
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 18 Apr 2025 (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.
In Zimbabwe, people who have cancer and HIV may have a difficult time staying engaged in their HIV care while they are being treated for cancer. This is because HIV and cancer care are usually provided at different health facilities, which can result in barriers to accessing clinical care for both HIV and cancer at the same time. It is important to remain engaged in HIV care, and continue taking medication to treat HIV throughout cancer treatment. The goal of this project is to identify barriers that make it difficult to stay engaged in HIV care and continue HIV treatment during cancer treatment and develop strategies to address them. The investigators will accomplish this by first observing a group of 150 people with cancer and HIV who are receiving cancer treatment at Parirenyatwa Hospital, in Harare, Zimbabwe. The investigators will measure barriers to accessing HIV care, and disruptions to HIV care engagement during cancer treatment. Next, the investigators will work with experts and key stakeholders to develop strategies that can be put in place at Parirenyatwa Hospital to better support engagement in HIV care during cancer treatment. The investigators will work with the cancer ward at the hospital to implement these strategies. Finally, the investigators will observe a second group of 150 people with cancer and HIV, who begin their cancer treatment at Parirenyatwa Hospital after the strategies have been put in place. The investigators will measure acceptability of these strategies to both patients and hospital staff. The investigators will also measure barriers to accessing HIV care and disruptions to HIV care engagement in the second group. The investigators will compare barriers to HIV care and HIV care engagement in the second group to the first group, to determine whether the strategies make it easier for people with cancer and HIV to remain engaged in HIV care during cancer treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pre-post, quasi-experimental study design, consisting of an initial (pre-intervention) observational cohort, a period of intervention development and process improvement, and a second observational (post-intervention) cohort. The primary outcome of acceptability will be assessed only in the second cohort. Secondary outcomes will be compared between the pre-intervention and post-intervention cohorts.
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention cohort | No intervention | –This is a pre-post study. The pre-intervention cohort will not experience any intervention. The barriers to HIV care experienced by the pre-intervention cohort will be documented and used to develop strategies to support engagement in HIV care during cancer treatment. After follow-up is complete for the pre-intervention cohort, we will implement the strategies to support engagement in HIV care at the Parirenyatwa Hospital Radiotherapy Centre. |
| Post-intervention cohort | Experimental | Other: Strategies to improve HIV care engagementThe intervention will be developed based on barriers to HIV care experienced by the pre-intervention cohort. It will be a system intervention, implemented at the Radiotherapy Centre at Parirenyatwa Hospital. It may include strategies like improving documentation of HIV-related information in oncology patient records, improving processes for referrals and access to HIV-related prescriptions, and supporting better communication between oncology and HIV clinical care teams. These strategies will be implemented with a period of process improvement between the pre- and post-intervention cohorts. Because the intervention will change the health system, all new patients who begin cancer treatment after the intervention is implemented will experience the health system updates. We will begin enrollment in the post-intervention cohort after process improvement is complete. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Registered patient at Parirenyatwa Hospital Radiotherapy Centre, receiving cancer treatment for a new diagnosis
- HIV-positive
Key exclusion criteria (1 listed)
- Benign diagnosis or cancer recurrence
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 |
|---|---|---|
| Strategies to improve HIV care engagementBased on the barriers to HIV care experienced by the pre-intervention cohort, we will design a system intervention to be implemented at the Radiotherapy Centre at Parirenyatwa Hospital. This intervention will include 2-3 components, each intended to improve engagement in HIV care or address specific barriers to HIV care. It may include strategies like improving documentation of HIV-related information in oncology patient records, improving processes for referrals and access to HIV-related prescriptions, and supporting better communication between oncology and HIV clinical care teams. | Other | Post-intervention cohort |
Primary outcome
Acceptability of strategies to improve engagement in HIV care during cancer treatment
Time frame: Acceptability assessed at Months 1, 3, and 6 after enrollment in pilot cohort
Acceptability of the strategies to improve engagement in HIV care during cancer treatment will be assessed using questionnaires administered during 6 months of follow-up after enrollment in the post-intervention cohort. The primary outcome will only be assessed in the post-intervention cohort.
3 secondary outcomes
Missed ART prescription refills
Time frame: From enrollment through 6 months of follow-up or completion of cancer treatment
ART adherence
Time frame: From enrollment through 6 months of follow-up or completion of cancer treatment
Missed HIV clinical visits
Time frame: From study enrollment through 6 months of follow-up or completion of cancer treatment
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 29 Oct 2026.
- Individual participant dataSharing planned: No. This is not an individual intervention - the intervention under study will be to the health system
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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.
Michalina Montaño, PhD principal investigator
Fred Hutchinson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategies to improve HIV care engagement in people with Cancer and HIV, run by Fred Hutchinson Cancer Center at 1 site in Zimbabwe.
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 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: looking for participants now, as of the sponsor's last update on 29 Oct 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 Zimbabwe. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of strategies to improve engagement in HIV care during cancer treatment (time frame: Acceptability assessed at Months 1, 3, and 6 after enrollment in pilot cohort). 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 29 Oct 2026.