Improving Engagement in HIV and Cancer Care in Zimbabwe

April 29, 2026 updated by: Michalina Montaño, Fred Hutchinson Cancer Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
      • Harare, Zimbabwe
        • Recruiting
        • Parirenyatwa Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 or older
  • Registered patient at Parirenyatwa Hospital Radiotherapy Centre, receiving cancer treatment for a new diagnosis
  • HIV-positive

Exclusion Criteria:

  • Benign diagnosis or cancer recurrence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Pre-intervention cohort
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.
Experimental: Post-intervention cohort
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.
Other: Strategies to improve HIV care engagement
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Acceptability assessed at Months 1, 3, and 6 after enrollment in pilot cohort

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Missed ART prescription refills
Time Frame: From enrollment through 6 months of follow-up or completion of cancer treatment
We will measure missed ART prescription refills by self-reported ability to collect ART during cancer treatment
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
We will measure ART adherence via self-reported missed ART doses, collected by questionnaire
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
We will measure missed HIV clinical visits by self-reported ability to attend HIV clinic visits during cancer treatment
From study enrollment through 6 months of follow-up or completion of cancer treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fred Hutchinson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michalina Montaño, PhD, Fred Hutchinson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RG1123169
  • K01MH132505 (U.S. NIH Grant/Contract)
  • NCI-2023-02951 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 11131 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is not an individual intervention - the intervention under study will be to the health system

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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