Improving Engagement in HIV and Cancer Care in Zimbabwe

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: Recruiting
• Conditions: Cancer; HIV
• Intervention / Treatment: Other: Strategies to improve HIV care engagement

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zimbabwe
  • Harare, Zimbabwe
    • Recruiting
    • Parirenyatwa Hospital
    • Contact: Margaret Borok; Phone Number: 263 (0) 712 400713; Email: mborok@mweb.co.zw

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Acceptability assessed at Months 1, 3, and 6 after enrollment in pilot cohort

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Missed ART prescription refills	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	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	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

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Michalina Montaño, PhD, Fred Hutchinson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID 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