Clinical trial NCT06934369: Improving Engagement in HIV and Cancer Care in Zimbabwe
Official title: Development and Evaluation of a Multi-Component Intervention to Support HIV Care Engagement Among Patients Receiving Cancer Treatment in Zimbabwe
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
HIV
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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. We 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. We will measure barriers to accessing HIV care, and disruptions to HIV care engagement during cancer treatment. Next, we 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. We will work with the cancer ward at the hospital to implement these strategies. Finally, we 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. We will measure acceptability of these strategies to both patients and hospital staff. We will also measure barriers to accessing HIV care and disruptions to HIV care engagement in the second group. We 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.


Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of strategies to improve engagement in HIV care during cancer treatment
timeFrame: Acceptability assessed at Months 1, 3, and 6 after enrollment in pilot cohort
Secondary outcomes:
measure: Missed ART prescription refills
timeFrame: From enrollment through 6 months of follow-up or completion of cancer treatment
measure: ART adherence
timeFrame: From enrollment through 6 months of follow-up or completion of cancer treatment
measure: Missed HIV clinical visits
timeFrame: From study enrollment through 6 months of follow-up or completion of cancer treatment
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: Parirenyatwa Hospital
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Michalina Montaño, PhD
role: PRINCIPAL_INVESTIGATOR
References: