Manipal HIV and Cancer Stigma Study
- Conditions
- Human immunodeficiency virus [HIV]disease, (2) ICD-10 Condition: C00-D49||Neoplasms,
- Registration Number
- CTRI/2019/03/018073
- Lead Sponsor
- NCI National Institute of Health
- Brief Summary
1Study OverviewAs improved access to HIV treatment has led to an increasein life expectancy, cancer incidence is rising among people living with HIV(PLWH) in the West and we anticipate a similar increase in low andmiddle-income countries (LMIC) over the next few years. Provision of palliativecare is woefully inadequate in many LMIC, and while research has been makingadvancements, studies on the unique challenges presented by dually diagnosedpatients across the care continuum are lagging. There is now an extensive globalliterature showing that stigma can have adverse health consequences and lead todelay of care seeking among patients diagnosed with either HIV or cancer inboth high-income settings and LMIC. However, its role has not yet been studiedin terms of access to appropriate and effective palliative and end of life careand we don’t know how stigma operates in people living with both HIV andcancer. Among PLWH, perceptions of and experiences with HIV stigma anddiscrimination, stigma fears and internalized stigma can lead tonon-disclosure, depression, and non-adherence. The addition of a cancerdiagnosis in a setting where health providers have less experience treatingPLWH may lead to additional layers of stigma, further complicating both careseeking and the provision of treatment.
The study builds on our research program on HIV stigma inIndia and cancer palliative care in sub-Saharan Africa and extends it topalliative care among co-morbid patients in India. The aim is to adapt ourqualitative and quantitative measures of HIV stigma and palliative careoutcomes using a culturally-sensitive model, for use among people living withco- morbid HIV and cancer in India, and to adapt a novel intervention showneffective in Africa to improve access to effective palliation and end of lifedecisions throughout the care continuum in India.
2 Specific AimsAim 1: Examinedimensions of stigma and their role in care seeking, palliation, and end-of-life decisions across the care continuum amongpatients with comorbid HIV and cancer, their family members, and oncologystaff.
Aim 2: Adaptour existing Indian HIV stigma model and study measures to PLWH with cancer andpilot the adapted Africa Palliative Outcome Scale (POS) and HIV stigma scale.
Aim 3: Test ouradapted HIV/cancer stigma model.
Study siteThis study is located at ManipalUniversity (Manipal Academy of Higher Education). It includes
· KasturbaMedical College (KMC)
· KMC’s teachinghospital, Kasturba Hospital
· KMC alsoincludes Shirdi Saibaba Cancer Hospital and Research Center
EligibilityCriteria**Inclusion Criteria**
Potential participants must meet the following general inclusioncriteria to be considered:
· Able to provide informed consent and participate in thestudy
· Speak Kannada or English
Specific inclusion criteria for the sub-populations are below:
- Patients
- Be 18 years of age or older
- Be HIV-positive per clinic records and have a diagnosed malignancy (per referring physician)
- Family Members
- Be 18 years of age or older
- Be an adult family member identified by a study patient who meets the above criteria
- Oncology staff
- Be 18 years of age or older
- Be a clinical oncology professional (medicine or nursing).
If a patient orhis/her family member does not meet all the inclusion criteria , theinterviewer will thank the individual for taking time to speak with us andoffer to escort him or her back to the clinic.
**Sampling Criteria**
We will recruit patients from different age groups and stages ofmalignancy, and we expect the sample to be approximately 50% female.
Family members will be recruited to reflect a variety ofrelationships to the patient, such as being the patient’s parent, spouse,sibling or son/daughter.
Oncology staff will be recruited to reflect professional diversity(medicine and nursing), their experience with treating PLWH, and the length oftheir clinical experience.
Study staff will keep a table of interviewees’ demographics (e.g.,gender, age, length of time since diagnosed with malignancy, family relationshipto patient, type of oncology staff, etc.), based on the initial quantitativeportion of the interview guide. During weekly study team meetings, staff will discuss recruitment status of intervieweedemographics during the previous week and whether certain subgroups needadditional outreach.
Enrollment, Referrals, and Screening **Sample Size**
The study investigators will determine when recruitment iscompleted, based on thematic saturation but approximately 20 patients who aredually diagnosed with HIV and a malignancy, 20 family members of thesepatients, and 20 oncology staff will be recruited for interviews.
**Referral and Recruitment**
*Note:Study interviewers will screen and conduct interviews with patient and familymember participants. The research fellow will screen and conduct the interviewswith oncology staff. All sections below refer to any individual who conductsinterviews as an “interviewer,†regardless if that is a staff interviewer orthe research fellow.*
Patients will be referred to study staff by our HIV andoncology colleagues at KMC. Family members will be identified byeligible and interested patients. Oncology staff will be recruited .
2.3 Qualitative Interview Guide The interview guides provided here will bereviewed, revised, and finalized prior to implementation, and are for the followingsamples: (1) Patients, (2) Families/Care givers, and (3) Oncology staff.
Datamanagement for qualitative interviews **Post-interviewprocedures for interviewer**
1. After completing the interview, the interviewer reviews the audio recording to ensure it was properly recorded. The interviewer will review their field notes for clarity and accuracy and summarize the interview while it is still fresh in their mind.
1. The audio recording will beuploaded to a secure password protected server in the audio recording folderand the file name will be labelled with the participant ID number and date ofthe interview. Each file will be kept in a folder identified by the participantID number and the date of the interview.
2. The field notes will be scanned to the same server in the field note folder with participant ID number and date of interview. Any direct identifying information will be removed.
3. The research fellow will review the audio recording to ensure it was uploaded properly before the recording is erased from the recorder. After correct uploading is confirmed, the interviewer will delete the recording from the recorder. The research fellow will review the field notes and return the notes to the interviewer for any clarifications within one day.
**Transcription**
1. The interviewer will complete the transcription of the audio file within 2 days of completing the interview.
2. The transcripts will note the participant ID number in the footer of each page.
3. The transcripts will not include any identifying information about the participant. Use the participant’s initial, not his/her name. Any identifying place name should instead be described as a village, small town, city etc.
4. Any interruptions that occurred during the interview will be transcribed as ellipses in parentheses in the text, i.e., (…). Examples of interruptions may include someone entering the room or the audio tape being stopped.
5. Any non-verbal expressions by a participant (sobbing, consoling, patting, etc.) will be included in the transcript by noting the type of non-verbal expression in parentheses, i.e., (laughs), (crying).
6. Once the transcription is completed, the second interviewer will cross-check the transcription against the audio recording for accuracy within 24 hours. If the second interviewer finds any discrepancies between the audio recording and the transcript, s/he will note the discrepancy in brackets, i.e., [xxxxx], in the transcript. Examples of discrepancies to be noted include, but are not limited to, typos, missed words, or misunderstood language.
**Translation**
1. Interviews completed in Kannada will be translated into English by a translation service and checked for accuracy within 48 hours of being transcribed.
2. The research fellow will review the translations to check that the English version captures if the English terminology makes sense, within 24 hours of receiving the translated interview.
3. Once the translation has been reviewed for accuracy, it will be saved to a secure password protected server to be accessed by the study investigators. Note, once two interviews have been completed, transcribed and translated, they also need to be emailed immediately to Maria and Richard. No additional interviews make be conducted by the interviewer whose transcripts were sent, until feedback has been obtained and discussed.
4. The research fellow will update the study investigators and UCSF project coordinator about uploaded transcripts on a weekly basis.
7. The research fellow will keeptrack of the status of interview completion, transcription, and translation inthe interview log.
1Protection of Human Subjects**RISKS TO HUMANSUBJECTS**
**Human Subjects Involvement, Characteristics, and Design:** Participants in thequalitative interviews (Aim 1) will include HIV-infected individuals referredfrom the participating HIV and oncology clinics in Manipal, India We willrecruit 20 patients, 20 family members and 20 oncology clinic staff (physiciansand nurses). For the cognitive interviews (Aim 2), 12 patients will berecruited. For the quantitative study (Aim 3), 240 patients will be recruited(80 with cancer and HIV, 80 with HIV only, and 80 with cancer only).
For **Aim 1**, we will interview a purposive sample of 20 patientswho are dually diagnosed with HIV and a malignancy and one family member perpatient for a total of 20 family members. Patient inclusion criteriaare: At least 18 years of age, with confirmed HIV infection (per clinicrecords) and a diagnosed malignancy, (per the referring clinician), and abilityto consent, per Katzman et al. “ShortOrientation-Memory-Concentration Test of cognitive impairment†(84) Apurposive sampling frame will be applied to recruit a diverse sample withrespect to gender, age, and malignancy (both early and late).
The semi-structuredinterviews with patients will address their understandings of their illness, fears,social dimensions of disease, how they ask questions of their HIV and oncologyteams, patient communication to family, friends, and oncologists, whatconstitutes good care, their understanding of opioids, and concepts ofincurable disease and palliation. The interview guide for Âfamily memberswill address similar topics to the patient interviews as well as asses theircommunication with HIV physicians and oncologists and informationsharing/withholding from patients, as well as economic costs to the family ofcancer treatment and care.
We will also recruit a purposive sampleof 20 clinical oncology professionals (medicine and nursing) from KMCManipal using flyers and presentations by investigators at staff meetings. Wechoose these professionals as they are usually responsible for sharingdiagnosis, prognosis, treatment planning and referral to palliative care. Inorder to develop an understanding of stigma within the delivery of HIV cancercare, our purposive approach will yield a diverse sample with respect toprofessional designation (oncological discipline) HIV experience (experience oftreating PLWH who have cancer) palliative care experience (thoseexperienced/trained and naïve),and length of experience. Samplingcharacteristics will include age, gender, and profession.
Interviews with oncologystaff will addressprofessional and personal concerns around treating cancer patients with HIV,whether stigma around transmission fears, blame, misconceptions, death, dying,and opioid use affect clinical management in terms of patient understanding,communication (disclosure, family vs patient-led decisions making), andchallenges to pain relief, perceived potential dangers(psychologically/physically to the patient, and professionally to theoncologist) and benefits of different strategies. We will explore these issuesin scenarios of diagnosis, poor prognosis, and terminal care.
All qualitative interviews in **aim 1** will be digitally recordedfollowing written consent and will take place in a setting of the participant’schoice. Interviews will be conducted face to face in the local and preferredlanguage of the participant. They will be made aware of the nature of theinterview topics and that they have the option to refuse to answer anyquestion, or pause or terminate the interview at any given time. Patientinterviews will be conducted separately from their family members, however,interviewees will be allowed to request to have joint interviews or to have afamily member present. Recruitment will continue until data saturation isachieved, i.e. we identify no more substantive themes during analysis. Based onour experience with similar populations, we anticipate needing no more than 20patients, 20 family members and 20 oncology staff to accomplish this.
**ADEQUACY OF PROTECTION AGAINSTRISKS**
**Recruitment andInformed Consent:** To maximize our recruitment of participants with comorbid cancer andHIV (aim 1 and aim 3), their family members (aim1) and patientsdiagnosed with either HIV or cancer (aim 2 and aim 3) we will use multiple outreach strategies foundeffective during our previous studies with this population to encouragereferrals by staff as well as patient self-referrals. Our team has excellent contacts in theoncology and palliative medicine departments and HIV clinic at KMC Manipal. Toinitiate recruitment project staff will visit all referral sites, speaking tostaff and administrators explaining the study and referral procedures andhanding out cards with the phone number of the study coordinator that can bedistributed to any interested patients.
**POTENTIAL BENEFITS OF THE PROPOSEDRESEARCH TO HUMANS SUBJECTS AND OTHERS**
Our previous research has shown thatparticipation in palliative care research interviews is perceived as beneficialin terms of contributing to palliative care science and also is beneficial inenabling the participant to reflect on important matters. However, we do notanticipate direct benefits in terms of patient and family health status andaccess to care will be identical regardless of study participation.
**DATA SAFETY AND MONITORING PLAN**
The safety and security of all study data are a part of theconfidentiality arrangement between the investigators and the participants. Thedata will be gathered through qualitative interviews andinterviewer-administered questionnaires. Hard copies of all study data will bestored in a locked file cabinet at the project office and will not include anyidentifying information. All data will be entered and securely stored onproject servers and will be uploaded to UCSF servers via a secure web-portal.All electronically gathered information will be accessible only throughpassword protected networks. Only the key investigators, the projectstatistician, the data manager, and the research fellow will have access to thefile cabinet and the electronic databases. All hard copies of participants’contact information will be destroyed upon completion of the project. Webelieve that these steps will provide protection of collected data and ensureparticipants’ confidentiality.
4 Adverse Event Reporting **Definition of an Adverse Event (AE)** An **AE**is any undesirable effect in a subject enrolled in a study. An AE does notnecessarily have a causal relationship with the procedures. An AE can be anyunintended and unfavorable sign, symptom, abnormality, or condition temporallyassociated with an investigational intervention whether or not related to studyparticipation.
Types of AdverseEvents:
***ExpectedAdverse Event*** is an AE that may be reasonably anticipated to occur as a resultof the study procedures or study participation.
***UnexpectedAdverse Event*** is an AE that may occur during the course of researchparticipation that was *unanticipated*, or was *more severe* or *more frequent*than expected.
***SeriousAdverse Event (SAE)*** is any AE that results in any of the following outcomes:
· Death
· Life-threateningadverse experience (as defined as any adverse event that places the respondentor subject, in the view of the investigator, at immediate risk of death fromthe reaction as it occurred, i.e., it does not include a reaction that, had itoccurred in a more severe form, might have caused death.)
· In respondenthospitalization or prolongation of existing hospitalization
· Any otherexperience that suggests a significant hazard, contraindication, side effect,or precaution that may require medical or surgical intervention to prevent oneof the outcomes listed above
· Event changes the risk/benefit ratio of the study
The followingdefinitions should be used to assess the AE relationship to studyparticipation:
· ***Related***: An AE is related to studyparticipation if there is a reasonable possibility that the event may have beencaused by study participation. A ***related***event has a **strongtemporal relationship** and an alternative cause is unlikely.
· ***ProbablyRelated***: An AE that has a reasonable possibility that the eventis likely to have been caused by study participation. The AE has a **timelyrelationship** to the study procedure(s) and **follows aknown pattern of response**, but a potential alternative causemay be present.
· ***PossiblyRelated***: AnAE that has a reasonable possibility that the event may have been caused bystudy participation. The AE has a **timely relationship** to the study procedure(s); **however,follows no known pattern of response**, and an alternative causeseems more likely, or there is significant uncertainty about the cause of theevent.
***Unrelated***: The cause of the AE is known and the event isin no way related to any aspect of study participation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Potential participants must meet the following general inclusion criteria to be considered: •Able to provide informed consent and participate in the study •Speak Kannada or English Specific inclusion criteria for the sub-populations are below: •Patients oBe 18 years of age or older oBe HIV-positive per clinic records and have a diagnosed malignancy (per referring physician) •Family Members oBe 18 years of age or older oBe an adult family member identified by a study patient who meets the above criteria •Oncology staff oBe 18 years of age or older oBe a clinical oncology professional (medicine or nursing).
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Examine dimensions of stigma and their role in care seeking, palliation, and end-of-life decisions across the care continuum among patients with comorbid HIV and cancer, their family members, and oncology staff 24months
- Secondary Outcome Measures
Name Time Method 1: Adapt our existing Indian HIV stigma model and study measures to PLWH with cancer and pilot the adapted Africa Palliative Outcome Scale (POS) and HIV stigma scale. 2: Test our adapted HIV/cancer stigma model.
Trial Locations
- Locations (1)
Kasturba Medical College and Hospital, Manipal
🇮🇳Udupi, KARNATAKA, India
Kasturba Medical College and Hospital, Manipal🇮🇳Udupi, KARNATAKA, IndiaDr Naveen SalinsPrincipal investigator9969683669naveensalins@gmail.com