RISE: Reducing Cancer and HIV Stigma Through Empowerment
2 other identifiers
interventional
440
1 country
1
Brief Summary
This multilevel randomized behavioral study evaluates participant- and provider-level stigma-reduction interventions in Zambia. Participant-level intervention: Women living with cervical cancer and HIV (WLC+H ) are randomized in a 2Ă—2 factorial design of storytelling versus neutral videos and storytelling versus neutral disclosure interventions to assess effects on quality of life, anxiety, and depressive symptoms. Provider-level intervention: Healthcare workers are randomized to storytelling or neutral videos to assess changes in stigma and compassion. The study also evaluates participant -reported stigma and satisfaction with care before and after implementation of the provider intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Sep 2026
Longer than P75 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2030
July 27, 2026
June 1, 2026
3.7 years
July 10, 2026
July 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quality of Life (Cancer)
Quality of life (cancer) will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G). The FACT-G contains 27 items that assess perceived quality of life of patients living with cancer over the past week.
Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up
Patient-level: Quality of Life (HIV)
Quality of life (HIV) will be assessed using a shortened version of the Patient-Reported Outcomes Quality of Life-HIV (PROQOL-HIV). The shortened PROQOL-HIV scale has four factors: physical health and symptoms; health concerns and mental distress, social and intimate relationships, and treatment impact.
Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up
Secondary Outcomes (2)
Patient-level: Depressive Symptoms
Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up
Patient-level: Anxiety Symptoms
Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up
Other Outcomes (5)
Provider-level: Social Stigma
Immediately before and immediately after the healthcare worker training session
Provider-level: Enacted Stigma
Immediately before and immediately after the healthcare worker training session
Provider-level: Compassion
Immediately before and immediately after the healthcare worker training session
- +2 more other outcomes
Study Arms (6)
Patient control group - neutral videos
EXPERIMENTALPatient storytelling group
EXPERIMENTALPatient self-disclosure group
EXPERIMENTALPatient combination group - storytelling video and storytelling disclosure
EXPERIMENTALProvider Storytelling group
EXPERIMENTALProvider waitlist control group
EXPERIMENTALInterventions
Participants in the control group will watch neutral videos and describe objective, non-emotional objects/events
The storytelling intervention group will watch the storytelling videos and then describe objective, non-emotional objects/events.
Participants will watch neutral videos and then talk/write about their cancer/HIV-related experiences to themselves.
The combination group will watch the storytelling videos and then talk/write about their cancer/HIV-related experiences to themselves.
Participants (healthcare workers) will watch storytelling videos in a group setting, followed by a facilitated discussion and role-playing to enhance empathy and understanding.
Participants will watch unrelated presentations in a group setting while on a waitlist. They will receive the intervention after completing the post-test.
Eligibility Criteria
You may qualify if:
- Patient-level intervention
- Women diagnosed with cervical cancer and HIV (stage I-IV)
- Receiving cancer treatment at the Cancer Disease Hospital in Zambia
- Aged 18 or above 4. Able to speak in English (the official language in Zambia) or one of four local languages (Bemba, Nyanja, Tonga, Lozi) for cultural inclusivity
- Provider-level intervention
- \. Employment at the Cancer Disease Hospital in Lusaka, Zambia
You may not qualify if:
- Patient-level intervention
- Inability to provide informed consent and presence of a major mental health disorder (e.g., schizophrenia or bipolar disorder), as determined by participant records or self-report.
- Provider-level intervention
- \. Inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qian Lu, MD, PHD
UT MD Anderson
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants and outcomes assessors
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2026
First Posted
July 27, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
May 31, 2030
Study Completion (Estimated)
August 31, 2030
Last Updated
July 27, 2026
Record last verified: 2026-06