RISE: Reducing Cancer and HIV Stigma Through Empowerment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neutral Video, Storytelling, Self disclosure, Combination.
- Who it may be relevant to
- Registry conditions: HIV, Cervical Cancer Stigma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 2×2 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.
Detailed description
People living with HIV face a substantially elevated risk of developing cancers due to compromised immunity. Among women, HIV significantly increases vulnerability to oncogenic human papillomavirus (HPV) infection, the primary cause of cervical cancer. This dual burden of cervical cancer and HIV disproportionately impacts low- and middle-income countries (LMICs), with Zambia exemplifying this crisis. Outcomes for affected individuals living with cervical cancer and HIV in LMICs are poor, with a one-year survival rate of just 65%. Addressing this intertwined public health challenge in LMICs is critical to advancing global efforts against cancer and HIV. This study uses a multilevel approach to address intersectional stigma at the patient and provider level.
In the participant -level component of the study, WLC+H (N=240) are randomly assigned to one of four conditions in a two (storytelling video vs. neutral video) by two (storytelling disclosure vs. neutral disclosure) factorial design. The primary outcome is quality of life (QOL), and the secondary outcomes are anxiety and depressive symptoms.
In the provider-level component of the study, healthcare workers (n=100) are randomly assigned to watch either storytelling or neutral videos. Outcomes (social and enacted stigma and compassion) among healthcare workers will be assessed pre-and post-intervention. An anonymous participant survey will also be administered to women living with cervical cancer and HIV (WLC+H) to compare outcomes between those treated before (control cohort, N=50) and after (intervention cohort, N=50) the implementation of the provider intervention. The anonymous patient survey will assess perceived stigma and satisfaction with care.
Interventions
- Behavioral Neutral Video
Participants in the control group will watch neutral videos and describe objective, non-emotional objects/events - Behavioral Storytelling
The storytelling intervention group will watch the storytelling videos and then describe objective, non-emotional objects/events. - Behavioral Self disclosure
Participants will watch neutral videos and then talk/write about their cancer/HIV-related experiences to themselves. - Behavioral Combination
The combination group will watch the storytelling videos and then talk/write about their cancer/HIV-related experiences to themselves. - Behavioral Video
Participants (healthcare workers) will watch storytelling videos in a group setting, followed by a facilitated discussion and role-playing to enhance empathy and understanding. - Behavioral Waitlist
Participants will watch unrelated presentations in a group setting while on a waitlist. They will receive the intervention after completing the post-test.
Primary outcome measures
- Quality of Life (Cancer) [Time frame: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up]
- Patient-level: Quality of Life (HIV) [Time frame: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up]
Secondary outcome measures (2)
- Patient-level: Depressive Symptoms [Time frame: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up]
- Patient-level: Anxiety Symptoms [Time frame: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up]
Eligibility criteria
Inclusion criteria
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
1\. Employment at the Cancer Disease Hospital in Lusaka, Zambia
Exclusion criteria
Patient-level intervention
1.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
1\. Inability to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- UT MD Anderson — Houston
Identifiers
NCT: NCT07728370 · 2025-1064 · NCI-2026-04821