HIVNCT07728370
RISE: Reducing Cancer and HIV Stigma Through Empowerment
A study testing Neutral Video, Storytelling and Self disclosure in people with HIV and Cervical Cancer Stigma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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 2×2 factorial design of storytelling versus neutral videos and storytelling versus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Cervical Cancer Stigma
- What is being tested?
- Neutral Video, Storytelling and Self disclosure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson
Houston, Texas, 77030
Qian Lu, MD, PHD, (713) 745-8324, qlu@mdanderson.org
Qian Lu, MD, PHD
About this study
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.
Read the 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.
- Conditions
- HIV, Cervical Cancer Stigma
- Being tested
- Neutral Video, Storytelling, Self disclosure, Combination, Video
- Keywords
- HIV, Stigma, Cervical Cancer, Storytelling, Self-disclosure, Videos, Healthcare Providers, Multilevel
- Medical subject headings
- Social Stigma, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neutral VideoBehavioural
Participants in the control group will watch neutral videos and describe objective, non-emotional objects/events
StorytellingBehavioural
The storytelling intervention group will watch the storytelling videos and then describe objective, non-emotional objects/events.
Self disclosureBehavioural
Participants will watch neutral videos and then talk/write about their cancer/HIV-related experiences to themselves.
CombinationBehavioural
The combination group will watch the storytelling videos and then talk/write about their cancer/HIV-related experiences to themselves.
VideoBehavioural
Participants (healthcare workers) will watch storytelling videos in a group setting, followed by a facilitated discussion and role-playing to enhance empathy and understanding.
WaitlistBehavioural
Participants will watch unrelated presentations in a group setting while on a waitlist. They will receive the intervention after completing the post-test.
| Study group | Role | What they receive |
|---|---|---|
| Patient control group - neutral videos | Experimental | Not described Receives: Behavioral: Neutral Video |
| Patient storytelling group | Experimental | Not described Receives: Behavioral: Storytelling |
| Patient self-disclosure group | Experimental | Not described Receives: Behavioral: Self disclosure |
| Patient combination group - storytelling video and storytelling disclosure | Experimental | Not described Receives: Behavioral: Combination |
| Provider Storytelling group | Experimental | Not described Receives: Behavioral: Video |
| Provider waitlist control group | Experimental | Not described Receives: Behavioral: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up
Secondary outcomes (2)
Patient-level: Depressive Symptoms
Depressive symptoms will be assessed using the 10-item short form of the Center of Epidemiologic Studies Depression Scale (CES-D-10). Participants are asked to rate the frequency with which each symptom or mood occurred during the prior week.
Measured: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up
Patient-level: Anxiety Symptoms
Anxiety symptoms will be measured using the 6-item Anxiety Subscale of the Brief Symptom Inventory (BIS). Participants are asked to indicate how much they have been othered/distressed by each symptom (e.g., nervousness or
Measured: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 May 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Diseases Hospital; University of Zambia
- Responsible party
- Sponsor
- Investigators
- Qian Lu, MD, PHD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728370
- Sponsor's protocol ID
- 2025-1064
- Other IDs
- NCI-2026-04821
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RISE: Reducing Cancer and HIV Stigma Through Empowerment
- ClinicalTrials.gov ID
- NCT07728370
- Acronym / sponsor ID
- 2025-1064
- Conditions
- HIV, Cervical Cancer Stigma
- Keywords
- HIV, Stigma, Cervical Cancer, Storytelling, Self-disclosure, Videos, Healthcare Providers, Multilevel
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cancer Diseases Hospital; University of Zambia
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patient control group - neutral videos | Experimental | Behavioral: Neutral Video |
| Patient storytelling group | Experimental | Behavioral: Storytelling |
| Patient self-disclosure group | Experimental | Behavioral: Self disclosure |
| Patient combination group - storytelling video and storytelling disclosure | Experimental | Behavioral: Combination |
| Provider Storytelling group | Experimental | Behavioral: Video |
| Provider waitlist control group | Experimental | Behavioral: Waitlist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neutral VideoParticipants in the control group will watch neutral videos and describe objective, non-emotional objects/events | Behavioural | Patient control group - neutral videos |
| StorytellingThe storytelling intervention group will watch the storytelling videos and then describe objective, non-emotional objects/events. | Behavioural | Patient storytelling group |
| Self disclosureParticipants will watch neutral videos and then talk/write about their cancer/HIV-related experiences to themselves. | Behavioural | Patient self-disclosure group |
| CombinationThe combination group will watch the storytelling videos and then talk/write about their cancer/HIV-related experiences to themselves. | Behavioural | Patient combination group - storytelling video and storytelling disclosure |
| VideoParticipants (healthcare workers) will watch storytelling videos in a group setting, followed by a facilitated discussion and role-playing to enhance empathy and understanding. | Behavioural | Provider Storytelling group |
| WaitlistParticipants will watch unrelated presentations in a group setting while on a waitlist. They will receive the intervention after completing the post-test. | Behavioural | Provider waitlist control group |
Primary outcome
Quality of Life (Cancer)
Time frame: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up
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.
Patient-level: Quality of Life (HIV)
Time frame: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qian Lu, MD, PHD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neutral Video, Storytelling and Self disclosure in people with HIV and Cervical Cancer Stigma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qian Lu, MD, PHD ((713) 745-8324, qlu@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (Cancer) (time frame: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.