[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07728370":3,"trial-entities:NCT07728370":118,"trial-summary:NCT07728370":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":66,"secondary_outcomes":74,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":14,"eligibility_criteria":84,"std_ages":88,"locations":91,"central_contacts":109,"overall_officials":111,"references":113,"see_also_links":114},"NCT07728370","2025-1064","RISE: Reducing Cancer and HIV Stigma Through Empowerment","NOT_YET_RECRUITING","2030-08-31","2026-06","2026-07-27","2026-09-01","M.D. Anderson Cancer Center","OTHER",false,"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.","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.\n\nIn 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.\n\nIn 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.",[18,19],"HIV","Cervical Cancer Stigma",[18,21,22,23,24,25,26,27],"Stigma","Cervical Cancer","Storytelling","Self-disclosure","Videos","Healthcare Providers","Multilevel","INTERVENTIONAL","SUPPORTIVE_CARE",[31],"NA",{"count":33,"type":34},440,"ESTIMATED",[36,42,46,51,56,61],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BEHAVIORAL","Neutral Video","Participants in the control group will watch neutral videos and describe objective, non-emotional objects\u002Fevents",[41],"Patient control group - neutral videos",{"type":37,"name":23,"description":43,"armGroupLabels":44},"The storytelling intervention group will watch the storytelling videos and then describe objective, non-emotional objects\u002Fevents.",[45],"Patient storytelling group",{"type":37,"name":47,"description":48,"armGroupLabels":49},"Self disclosure","Participants will watch neutral videos and then talk\u002Fwrite about their cancer\u002FHIV-related experiences to themselves.",[50],"Patient self-disclosure group",{"type":37,"name":52,"description":53,"armGroupLabels":54},"Combination","The combination group will watch the storytelling videos and then talk\u002Fwrite about their cancer\u002FHIV-related experiences to themselves.",[55],"Patient combination group - storytelling video and storytelling disclosure",{"type":37,"name":57,"description":58,"armGroupLabels":59},"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.",[60],"Provider Storytelling group",{"type":37,"name":62,"description":63,"armGroupLabels":64},"Waitlist","Participants will watch unrelated presentations in a group setting while on a waitlist. They will receive the intervention after completing the post-test.",[65],"Provider waitlist control group",[67,71],{"measure":68,"description":69,"timeFrame":70},"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",{"measure":72,"description":73,"timeFrame":70},"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.",[75,78],{"measure":76,"description":77,"timeFrame":70},"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.",{"measure":79,"description":80,"timeFrame":70},"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\u002Fdistressed by each symptom (e.g., nervousness or","ALL","18 Years",null,{"inclusion":85,"exclusion":86,"raw_text":87},[],[],"Inclusion Criteria:\n\nPatient-level intervention\n\n1. Women diagnosed with cervical cancer and HIV (stage I-IV)\n2. Receiving cancer treatment at the Cancer Disease Hospital in Zambia\n3. 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\n\nProvider-level intervention\n\n1\\. Employment at the Cancer Disease Hospital in Lusaka, Zambia\n\nExclusion Criteria:\n\nPatient-level intervention\n\n1.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.\n\nProvider-level intervention\n\n1\\. Inability to provide informed consent",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":93,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":106},"UT MD Anderson","Houston","Texas","77030","United States",[99,104],{"name":100,"role":101,"phone":102,"email":103},"Qian Lu, MD, PHD","CONTACT","(713) 745-8324","qlu@mdanderson.org",{"name":100,"role":105},"PRINCIPAL_INVESTIGATOR",{"lat":107,"lon":108},29.76328,-95.36327,[110],{"name":100,"role":101,"phone":102,"email":103},[112],{"name":100,"affiliation":93,"role":105},[],[115],{"label":116,"url":117},"MD Anderson Cancer Center","http:\u002F\u002Fwww.mdanderson.org",{"nct_id":4,"conditions":119,"biomarkers":122},[120,121],"Cervical Carcinoma","HIV Infection",[],{"nct_id":4,"found":124,"summary":125,"prompt_version":133},true,{"design":126,"status":127,"heading":6,"summary":128,"follow_up":126,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"Not specified.","completed","{\n   \"RISE: Reducing Cancer and HIV Stigma Through Empowerment\",\n   \"This study, called RISE, is looking at ways to reduce the stigma (negative feelings or beliefs) associated with having both cervical cancer and HIV. It's testing different behavioral interventions, including watching neutral videos, watching storytelling videos, talking or writing about experiences (self-disclosure), or a combination of these. The study involves women with cervical cancer and HIV, as well as healthcare workers. Researchers want to see if these interventions can improve quality of life for patients and reduce stigma and increase compassion among healthcare workers. The study is taking place in Zambia and aims to enroll 440 participants.\",\n  \"design\": \"This is an interventional study with a planned enrollment of 440 participants. It uses a randomized design, meaning participants are assigned by chance to different intervention groups.\",\n  \"commitments\": \"Participants will watch videos and\u002For talk\u002Fwrite about their experiences. Quality of life will be measured at baseline, immediately after the intervention, and at 1, 3, 6, and 12 months.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be followed for 12 months after the intervention to assess quality of life.\",\n}",188,"Not specified in the trial record.","Not stated in the trial record.",[38,23,52,57],"v2"]