Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07728370

RISE: Reducing Cancer and HIV Stigma Through Empowerment

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

HIV Behavior Cervical Cancer Stigma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Social Behavior Social Stigma Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT MD Anderson

Houston, Texas, 77030, United States

Location contact

Qian Lu, MD, PHD

CONTACT

[email protected]

(713) 745-8324

Qian Lu, MD, PHD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

  • Inability to provide informed consent

Treatment and study plan

Neutral video

Behavioral

Participants in the control group will watch neutral videos and describe objective, non-emotional objects/events

Storytelling

Behavioral

The storytelling intervention group will watch the storytelling videos and then describe objective, non-emotional objects/events.

Self disclosure

Behavioral

Participants will watch neutral videos and then talk/write about their cancer/HIV-related experiences to themselves.

Combination

Behavioral

The combination group will watch the storytelling videos and then talk/write about their cancer/HIV-related experiences to themselves.

Video

Behavioral

Participants (healthcare workers) will watch storytelling videos in a group setting, followed by a facilitated discussion and role-playing to enhance empathy and understanding.

Waitlist

Behavioral

Participants will watch unrelated presentations in a group setting while on a waitlist. They will receive the intervention after completing the post-test.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Patient-level: Depressive Symptoms

    Time frame: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up

    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.

  2. Patient-level: Anxiety Symptoms

    Time frame: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up

    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

Other outcomes

  1. Provider-level: Social Stigma

    Time frame: Immediately before and immediately after the healthcare worker training session

    Social stigma will be measured using the Health Care Provider HIV/AIDS Stigma Scale (HPASS) prejudice (13-items) and stereotyping (11-items) subscales. Healthcare workers will rate each item on a 6-point scale ranging from 1 (strongly disagree) to 6 (strongly agree).

  2. Provider-level: Enacted Stigma

    Time frame: Immediately before and immediately after the healthcare worker training session

    The Health Care Provider HIV/AIDS Stigma Scale (HPASS) Discrimination Subscale will be used to assess enacted stigma from providers. The HPASS is a 30-item measure comprising three subscales: prejudice, stereotyping, and discrimination.

  3. Provider-level: Compassion

    Time frame: Immediately before and immediately after the healthcare worker training session

    Compassion from healthcare workers will be measured using the 17-item Compassion Competence Scale (CCS). The CCS contains three factors that tap into communication, sensitivity, and insight. Healthcare workers will be asked to respond to each item using a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree).

  4. Provider-level: Perceived Stigma

    Time frame: Immediately before and immediately after the healthcare worker training session

    atients' perceived stigma related to HIV and cancer will be measured using the 9-item Social Rejection Subscale of the Social Impact Scale (SIS). Participants rate each item (e.g., due to my [HIV and cancer] others at [hospital/clinic] seem to feel awkward and tense when they are around me) on a 4-point scale ranging from 1(strongly disagree) to 4 (strongly agree).

  5. Provider-level: Care Satisfaction

    Time frame: Immediately before and immediately after the healthcare worker training session

    The Short Assessment of Patient Satisfaction (SAPS) will be used to measure care satisfaction among patients. SAPS is a 7-item questionnaire. Participants are asked to answer each question (e.g., Are you satisfied with the care you received in the [hospital/clinic]?) using a 5-point scale ranging from 0 (very dissatisfied) to 4 (very satisfied).

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Lu, MD, PHD

CONTACT

[email protected]

(713) 745-8324

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Cancer Diseases Hospital; University of Zambia

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.