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. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
440
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.
UT MD Anderson
Houston, Texas, United States
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.
Time frame: 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.
Time frame: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up
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.
Time frame: 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
Time frame: Baseline, immediately after the intervention, and 1-, 3-, 6-, and 12- month follow up
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