Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India

NANot yet recruitingINTERVENTIONAL
Enrollment

420

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

October 1, 2029

Study Completion Date

January 1, 2030

Conditions
Cervical CancerHuman Papillomavirus (HPV) InfectionHuman Immunodeficiency Virus (HIV) Infection
Interventions
BEHAVIORAL

ASHA-Health HPV Intervention

The ASHA-Health HPV program will include three components: 1) Individual 1:1 weekly ASHA support; 2) 8 group sessions for the 42 W-Co-V in the ASHAHealth cohort, covering content in Modules 1-4; and 3) referral to life skills classes. The assigned ASHA will provide services to support the W-Co- V in accessing and/or adhering to HPV and ART appointments (arrange transportation, provide counseling, promote healthy lifestyle choices, and link with community resources). ASHA will also promote positive coping, social support, and aid in dealing with stigma. The 8 group sessions will be held over the six months, based on the needs identified by the women. Overall, the intervention content targets the provision of emotional support, skill building, HPV/ HIV and nutrition education, and protein-enriched food supplements, and ways to deal with stress, stigma, and the importance of engagement and retention in care. Food selections will be guided by our nutrition experts.

BEHAVIORAL

Enhanced Standard of Care (SOC+)

Selecting our base at the Belgaum ART Centers will provide the most up to date services for the SOC+ group. Yet, there is no typical standard of care in India as it relates to HPV screening for W-Co-V and stigma associated with both diseases is high. Further, in India, screening services are lacking at most ART centers. Since it would be unethical to withhold potentially lifesaving information about HPV, the investigators will offer an enhanced standard of care to include usual care + 3 (1.5 hour) group sessions on wellness, basic nutrition, coping with mental health issues, and HIV/ HPV information. Thus, women will meet as a group three times over the six-month period. In addition, the women have access to our SOC+ nurse and ASHA to respond to questions.

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

University of California, San Francisco

OTHER

collaborator

National Institute of Mental Health and Neuro Sciences (NIMHANS)

UNKNOWN

lead

University of California, Irvine

OTHER