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

MI-összefoglaló

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A vizsgálat 25 és 50 év közötti, HIV-vel élő nőket keres, akik HIV elleni gyógyszert (ART) szednek, magas kockázatú HPV-fertőzésük van, de a VIA-tesztjük negatív.

Életkor

25–50 év

Nem

Csak nők

A betegség stádiuma

Onkogén HPV-pozitivitás RT-PCR vizsgálattal, és negatív VIA-teszt

Korábbi kezelés

Több mint 12 hónapja kell ART-t szedniük, amit ART-kártya igazol

Biomarker vagy leletérték

Pozitív RT-PCR teszt az onkogén HPV-génekre; negatív VIA-teszt

A részvétel fő kizáró okai

• Terhes vagy szoptató nők
• 50 évnél idősebb nők
• Akik részt vettek az I. fázisú előkészítő vizsgálatban

Ez a vizsgálat csak HIV-vel élő résztvevőket keres. A regiszter mondata, amelyen ez alapul: WLH, 25 - 50 years of age; based on HIV-based guidelines;

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• 25 és 50 év között vagy?IgenNem

Mit akar kideríteni a vizsgálat

Cervical cancer (CC) remains one of the most common malignancies among women in India, with nearly 100,000 women diagnosed annually and over 60,000 preventable deaths annually. With high-risk human papillomavirus (HR-HPV) as the causative agent for CC, one risk factor that places women at high risk for CC is human immunodeficiency virus (HIV), as impaired immune response against Human papillomavirus (HPV) may result in persistent HR-HPV infection, a critical risk factor for progression of HPV-related cervical oncogenesis. Progression of precancerous lesions among women living with HIV (WLH) is also associated with: 1) lack of HPV screening; 2) high levels of depressive symptoms and stigma; and 3) malnutrition, which negatively impacts the activation and proliferation of immune cells. Yet programs that offer WLH with comprehensive services focused on HPV screening and psychological and nutritional support are almost non-existent, and the gap is critical. Nutrition plays an integral role in relationship to HPV/HIV co-infection, as demonstrated by an increased risk of HR-HPV associated with poor nutrition; nutritional deficiencies are likewise linked to cervical intra-epithelial neoplasia. The immunological effect of malnutrition may also be exacerbated among WLH due to elevated energy demands of chronic immune activation; worsened with HPV/HIV co-infection. Further, depressive symptoms (aka depression for brevity) partially mediate the effect of food insecurity on HIV viral suppression. In our completed ASHA-Nutrition R01 study of antiretroviral (ART) adherence, the investigators trained lay community health peer counselors, named Accredited Social Health Activist (ASHA), to improve the health of 600 rural WLH by providing emotional support, skill-building, nutrition education, and/or protein-enriched food supplements. In that study, our intervention, co-delivered by our trained peer counselors, and guided by nurses, led to increased CD4+ T cell recovery and improved anthropometric and psychosocial outcomes. The investigators found that peer counselors support plus protein supplements and nutritional education were significantly associated with improved CD4 counts and increased lean mass at 18 months (P < 0.001), as well as significant improvements in depression, ART adherence, social support and internalized stigma. In our sub study, CC screening of 598 of these WLH revealed that 13% were found to have abnormal cervical lesions and 4 (1%) had squamous CC. Preliminary evidence also revealed that nutritional supplements may be associated with a 40% reduction in the risk of abnormal cervical lesions (adjusted odds ratio [aOR] = 0.60), with an association between serum albumin and reduced risk of abnormal lesions (aOR= 0.39).

A vizsgálat 2 csoportja

• SAKHI HPV InterventionA vizsgált kezelés

  The SAKHI program will include: 1) 8 group sessions, led by the nurse, and inclusive of other experts (such as HPV/HIV physician, nutritionist, psychologist) to provide the group classes for each cohort of 8 W-Co-V in the program, covering content about staying healthy, taking care of self/family, skills building, and eating healthy; 2) Individual 1:1 weekly peer counselor support; and 3) referral to grant-supported life skills classes taught by experts.

• SOC+Egyéb csoport

  The investigators will offer an enhanced standard of care to include usual care + three (1.5 hour) group sessions on wellness, basic nutrition, coping with mental health issues, importance of HPV screening and treatment as needed, and ART adherence (similar to Modules for SAKHI), and similarly delivered by the nurse and content experts over the six-month intervention.

  Kezelés: Enhanced Standard of Care (SOC+)