observational research topics PharmD 5th year students pharmacy practice 2025

pharmacy practice observational study drug related problems

community pharmacy observational study medication adherence self-medication

community based observational research topics PharmD pharmacy students 2025 2026

HPV vaccine knowledge attitudes acceptance India community

HPV vaccination barriers perceived India cross-sectional survey

HPV vaccination coverage awareness India Gujarat cervical cancer 2024 2025

PMID: 40022716

PMID: 39264332

India cervical cancer 25 percent global deaths 8 women per hour WHO ICMR citation 2024

India HPV vaccination national rollout November 2024 coverage 22 percent NFHS-5 screening coverage citation

PMID: 40022716

PMID: 39264332

HPV vaccine knowledge attitude community India marginalized population

PMID: 42100579

HPV infection cervical cancer epidemiology vaccine efficacy review

HPV vaccination knowledge attitude practice KAP study India

HPV virus types oncogenic cervical cancer pathogenesis vaccine Gardasil Cervarix Cervavac 2024 2025

PMID: 38793561

PMID: 40485552

PMID: 39398714

PMID: 41445902

PMID: 39238704

PMID: 37529935

PMID: 41063879

mkdir -p /home/daytona/workspace/hpv-protocol && ls /home/daytona/workspace/hpv-…

~/hpv-protocol/generate.js

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      // ── TITLE PAGE ──────────────────────────────────────────────────────────
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      divider(), space(),

      // ── 1. INTRODUCTION ─────────────────────────────────────────────────────
      h1("1. Introduction"),
      body("Human Papillomavirus (HPV) is a double-stranded DNA virus with over 200 known genotypes, of which high-risk types 16 and 18 are responsible for approximately 70% of all cervical cancers globally.1 HPV infection is the most common sexually transmitted infection worldwide, and persistent infection with oncogenic HPV types is the primary causative factor in the development of cervical cancer.2 As of 2024, cervical cancer accounts for an estimated 604,000 new cases and 280,000 deaths annually, with the highest burden in low- and middle-income countries.3"),
      space(),
      body("Safe and effective prophylactic vaccines are available, including the bivalent (Cervarix), quadrivalent (Gardasil), nonavalent (Gardasil-9), and India's indigenous quadrivalent vaccine Cervavac (Serum Institute of India), all targeting HPV types 16 and 18.4 Systematic reviews confirm that vaccination significantly reduces HPV infection, precancerous lesions, and invasive cervical cancer, with greatest effectiveness when administered to girls aged 9 to 14 years before exposure.5 Despite this, community-level vaccine acceptance in India remains low due to insufficient awareness, cultural barriers, and widespread misinformation, necessitating urgent community-based research and targeted health education."),

      space(), divider(), space(),

      // ── 2. REVIEW OF LITERATURE ─────────────────────────────────────────────
      h1("2. Review of Literature"),
      body("Studies from India consistently reveal poor HPV vaccination awareness across all population groups. Aggarwal et al. (2025) found significant knowledge gaps regarding vaccine schedules and target age groups even among healthcare providers at a Delhi tertiary centre.6 Kavyarani et al. (2025) reported that less than half of medical professionals could correctly identify HPV vaccine target groups.7 Gandhi et al. (2024) conducted a KAP study among rural women in Gujarat - geographically proximate to the present study site - and found low awareness of HPV infection and the existence of a preventive vaccine.8"),
      space(),
      body("Ganeshkumar et al. (2025) identified low education, rural residence, and lack of health education as the strongest predictors of poor HPV vaccine knowledge and acceptance in India.9 Vasudevan et al. (2026) reported that knowledge, attitudes, and acceptance of HPV vaccination among marginalized Indian communities varied significantly by caste, education, and geographic setting, with safety concerns and cultural taboos being the most commonly cited barriers.10 Mullassery and Posmontier (2024) highlighted that traditional health beliefs and cultural taboos significantly reduce parental willingness to vaccinate.11"),
      space(),
      body("Collectively, the literature identifies a critical lack of community-level, post-rollout KAP data from Gujarat, absence of validated regional-language tools, and shortage of locally appropriate health education materials - all of which the present study aims to address."),

      space(), divider(), space(),

      // ── 3. NEED OF THE STUDY ────────────────────────────────────────────────
      h1("3. Need of the Study"),
      body("India accounts for approximately 25% of global cervical cancer deaths, with one woman dying every eight minutes from the disease.12 Despite the national HPV vaccination program launched in November 2024 for girls aged 9-14 years using Cervavac, early coverage has been alarmingly low, driven by misinformation, cultural misconceptions, and poor community awareness. Cervical cancer screening coverage in India remains at just 2% as per NFHS-5.13"),
      space(),
      body("Most existing KAP studies are hospital-based, use non-validated tools, and have not been conducted in semi-urban Gujarat. No published community-level data exists from Anand, Gujarat post the 2024 national rollout. A validated, Gujarati-language assessment tool and locally relevant health education resource are urgently needed to generate reliable data and support improved vaccine uptake in this region."),

      space(), divider(), space(),

      // ── 4. RATIONALE ────────────────────────────────────────────────────────
      h1("4. Rationale of the Study"),
      body("Anand, Gujarat lacks community-specific data on HPV vaccination KAP following India's 2024 national rollout. Existing studies rely on non-validated questionnaires with no linguistic or cultural adaptation for the Gujarati population. This study will generate local evidence, produce a validated bilingual (English/Gujarati) KAP tool reusable by future researchers, and create health education resources directly applicable to ongoing national vaccination efforts. Pharmacy students, as accessible community health promoters, are well positioned to conduct this assessment and bridge the gap between policy and community acceptance."),

      space(), divider(), space(),

      // ── 5. OBJECTIVES ───────────────────────────────────────────────────────
      h1("5. Objectives"),
      h2("5.1 Primary Objectives"),
      numbered("To assess the knowledge, attitudes, perceived barriers, and acceptance of HPV vaccination among college students and parents in Anand, Gujarat."),
      numbered("To develop and validate two separate KAP questionnaires - one for college students and one for parents of girls aged 9-18 years - in English and Gujarati."),
      space(),
      h2("5.2 Secondary Objectives"),
      numbered("To identify sociodemographic factors associated with HPV vaccination knowledge and acceptance in each study arm."),
      numbered("To compare knowledge, attitudes, perceived barriers, and acceptance between college students and parents."),
      numbered("To develop a culturally appropriate health education resource (bilingual leaflet/poster) on HPV vaccination for community use."),
      numbered("To assess the acceptability of the developed health education resource among community members."),

      space(), divider(), space(),

      // ── 6. METHODOLOGY ──────────────────────────────────────────────────────
      h1("6. Methodology"),

      h2("6.1 Study Design"),
      body("Cross-sectional, community-based observational study with an embedded tool validation component."),

      space(), h2("6.2 Study Setting"),
      body("Residential areas, colleges, community health centres, PHCs, and Anganwadi centres in Anand district, Gujarat."),

      space(), h2("6.3 Study Duration"),
      body("6 months - including tool development and validation, data collection, analysis, and health education resource development."),

      space(), h2("6.4 Study Population - Two Arms"),
      makeTable([
        ["", "Arm 1: College Students", "Arm 2: Parents"],
        ["Who", "Students enrolled in colleges in Anand", "Parents of girls aged 9-18 years in Anand"],
        ["Age", "18-25 years", "25-55 years (approximately)"],
        ["Rationale", "Near target age group; personal acceptance", "Primary decision-makers for daughter's vaccination"],
        ["Recruitment site", "College campuses", "PHCs, Anganwadis, residential areas"]
      ]),

      space(), h2("6.5 Sample Size"),
      body("Formula: n = Z2 x p x (1-p) / d2"),
      body("Z = 1.96 (95% CI); p = 0.50 (conservative estimate); d = 0.07 (margin of error)"),
      body("n = (1.96)2 x 0.5 x 0.5 / (0.07)2 = ~196 per arm"),
      body("Adding 10% non-response: ~216 per arm"),
      bold("Total sample = ~432 participants (216 students + 216 parents)"),

      space(), h2("6.6 Sampling Method"),
      body("Arm 1 (Students): Convenient sampling from colleges/universities in Anand district."),
      body("Arm 2 (Parents): Purposive sampling from PHCs, Anganwadi centres, and residential areas where parents of young girls are accessible."),

      space(), h2("6.7 Inclusion Criteria"),
      makeTable([
        ["Criterion", "Arm 1: College Students", "Arm 2: Parents"],
        ["Age", "18-25 years", "25 years or above"],
        ["Specific", "Currently enrolled in college in Anand", "Parent of at least one girl aged 9-18 years"],
        ["Residence", "Anand district for ≥6 months", "Anand district for ≥6 months"],
        ["Consent", "Willing to give written informed consent", "Willing to give written informed consent"]
      ]),

      space(), h2("6.8 Exclusion Criteria"),
      bullet("Healthcare professionals (doctors, nurses, pharmacists) - excluded to assess general community knowledge"),
      bullet("Participants with known cognitive impairment"),
      bullet("Individuals who decline to participate or withdraw consent"),

      space(), divider(), space(),

      // ── 7. DATA COLLECTION TOOL ─────────────────────────────────────────────
      h1("7. Data Collection Tool"),

      h2("7.1 Questionnaire Development"),
      body("Two structured questionnaires will be developed de novo - one for college students and one for parents. Both will be prepared in English and translated into Gujarati using standard forward-backward translation methodology. Each questionnaire will consist of five sections:"),
      space(),
      makeTable([
        ["Section", "Content", "Students (items)", "Parents (items)"],
        ["A", "Sociodemographic information", "8 items", "8 items"],
        ["B", "Knowledge of HPV and cervical cancer", "15 items (MCQ/True-False)", "15 items (MCQ/True-False)"],
        ["C", "Attitudes toward HPV vaccination", "10 items (5-pt Likert)", "10 items (5-pt Likert)"],
        ["D", "Perceived barriers to HPV vaccination", "10 items (5-pt Likert)", "10 items (5-pt Likert)"],
        ["E", "Vaccine acceptance", "5 items (personal acceptance)", "5 items (intent to vaccinate daughter)"]
      ]),

      space(), h2("7.2 Tool Validation Steps"),
      makeTable([
        ["Validation Step", "Method", "Acceptable Threshold"],
        ["Content Validity", "Expert panel of 5-7 (physicians, pharmacists, public health experts) - Content Validity Index (CVI)", "CVI ≥ 0.80"],
        ["Face Validity", "Pilot testing on 15 community members for language clarity", "Majority comprehension confirmed"],
        ["Internal Consistency", "Cronbach's alpha for attitude and barrier subscales", "α ≥ 0.70"],
        ["Test-Retest Reliability", "Re-administration to 30 participants after 2 weeks - ICC", "ICC ≥ 0.75"]
      ]),

      space(), divider(), space(),

      // ── 8. HEALTH EDUCATION RESOURCE ────────────────────────────────────────
      h1("8. Health Education Resource Development"),
      body("A bilingual (Gujarati/Hindi) health education leaflet will be developed covering:"),
      bullet("What is HPV and how is it transmitted?"),
      bullet("Link between HPV and cervical cancer"),
      bullet("Who should receive the HPV vaccine and when?"),
      bullet("Government's free national vaccination program details"),
      bullet("Addressing common myths and misconceptions"),
      bullet("Where to get vaccinated in Anand district"),
      space(),
      body("The leaflet will be reviewed by an expert panel for content accuracy and by 20 community members for readability and acceptability. Readability will be assessed using a validated checklist. Acceptability will be rated on a 5-point scale."),

      space(), divider(), space(),

      // ── 9. STATISTICAL ANALYSIS ─────────────────────────────────────────────
      h1("9. Statistical Analysis Plan"),
      body("Data will be entered in Microsoft Excel and analyzed using SPSS v26 or JASP (free)."),
      space(),
      makeTable([
        ["Analysis", "Purpose"],
        ["Descriptive statistics (frequency, mean, SD)", "Summarize sociodemographic data and KAP scores"],
        ["Chi-square test", "Association between sociodemographic variables and KAP"],
        ["Independent t-test / ANOVA", "Compare KAP scores across groups and between two arms"],
        ["Pearson/Spearman correlation", "Correlation between knowledge, attitude, and acceptance scores"],
        ["Binary logistic regression", "Predictors of HPV vaccine acceptance"]
      ]),
      space(),
      body("Knowledge scores will be graded as: Poor (<50%), Moderate (50-74%), Good (≥75%). A p-value of <0.05 will be considered statistically significant."),

      space(), divider(), space(),

      // ── 10. ETHICAL CONSIDERATIONS ──────────────────────────────────────────
      h1("10. Ethical Considerations"),
      numbered("Institutional Ethics Committee (IEC) approval will be obtained prior to study initiation."),
      numbered("Written informed consent will be taken from all participants."),
      numbered("Participation is voluntary; participants may withdraw at any time without penalty."),
      numbered("Anonymity and confidentiality of participant data will be strictly maintained."),
      numbered("No biological samples or interventions will be performed - the study is purely observational."),
      numbered("The study will adhere to ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017)."),

      space(), divider(), space(),

      // ── 11. EXPECTED OUTCOMES ───────────────────────────────────────────────
      h1("11. Expected Outcomes"),
      numbered("Two validated bilingual (English/Gujarati) KAP questionnaires on HPV vaccination - one for students, one for parents."),
      numbered("Community-level data on HPV vaccination KAP from Anand, Gujarat post-2024 national rollout."),
      numbered("Identification of key sociodemographic predictors of vaccine acceptance in both population groups."),
      numbered("A ready-to-distribute, expert-validated bilingual health education leaflet on HPV vaccination."),

      space(), divider(), space(),

      // ── 12. LIMITATIONS ─────────────────────────────────────────────────────
      h1("12. Limitations"),
      bullet("Self-reported data may be subject to social desirability bias."),
      bullet("Cross-sectional design limits causal inference."),
      bullet("Convenience sampling in Arm 1 may limit generalizability."),
      bullet("Study restricted to Anand district; findings may not represent all of Gujarat."),

      space(), divider(), space(),

      // ── 13. REFERENCES ──────────────────────────────────────────────────────
      h1("13. References"),
      body("1. Jensen JE, Becker GL, Jackson JB, Rysavy MB. Human Papillomavirus and Associated Cancers: A Review. Viruses. 2024;16(5):680. PMID: 38793561"),
      body("2. Centers for Disease Control and Prevention. Chapter 11: Human Papillomavirus. In: Pink Book. Atlanta: CDC; 2024."),
      body("3. World Health Organization. Cervical cancer. Geneva: WHO; 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/cervical-cancer"),
      body("4. Serum Institute of India. Cervavac: Vaccine Information. 2024. Available from: https://cervavac.com"),
      body("5. Ellingson MK, Sheikha H, Nyhan K, et al. HPV vaccine effectiveness by age at vaccination: A systematic review. Hum Vaccin Immunother. 2023;19(2):2239085. PMID: 37529935"),
      body("6. Aggarwal I, Mehta D, Yadav P, et al. KAP on HPV Vaccination among Healthcare Providers in North Delhi. Asian Pac J Cancer Prev. 2025;26(2):671. PMID: 40022716"),
      body("7. Kavyarani C, Kannan Karur A, Chaitra C, et al. KAP of Medical Professionals Regarding Cervical Cancer Prevention and HPV Vaccination. Cureus. 2025. PMID: 41063879"),
      body("8. Gandhi R, Patel A, Patel M, et al. Cervical Cancer Prevention Among Rural Women in Gujarat: A Mixed Methods KAP Study. Cureus. 2024. PMID: 39398714"),
      body("9. Ganeshkumar P, Tank J, Choudhury SS, et al. KAP Study on Cervical Cancer Prevention and HPV Vaccination. South Asian J Cancer. 2025. PMID: 41445902"),
      body("10. Vasudevan U, Kelly-Hanku A, Limbu P, et al. Marginalized voices on HPV vaccination in India. Front Glob Womens Health. 2026. PMID: 42100579"),
      body("11. Mullassery D, Posmontier B. Health beliefs and acculturation on HPV vaccination acceptance among Asian Indian parents. J Am Assoc Nurse Pract. 2024. PMID: 39264332"),
      body("12. Gavi. India, home to 25% of world's cervical cancer deaths, launches nationwide HPV vaccination. 2025. Available from: https://www.gavi.org/vaccineswork/"),
      body("13. National Family Health Survey (NFHS-5). Factsheet. India; 2021."),
      body("14. Harper DM, Navarro-Alonso JA, Bosch FX, et al. Impact of HPV vaccines in reduction of infection, precursor lesions, and cervical cancer: A systematic review. Hum Vaccin Immunother. 2025. PMID: 40485552"),
      body("15. ICMR. National Ethical Guidelines for Biomedical and Health Research Involving Human Participants. New Delhi: ICMR; 2017."),

    ]
  }]
});

Packer.toBuffer(doc).then(buffer => {
  fs.writeFileSync('/home/daytona/workspace/hpv-protocol/HPV_Vaccination_KAP_Protocol.docx', buffer);
  console.log('SUCCESS: Document created');
}).catch(err => {
  console.error('ERROR:', err);
  process.exit(1);
});

cd /home/daytona/workspace/hpv-protocol && node generate.js 2>&1

python3 /home/daytona/skills/docx/scripts/office/validate.py /home/daytona/works…

cd /home/daytona/workspace/hpv-protocol && python3 -c " import zipfile, os with …

cd /home/daytona/workspace/hpv-protocol && python3 /home/daytona/skills/docx/scr…

cd /home/daytona/workspace/hpv-protocol && python3 /home/daytona/skills/docx/scr…

cp /home/daytona/workspace/hpv-protocol/HPV_Vaccination_KAP_Protocol.docx /tmp/h…

chmod 777 /home/daytona/workspace/hpv-protocol/ && python3 /home/daytona/skills/…

mkdir -p /home/daytona/hpv-out && cp /tmp/hpv_test.docx /home/daytona/hpv-out/ &…

cp /home/daytona/hpv-out/hpv_test.docx /home/daytona/hpv-out/HPV_Vaccination_KAP…

HPV pathogenesis oncogenesis cervical cancer natural history

HPV vaccine acceptance barriers community KAP parents students India

HPV types classification high risk low risk cervical cancer WHO 2024 epidemiology India

HPV vaccination KAP knowledge attitude students parents community India cross sectional

PMID: 36812987

HPV vaccination awareness acceptance India parents adolescents women survey

PMID: 39398714

PMID: 41445902

PMID: 42100579

PMID: 40022716

PMID: 39238704

/home/daytona/hpv-out/generate_pdf.py

from reportlab.lib.pagesizes import A4
from reportlab.lib.styles import getSampleStyleSheet, ParagraphStyle
from reportlab.lib.units import cm
from reportlab.lib import colors
from reportlab.platypus import (
    SimpleDocTemplate, Paragraph, Spacer, Table, TableStyle,
    HRFlowable, PageBreak, KeepTogether
)
from reportlab.lib.enums import TA_LEFT, TA_CENTER, TA_JUSTIFY
from reportlab.platypus import Frame, PageTemplate

# ── Output path ──────────────────────────────────────────────────────────────
OUTPUT = "/home/daytona/hpv-out/HPV_KAP_Protocol_Full.pdf"

# ── Colors ───────────────────────────────────────────────────────────────────
DARK_BLUE   = colors.HexColor("#1F3864")
MID_BLUE    = colors.HexColor("#2E74B5")
LIGHT_BLUE  = colors.HexColor("#EBF3FB")
HEADER_BG   = colors.HexColor("#2E74B5")
ROW_ALT     = colors.HexColor("#F0F6FC")
WHITE       = colors.white
BLACK       = colors.black
GREY_LINE   = colors.HexColor("#CCCCCC")

# ── Styles ───────────────────────────────────────────────────────────────────
styles = getSampleStyleSheet()

def make_style(name, parent="Normal", **kwargs):
    return ParagraphStyle(name, parent=styles[parent], **kwargs)

Title       = make_style("Title",      fontSize=22, textColor=DARK_BLUE,
                          alignment=TA_CENTER, spaceAfter=6, leading=28, fontName="Helvetica-Bold")
SubTitle    = make_style("SubTitle",   fontSize=13, textColor=MID_BLUE,
                          alignment=TA_CENTER, spaceAfter=4, leading=18, fontName="Helvetica")
H1          = make_style("H1",         fontSize=13, textColor=DARK_BLUE,
                          spaceBefore=14, spaceAfter=4, leading=18, fontName="Helvetica-Bold")
H2          = make_style("H2",         fontSize=11, textColor=MID_BLUE,
                          spaceBefore=10, spaceAfter=3, leading=16, fontName="Helvetica-Bold")
Body        = make_style("Body",       fontSize=10, textColor=BLACK,
                          spaceAfter=6, leading=15, alignment=TA_JUSTIFY, fontName="Helvetica")
BodyBold    = make_style("BodyBold",   fontSize=10, textColor=BLACK,
                          spaceAfter=4, leading=15, fontName="Helvetica-Bold")
Bullet      = make_style("Bullet",     fontSize=10, textColor=BLACK,
                          leftIndent=16, spaceAfter=3, leading=14,
                          bulletIndent=4, fontName="Helvetica")
RefStyle    = make_style("RefStyle",   fontSize=9,  textColor=colors.HexColor("#333333"),
                          spaceAfter=3, leading=13, alignment=TA_JUSTIFY, fontName="Helvetica")
TCell       = make_style("TCell",      fontSize=9,  textColor=BLACK,
                          leading=13, fontName="Helvetica")
TCellH      = make_style("TCellH",     fontSize=9,  textColor=WHITE,
                          leading=13, fontName="Helvetica-Bold")
TitlePage   = make_style("TitlePage",  fontSize=11, textColor=BLACK,
                          alignment=TA_CENTER, spaceAfter=3, leading=16, fontName="Helvetica")

def hr(): return HRFlowable(width="100%", thickness=1, color=GREY_LINE, spaceAfter=8, spaceBefore=8)
def sp(h=6): return Spacer(1, h)

def bullet_item(text):
    return Paragraph(f"\u2022\u00a0\u00a0{text}", Bullet)

def table(data, col_widths=None, header=True):
    t = Table(data, colWidths=col_widths, repeatRows=1 if header else 0)
    style = [
        ("BACKGROUND", (0,0), (-1,0), HEADER_BG),
        ("TEXTCOLOR",  (0,0), (-1,0), WHITE),
        ("FONTNAME",   (0,0), (-1,0), "Helvetica-Bold"),
        ("FONTSIZE",   (0,0), (-1,-1), 9),
        ("GRID",       (0,0), (-1,-1), 0.4, GREY_LINE),
        ("ROWBACKGROUNDS", (0,1), (-1,-1), [WHITE, ROW_ALT]),
        ("VALIGN",     (0,0), (-1,-1), "TOP"),
        ("LEFTPADDING",(0,0), (-1,-1), 6),
        ("RIGHTPADDING",(0,0),(-1,-1), 6),
        ("TOPPADDING", (0,0), (-1,-1), 4),
        ("BOTTOMPADDING",(0,0),(-1,-1), 4),
    ]
    t.setStyle(TableStyle(style))
    return t

def p(text, style=Body): return Paragraph(text, style)
def h1(text): return p(text, H1)
def h2(text): return p(text, H2)
def bb(text): return p(text, BodyBold)

# ── Page header/footer ───────────────────────────────────────────────────────
def header_footer(canvas, doc):
    canvas.saveState()
    w, h = A4
    # Header bar
    canvas.setFillColor(DARK_BLUE)
    canvas.rect(1.5*cm, h-1.4*cm, w-3*cm, 0.55*cm, fill=1, stroke=0)
    canvas.setFillColor(WHITE)
    canvas.setFont("Helvetica-Bold", 8)
    canvas.drawString(1.8*cm, h-1.18*cm, "HPV Vaccination KAP Study Protocol")
    canvas.setFont("Helvetica", 8)
    canvas.drawRightString(w-1.5*cm, h-1.18*cm, "Anand, Gujarat  |  Pharm.D 5th Year Project")
    # Footer
    canvas.setFillColor(colors.HexColor("#555555"))
    canvas.setFont("Helvetica", 8)
    canvas.drawString(1.5*cm, 1.0*cm, "Confidential - For IEC Submission Only")
    canvas.drawRightString(w-1.5*cm, 1.0*cm, f"Page {doc.page}")
    canvas.restoreState()

# ── Build content ─────────────────────────────────────────────────────────────
story = []

# ════════════════════════════════════════════════════════════
# TITLE PAGE
# ════════════════════════════════════════════════════════════
story += [
    sp(60),
    p("RESEARCH PROTOCOL", ParagraphStyle("TP1", fontSize=28, textColor=DARK_BLUE,
       alignment=TA_CENTER, fontName="Helvetica-Bold", spaceAfter=8, leading=34)),
    HRFlowable(width="60%", thickness=2, color=MID_BLUE, spaceAfter=16, spaceBefore=8),
    p("Community-Based Assessment of Knowledge, Attitudes, Perceived Barriers, and Acceptance of Human Papillomavirus (HPV) Vaccination: Tool Validation and Health Education Resource Development",
      ParagraphStyle("TP2", fontSize=14, textColor=DARK_BLUE, alignment=TA_CENTER,
                     fontName="Helvetica-Bold", leading=20, spaceAfter=30)),
    sp(20),
    p("Principal Investigator: [Student Name], Pharm.D 5th Year", TitlePage),
    p("Guide: [Faculty Name], Department of Pharmacy Practice", TitlePage),
    p("Institution: [College Name], Anand, Gujarat", TitlePage),
    p("Duration: [Start Month, Year] to [End Month, Year] (6 months)", TitlePage),
    sp(8),
    p("Submitted to: Institutional Ethics Committee (IEC)", TitlePage),
    sp(60),
    HRFlowable(width="80%", thickness=1, color=GREY_LINE, spaceAfter=8),
    p("This protocol is prepared as part of the Pharm.D 5th Year Observational Research Project curriculum.",
      ParagraphStyle("footer_note", fontSize=9, textColor=colors.grey, alignment=TA_CENTER,
                     fontName="Helvetica")),
    PageBreak()
]

# ════════════════════════════════════════════════════════════
# 1. INTRODUCTION
# ════════════════════════════════════════════════════════════
story += [
    h1("1. INTRODUCTION"),
    hr(),
    p("Human Papillomavirus (HPV) is a small, non-enveloped, double-stranded DNA virus with over 200 known genotypes, of which approximately 14 are classified as high-risk or oncogenic types.<sup>1</sup> HPV types are broadly divided into low-risk types (6, 11) causing genital warts, and high-risk types (16, 18, 31, 33, 45, 52, 58) associated with malignant transformation.<sup>2</sup> Type 16 alone accounts for approximately 50-60% of all cervical cancers, while types 16 and 18 together are responsible for nearly 70% of cases globally.<sup>3</sup>"),
    sp(4),
    p("The oncogenic mechanism involves two key viral proteins: E6, which degrades the tumour suppressor p53, and E7, which inactivates the retinoblastoma protein (pRb), together driving uncontrolled cell cycle progression and genomic instability.<sup>4</sup> This progression from normal epithelium to cervical intraepithelial neoplasia (CIN) and ultimately invasive carcinoma typically spans 10 to 15 years, offering a wide preventive window.<sup>4</sup> In most individuals, HPV infection is transient and self-cleared within 1-2 years; persistent infection with high-risk types is what drives malignant transformation.<sup>1</sup>"),
    sp(4),
    p("Globally, cervical cancer is the fifth most common cancer in women, with 604,000 new cases and 280,000 deaths in 2024, over 90% of which occur in low- and middle-income countries.<sup>5</sup> The WHO's 90-70-90 elimination strategy by 2030 calls for 90% of girls to be vaccinated with HPV vaccine by age 15 as its primary pillar.<sup>5</sup> As of 2025, eight licensed HPV vaccines are available globally, all protecting against types 16 and 18. These include the bivalent Cervarix, quadrivalent Gardasil, nonavalent Gardasil-9, and India's own indigenous quadrivalent vaccine Cervavac (Serum Institute of India, targeting HPV 6, 11, 16, 18), indicated for females aged 9-26 years on a 2-dose schedule at ages 9-14 and a 3-dose schedule at ages 15-26.<sup>6</sup> Systematic review evidence confirms vaccine effectiveness is highest when administered at 9-14 years before HPV exposure.<sup>7</sup>"),
    sp(4),
    p("Despite evidence of vaccine efficacy, community acceptance remains a critical bottleneck in India, where sociocultural barriers, safety misconceptions, and limited awareness continue to impede uptake. This study was conceived to systematically assess these community-level barriers in Anand, Gujarat, while developing validated, locally appropriate tools and health education resources."),
]

# ════════════════════════════════════════════════════════════
# 2. REVIEW OF LITERATURE
# ════════════════════════════════════════════════════════════
story += [
    sp(10), h1("2. REVIEW OF LITERATURE"), hr(),

    h2("2.1 Studies Among Healthcare Providers"),
    p("Aggarwal et al. (2025) surveyed 399 healthcare providers at a tertiary care centre in North Delhi and found that while 95.9% of doctors were aware of HPV, only 66.7% of nurses and 73.4% of paramedical staff had equivalent knowledge. Despite 89.34% of doctors expressing confidence in vaccine safety, only 11.67% had personally received the HPV vaccine, and fewer than 9% of nursing staff were vaccinated - with affordability and lack of awareness as primary barriers.<sup>8</sup> Mandal et al. (2024), at AIIMS Kalyani, found good knowledge among 85.5% of doctors and 70.2% of nursing officers, yet the overall good practice score was critically low at just 31.3%, highlighting a persistent knowledge-to-action gap.<sup>9</sup> Kavyarani et al. (2025) reported that less than 50% of medical professionals could correctly identify all HPV vaccine target age groups or dosing schedules across South India.<sup>10</sup>"),

    sp(6), h2("2.2 Studies Among Community and Rural Populations"),
    p("Gandhi et al. (2024) conducted the most directly relevant published study - a mixed-methods KAP study among 400 rural women in Gujarat. Only 27% had heard of cervical cancer, 83% demonstrated poor knowledge, and critically, none of the 400 participants had ever received the HPV vaccine. Despite 64% expressing positive attitudes, only 9% had undergone cervical cancer screening. Stigma, gender roles, spousal communication gaps, and access barriers emerged as dominant themes.<sup>11</sup> Ganeshkumar et al. (2025), in a 15-state survey of 451 gynecologists and practitioners, found that patients consistently presented with misconceptions about personal risk and vaccine safety, and identified social media, digital platforms, and visual aids as the most effective channels for patient education.<sup>12</sup>"),

    sp(6), h2("2.3 Marginalized and Culturally Vulnerable Populations"),
    p("Vasudevan et al. (2026) conducted a multi-site qualitative study across Delhi-NCR, Tripura, and Karnataka among 89 marginalized individuals. Only 14 of 89 participants had ever heard of the HPV vaccine. Concerns about side effects, fertility, moral beliefs, and confusion from the COVID-19 vaccination experience drove hesitancy. Gendered decision-making was strongly present, with most women requiring husband or senior family member consent before accepting vaccination.<sup>13</sup> Mullassery and Posmontier (2024) further identified that traditional Indian health beliefs - including stigma around sexually transmitted infections - significantly reduced parental willingness to vaccinate daughters, even among educated communities.<sup>14</sup>"),

    sp(6), h2("2.4 Post-Rollout Evidence and Misinformation"),
    p("India's national HPV vaccination program was launched in November 2024 after over a decade of delay. Initial single-dose coverage reached only 22%, severely hampered by a mid-November 2024 social media campaign falsely claiming the vaccine contained toxic substances from aborted foetal tissues.<sup>15</sup> This demonstrates that even in the presence of a functional national program, community misinformation and low awareness can cripple uptake - making local KAP data from newly covered regions like Anand essential."),

    sp(6), h2("2.5 Gaps in Existing Literature"),
    p("Most Indian KAP studies are hospital-based, rely on non-validated questionnaires without linguistic adaptation, and have not been conducted at the community level in Gujarat post-2024 rollout. No published study has separately assessed HPV vaccination KAP among college students and parents as distinct target groups in this setting. A validated, bilingual (English/Gujarati) KAP tool and locally relevant health education materials for the Anand community are entirely absent from the existing literature."),
]

# ════════════════════════════════════════════════════════════
# 3. NEED OF THE STUDY
# ════════════════════════════════════════════════════════════
story += [
    sp(10), h1("3. NEED OF THE STUDY"), hr(),
    p("India accounts for approximately 25% of all global cervical cancer deaths, with one woman dying from the disease every eight minutes.<sup>15</sup> National cervical cancer screening coverage remains at a critically low 2% as per NFHS-5.<sup>16</sup> Despite the November 2024 launch of the national HPV vaccination program using the indigenous Cervavac vaccine for girls aged 9-14 years, initial coverage has collapsed to just 22% - driven by misinformation, cultural taboos, and a fundamental lack of community awareness.<sup>15</sup> Addressing this gap requires understanding what specific knowledge deficits, attitudes, and perceived barriers exist at the ground level in communities like Anand, Gujarat."),
    sp(4),
    p("Existing research confirms that the knowledge gap is profound even among healthcare providers,<sup>8,9</sup> and is far more severe in community and rural populations.<sup>11,13</sup> Yet no published community-level KAP data exists from Anand district, and virtually no study has collected this data following the 2024 national rollout. Most existing Indian studies use non-validated, non-standardized questionnaires that have not been linguistically adapted for Gujarati-speaking populations, making their findings unreliable for guiding local policy. Additionally, there is a complete absence of validated, culturally appropriate, Gujarati-language health education resources on HPV vaccination that can be practically deployed in community settings by healthcare workers, pharmacists, or volunteers."),
    sp(4),
    p("This study is therefore urgently needed to generate community-specific, post-rollout KAP data from Anand, Gujarat; to fill the methodological gap by developing and validating a bilingual questionnaire; and to produce ready-to-use health education materials that translate evidence into community action."),
]

# ════════════════════════════════════════════════════════════
# 4. RATIONALE OF THE STUDY
# ════════════════════════════════════════════════════════════
story += [
    sp(10), h1("4. RATIONALE OF THE STUDY"), hr(),
    p("While the global and national evidence base confirms the efficacy of HPV vaccination and the existence of serious community-level barriers to its acceptance, no study has yet addressed this problem specifically within the community of Anand, Gujarat. The district's semi-urban demographic profile - with mixed educational attainment, co-existing traditional health beliefs, and a newly established national vaccination program - presents a unique and timely setting for this investigation."),
    sp(4),
    p("Two distinct community groups - college students and parents of girls aged 9-18 years - have been identified as primary target populations because they represent complementary decision-making perspectives: students as potential vaccine recipients themselves, and parents as the primary consent-givers for the eligible 9-14 year age group. Assessing both groups simultaneously, using separate, tailored questionnaires, is a methodological approach that no published Indian study has yet adopted for this topic, making it a key novelty of this project."),
    sp(4),
    p("Furthermore, pharmacy students at the 5th year Pharm.D level are uniquely positioned as frontline community health educators, given their training in patient counselling, pharmacology, and public health. This project leverages that positioning to not only generate evidence but also directly produce validated tools and health education resources that can be reused by future researchers, community health workers, and local health authorities - directly contributing to India's national goal of achieving 90% HPV vaccination coverage by 2030.<sup>5</sup>"),
]

# ════════════════════════════════════════════════════════════
# 5. OBJECTIVES
# ════════════════════════════════════════════════════════════
story += [
    sp(10), h1("5. OBJECTIVES"), hr(),
    h2("5.1 Primary Objectives"),
    bullet_item("To assess the knowledge, attitudes, perceived barriers, and acceptance of HPV vaccination among college students and parents of girls aged 9-18 years in Anand, Gujarat."),
    bullet_item("To develop and validate two separate bilingual (English/Gujarati) KAP questionnaires - one for college students and one for parents."),
    sp(4), h2("5.2 Secondary Objectives"),
    bullet_item("To identify sociodemographic factors associated with HPV vaccination knowledge and acceptance in each study arm."),
    bullet_item("To compare KAP profiles between college students and parents."),
    bullet_item("To develop a culturally appropriate bilingual health education leaflet/poster on HPV vaccination for community use."),
    bullet_item("To assess the readability and acceptability of the developed health education resource."),
]

# ════════════════════════════════════════════════════════════
# 6. METHODOLOGY
# ════════════════════════════════════════════════════════════
story += [
    sp(10), h1("6. METHODOLOGY"), hr(),

    h2("6.1 Study Design"),
    p("Cross-sectional, community-based observational study with an embedded tool validation component."),

    sp(4), h2("6.2 Study Setting"),
    p("Residential areas, colleges, community health centres, PHCs, and Anganwadi centres in Anand district, Gujarat."),

    sp(4), h2("6.3 Study Duration"),
    p("6 months - including tool development, validation, data collection, analysis, and health education resource development."),

    sp(4), h2("6.4 Study Population - Two Arms"),
    table(
        [
            [p("", TCellH), p("Arm 1: College Students", TCellH), p("Arm 2: Parents", TCellH)],
            [p("Who", TCell), p("Students enrolled in colleges in Anand", TCell), p("Parents of girls aged 9-18 years in Anand", TCell)],
            [p("Age", TCell), p("18-25 years", TCell), p("25-55 years (approx.)", TCell)],
            [p("Rationale", TCell), p("Near target age group; personal acceptance", TCell), p("Primary decision-makers for daughter's vaccination", TCell)],
            [p("Recruitment", TCell), p("College campuses", TCell), p("PHCs, Anganwadis, residential areas", TCell)],
        ],
        col_widths=[3*cm, 7.5*cm, 7.5*cm]
    ),

    sp(6), h2("6.5 Sample Size"),
    p("Formula: n = Z\u00b2 \u00d7 p \u00d7 (1-p) / d\u00b2"),
    p("Z = 1.96 (95% CI); p = 0.50 (conservative estimate); d = 0.07 (margin of error)"),
    p("n = (1.96)\u00b2 \u00d7 0.5 \u00d7 0.5 / (0.07)\u00b2 \u2248 196 per arm; adding 10% non-response = <b>~216 per arm</b>"),
    p("<b>Total sample = ~432 participants (216 students + 216 parents)</b>"),

    sp(4), h2("6.6 Inclusion & Exclusion Criteria"),
    table(
        [
            [p("Criterion", TCellH), p("Arm 1: Students", TCellH), p("Arm 2: Parents", TCellH)],
            [p("Age", TCell), p("18-25 years", TCell), p("\u226525 years", TCell)],
            [p("Specific", TCell), p("Enrolled in college in Anand", TCell), p("Parent of girl aged 9-18 years", TCell)],
            [p("Residence", TCell), p("Anand district \u22656 months", TCell), p("Anand district \u22656 months", TCell)],
            [p("Exclusion", TCell), p("Healthcare professionals; cognitive impairment; refusal of consent", TCell), p("Healthcare professionals; cognitive impairment; refusal of consent", TCell)],
        ],
        col_widths=[3*cm, 7.5*cm, 7.5*cm]
    ),
]

# ════════════════════════════════════════════════════════════
# 7. DATA COLLECTION TOOL
# ════════════════════════════════════════════════════════════
story += [
    sp(10), h1("7. DATA COLLECTION TOOL"), hr(),
    h2("7.1 Questionnaire Structure"),
    p("Two structured questionnaires will be developed de novo in English and translated into Gujarati using forward-backward translation methodology. Both share a common core structure but with population-specific items:"),
    sp(4),
    table(
        [
            [p("Section", TCellH), p("Content", TCellH), p("Students", TCellH), p("Parents", TCellH)],
            [p("A", TCell), p("Sociodemographic information", TCell), p("8 items", TCell), p("8 items", TCell)],
            [p("B", TCell), p("Knowledge of HPV and cervical cancer", TCell), p("15 items (MCQ/True-False)", TCell), p("15 items (MCQ/True-False)", TCell)],
            [p("C", TCell), p("Attitudes toward HPV vaccination", TCell), p("10 items (5-pt Likert)", TCell), p("10 items (5-pt Likert)", TCell)],
            [p("D", TCell), p("Perceived barriers", TCell), p("10 items (5-pt Likert)", TCell), p("10 items (5-pt Likert)", TCell)],
            [p("E", TCell), p("Vaccine acceptance", TCell), p("5 items (personal)", TCell), p("5 items (intent to vaccinate daughter)", TCell)],
        ],
        col_widths=[1.5*cm, 5.5*cm, 5*cm, 6*cm]
    ),
    sp(6), h2("7.2 Validation Steps"),
    table(
        [
            [p("Step", TCellH), p("Method", TCellH), p("Threshold", TCellH)],
            [p("Content Validity", TCell), p("Expert panel of 5-7 (physicians, pharmacists, public health experts) - Content Validity Index (CVI)", TCell), p("CVI \u22650.80", TCell)],
            [p("Face Validity", TCell), p("Pilot testing on 15 community members for language clarity", TCell), p("Majority comprehension confirmed", TCell)],
            [p("Internal Consistency", TCell), p("Cronbach's alpha for attitude and barrier subscales", TCell), p("\u03b1 \u22650.70", TCell)],
            [p("Test-Retest Reliability", TCell), p("Re-administration to 30 participants after 2 weeks", TCell), p("ICC \u22650.75", TCell)],
        ],
        col_widths=[4*cm, 10*cm, 4*cm]
    ),
]

# ════════════════════════════════════════════════════════════
# 8. HEALTH EDUCATION RESOURCE
# ════════════════════════════════════════════════════════════
story += [
    sp(10), h1("8. HEALTH EDUCATION RESOURCE DEVELOPMENT"), hr(),
    p("A bilingual (Gujarati/Hindi) health education leaflet will be developed covering:"),
    bullet_item("What is HPV and how is it transmitted?"),
    bullet_item("Link between HPV and cervical cancer"),
    bullet_item("Who should receive the HPV vaccine and when?"),
    bullet_item("Government's free national vaccination program (Cervavac) details"),
    bullet_item("Addressing common myths and misconceptions"),
    bullet_item("Where to get vaccinated in Anand district"),
    sp(4),
    p("The leaflet will be reviewed by an expert panel for content accuracy and by 20 community members for readability and acceptability. Readability will be assessed using a validated checklist and acceptability rated on a 5-point scale."),
]

# ════════════════════════════════════════════════════════════
# 9. STATISTICAL ANALYSIS
# ════════════════════════════════════════════════════════════
story += [
    sp(10), h1("9. STATISTICAL ANALYSIS PLAN"), hr(),
    p("Data will be entered in Microsoft Excel and analyzed using SPSS v26 or JASP (free software)."),
    sp(4),
    table(
        [
            [p("Analysis", TCellH), p("Purpose", TCellH)],
            [p("Descriptive statistics (frequency, mean, SD)", TCell), p("Summarize sociodemographic data and KAP scores", TCell)],
            [p("Chi-square test", TCell), p("Association between sociodemographic variables and KAP", TCell)],
            [p("Independent t-test / ANOVA", TCell), p("Compare KAP scores across groups and between arms", TCell)],
            [p("Pearson/Spearman correlation", TCell), p("Correlation between knowledge, attitude, and acceptance scores", TCell)],
            [p("Binary logistic regression", TCell), p("Predictors of HPV vaccine acceptance", TCell)],
        ],
        col_widths=[9*cm, 9*cm]
    ),
    sp(4),
    p("Knowledge scores: Poor (<50%), Moderate (50-74%), Good (\u226575%). p-value <0.05 considered statistically significant."),
]

# ════════════════════════════════════════════════════════════
# 10. ETHICAL CONSIDERATIONS
# ════════════════════════════════════════════════════════════
story += [
    sp(10), h1("10. ETHICAL CONSIDERATIONS"), hr(),
    bullet_item("IEC approval will be obtained prior to study initiation."),
    bullet_item("Written informed consent will be taken from all participants."),
    bullet_item("Participation is voluntary; participants may withdraw at any time without penalty."),
    bullet_item("Anonymity and confidentiality of participant data will be strictly maintained."),
    bullet_item("No biological samples or interventions will be performed - purely observational study."),
    bullet_item("Study will adhere to ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017)."),
]

# ════════════════════════════════════════════════════════════
# 11. EXPECTED OUTCOMES & LIMITATIONS
# ════════════════════════════════════════════════════════════
story += [
    sp(10), h1("11. EXPECTED OUTCOMES"), hr(),
    bullet_item("Two validated bilingual (English/Gujarati) KAP questionnaires on HPV vaccination."),
    bullet_item("Community-level KAP data from Anand, Gujarat post-2024 national rollout."),
    bullet_item("Identification of key sociodemographic predictors of vaccine acceptance."),
    bullet_item("A ready-to-distribute, expert-validated bilingual health education leaflet on HPV vaccination."),

    sp(10), h1("12. LIMITATIONS"), hr(),
    bullet_item("Self-reported data may be subject to social desirability bias."),
    bullet_item("Cross-sectional design limits causal inference."),
    bullet_item("Convenience sampling in Arm 1 may limit generalizability."),
    bullet_item("Study restricted to Anand district; findings may not represent all of Gujarat."),
]

# ════════════════════════════════════════════════════════════
# 13. REFERENCES
# ════════════════════════════════════════════════════════════
story += [
    PageBreak(),
    h1("13. REFERENCES"), hr(),
    p("1. WHO. Human papillomavirus and cancer. Geneva: WHO; 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/human-papilloma-virus-and-cancer", RefStyle),
    p("2. FOGSI. Preventing Cervical Cancer through HPV Vaccination in India. 2024.", RefStyle),
    p("3. HPV Information Centre. HPV and Related Diseases Report: India. IARC/ICO; 2023. Available from: https://hpvcentre.net/statistics/reports/IND.pdf", RefStyle),
    p("4. Palomino-Vizcaino G, et al. The Natural History of Cervical Cancer and the Case for MicroRNAs. Int J Mol Sci. 2024. [PMID: 39684702]", RefStyle),
    p("5. World Health Organization. Cervical cancer. Geneva: WHO; 2024. Available from: https://www.who.int/news-room/fact-sheets/detail/cervical-cancer", RefStyle),
    p("6. Serum Institute of India. Cervavac: Vaccine Information. 2024. Available from: https://cervavac.com", RefStyle),
    p("7. Ellingson MK, Sheikha H, Nyhan K, et al. HPV vaccine effectiveness by age at vaccination: A systematic review. Hum Vaccin Immunother. 2023;19(2):2239085. [PMID: 37529935]", RefStyle),
    p("8. Aggarwal I, Mehta D, Yadav P, et al. KAP on HPV Vaccination among Healthcare Providers at a Tertiary Care Centre in North Delhi. Asian Pac J Cancer Prev. 2025;26(2):671. [PMID: 40022716]", RefStyle),
    p("9. Mandal M, Sarkar S, Panda S. KAP of Young Female Nursing Officers and Female Doctors About the HPV Vaccine. Cureus. 2024. doi:10.7759/cureus.66284 [PMID: 39238704]", RefStyle),
    p("10. Kavyarani C, Kannan Karur A, Chaitra C, et al. KAP of Medical Professionals Regarding Cervical Cancer Prevention and HPV Vaccination. Cureus. 2025. [PMID: 41063879]", RefStyle),
    p("11. Gandhi R, Patel A, Patel M, et al. Cervical Cancer Prevention Among Rural Women in Gujarat: A Mixed Methods KAP Study. Cureus. 2024. doi:10.7759/cureus.69169 [PMID: 39398714]", RefStyle),
    p("12. Ganeshkumar P, Tank J, Choudhury SS, et al. KAP Study on Cervical Cancer Prevention and HPV Vaccination. South Asian J Cancer. 2025. [PMID: 41445902]", RefStyle),
    p("13. Vasudevan U, Kelly-Hanku A, Limbu P, et al. Marginalized voices on HPV vaccination in India. Front Glob Womens Health. 2026. [PMID: 42100579]", RefStyle),
    p("14. Mullassery D, Posmontier B. Health beliefs and acculturation on HPV vaccination acceptance among Asian Indian parents. J Am Assoc Nurse Pract. 2024. [PMID: 39264332]", RefStyle),
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]

# ── Build PDF ─────────────────────────────────────────────────────────────────
doc = SimpleDocTemplate(
    OUTPUT,
    pagesize=A4,
    leftMargin=1.8*cm,
    rightMargin=1.8*cm,
    topMargin=2.2*cm,
    bottomMargin=2.0*cm,
    title="HPV Vaccination KAP Study Protocol",
    author="Pharm.D 5th Year Student, Anand Gujarat",
)

doc.build(story, onFirstPage=header_footer, onLaterPages=header_footer)
print(f"SUCCESS: PDF created at {OUTPUT}")

cd /home/daytona/hpv-out && python3 generate_pdf.py 2>&1

ls -lh /home/daytona/hpv-out/HPV_KAP_Protocol_Full.pdf