Adults 50 to 64, any sex, with Human Papillomavirus or Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Are Screened for All ConditionsPrimary· Baseline
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.
Female Participants
Group
Value
95% CI
Home Based Screening
25.18
20.22 – 30.24
Clinic Based Screening
8.16
5.24 – 11.99
Male Participants
Group
Value
95% CI
Home Based Screening
32.63
23.36 – 43.02
Clinic Based Screening
15.79
9.02 – 24.70
Change in Percentage of Participants Completing Screening Test From Baseline to 6 MonthsSecondary· Baseline, Up to 6 months
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.
HCV Screening Test
Group
Value
95% CI
Home Based Screening
71.88
67.35 – 76.42
Clinic Based Screening
31.56
26.87 – 36.26
HIV Screening Test
Group
Value
95% CI
Home Based Screening
46.15
41.12 – 51.19
Clinic Based Screening
20.95
16.85 – 25.06
HPV Screening Test
Group
Value
95% CI
Home Based Screening
24.47
19.45 – 29.49
Clinic Based Screening
12.06
8.26 – 15.86
FIT Screening Test
Group
Value
95% CI
Home Based Screening
39.26
34.33 – 44.19
Clinic Based Screening
18.57
14.64 – 22.49
Median Number of Screenings CompletedSecondary· At baseline and at 6 months
As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.
Female Participants at Baseline
Group
Value
95% CI
Home Based Screening
1
1 – 2
Clinic Based Screening
1
0 – 2
Female Participants at 6 months
Group
Value
95% CI
Home Based Screening
4
2 – 4
Clinic Based Screening
2
1 – 3
Male participants at Baseline
Group
Value
95% CI
Home Based Screening
1
0 – 1
Clinic Based Screening
1
0 – 1
Male Participants at 6 months
Group
Value
95% CI
Home Based Screening
3
2 – 3
Clinic Based Screening
2
1 – 3
Sponsor's own description
The purpose of this research study is to determine the best way to increase screening for cervical cancer, colorectal cancer, HIV, and Hepatitis C among under screened Hispanic, Haitian and African-American individuals in Hialeah, South Dade, and Little Haiti. The investigator will compare home testing led by a community health worker (CHW) versus clinic testing guided by a CHW. Community Health Workers are people who have undergone several weeks of community outreach and health education training. During the study period the participant will continue to receive all of their regular medical care from their regular health care providers. If the participant does not have a health care provider, the Community Health Workers would be able to help in referring the participant for care at a local health care clinic located in their community.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06519994 — Feasibility of Intravaginal Artesunate as Adjuvant HPV & Cervical Precancer Treatment in Kenya
· Phase 2
· active not recruiting
NCT06434337 — Evaluation of a Novel Point-of-Care Diagnostic Test for Human Papillomavirus (HPV)
· recruiting
NCT05365048 — Provider Recommendation and HPV Vaccination
· NA
· recruiting
NCT05026138 — Natural History, Epidemiology and Pathogenesis of Severe HPV-Related Diseases (Neptune)
· recruiting
NCT04708470 — A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel,
· Phase 1, PHASE2
· active not recruiting
Other University of Miami trials
Trials by the same sponsor.
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· NA
· not yet recruiting
NCT06077071 — MRIdian "RADAR" Trial
· NA
· not yet recruiting
NCT07472413 — Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project
· Phase 3
· not yet recruiting
NCT07322289 — Antibiotic-coated Braided Suture Study
· NA
· not yet recruiting
NCT07469592 — eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Miami
Last refreshed: 28 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02970136.