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NCT02970136

Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention

Completed NA Results posted Last updated 28 December 2021
What this trial tests

NA trial testing OraQuick Swab in Human Papillomavirus in 754 participants. Completed in 30 October 2020.

Timeline
11 April 2017
Primary endpoint
30 October 2020
30 October 2020

Quick facts

Lead sponsorUniversity of Miami
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposescreening
Enrollment754
Start date11 April 2017
Primary completion30 October 2020
Estimated completion30 October 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Miami

Who can join

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 Conditions Primary · 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
GroupValue95% CI
Home Based Screening25.1820.22 – 30.24
Clinic Based Screening8.165.24 – 11.99
Male Participants
GroupValue95% CI
Home Based Screening32.6323.36 – 43.02
Clinic Based Screening15.799.02 – 24.70
Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months Secondary · 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
GroupValue95% CI
Home Based Screening71.8867.35 – 76.42
Clinic Based Screening31.5626.87 – 36.26
HIV Screening Test
GroupValue95% CI
Home Based Screening46.1541.12 – 51.19
Clinic Based Screening20.9516.85 – 25.06
HPV Screening Test
GroupValue95% CI
Home Based Screening24.4719.45 – 29.49
Clinic Based Screening12.068.26 – 15.86
FIT Screening Test
GroupValue95% CI
Home Based Screening39.2634.33 – 44.19
Clinic Based Screening18.5714.64 – 22.49
Median Number of Screenings Completed Secondary · 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
GroupValue95% CI
Home Based Screening11 – 2
Clinic Based Screening10 – 2
Female Participants at 6 months
GroupValue95% CI
Home Based Screening42 – 4
Clinic Based Screening21 – 3
Male participants at Baseline
GroupValue95% CI
Home Based Screening10 – 1
Clinic Based Screening10 – 1
Male Participants at 6 months
GroupValue95% CI
Home Based Screening32 – 3
Clinic Based Screening21 – 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):

  1. Cervical cancer risk and access: Utilizing three statistical tools to assess Haitian women in South Florida.
    Moise RK, Balise R, Ragin C, Kobetz E. · · 2021 · cited 7× · PMID 34228766 · DOI 10.1371/journal.pone.0254089
  2. Acceptability and Feasibility of Home-Based Hepatitis B Screening Among Haitian Immigrants.
    Jones PD, Gmunder K, Batrony S, Martin P, et al · · 2021 · cited 4× · PMID 33686574 · DOI 10.1007/s10903-021-01165-z
  3. Increasing uptake of evidence-based screening services though a community health worker-delivered multimodality program: study protocol for a randomized pragmatic trial.
    Carrasquillo O, Seay J, Jhaveri V, Long T, et al · · 2020 · cited 3× · PMID 32349789 · DOI 10.1186/s13063-020-4213-7

Verify or expand the search:

Other recruiting trials for Human Papillomavirus

Currently open trials in the same condition.

Other University of Miami trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing