Trial · NCT04092257

HPV-Based Screen-and-Treat Demonstration Project in Lilongwe

NCT04092257, Not applicable, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2025-08-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. HPV-Based Screen-and-Treat Demonstration Project in Lilongwe. Trials, record NCT04092257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04092257

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
NCT number: NCT04092257
Status: Completed
Phases: Not applicable
Enrollment: 1,250 participants, actual
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Conditions: HPV Infection, Cervical Cancer, HIV Infections
Interventions: VIA and thermocoagulation
First posted: 2019-09-17
Last updated: 2025-08-06
Results first posted: 2025-08-06
Limitations and caveats: The small sample size of women with cervical precancer and the experienced research team may limit the generalizability of findings, especially in national screening programs where providers have multiple tasks.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Same-day Visual Inspection With Acetic Acid (VIA) Rate	Baseline	The proportion of women who were HPV-positive and underwent same-day VIA following self-collected vaginal sampling was assessed, including both HIV-positive and HIV-negative participants. As per the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day VIA completion by HIV status.
Primary	Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage	Baseline	Among women who tested HPV-positive through primary screening, those eligible for thermocoagulation by colposcopy triage received thermocoagulation treatment on the same day as self-collection. As specified in the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day colposcopy completion by HIV status.
Primary	High Risk (hr)-Human Papillomavirus (HPV) Positive Rate	Baseline	The proportion of women who tested High risk (hr)-human papillomavirus (HPV) positive on a self-collected vaginal brush among enrolled participants.
Secondary	HPV Screen-triage-treat Algorithm for Cervical Cancer Screening	Up to 24 weeks	To evaluate the performance of the proposed ICC screen-and-treat strategy for cervical carcinoma screening among women who are HIV- positive, the rates of overtreatment and undertreatment rates were estimated. Overtreatment for women who are HPV-positive VIA- positive/ablation-eligible and would have received thermocoagulation but had no cervical precancer (i.e., high-grade cervical intraepithelial neoplasia), and undertreatment among HPV-positive with high-grade cervical intraepithelial neoplasia but were VIA-positive and eligible for thermocoagulation, and those who were VIA-negative.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Same-day Visual Inspection With Acetic Acid (VIA) Rate	Baseline	Participants who underwent HPV-based primary screening for cervical cancer and tested HPV-positive on self-collected vaginal sample and had VIA triage performed on the same day of self-collection.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage	Baseline	Participants who underwent HPV-based primary screening for cervical cancer and tested HPV-positive and were eligible for thermocoagulation by colposcopy triage and had thermocoagulation performed on the same day of self-collection.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	High Risk (hr)-Human Papillomavirus (HPV) Positive Rate	Baseline	Participants joined the study and provided self-collected vaginal samples using a Viba-Brush® for HPV testing.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	HPV Screen-triage-treat Algorithm for Cervical Cancer Screening	Up to 24 weeks	Participants who tested HPV-positive for cervical cancer screening in the study and completed the screen-triage-treat algorithm.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Same-day Visual Inspection With Acetic Acid (VIA) Rate	HPV Positive	Visual Inspection with Acetic Acid (VIA) performed	469	Participants
Same-day Visual Inspection With Acetic Acid (VIA) Rate	HPV Positive	Visual Inspection with Acetic Acid (VIA) performed on the same day	459	Participants
Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage	HPV Positive	HPV-positive participants eligible for thermocoagulation based on colposcopy triage	110	Participants
Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage	HPV Positive	Thermocoagulation completed among HPV-positive participants on same day of self-collection	109	Participants
High Risk (hr)-Human Papillomavirus (HPV) Positive Rate	HIV Positive		295	Participants
High Risk (hr)-Human Papillomavirus (HPV) Positive Rate	HIV Negative		181	Participants
HPV Screen-triage-treat Algorithm for Cervical Cancer Screening	HIV Positive, HPV Positive, VIA Positive, and Had no High Grade Cervical Intraepithelial Neoplasia		49	Participants
HPV Screen-triage-treat Algorithm for Cervical Cancer Screening	HIV Positive,HPV Positive, VIA Positive, and Had Biopsy-proven Cervical Precancer in the Endocervix		10	Participants
HPV Screen-triage-treat Algorithm for Cervical Cancer Screening	HIV Positive, HPV Negative, VIA Positive		0	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	HIV Positive	625
Overall Study	STARTED	HIV Negative	625
Overall Study	COMPLETED	HIV Positive	602
Overall Study	COMPLETED	HIV Negative	618
Overall Study	NOT COMPLETED	HIV Positive	23
Overall Study	NOT COMPLETED	HIV Negative	7

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dysuria	Renal and urinary disorders	HIV Positive -VIA and Thermocoagulation	0	22
other	Dysuria	Renal and urinary disorders	HIV Negative -VIA and Thermocoagulation	1	28
other	Vaginal Inflammation	Infections and infestations	HIV Positive -VIA and Thermocoagulation	0	22
other	Vaginal Inflammation	Infections and infestations	HIV Negative -VIA and Thermocoagulation	1	28
other	Back pain	Musculoskeletal and connective tissue disorders	HIV Positive -VIA and Thermocoagulation	1	22
other	Back pain	Musculoskeletal and connective tissue disorders	HIV Negative -VIA and Thermocoagulation	0	28
other	Amenorrhea	Reproductive system and breast disorders	HIV Positive -VIA and Thermocoagulation	0	22
other	Amenorrhea	Reproductive system and breast disorders	HIV Negative -VIA and Thermocoagulation	2	28
other	Menorrhagia	Reproductive system and breast disorders	HIV Positive -VIA and Thermocoagulation	0	22
other	Menorrhagia	Reproductive system and breast disorders	HIV Negative -VIA and Thermocoagulation	2	28

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	HIV Positive -VIA and Thermocoagulation	1	22
Total, all-cause mortality	HIV Negative -VIA and Thermocoagulation	0	28
Total, other adverse events	HIV Positive -VIA and Thermocoagulation	19	22
Total, other adverse events	HIV Negative -VIA and Thermocoagulation	21	28
Total, serious adverse events	HIV Positive -VIA and Thermocoagulation	0	22
Total, serious adverse events	HIV Negative -VIA and Thermocoagulation	0	28

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21CA236770	A novel cervical cancer screen-and-treat demonstration project with HPV self-testing and thermocoagulation for HIV-infected women in Malawi	CHINULA, LAMECK	UNIV OF NORTH CAROLINA CHAPEL HILL	NATIONAL CANCER INSTITUTE	2019 to 2020

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
HIV Positive vs HIV Negative: High Risk (hr)-Human Papillomavirus (HPV) Positive Rate	Trial comparisons
HIV Positive -VIA and Thermocoagulation vs HIV Negative -VIA and Thermocoagulation: deaths from any cause	Trial comparisons
HIV Positive -VIA and Thermocoagulation vs HIV Negative -VIA and Thermocoagulation: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04092257

GET https://conductscience.org/api/trials/v1/NCT04092257/registered

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