Trial Outcomes & Findings for HPV-Based Screen-and-Treat Demonstration Project in Lilongwe (NCT NCT04092257)
NCT ID: NCT04092257
Last Updated: 2025-08-06
Results Overview
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.
COMPLETED
NA
1250 participants
Baseline
2025-08-06
Participant Flow
Participants were recruited from health facilities with outpatient clinics that provide sexual and reproductive health services and/or HIV care services in Lilongwe, Malawi between 6/24/2020- 2/28/2022. The first participant was enrolled on 6/24/2020, and the last participant was enrolled on 2/28/2022.
Participants were assigned HIV-positive or HIV-negative groups based on HIV testing result.
Participant milestones
| Measure |
HIV Positive
Women living with HIV
|
HIV Negative
Women living without HIV
|
|---|---|---|
|
Overall Study
STARTED
|
625
|
625
|
|
Overall Study
COMPLETED
|
602
|
618
|
|
Overall Study
NOT COMPLETED
|
23
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
Baseline characteristics by cohort
| Measure |
HIV Positive
n=625 Participants
Women living with HIV
|
HIV Negative
n=625 Participants
Women living without HIV
|
Total
n=1250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=93 Participants
|
33 years
n=4 Participants
|
35 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
625 Participants
n=93 Participants
|
625 Participants
n=4 Participants
|
1250 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
625 Participants
n=93 Participants
|
625 Participants
n=4 Participants
|
1250 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
625 Participants
n=93 Participants
|
625 Participants
n=4 Participants
|
1250 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Malawi
|
625 participants
n=93 Participants
|
625 participants
n=4 Participants
|
1250 participants
n=27 Participants
|
|
Level of education
No education
|
94 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
133 Participants
n=27 Participants
|
|
Level of education
Primary
|
344 Participants
n=93 Participants
|
305 Participants
n=4 Participants
|
649 Participants
n=27 Participants
|
|
Level of education
Secondary
|
172 Participants
n=93 Participants
|
245 Participants
n=4 Participants
|
417 Participants
n=27 Participants
|
|
Level of education
Tertiary
|
15 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Marital status
Never married
|
9 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Marital status
Married/Living with partner
|
395 Participants
n=93 Participants
|
475 Participants
n=4 Participants
|
870 Participants
n=27 Participants
|
|
Marital status
Widowed/divorced/separated
|
221 Participants
n=93 Participants
|
121 Participants
n=4 Participants
|
342 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
HPV Positive
n=476 Participants
All HPV positive women.
|
HIV Negative
Women living without HIV
|
HIV Positive, HPV Negative, VIA Positive
Women living with HIV, human, papillomavirus (HPV) negative and Visual Inspection with Acetic Acid test positive.
|
|---|---|---|---|
|
Same-day Visual Inspection With Acetic Acid (VIA) Rate
Visual Inspection with Acetic Acid (VIA) performed
|
469 Participants
|
—
|
—
|
|
Same-day Visual Inspection With Acetic Acid (VIA) Rate
Visual Inspection with Acetic Acid (VIA) performed on the same day
|
459 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: 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.
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.
Outcome measures
| Measure |
HPV Positive
n=476 Participants
All HPV positive women.
|
HIV Negative
Women living without HIV
|
HIV Positive, HPV Negative, VIA Positive
Women living with HIV, human, papillomavirus (HPV) negative and Visual Inspection with Acetic Acid test positive.
|
|---|---|---|---|
|
Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage
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
Thermocoagulation completed among HPV-positive participants on same day of self-collection
|
109 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Participants joined the study and provided self-collected vaginal samples using a Viba-Brush® for HPV testing.
The proportion of women who tested High risk (hr)-human papillomavirus (HPV) positive on a self-collected vaginal brush among enrolled participants.
Outcome measures
| Measure |
HPV Positive
n=625 Participants
All HPV positive women.
|
HIV Negative
n=625 Participants
Women living without HIV
|
HIV Positive, HPV Negative, VIA Positive
Women living with HIV, human, papillomavirus (HPV) negative and Visual Inspection with Acetic Acid test positive.
|
|---|---|---|---|
|
High Risk (hr)-Human Papillomavirus (HPV) Positive Rate
|
295 Participants
|
181 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Participants who tested HPV-positive for cervical cancer screening in the study and completed the screen-triage-treat algorithm.
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.
Outcome measures
| Measure |
HPV Positive
n=74 Participants
All HPV positive women.
|
HIV Negative
n=42 Participants
Women living without HIV
|
HIV Positive, HPV Negative, VIA Positive
n=38 Participants
Women living with HIV, human, papillomavirus (HPV) negative and Visual Inspection with Acetic Acid test positive.
|
|---|---|---|---|
|
HPV Screen-triage-treat Algorithm for Cervical Cancer Screening
|
49 Participants
|
10 Participants
|
0 Participants
|
Adverse Events
HIV Positive -VIA and Thermocoagulation
HIV Negative -VIA and Thermocoagulation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
HIV Positive -VIA and Thermocoagulation
n=22 participants at risk
HIV Positive Participants will undergo the same-day VIA and thermocoagulation were included.
|
HIV Negative -VIA and Thermocoagulation
n=28 participants at risk
HIV HIV-negative participants will undergo the same-day VIA and thermocoagulation were included.
|
|---|---|---|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/22 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
3.6%
1/28 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
|
Infections and infestations
Vaginal Inflammation
|
0.00%
0/22 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
3.6%
1/28 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
0.00%
0/28 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
|
Reproductive system and breast disorders
Amenorrhea
|
0.00%
0/22 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
7.1%
2/28 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/22 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
7.1%
2/28 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
|
Reproductive system and breast disorders
Pelvic pain
|
18.2%
4/22 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
14.3%
4/28 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
|
Reproductive system and breast disorders
vaginal bleeding
|
4.5%
1/22 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
14.3%
4/28 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
|
Reproductive system and breast disorders
vaginal discharge
|
63.6%
14/22 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
50.0%
14/28 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
4.5%
1/22 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
14.3%
4/28 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
3.6%
1/28 • Up to 4 weeks.
Adverse events were collected from day one of the study to 4 weeks after completion of the thermocoagulation intervention in participants who received thermocoagulation only. Adverse events were not monitored/assessed in any other participants.
|
Additional Information
Melahat Garipagaoglu
UNC Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place