Trial Outcomes & Findings for Identification and Treatment of Cervical Abnormalities in Perú Through Integration of Pocket Colposcopy and Telemedicine (NCT NCT05340322)

Results Overview

Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

503 participants

Primary outcome timeframe

up to approximately 1 year

Results posted on

2024-07-23

Participant Flow

3734 HPV tests were administered for screening purposes to participate in this study. Of these, 534 women were HPV+. 503 of those were consented to the study

Participant milestones

Participant milestones
Measure	HPV+ Pap Smear Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation. Colposcopy using pocket colpscope and thermocoagulator: If HPV+, visualization with pocket colposcope and treatment with thermocoagulator
Overall Study STARTED	503
Overall Study COMPLETED	503
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HPV+ Pap Smear n=503 Participants Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation. Colposcopy using pocket colpscope and thermocoagulator: If HPV+, visualization with pocket colposcope and treatment with thermocoagulator
Age, Categorical <=18 years	0 Participants n=503 Participants
Age, Categorical Between 18 and 65 years	503 Participants n=503 Participants
Age, Categorical >=65 years	0 Participants n=503 Participants
Age, Continuous	37.49 years n=503 Participants
Sex: Female, Male Female	503 Participants n=503 Participants
Sex: Female, Male Male	0 Participants n=503 Participants
Region of Enrollment Peru	503 Participants n=503 Participants

PRIMARY outcome

Timeframe: up to approximately 1 year

Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope

Outcome measures

Outcome measures
Measure	HPV+ Pap Smear n=503 Participants Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation. Colposcopy using pocket colpscope and thermocoagulator: If HPV+, visualization with pocket colposcope and treatment with thermocoagulator
Number of HPV Positive Women Examined	503 Participants

SECONDARY outcome

Timeframe: 6 months after initial visit

Outcome measures

Outcome measures
Measure	HPV+ Pap Smear n=503 Participants Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation. Colposcopy using pocket colpscope and thermocoagulator: If HPV+, visualization with pocket colposcope and treatment with thermocoagulator
Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment	488 Participants

Adverse Events

HPV+ Pap Smear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nimmi Ramanujam, PhD

Duke University

Phone: 9196605307

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place