An interventional study of Colposcopy using pocket colpscope and thermocoagulator in Cervical Cancer, HPV Infection and HIV Infections, sponsored by Duke University. Completed at 1 site in Peru. Open to female participants aged 30 Years to 49 Years. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. The objective is to provide colposcopy capability to rural communities in Peru potentially using Telehealth. Approximately 10,000 women will receive self HPV test kit for community health workers. Of these participants, approximately 1,000 HPV+ participants will be invited to participate in this pocket colposcopy study. Approximately 500 of these participants may require treatment using thermocoagulation.
The goal is to demonstrate that the combination of self-sampling, the Pocket colposcope and the thermocoagulator will yield a high proportion of HPV positive women who complete treatment and follow-up care. The bulk of this trial will occur over a two-year period in Peru. Duke will provide the Pocket colposcope and the Calla application to run the device only. Dr. Garcia will recruit and train community women for the distribution of self-collection HPV test kits, identify and partner with 10 to 12 health centers in the Andean region of Peru, conduct baseline data collection in each health center, procure necessary equipment and technology, and conduct training for HPV testing, Pocket colposcopy, and thermocoagulation. Within 18 months trained community women will distribute 10,000 HPV tests to women within the region. The investigators anticipate that 10% of the women screened will be HPV positive and they will be recruited for our trial. As part of the study the participants will be followed to determine if the participants attend a health center, receive Pocket colposcopy, and if needed whether the participants are treated with the thermocoagulator device. All women will be appointed to return to the health center for a follow-up evaluation six months post-treatment.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 503 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
Visualization of cervix and if abnormalities are present treat with SOC thermocoagulation.
Device: Colposcopy using pocket colpscope and thermocoagulator
If HPV+, visualization with pocket colposcope and treatment with thermocoagulator
Number of HPV Positive Women Examined
Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope
Time frame: up to approximately 1 year
Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment
Time frame: 6 months after initial visit
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
| Milestone | HPV+ Pap Smear |
|---|---|
| Started | 503 |
| Completed | 503 |
| Not completed | 0 |
Total number of HPV positive women that went to a Peruvian health center for treatment and were examined using the Pocket Colposcope
| Participants | HPV+ Pap Smear |
|---|---|
| Number of HPV Positive Women Examined | 503 |
| Participants | HPV+ Pap Smear |
|---|---|
| Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment | 488 |
Collected over Approximately 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HPV+ Pap Smear | 0/503 (0%) | 0/503 (0%) | 0/503 (0%) |
| Age, Categorical(Participants) | HPV+ Pap Smear |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 503 |
| >=65 years | 0 |
| Age, Continuous(years) | HPV+ Pap Smear |
|---|---|
| Median | 37.49 (30 to 49) |
| Sex: Female, Male(Participants) | HPV+ Pap Smear |
|---|---|
| Female | 503 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | HPV+ Pap Smear |
|---|
| Region of Enrollment(Participants) | HPV+ Pap Smear |
|---|---|
| Peru | 503 |
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