Cervical Cancer, HIV Infections, HPV Infection
Conditions
Keywords
cervical cancer screening, Pap smear, colposcopy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEColposcopy using pocket colpscope and thermocoagulator
If HPV+, visualization with pocket colposcope and treatment with thermocoagulator
Sponsors
United States Agency for International Development (USAID)
Universidad Peruana Cayetano Heredia
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* HPV+ pap smear * Women must between the ages of 30-49yo
Exclusion criteria
* HPV (-) pap smear * people without a cervix
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of HPV Positive Women Examined | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment | 6 months after initial visit |
Countries
Peru
Participant flow
Recruitment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 503 |
| Total | 503 |
Baseline characteristics
| Characteristic | HPV+ Pap Smear | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 503 Participants | — |
| Age, Continuous | 37.49 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Peru | 503 Participants | — |
| Sex: Female, Male Female | 503 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 503 |
| other Total, other adverse events | 0 / 503 |
| serious Total, serious adverse events | 0 / 503 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV+ Pap Smear | Number of HPV Positive Women Examined | 503 Participants |
Secondary
Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment
Time frame: 6 months after initial visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HPV+ Pap Smear | Number of HPV Positive Women Who Completed the 6 Month Follow-up After Evaluation and Treatment | 488 Participants |