2-stage Cervical Cancer Screening in Botswana

NCT03324009 | Completed

• 2 other identifiers: 2017P0003885P30AI060354-14
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical cancer is the leading cause of cancer death among women in Botswana. The burden of cervical cancer is largely related to the high prevalence of HIV in Botswana (22%), as HIV is known to be a significant risk factor for cervical cancer. Cervical cancer screening is life-saving and has been shown to reduce cervical cancer incidence in multiple settings. Yet, there is no consensus on appropriate screening algorithms for women living with HIV, across resource settings. Botswana is in a unique position, relative to its neighbors in Sub-Saharan Africa, in that there exists capacity for advanced screening modalities, including primary high risk human papilloma virus (hrHPV) testing and cytology-based screening. To address this issue, this study seeks to evaluate two-stage cervical cancer screening algorithms for women living with HIV in Botswana using hrHPV testing. The protocols include hrHPV testing followed by Pap Smear evaluation, VIA and colposcopy. These same participants will be invited back at one-year for cervical cancer screening using hrHPV testing (followed by triage testing) in order to inform guidelines on the frequency of HPV testing in women living with HIV. The evidence generated will be critical to guiding cervical cancer screening in HIV-infected women across resource settings.

Conditions

Cervical Cancer; HIV/AIDS

Outcome Measures

Primary Outcomes (5)

• Performance of HPV-Pap screening algorithm

  Measurement of the sensitivity, specificity and positive predictive value of Pap smear in predicting cervical precancer and cancer in HPV positive, HIV positive women.

  2 months

• Performance of HPV-VIA screening algorithm

  Measurement of the sensitivity, specificity and positive predictive value of VIA in predicting cervical precancer and cancer in HPV positive, HIV positive women.

  2 months

• Performance of HPV-Colposcopy screening algorithm

  Measurement of the sensitivity, specificity and positive predictive value of Colposcopy in predicting cervical precancer and cancer in HPV positive, HIV positive women.

  6 months

• Incident and persistent HPV infection at one-year follow-up

  18 months

• Incidence, persistence and progression of histopathologic abnormality at one-year follow-up

  18 months

Study Arms (1)

2-stage screen

EXPERIMENTAL

All patients will be enrolled in the two-stage cervical cancer screening protocol

Diagnostic Test: 2-stage screen

Interventions

2-stage screen DIAGNOSTIC_TEST

Pap smear is currently the standard of care for cervical cancer screening in Botswana. In this study, participants will undergo HPV DNA testing at the time of Pap smear collection. If HPV DNA test is positive, they will be referred for colposcopy. Patients who have an HPV negative test but positive Pap smear will be referred for colposcopy per Botswana cervical cancer screening guidelines.

2-stage screen

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥25 years of age
• HIV-positive
• Competent to understand study procedures and give informed consent.

You may not qualify if:

• Currently pregnant
• Currently menstruating or having persistent vaginal discharge
• Previous hysterectomy
• Previous diagnosis of cervical cancer

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Princess Marina Hospital

Gaborone, Botswana

Location

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Related Links

• Worldwide cervical cancer statistics
• Sensitivity of cervical cytology in low- and middle-income countries

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Rebecca Luckett, MD MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Obstetrics, Gynecology and Reproductive Biology

Model Details: Prospective cohort

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 27, 2017
• Study Start: April 20, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)