HPV Vaccine Effectiveness Study in Rwandan Women Living With HIV

Summary

Our study will assess and measure population effectiveness of prophylactic HPV vaccine in reducing cervical, anal, and/or oral prevalent and 6-month persistent infections among HPV-vaccinated and 757 HPV-unvaccinated Rwandan WLWH aged 18-26 years. Additional objectives include the quantification \& examination of long-term antibody (into young adulthood) responses to HPV vaccination and to validate the performance (e.g., sensitivity and specificity) of a low-cost, POC (point-of-care) anti-HPV16 antibody test to determine/confirm HPV vaccination status. The findings for this study will provide necessary evidence regarding the long-term protection afforded by HPV vaccination in WLWH living in SSA, who are at the greatest risk of HPV-related cancers.

Conditions

• Cervical Cancer
• Human Papilloma Virus
• Human Immunodeficiency Virus
• HPV-Related Carcinoma

Interventions

PROCEDURE

Blood collection

Blood collection at enrollment visit

PROCEDURE

Oral, cervicovaginal and anal specimen collection

Oral, cervicovaginal and anal specimen collection at enrollment and follow-up visits

PROCEDURE

Anoscopy & Biopsy of Acetowhite Lesions

Used for management in follow-up visits of persistent anal HPV16/18+ in WLWH

PROCEDURE

Colposcopy & Biopsy of Acetowhite Lesions

Used for management in follow-up visits of persistent type-specific high-risk HPV cervicovaginal HPV

PROCEDURE

Ablative Treatment

Use for management in follow-up visits of persistent cervicovaginal HPV 16/18+ in WLWH, as identified in colposcopy and biopsy

PROCEDURE

LEEP (Loop Electrosurgical Excision Procedure)

Use for management in follow-up visits of persistent cervicovaginal HPV 16/18+ in WLWH, as identified in colposcopy and biopsy that ablation ineligible

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Rwanda Military Hospital

  collaborator OTHER

• University of Rwanda

  collaborator OTHER

• Montefiore Medical Center

  lead OTHER

Principal Investigators

• Marcel Yotebieng, MD, PhD · Albert Einstein College of Medicine

Eligibility

Min Age

18 Years

Max Age

28 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-03

Primary Completion

2024-12-12

Completion

2024-12-12

Countries

• Rwanda

Study Locations