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HPV Vaccine Effectiveness Study in Rwandan Women Living With HIV

CompletedN/A

Sponsor: Montefiore Medical Center

Conditions: Cervical Cancer, Human Papilloma Virus, Human Immunodeficiency Virus, HPV-Related Carcinoma

Interventions: Blood collection, Oral, cervicovaginal and anal specimen collection, Anoscopy & Biopsy of Acetowhite Lesions, Colposcopy & Biopsy of Acetowhite Lesions, Ablative Treatment

Countries: Rwanda

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 28 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Female
* 18-28 years. The age of inclusion criteria will likely be restricted as age-specific enrollment goals are met.
* Physically and mentally able and willing to participate in the study.
* Willing to provide written and signed or thumb printed, informed consent.
* Known to be living with HIV (i.e., enrolled in a treatment program), or consent to HIV testing to confirm HIV status.

Exclusion Criteria:

* Have positive pregnancy test or report to be pregnant at the time of visit or less than 6 weeks post-partum (will be asked to make an appointment 6 or more weeks post-partum)
* Report to be menstruating at the time of visit (will be asked to make new appointment)
* History of hysterectomy and no longer have a cervix
* History of treatment for cervical abnormalities after cervical screening
* History of cervical cancer
* Report no previous sexual activity
* HIV status is unknown, and date of birth is 12/31/1995 or earlier
* Because this study has age-specific enrollment goals for WLWH and HIV\[-\] women, once those enrollment goals are met for each study group, the respective cohorts will be closed and other eligible women will be excluded.

Locations (1)

Kigali, Rwanda