Clinical trial · Observational
Self-collected Vaginal and Urine Samples in HIV-positive Women
Self-collected Cervical Cancer Screening Samples for Detection of Human Papillomavirus in HIV-positive Women - a Pilot Study of Self-collected Vaginal and Urine Samples
NCT05783167CI-TRIAL-00080275completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study assesses topics as Human Immunodeficiency Virus (HIV), Human Papilloma Virus (HPV), and cancer screening methods. The focus will be on evaluating feasibility of implementing novel cancer screening modalities in a low-resource setting in Guinea-Bissau and further to estimate the prevalence of the precancerous virus HPV amongst women living with HIV. In the study the investigators will collect urinary and vaginal self-samples for HPV testing, and further evaluate the feasibility of implementing the devices as screening modalities through questionnaires given to the women.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Coinfection, HIV | — | UNRESOLVED | — |
| HIV Infections | — | UNRESOLVED | — |
| HPV-Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-sampling for HPV infection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HIV-positive females in Guinea-Bissau
- description
- The study is conducted on female HIV-infected patients in the Nationwide HIV-cohort at the 9 biggest HIV-clinics in Guinea-Bissau. Participants will be invited to enroll in the project when they present to the HIV-clinics for HIV-treatment and consultations.
- interventionNames
- Diagnostic Test: Self-sampling for HPV infection
Primary outcomes (2)
- measure
- Feasibility of implementing HPV self sampling for cervical cancer screening
- timeFrame
- April 2023 - February 2024
- description
- Among women meeting the inclusion criteria, the investigators want to estimate the prevalence of how many accepts the offer to collect self-samples, thereby gaining knowledge on the feasibility of implementing self-sampling as a cervical cancer screening method in Guinea-Bissau.
- measure
- HPV-prevalence among HIV-infected women in Guinea-Bissau
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * HIV-positive (women with HIV-1, HIV-2 AND HIV1/2 are all eligible) * Age between 18 and 65 years Exclusion Criteria: * Current pregnancy * Pregnancy within the last 3 months * Prior hysterectomy * Women using other vaginal products than contraceptives and water based lubricants * Women who don't understand the extent of the study * Bleeding due to ongoing period
References
Publications (13)
- BACKGROUNDChaturvedi AK, Madeleine MM, Biggar RJ, Engels EA. Risk of human papillomavirus-associated cancers among persons with AIDS. J Natl Cancer Inst. 2009 Aug 19;101(16):1120-30. doi: 10.1093/jnci/djp205. Epub 2009 Jul 31. PMID 19648510
- BACKGROUNDHawes SE, Critchlow CW, Faye Niang MA, Diouf MB, Diop A, Toure P, Aziz Kasse A, Dembele B, Salif Sow P, Coll-Seck AM, Kuypers JM, Kiviat NB. Increased risk of high-grade cervical squamous intraepithelial lesions and invasive cervical cancer among African women with human immunodeficiency virus type 1 and 2 infections. J Infect Dis. 2003 Aug 15;188(4):555-63. doi: 10.1086/376996. Epub 2003 Jul 23. PMID 12898443
- BACKGROUNDMezei AK, Armstrong HL, Pedersen HN, Campos NG, Mitchell SM, Sekikubo M, Byamugisha JK, Kim JJ, Bryan S, Ogilvie GS. Cost-effectiveness of cervical cancer screening methods in low- and middle-income countries: A systematic review. Int J Cancer. 2017 Aug 1;141(3):437-446. doi: 10.1002/ijc.30695. Epub 2017 Apr 3. PMID 28297074
- BACKGROUNDWright TC, Stoler MH, Behrens CM, Sharma A, Zhang G, Wright TL. Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol. 2015 Feb;136(2):189-97. doi: 10.1016/j.ygyno.2014.11.076. Epub 2015 Jan 8. PMID 25579108
- BACKGROUNDGilham C, Sargent A, Kitchener HC, Peto J. HPV testing compared with routine cytology in cervical screening: long-term follow-up of ARTISTIC RCT. Health Technol Assess. 2019 Jun;23(28):1-44. doi: 10.3310/hta23280. PMID 31219027
- BACKGROUNDCoorevits L, Traen A, Binge L, Van Dorpe J, Praet M, Boelens J, Padalko E. Are vaginal swabs comparable to cervical smears for human papillomavirus DNA testing? J Gynecol Oncol. 2018 Jan;29(1):e8. doi: 10.3802/jgo.2018.29.e8. PMID 29185266
- Boggan JC, Walmer DK, Henderson G, Chakhtoura N, McCarthy SH, Beauvais HJ, Smith JS. Vaginal Self-Sampling for Human Papillomavirus Infection as a Primary Cervical Cancer Screening Tool in a Haitian Population. Sex Transm Dis. 2015 Nov;42(11):655-9. doi: 10.1097/OLQ.0000000000000345.