Health TrialsbyHealthPanel

The Mother-Daughter Project: Merck-4

ConditionCervical Dysplasia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age9-49
SponsorIndiana University

About this trial

This project serves to continue a community-based initiative, known as the Kenya Mother-Daughter Cervical Cancer Eradication Project, or the Mother-Daughter Project (MDP), in the Webuye region of Western Kenya. The MDP project, since its initiation in 2018, has sought to develop a framework for the eradication of cervical cancer through effective screening of adult women and through the vaccination of female children.

This project specifically aims to collect additional data on the ability for HR-HPV testing to detect premalignant lesions of the cervix, especially in HIV-infected women, to investigate and identify barriers leading to non-participation in previous MDP efforts, and to examine factors associated with the immune response to HPV vaccination among rural Kenyan girls.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

ages 25 through 49 years

able/willing to sign informed consent

willing to participate in the community meetings

Disqualifiers

ages 9 through 14 years

have mother that is able/willing to sign informed consent for vaccination

can return for the second HPV vaccine dose in 6 - 12 months

Trial design

Design model

Single group

Treatments tested in this trial

  • Gardisil-9

    Biological/Vaccine

    The 9 valent vaccine will be offfered to 2000 adolescent girls. The 9 valent vaccine will be offered to 2000 adolescent girls. The first vaccination dose will be administered at a community meeting, after parental consent has been obtained. The second vaccination dose will be administered at a subsequent community meeting, 6 to 12 months after the first dose.

  • High Risk HPV DNA Testing

    Diagnostic test

    Self-collected cervical swabs will be tested for high-risk HPV using the Roche Cobas Assay. This assay provides specific HPV 16 or 18 detection, as well as detection of any of 12 additional oncogenic types (HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68).

  • Visual Inspection with acetic acid (VIA) and possible cervical biopsy

    Procedure/Surgery

    Cervical screening in Kenya is usually done through pelvic examination and VIA. Cervical biopsy will additionally be performed for all HIV-infected women, and for HIV-uninfected women with abnormal VIA results.

Treatment groups

2,500 Participants
are divided into 2 treatment groups
Group A: Kenyan womenOther 2 interventions
Group B: Kenyan daughtersOther 1 intervention

Trial outcomes

Primary outcomes

1

Detection of CIN2/3

Following a community meeting at which education on cervical cancer, self-collection of swabs for analysis and HPV vaccination are discussed, participating adult women will provide a self collected swab that will be analyzed for high risk HPV. All participating adult women will additionally undergo pelvic examination and VIA (the Kenyan standard of care). Cervical biopsy will be performed on all HIV-infected women and those HIV-uninfected women with abnormal VIA examinations. For the cohort of women who will undergo cervical biopsy, the rates of HR-HPV positivity, VIA abnormality and CIN2/3 detection will be reported for all women and by HIV status. Sensitivity, specificity, positive predictive value, and negative predictive value between HR-HPV and VIA in the detection of biopsy-proven cervical intraepithelial lesion grades 2 and 3, or invasive cancer (CIN2/3) will be compared.

Time frame
Baseline
2

Local knowledge and attitudes

Adult women and their daughters (if they have daughters), will be asked to fill out questionnaires that will evaluate women's knowledge of cervical cancer screening and HPV vaccination and attitudes towards their own health and health of their daughters.

Time frame
Baseline and after HPV vaccination of daughters is complete (assessed 2 weeks after second vaccine)
3

Barriers to participation

Both women who attend the MDP community meeting but decline to participate, and women in the village who were invited but did not attend the community meeting can be identified by the local counselor. The counselor will later contact these women for an interview to determine the reasons for declining participation. It is expected that 20 non-participants will be interviewed to identify barriers. Specific barriers mentioned by the women will then be grouped into several categories. Potential categories may be "lack of confidence in safety of the procedures" (self-collection swab or HPV vaccination of children), "other obligations competing for time", or "cultural-related inhibition". The frequency and percentage of each specific barrier mentioned by the women will be reported.

Time frame
During a one-time interview
4

Factors that influence immunity to the HPV vaccine

The HPV vaccine will be administered at community meetings to participating girls. Approximately 24 months after receiving the second vaccine dose, a subset of girls will undergo a blood sample and BMI measurement at another community meeting. The blood sample will be analyzed for plasma aflatoxin, for antibody titers to each of the nine HPV types in the vaccine, and for folate, iron, and hemoglobin (indicators of nutrition). The girls will also be interviewed with their mothers regarding specific dietary habits.

Time frame
24 months after second HPV vaccine

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov

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