Dataset Information

Acceptability and feasibility of repeated mucosal specimen collection in clinical trial participants in Kenya.

ABSTRACT: Mucosal specimens are essential to evaluate compartmentalized immune responses to HIV vaccine candidates and other mucosally targeted investigational products. We studied the acceptability and feasibility of repeated mucosal sampling in East African clinical trial participants at low risk of HIV and other sexually transmitted infections.The Kenya AIDS Vaccine Initiative (KAVI) enrolled participants into three Phase 1 trials of preventive HIV candidate vaccines in 2011-2012 at two clinical research centers in Nairobi. After informed consent to a mucosal sub-study, participants were asked to undergo collection of mucosal secretions (saliva, oral fluids, semen, cervico-vaginal and rectal), but could opt out of any collection at any visit. Specimens were collected at baseline and two additional time points. A tolerability questionnaire was administered at the final sub-study visit. Of 105 trial participants, 27 of 34 women (79%) and 62 of 71 men (87%) enrolled in the mucosal sub-study. Nearly all sub-study participants gave saliva and oral fluids at all visits. Semen was collected from about half the participating men (47-48%) at all visits. Cervico-vaginal secretions were collected by Softcup from about two thirds of women (63%) at baseline, increasing to 78% at the following visits, with similar numbers for cervical secretion collection by Merocel sponge; about half of women (52%) gave cervico-vaginal samples at all visits. Rectal secretions were collected with Merocel sponge from about a quarter of both men and women (24%) at all 3 visits, with 16% of men and 19% of women giving rectal samples at all visits.Repeated mucosal sampling in clinical trial participants in Kenya is feasible, with a good proportion of participants consenting to most sampling methods with the exception of rectal samples. Experienced staff members of both sexes and trained counselors with standardized messaging may improve acceptance of rectal sampling.

SUBMITTER: Omosa-Manyonyi G

PROVIDER: S-EPMC4215886 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Acceptability and feasibility of repeated mucosal specimen collection in clinical trial participants in Kenya.

Omosa-Manyonyi Gloria G Park Harriet H Mutua Gaudensia G Farah Bashir B Bergin Philip J PJ Laufer Dagna D Lehrman Jennifer J Chinyenze Kundai K Barin Burc B Fast Pat P Gilmour Jill J Anzala Omu O

PloS one 20141031 10

<h4>Background</h4>Mucosal specimens are essential to evaluate compartmentalized immune responses to HIV vaccine candidates and other mucosally targeted investigational products. We studied the acceptability and feasibility of repeated mucosal sampling in East African clinical trial participants at low risk of HIV and other sexually transmitted infections.<h4>Methods and findings</h4>The Kenya AIDS Vaccine Initiative (KAVI) enrolled participants into three Phase 1 trials of preventive HIV candid ...[more]

PMID: 25360819

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Project description:Informed consent (IC) has been an international standard for decades for the ethical conduct of clinical trials. Yet frequently study participants have incomplete understanding of key issues, a problem exacerbated by language barriers or lack of familiarity with research concepts. Few investigators measure participant comprehension of IC, while even fewer conduct interim assessments once a trial is underway.We assessed comprehension of IC using a 20-question true/false quiz administered in 6-month intervals in the context of a placebo-controlled, randomized trial for the prevention of tuberculosis among HIV-infected adults in Botswana (2004-2009). Quizzes were offered in both Setswana and English. To enroll in the TB trial, participants were required to have ? 16/20 correct responses. We examined concepts understood and the degree to which understanding changed over three-years. We analyzed 5,555 quizzes from 1,835 participants. The participants' highest education levels were: 28% primary, 59% secondary, 9% tertiary and 7% no formal education. Eighty percent of participants passed the enrollment quiz (Quiz1) on their first attempt and the remainder passed on their second attempt. Those having higher than primary education and those who took the quiz in English were more likely to receive a passing score on their first attempt (adjusted odds ratios and 95% confidence intervals, 3.1 (2.4-4.0) and 1.5 (1.2, 1.9), respectively). The trial's purpose or procedures were understood by 90-100% of participants, while 44-77% understood randomization, placebos, or risks. Participants who failed Quiz1 on their initial attempt were more likely to fail quizzes later in the trial. Pass rates improved with quiz re-administration in subsequent years.Administration of a comprehension quiz at enrollment and during follow-up was feasible in a large, international collaboration and efficiently determined IC comprehension by trial participants. Strategies to improve understanding of concepts like placebos and randomization are needed. Comprehension assessments throughout a study may reinforce key concepts.

Project description:PurposeAdjunct cervical cancer screening methods are under evaluation to improve the diagnostic accuracy of human papillomavirus (HPV)-based screening in low- and middle-income countries. We evaluated the feasibility and acceptability of smartphone-based cervicography among HPV-positive women living with HIV (WLWH) in Western Kenya.MethodsHPV-positive WLWH of 25-49 years of age enrolled in a clinical trial (ClinicalTrials.gov identifier: NCT04191967) had digital images of the cervix taken using a smartphone by a nonphysician provider following visual inspection with acetic acid. All participants had colposcopy-directed biopsy before treatment. Cervical images were evaluated by three off-site colposcopists for quality, diagnostic utility, and assigned a presumed diagnosis. We determined the proportion of images rates as low, medium, or high quality, interobserver agreement using Cohen's Kappa statistic, and the off-site colposcopist's sensitivity and specificity for diagnosis of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) compared with histopathology. Acceptability was evaluated using a questionnaire.ResultsOne hundred sixty-four HPV-positive WLWH underwent cervicography during the study period. Mean age was 37.3 years. Images from the first 94 participants were evaluated by off-site colposcopists, with a majority (70.9%) rated as high quality. Off-site colposcopists had a sensitivity ranging from 21.4% (95% CI, 0.06 to 0.43) to 35.7% (95% CI, 0.26 to 0.46) and a specificity between 85.5% (95% CI, 0.81 to 0.90) to 94.9% (95% CI, 0.92 to 0.98) for diagnosis of CIN2+ based compared with histopathology. The majority of women, 99.4%, were comfortable having an image of their cervix taken as part of screening.ConclusionCervicography by a nonphysician provider as an adjunct to HPV-based screening among WLWH in a low- and middle-income country setting is feasible and acceptable. However, low sensitivity for diagnosis of CIN2+ by off-site expert colposcopists highlights the limitations of cervicography.

Project description:Early childhood is a critical phase of development. In low resource settings, monitoring this stage of development and providing appropriate and timely feedback is a challenge. Community-based service providers play a key role in promoting early childhood development in areas where government services are weak. These community-based service providers are also tasked with the collection of monitoring and evaluation data for donors and local government. Usually, collection of these data aims to provide accountability, learning, and correction leading to improvement. However, such data is rarely used beyond the accountability stage.The purpose of this study was to test the feasibility and acceptability of the Information for Action (IFA) mobile phone app. The IFA app was designed for use by community health volunteers (CHVs), and repackages routinely collected data about children into useful, offline decision support for caregivers and program managers.The IFA app was tested with a convenience sample of 10 CHVs in West Katweng'a, a sublocation of Rarieda subcounty in western Kenya. CHVs used the IFA app for 5 months as part of their regular home visits to households containing children aged 0 to 5 years, after which a qualitative assessment of the app was conducted. A total of 16 caregivers who received services from the CHVs were randomly selected to participate in 1 of 2 focus group discussions about their experience.The app was reported to help facilitate interactive dialog between CHVs and caregivers, leading to improved quality of home visits. Caregivers described the app as shifting the relationship from feeling harassed by CHVs to experiencing genuine interest from CHVs. CHVs reported feasibility challenges primarily related to infrastructure. The limited battery life of mobile phones combined with the lack of readily available electricity made it difficult to keep the phones charged. CHVs reported initial anxiety as first-time mobile phones users, including concerns about using the IFA app. With time, increased levels of confidence were seen.Acceptability was high with both CHVs and caregivers, who reported an improvement in their client-provider relationship. A number of feasibility challenges were experienced.

Dataset Information

Acceptability and feasibility of repeated mucosal specimen collection in clinical trial participants in Kenya.

Publications

Acceptability and feasibility of repeated mucosal specimen collection in clinical trial participants in Kenya.

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