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

PLoS One. 2014 Oct 31;9(10):e110228. doi: 10.1371/journal.pone.0110228. eCollection 2014.


Background: 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.

Methods and findings: 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.

Conclusions: 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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • AIDS Vaccines / immunology
  • Adolescent
  • Adult
  • Clinical Trials, Phase I as Topic*
  • Feasibility Studies
  • Female
  • HIV-1 / immunology
  • Humans
  • Kenya
  • Male
  • Mucous Membrane / immunology
  • Mucous Membrane / virology
  • Patient Acceptance of Health Care / psychology
  • Patient Acceptance of Health Care / statistics & numerical data*
  • Species Specificity
  • Specimen Handling / methods*
  • Specimen Handling / psychology
  • Young Adult


  • AIDS Vaccines

Grants and funding

IAVI's work is made possible by generous support from many donors including: the Bill & Melinda Gates Foundation; the Ministry of Foreign Affairs of Denmark; Irish Aid; the Ministry of Finance of Japan; the Ministry of Foreign Affairs of the Netherlands; the Norwegian Agency for Development Cooperation (NORAD); the United Kingdom Department for International Development (DFID), and the United States Agency for International Development (USAID). The full list of IAVI donors is available at This study was made possible by the generous support of the American people through USAID. The contents are the responsibility of the International AIDS Vaccine Initiative and do not necessarily reflect the views of USAID or the United States Government. Funding was also provided by the OPEC Fund for International Development (OFID), a development finance institution of the OPEC Member States, established to provide financial support for socio-economic development, particularly for low-income countries. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Co-author Burc Barin is employed by The EMMES Corporation. EMMES provided support in the form of salary for author BB and other EMMES employees involved in the study design, data collection and analysis, and preparation of the manuscript. The specific role of the author BB is articulated in the ‘author contributions’ section. The EMMES Corporation otherwise did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.