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

Omosa-Manyonyi G, Park H, Mutua G, Farah B, Bergin PJ, Laufer D, Lehrman J, Chinyenze K, Barin B, Fast P, Gilmour J, Anzala O - PLoS ONE (2014)

Bottom Line: Mucosal specimens are essential to evaluate compartmentalized immune responses to HIV vaccine candidates and other mucosally targeted investigational products.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.

View Article: PubMed Central - PubMed

Affiliation: Kenya AIDS Vaccine Initiative Institute of Clinical Research, University of Nairobi, Nairobi, Kenya.

ABSTRACT

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.

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Total number of participants undergoing mucosal collection by gender.A. Total number of female participants in the three trials combined and the number providing each type of specimen at the three time points. B. Total combined number of male participants and the number providing specimens at each time point.
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pone-0110228-g001: Total number of participants undergoing mucosal collection by gender.A. Total number of female participants in the three trials combined and the number providing each type of specimen at the three time points. B. Total combined number of male participants and the number providing specimens at each time point.

Mentions: Saliva and oral fluids, the least invasive samples, were collected from all participants in the mucosal sub-study at nearly all visits, while rectal sample collection was the least likely to be accepted (Figure 1). Based on overall acceptance and corresponding 95% confidence intervals, female participants agreed to both types of cervico-vaginal sampling more readily than rectal sampling (Table 2). Similarly, male participants were more likely to provide semen than rectal samples.


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

Omosa-Manyonyi G, Park H, Mutua G, Farah B, Bergin PJ, Laufer D, Lehrman J, Chinyenze K, Barin B, Fast P, Gilmour J, Anzala O - PLoS ONE (2014)

Total number of participants undergoing mucosal collection by gender.A. Total number of female participants in the three trials combined and the number providing each type of specimen at the three time points. B. Total combined number of male participants and the number providing specimens at each time point.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4215886&req=5

pone-0110228-g001: Total number of participants undergoing mucosal collection by gender.A. Total number of female participants in the three trials combined and the number providing each type of specimen at the three time points. B. Total combined number of male participants and the number providing specimens at each time point.
Mentions: Saliva and oral fluids, the least invasive samples, were collected from all participants in the mucosal sub-study at nearly all visits, while rectal sample collection was the least likely to be accepted (Figure 1). Based on overall acceptance and corresponding 95% confidence intervals, female participants agreed to both types of cervico-vaginal sampling more readily than rectal sampling (Table 2). Similarly, male participants were more likely to provide semen than rectal samples.

Bottom Line: Mucosal specimens are essential to evaluate compartmentalized immune responses to HIV vaccine candidates and other mucosally targeted investigational products.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.

View Article: PubMed Central - PubMed

Affiliation: Kenya AIDS Vaccine Initiative Institute of Clinical Research, University of Nairobi, Nairobi, Kenya.

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus