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Acceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, 'Praneem polyherbal tablet', in Pune, India.
Trans R Soc Trop Med Hyg. 2010 Jun; 104(6):412-5.TR

Abstract

Acceptability and adherence in clinical trials of microbicides may possibly predict their acceptance by the community. In this study, we investigated the acceptability and adherence of Praneem polyherbal tablet, a candidate microbicide, among 100 HIV-uninfected participants of a Phase II randomised, double-blind, placebo-controlled trial in Pune, India, conducted between June 2004 and February 2006 involving 6 months of coitally-dependent product use. The relationship between five acceptability domains and adherence to product use during the study period was explored. Acceptability and adherence were assessed among 95 study participants completing all study follow-ups. One hundred percent adherence (product use during each sex act for the study period) was reported by 67 participants (70.5%). The majority of participants reported acceptability towards all product characteristics. Product odour was reported to be a concern both in the placebo and Praneem arms. Participants from the Praneem arm [adjusted odds ratio (AOR)=3.8; 95% CI 1.4-10.8] and participants reporting lower acceptability for experience of product use during the sex act (AOR=4.2; 95% CI 1.0-17.3) were more likely to have partial adherence. In conclusion, the study product was acceptable to the majority of participants. However, barriers to adherence attributable to undesirable sexual experiences need to be addressed.

Authors+Show Affiliations

National AIDS Research Institute, G73, MIDC, Bhosari, Pune 411026, India. joglekarneelam@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20096909

Citation

Joglekar, N S., et al. "Acceptability and Adherence: Findings From a Phase II Study of a Candidate Vaginal Microbicide, 'Praneem Polyherbal Tablet', in Pune, India." Transactions of the Royal Society of Tropical Medicine and Hygiene, vol. 104, no. 6, 2010, pp. 412-5.
Joglekar NS, Joshi SN, Deshpande SS, et al. Acceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, 'Praneem polyherbal tablet', in Pune, India. Trans R Soc Trop Med Hyg. 2010;104(6):412-5.
Joglekar, N. S., Joshi, S. N., Deshpande, S. S., Parkhe, A. N., Katti, U. R., & Mehendale, S. M. (2010). Acceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, 'Praneem polyherbal tablet', in Pune, India. Transactions of the Royal Society of Tropical Medicine and Hygiene, 104(6), 412-5. https://doi.org/10.1016/j.trstmh.2009.12.007
Joglekar NS, et al. Acceptability and Adherence: Findings From a Phase II Study of a Candidate Vaginal Microbicide, 'Praneem Polyherbal Tablet', in Pune, India. Trans R Soc Trop Med Hyg. 2010;104(6):412-5. PubMed PMID: 20096909.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Acceptability and adherence: findings from a Phase II study of a candidate vaginal microbicide, 'Praneem polyherbal tablet', in Pune, India. AU - Joglekar,N S, AU - Joshi,S N, AU - Deshpande,S S, AU - Parkhe,A N, AU - Katti,U R, AU - Mehendale,S M, Y1 - 2010/01/22/ PY - 2009/06/12/received PY - 2009/12/15/revised PY - 2009/12/15/accepted PY - 2010/1/26/entrez PY - 2010/1/26/pubmed PY - 2010/9/18/medline SP - 412 EP - 5 JF - Transactions of the Royal Society of Tropical Medicine and Hygiene JO - Trans R Soc Trop Med Hyg VL - 104 IS - 6 N2 - Acceptability and adherence in clinical trials of microbicides may possibly predict their acceptance by the community. In this study, we investigated the acceptability and adherence of Praneem polyherbal tablet, a candidate microbicide, among 100 HIV-uninfected participants of a Phase II randomised, double-blind, placebo-controlled trial in Pune, India, conducted between June 2004 and February 2006 involving 6 months of coitally-dependent product use. The relationship between five acceptability domains and adherence to product use during the study period was explored. Acceptability and adherence were assessed among 95 study participants completing all study follow-ups. One hundred percent adherence (product use during each sex act for the study period) was reported by 67 participants (70.5%). The majority of participants reported acceptability towards all product characteristics. Product odour was reported to be a concern both in the placebo and Praneem arms. Participants from the Praneem arm [adjusted odds ratio (AOR)=3.8; 95% CI 1.4-10.8] and participants reporting lower acceptability for experience of product use during the sex act (AOR=4.2; 95% CI 1.0-17.3) were more likely to have partial adherence. In conclusion, the study product was acceptable to the majority of participants. However, barriers to adherence attributable to undesirable sexual experiences need to be addressed. SN - 1878-3503 UR - https://www.unboundmedicine.com/medline/citation/20096909/Acceptability_and_adherence:_findings_from_a_Phase_II_study_of_a_candidate_vaginal_microbicide_'Praneem_polyherbal_tablet'_in_Pune_India_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0035-9203(09)00400-3 DB - PRIME DP - Unbound Medicine ER -