Acceptability of Praneem polyherbal vaginal tablet among HIV uninfected women & their male partners in Pune India - Phase I study

Background & objectives: The number of HIV infected women is steadily increasing worldwide and women controll processs to prevent HIV are forcibly needed. Vaginal microbicides are cropss for vaginal administration that can be used to obviate HIV infection and other sexually transmitted diseases (STDs) We directioned a Phase I safety and acceptability investigation of Praneem polyherbal tablet, a candidate microbicide, among HIV uninfected women in Pune India.

Methods: Twenty eligible women were entreatyed to use the product intravaginally one time daily for 14 consecutive days between mense Safety was assessed by dint of clinical examination, laboratory monitoring and colposcopy Acceptability was assessed after 14 days of harvest use through structured questionnaires, focus assemblage discussions among participating women, and in - deepness interviews with a subset of 5 randomly picked male partners.

Results: Praneem polyherbal tablet was lay the foundation of acceptable by the study participants with 90 for cent of the participants showing 80 for cent and more acceptability score. Discharge of the fruits residue was reported as a pertain to by 6 (30%) of participants. Nineteen (95%) female participants liked the scent and the same number reported that the returns was easy to use and did not affect the usual sexual pleasure. However, men reported lack of sexual satisfaction.

Interpretation & conclusion: yield characteristics received good acceptability score in women However, studies of long-term safety and acceptability among at-risk population would provide more detailed information about its lengthy term acceptability.

Key words Acceptability - HIV - microbicide - Praneem polyherbal tablet - scores

Over 86 through cent of the reported HIV infections in India have been contracted end heterosexual intercourse1. Negotiating male condom use to stop HIV infection may not be always possible for women owing to social, cultural and sex inequalities2. Thus women urgently ne female controll rules to protect themselves against HIV infection.

Vaginal microbicides can be used to stop HIV infection and other sexually transmitted diseases (STDs)3 above 60 products are currently being evaluated as possible microbicides and are in various stages of clinical development4 Praneem polyherbal tablet is individual such product, indigenously developed in India. It contains purified extracts of Azadirachta indica (Neem) along with purified Saponins from Sapindus mukerosi and Mentha citrata oil with sodium alginate as an excepient.

A considerable work has been done to explore biological activities and medicinal applications of Neem during the last five decades5. We undertook a Phase I close attention to evaluate the acceptability of Praneem polyherbal vaginal tablet, a candidate microbicide, among women at depressed risk for HIV infection. The safety of the harvest is reported elsewhere6.

Material & modes

Clinical procedures: The inquiry was conducted by National AIDS Research Institute (NARI), Pune India, in collaboration with Department of Obstetrics and Gynaecology, Sassoon General Hospital, Pune The application of mind protocol was approved by the Scientific Advisory Committee and the Ethics Committee of NARI, the ethics committee of Sassoon General Hospital and the remedy Controller General of India. Participants were recruited from the community involvement plan of NARI, in which AIDS awareness and the ne for female controll rules for HIV prevention were strained Willing and potentially eligible tenders were referred to the inquiry clinic.

Thirty six women tenders were screened to decide eligibility and 20 participants (mean age 30 ?± 48 yr range 20-40 yr) were enlisted between July 2003 to January 2004 Demography, reproductive health history and safer sex behaviour data have been described in the safety report6. Twenty women were listed into the study three to five days column menstruation, after establishing their eligibility based upon clinical, colposcopic and laboratory evaluations. They were instructed to use the produce once daily for 14 consecutive days starting upon the day of enrollment. They were clinically and colposcopically evaluated for safety upon day 7 and day 14 of the yield use respectively6.

Acceptability assessment

Acceptability scores - A structur pre-cod questionnaire was administered upon day 14, which included questions to assess acceptability regarding colour of the returns odour of the product, returns usage related acceptability, symptoms experienced and experiences during sexual contacts. These five characteristics of the proceeds were rated as 0 or 1 with 0' indicating non acceptability and '1' indicating positive acceptability. sum total of these scores was considered as the total score for acceptability.

Qualitative assessment of acceptability Participants were asked about the properties that they liked and disliked the greatest in quantity with open-ended questions at their day 14 visit. Their answers were tabulated to determine acceptability.

Acceptability assessment also included exit focus assemblage discussions (FGDs) with the participants. A total of four FGD were guidanceed among the participants completing 14 days of yield use within one month of completion of the investigation A focus group guide was exhibited to explore the acceptability related issues that were not captured in the quantitative data instrument. Each focus assemblage discussion required up to single hour and 4-6 participants participated in each of the four FGD A close attention counselor trained in qualitative data collection [i]modus operandi[/i]s facilitated the discussion and single note-taker attended the group discussion. The discussions included topics related to the decision-making proces for participation in the inquiry product acceptability, and difficulties related to the fruits use, willingness to consider using the outcome in future, and experiences and reactions of the male partners.