POPULATION COUNCIL CLINICAL STUDIES
Protocol 342

Name of study: Analytical method for determining applicator usage

Type of study: Microbicide product development

Study phase: Phase 1/2

Study design: Each subject was asked to do the following:

1. Squeeze out the contents of two applicators and give the applicators to the nurse or physician. These were considered control applicators, and underwent the same analysis as the used (vaginally inserted) applicators. The nurse or physician observed the subject during this process to ensure that she expelled the contents of both applicators. The nurse or physician then placed one applicator in an individual plastic bag and the other in a bag containing three emptied unused applicators provided by the Population Council.

2. Squeeze out the contents of one applicator containing methyl cellulose placebo, vaginally insert it, as if to apply the study gel, then remove the applicator. The subject then gave the applicator to the nurse or physician. The nurse or physician observed the subject to confirm that she inserted the applicator. The nurse or physician placed the applicator into an individual plastic bag, or into a plastic bag with three emptied unused applicators (depending on the randomization scheme), provided by the Council, for storage.

3. Vaginally insert one applicator containing methyl cellulose placebo and squeeze the contents into the vagina. The subject then removed the applicator and gave the applicator to the nurse or physician. As before, the nurse or physician observed the subject to confirm that she inserted the applicator. The nurse or physician placed the applicator into a plastic bag, or into a plastic bag with three empty unused applicators (depending on the randomization scheme) for storage.

Purpose of the study: To determine which women in a microbicide study use the study gel. This assay is an important tool in determining whether an individual or population is using the study gel and, therefore, is suitable for participation in an effectiveness trial. In addition, the method is an important tool to ascertain the impact of social intervention techniques on study gel use.

Products to be investigated or studied (including trade and generic names):
No product

Study start date: May 2003

Study end date: Closed out; final status report pending

Study sites and associated numbers of subjects at each site:

New York (30 subjects)

South Africa (30 subjects)

Criteria for inclusion in study (if applicable): Women in good general health; normal Pap test within the past 12 months; able to give informed consent; able to return to the clinic for follow-up visits; unlikely to become pregnant based on one of the following: subject has undergone sterilization, subject is monogamous and her male partner has undergone sterilization, subject abstains from sex with men, subject uses an acceptable method of contraception (e.g., one of the following: oral contraceptives, diaphragm, condoms, intrauterine device, or injectable contraceptive); willing to abstain from vaginal intercourse for 72 hours prior to participation and 48 hours following participation in the evaluation.

Note: All clinical studies have appropriate approval from the Institutional Review Boards in the countries in which they are being conducted.