Paper Applicator Acceptability Study

April 9, 2015 updated by: CONRAD

EVALUATION OF A USER-FILLED, PAPER APPLICATOR FOR DELIVERY OF TENOFOVIR 1% GEL AMONG WOMEN IN RURAL KWAZULU-NATAL, SOUTH AFRICA

To assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir (TFV) gel among women at high risk of acquiring human immunodeficiency virus (HIV) in rural KwaZulu-Natal, South Africa.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

CAPRISA 070 is designed to enroll rural women who exit from CAPRISA 008 - an ongoing trial assessing implementation, effectiveness and safety of TFV gel in KwaZulu-Natal, South Africa. All study participants in CAPRISA 008 have also participated in CAPRISA 004 and thus have several years of experience using TFV gel with the prefilled, plastic applicator. CAPRISA 070 will allow us to assess acceptability of the user-filled, paper applicator among women who have had extensive experience with the pre-filled, plastic applicator and are well-positioned to provide feedback and comparisons on a new gel delivery method.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • KwaZulu-Natal,
      • Pietermaritzburg, KwaZulu-Natal,, South Africa
        • CAPRISA Vulindlela Clinical Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18 years and older
  • Women who previously participated in CAPRISA 008
  • Able and willing to provide first person informed consent to be screened for, and to enroll in, the study
  • Allow access to their CAPRISA 008 data, including study exit data
  • Able and willing to provide adequate locator information for study retention purposes
  • Sexually active (at least one coital act in the last 3 months prior to screening)
  • HIV negative
  • Negative pregnancy test *
  • Agree to use a non-barrier form of contraceptive

  • Agree to adhere to study visits and procedures

    • breastfeeding is not exclusionary but participants must be informed of the presence of TFV in breast milk in negligible amounts

Exclusion Criteria:

  • Has creatinine clearance ,<50ml/min, as estimated using the method of Cockcroft and Gault
  • Has any other condition, that based on the opinion of the investigator or designee would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of the study outcome data, or otherwise interfere with achieving the study objectives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: TFV 1% Gel
TFV 1% gel with the user-filled paper applicator
Drug: TFV 1% gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall acceptability
Time Frame: over 3 months of use
Overall acceptability of user-filled, paper applicator compared to prefilled, plastic applicator
over 3 months of use
context of use
Time Frame: over three months
Description of context of use of user-filled, paper applicator
over three months
challenges encountered
Time Frame: over three months
Challenges encountered during use of user-filled, paper applicator and recommendations to address challenges
over three months
Applicator Preference
Time Frame: Over three months
Applicator preferences between the user-filled, paper applicator and prefilled, plastic applicator
Over three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CONRAD

Investigators

  • Principal Investigator: Leila E Mansoor, Ph.D., Centre for the AIDS Programme of Research in South Africa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 27, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • CAPRISA 070

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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