Paper Applicator Acceptability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02179138
Recruitment Status : Withdrawn (Study no longer relevant based on change in regulatory pathway for TFV 1% gel)
First Posted : July 1, 2014
Last Update Posted : April 10, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Prevention Drug: TFV 1% gel Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Actual Primary Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
TFV 1% Gel
TFV 1% gel with the user-filled paper applicator
Drug: TFV 1% gel

Primary Outcome Measures :
  1. Overall acceptability [ Time Frame: over 3 months of use ]
    Overall acceptability of user-filled, paper applicator compared to prefilled, plastic applicator

  2. context of use [ Time Frame: over three months ]
    Description of context of use of user-filled, paper applicator

  3. challenges encountered [ Time Frame: over three months ]
    Challenges encountered during use of user-filled, paper applicator and recommendations to address challenges

  4. Applicator Preference [ Time Frame: Over three months ]
    Applicator preferences between the user-filled, paper applicator and prefilled, plastic applicator

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02179138

South Africa
CAPRISA Vulindlela Clinical Research Site
Pietermaritzburg, KwaZulu-Natal,, South Africa
Sponsors and Collaborators
Principal Investigator: Leila E Mansoor, Ph.D. Centre for the AIDS Programme of Research in South Africa

Responsible Party: CONRAD Identifier: NCT02179138     History of Changes
Other Study ID Numbers: CAPRISA 070
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015