Paper Applicator Acceptability Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by CONRAD
Sponsor:
Information provided by (Responsible Party):
CONRAD
ClinicalTrials.gov Identifier:
NCT02179138
First received: June 27, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

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 Intervention Phase
HIV Prevention
Drug: TFV 1% gel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: EVALUATION OF A USER-FILLED, PAPER APPLICATOR FOR DELIVERY OF TENOFOVIR 1% GEL AMONG WOMEN IN RURAL KWAZULU-NATAL, SOUTH AFRICA

Resource links provided by NLM:


Further study details as provided by CONRAD:

Primary Outcome Measures:
  • Overall acceptability [ Time Frame: over 3 months of use ] [ Designated as safety issue: No ]
    Overall acceptability of user-filled, paper applicator compared to prefilled, plastic applicator

  • context of use [ Time Frame: over three months ] [ Designated as safety issue: No ]
    Description of context of use of user-filled, paper applicator

  • challenges encountered [ Time Frame: over three months ] [ Designated as safety issue: No ]
    Challenges encountered during use of user-filled, paper applicator and recommendations to address challenges

  • Applicator Preference [ Time Frame: Over three months ] [ Designated as safety issue: No ]
    Applicator preferences between the user-filled, paper applicator and prefilled, plastic applicator


Estimated Enrollment: 100
Study Start Date: March 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TFV 1% Gel
TFV 1% gel with the user-filled paper applicator
Drug: TFV 1% gel

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02179138

Locations
South Africa
CAPRISA Vulindlela Clinical Research Site Not yet recruiting
Pietermaritzburg, KwaZulu-Natal,, South Africa
Contact: Sarah Dlamini, MBChB    27-33-260-6861    dlaminis10@ukzn.ac.za   
Sponsors and Collaborators
CONRAD
Investigators
Principal Investigator: Leila E Mansoor, Ph.D. Centre for the AIDS Programme of Research in South Africa
  More Information

No publications provided

Responsible Party: CONRAD
ClinicalTrials.gov Identifier: NCT02179138     History of Changes
Other Study ID Numbers: CAPRISA 070
Study First Received: June 27, 2014
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014