Paper Applicator Acceptability Study

HIV Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02179138
• Other study ID #: CAPRISA 070
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: June 27, 2014
• Last updated: April 9, 2015

Study information

• Verified date: April 2015
• Source: CONRAD
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Drug:
• TFV 1% gel

Locations

Country	Name	City	State
South Africa	CAPRISA Vulindlela Clinical Research Site	Pietermaritzburg	KwaZulu-Natal,

Sponsors (1)

Lead Sponsor	Collaborator
CONRAD

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall acceptability	Overall acceptability of user-filled, paper applicator compared to prefilled, plastic applicator	over 3 months of use	No
Primary	context of use	Description of context of use of user-filled, paper applicator	over three months	No
Primary	challenges encountered	Challenges encountered during use of user-filled, paper applicator and recommendations to address challenges	over three months	No
Primary	Applicator Preference	Applicator preferences between the user-filled, paper applicator and prefilled, plastic applicator	Over three months	No