Paper Applicator Acceptability Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Prevention

Intervention / Treatment
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* Drug: TFV 1% gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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