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.
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
Allocation
NA
Masking
NONE
CAPRISA Vulindlela Clinical Research Site
Pietermaritzburg, KwaZulu-Natal, South Africa
Overall acceptability
Overall acceptability of user-filled, paper applicator compared to prefilled, plastic applicator
Time frame: over 3 months of use
context of use
Description of context of use of user-filled, paper applicator
Time frame: over three months
challenges encountered
Challenges encountered during use of user-filled, paper applicator and recommendations to address challenges
Time frame: over three months
Applicator Preference
Applicator preferences between the user-filled, paper applicator and prefilled, plastic applicator
Time frame: Over three months
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