Acceptability of the live biotherapeutic LACTIN-V (Lactobacillus crispatus CTV-05) among young women at high risk of HIV acquisition in South Africa: data from the Phase 2 placebo-controlled trial

Anke Hemmerling ^1* Vaneshree Govender ² Krista Dong ^3,4,5,6 Mary Dong ^3,4 Susheela Vanessa Pillay ³ Thumbi Ndung'u ^4,7,8,9 Aruna Bhoola ² Jayajothi Moodley ² Gardenia Casillas ¹ Laurel Lagenaur ¹⁰ Caroline Mitchell ^5,6 Douglas S. Kwon ^4,5,6 Craig Randall Cohen ¹

• ¹ University of California, San Francisco, San Francisco, United States
• ² The Aurum Institute, Johannesburg, South Africa
• ³ Females Rising Through Education, Support and Health, Ragon Institute, Cambridge, Massachusetts, United States
• ⁴ Ragon Institute, Cambridge, Massachusetts, United States
• ⁵ Harvard Medical School, Boston, Massachusetts, United States
• ⁶ Massachusetts General Hospital, Boston, Massachusetts, United States
• ⁷ HIV Pathogenesis Programme, University of KwaZulu-Natal, Durban, South Africa
• ⁸ Africa Health Research Institute (AHRI), Durban, South Africa
• ⁹ Division of Infection and Immunity, Faculty of Medical Sciences, University College London, London, England, United Kingdom
• ¹⁰ Osel (United States), Mountain View, California, United States

Introduction: Live biotherapeutic products (LBPs) containing Lactobacillus crispatus may optimize the vaginal microbiota, reduce genital inflammation, and protect against HIV acquisition. Determining acceptability of LBPs among African women at high risk of HIV is essential to guide product development. Methods: The phase 2 double-blind randomized placebo-controlled trial recruited young sexually active cis-women with vaginal dysbiosis from a community-based research clinic. Following antibiotics (oral metronidazole), participants were randomized (2:1) to receive 11 doses of LACTIN-V (2x10 9 L. crispatus CTV-05) or placebo over 4 weeks. A questionnaire assessed product acceptability. Results: Forty-five young Black South African women were randomized to LACTIN-V (N=32) or placebo (N=13). Forty-two (93.3%) had an active sexual partner. Adherence was high with 36 participants (80.0%) completing all 11 doses. Of the 43 participants who completed the acceptability questionnaire, 38 (88.4%) were satisfied using the vaginal applicator and 41 (95.5%) confirmed ease of use. For 14 (32.5%) participants, product use without the partner knowing was important. Thirty-one (72.1%) participants felt that partner approval for product use was not important. On Likert scales of 0-10 (lowest to highest), agreement with positive product attributes (effective, comfortable, easy to use) scored at means of ≥ 6.7. Negative product attributes (dosing, leakage, vaginal dryness, partner's disapproval) were rated less important with lower mean scores ≤ 3.2. Overall, 75% of participants would use the product again, with no significant difference between study arms. Conclusions: Young South African women at high risk of HIV found the LACTIN-V study product highly acceptable and easy to use.